Asacol is used to treat and prevent an inflammatory bowel disease called ulcerative colitis. It works inside the intestines (bowel) to reduce the inflammation and other symptoms of the disease.
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Asacol is used to treat and prevent an inflammatory bowel disease called ulcerative colitis. It works inside the intestines (bowel) to reduce the inflammation and other symptoms of the disease.
Active Ingredient: Mesalamine
Asacol (Claversal) as known as: Apriso, Asacolon, Asalazin medichrom, Asalex, Asalit, Asamax, Asavixin, Asazine, Bufexan, Canasa, Claversal, Colitan, Colitofalk, Crohnax, Crohnezine, Ectospasmol, Enteraproct, Enterasin, Etiasa, Favorat, Fivasa, Ipocol, Jucolon, Laboxantryl, Lextrasa, Lialda, Lixacol, Mesacol, Mesaflor, Mesagin, Mesagran, Mesalamina, Mesalazine, Mesalazinum, Mesasal, Mesatec, Mesazin, Mesren, Mezavant, Pentacol, Pentasa, Proctasacol, Prozylex, Rafassal, Rowasa, Salofalk, Samezil, Sfrowasa, Tidocol, Xalazin, Xalazina, Yolecol
An anti-inflammatory agent, structurally related to the salicylates, which is active in inflammatory bowel disease. It is considered to be the active moiety of sulphasalazine. (From Martindale, The Extra Pharmacopoeia, 30th ed)Pharmacology of Claversal
Claversal (INN, BAN), also known as Mesalamine (USAN) or 5-aminosalicylic acid (5-ASA), is an anti-inflammatory drug used to treat inflammation of the digestive tract (Crohn's disease) and mild to moderate ulcerative colitis. Claversal is a bowel-specific aminosalicylate drug that is metabolized in the gut and has its predominant actions there, thereby having fewer systemic side effects. As a derivative of salicylic acid, 5-ASA is also an antioxidant that traps free radicals, which are potentially damaging by-products of metabolism.Claversal for patients
CANASA® Rectal Suppositories (Mesalamine, USP) 500 and 1000 mg
Read this information carefully before you begin treatment. Also, read the information you get whenever you get more medicine. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment. If you have any questions about this medicine, ask your doctor or pharmacist.
What is CANASA®?
CANASA® (can-AH-sah) is a medicine used to treat ulcerative proctitis (ulcerative rectal colitis). CANASA® works inside your rectum (lower intesti ne) to help reduce bleeding, mucous and bloody diarrhea caused by inflammation (swelling and soreness) of the rectal area. You use CANASA® by inserting it into your rectum.
Who should not use CANASA®?
Do not use CANASA® if you are allergic to the active ingredient mesalamine (also found in drugs such as Rowasa, Asacol, Pentasa, Azulfidine, and Dipentum), if you are allergic to the inactive ingredients, or if you have had any unusual reaction to the ingredients.
Tell your doctor if you:
How should I use CANASA®?
Follow your doctor's instructions about how often to use CANASA® and how long to use it. For the 500 mg suppository, the usual dose is one suppository 2 times a day for 3-6 weeks. For the 1000 mg suppository, the usual dose is one suppository at bedtime for 3-6 weeks. We do not know if CANASA® will work for children or is safe for them.
Follow these steps to use CANASA®:
1. For best results, empty your rectum (have a bowel movement) just before using CANASA®.
2. Detach one CANASA® suppository from the strip of suppositories. 3. Hold the suppository upright and carefully peel open the plastic at the pre-cut line to take out the suppository.
4. Insert the suppository with the pointed end first completely into your rectum, using gentle pressure.
5. For best results, keep the suppository in your rectum for 3 hours or longer, if possible.
If you have trouble inserting CANASA®, you may put a little bit of lubricating gel on the suppository.
Do not handle the suppository too much, since it may begin to melt from the heat from your hands and body.
If you miss a dose of CANASA®, use it as soon as possible, unless it is almost time for next dose. Do not use two CANASA®suppositories at the same time to make up for a missed dose.
Keep using CANASA® as long as your doctor tells you to use it, even if you feel better.
CANASA® can cause stains on things it touches. Therefore keep it away from clothing and other fabrics, flooring, painted surfaces, marble, granite, plastics, and enamel. Be careful since CANASA® may stain clothing.
What should I avoid while taking CANASA®?
Do not breast feed while using CANASA®. We do not know if CANASA® can pass through the milk and harm the baby. Tell your doctor if you become pregnant while using CANASA®.
What are the possible side effects of CANASA®?
If you notice any other side effects, check with your doctor or pharmacist.
How should I store CANASA®?
Store CANASA® below 25 °C (77 °F), do not freeze it. Keep it away from direct heat, light, or humidity. Keep it out of the reach of children.
General advice about prescription medicines
Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use CANASA® for a condition for which it was not prescribed. Do not give CANASA® to other people, even if they have the same symptoms you have.
This leaflet summarizes the most important information about CANASA®. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about CANASA® that is written for health professionals.Claversal Interactions
No information provided.Claversal Contraindications
CANASA® 500 mg and 1000 mg Suppositories are contraindicated in patients who have demonstrated hypersensitivity to mesalamine (5-aminosalicylic acid) or to the suppository vehicle [saturated vegetable fatty acid esters (Hard Fat, NF)], or to salicylates (including aspirin).Additional information about Claversal
Claversal Indication: For the treatment of active ulcerative proctitis.
Mechanism Of Action: Although the mechanism of action of mesalazine is not fully understood, it appears to be topical rather than systemic. Mucosal production of arachidonic acid metabolites, both through the cyclooxygenase pathways, i.e. prostanoids, and through the lipoxygenase pathways, i.e. leukotrienes and hydroxyeicosatetraenoic acids, is increased in patients with chronic inflammatory bowel disease, and it is possible that mesalamine diminishes inflammation by blocking cyclooxygenase and inhibiting prostaglandin production in the colon.
Drug Interactions: Azathioprine The 5-ASA derivative increases the toxicity of thiopurine
Mercaptopurine The 5-ASA derivative increases the toxicity of thiopurine
Thioguanine The 5-ASA derivative increases the toxicity of thiopurine
Food Interactions: Not Available
Generic Name: Mesalazine
Synonyms: 5-aminosalicylate; 5-aminosalicylic acid; 5-ASA; Mesalamine
Drug Category: Anti-Inflammatory Agents, Non-Steroidal
Drug Type: Small Molecule; Approved
Other Brand Names containing Mesalazine: Asacol; Asacolitin; Canasa; Claversal; Fisalamine; Lixacol; Mesasal; Pentasa; Rowasa; Salofalk;
Absorption: 20 to 30% absorbed following oral administration. 10 to 35% absorbed from the colon (rectal suppository) - extent of absorption is determined by the length of time the drug is retained in the colon.
Toxicity (Overdose): Oral, mouse: LD50 = 3370 mg/kg; Oral, rat: LD50 = 2800 mg/kg; Skin, rabbit: LD50 = >5 gm/kg. There have been no documented reports of serious toxicity in man resulting from massive overdosing with mesalamine. Under ordinary circumstances, mesalamine absorption from the colon is limited.
Protein Binding: About 80% of N-Ac-5-ASA is bound to plasma proteins, whereas 40% of mesalamine is protein bound.
Biotransformation: Rapidly and extensively metabolized, mainly to N-acetyl-5-ASA (Ac-5-ASA) in the intestinal mucosal wall and the liver. Ac-5-ASA is further acetylated (deactivated) in at least 2 sites, the colonic epithelium and the liver.
Half Life: The mean elimination half-life was 5 hours for 5-ASA and six hours for N-acetyl-5-ASA following the initial dose. At steady state, the mean elimination half-life was seven hours for both 5-ASA and N-acetyl-5-ASA.
Dosage Forms of Claversal: Suspension Rectal
Tablet, extended release Oral
Tablet, delayed release Oral
Tablet, coated Oral
Chemical IUPAC Name: 5-amino-2-hydroxybenzoic acid
Chemical Formula: C7H7NO3
Mesalazine on Wikipedia: http://en.wikipedia.org/wiki/Mesalazine
Organisms Affected: Humans and other mammals
Author(s): Rutgeerts P
Affiliation(s): Department of Medicine, University Hospital, Leuven, Belgium.
Publication date & source: 1989-04, Aliment Pharmacol Ther. 3(2):183-91.
Publication type: Clinical Trial; Randomized Controlled Trial
The safety and efficacy of Claversal (coated, oral 5-aminosalicylic acid (5-ASA) 0.75 g/day) and sulphasalazine 1.5-2.0 g/day were compared for the maintenance treatment of ulcerative colitis in a 1-year double-blind trial. Three hundred and thirty-four patients, whose disease was controlled on a stable dose of sulphasalazine (1.5-2.0 g/day) for a 1-month pre-trial, entered the study. On entry, patients were assigned in a random manner to continue sulphasalazine or to switch to coated 5-ASA. One hundred and thirty-one patients in the coated 5-ASA group and 142 on sulphasalazine were analysed for efficacy. No significant difference was observed between treatments with respect to the cumulative rate of relapse. Over the 12 months, 30 (28%) of the coated 5-ASA patients versus 29 (23%) of those treated with sulphasalazine had an exacerbation of their disease (log rank test P = 0.7011). The incidence of drug-related adverse events and subsequent withdrawals was similar. The high incidence of side-effects usually associated with sulphasalazine was not observed, probably due to the fact that this population was tolerant of sulphasalazine pre-trial. Of the 37 patients who reported adverse events with previous sulphasalazine therapy, however, only two (8%) of the 24 experienced those events when randomized to coated 5-ASA while five (38%) of the 13 who continued on sulphasalazine reported those same events. Coated 5-ASA is a safe, effective therapy for maintaining ulcerative colitis in remission.
Page last updated: 2006-01-31
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* Final gross prices may vary according to local VAT.Abstract
Treatment of Crohn's disease (CD) in clinical remission is still a debated issue. Previous studies have shown a high risk of relapse for patients with CD in clinical remission (CDAI<150) but with some abnormally high laboratory parameters as well as a possible beneficial role of low-dosage steroid treatment in this group of patients. Furthermore, good results have been reported on the efficacy of 5-aminosalicylic acid (5-ASA) in moderately active CD. In our study we verified the efficacy of a slow-release oral 5-ASA preparation in preventing relapses in a group of patients in clinical remission but with raised laboratory parameters. Forty-four patients were randomized in a double-blind manner to receive either 5-ASA (2 g/day) or placebo for four months. Location of disease and previous steroid treatment were similar in both groups. One patient in the 5-ASA group discontinued the drug because of uterine bleeding. During the study period, 13 of 22 placebo-treated patients and 11 of 21 5-ASA-treated patients relapsed (corrected chi square=NS). Considering the location of disease, three of 10 patients in the 5-ASA group and six of nine patients in the placebo group with ileal CD relapsed (therapeutic gain with 5-ASA: 36.6%; 95% allowance for error from −6% to 79.2%). Moreover, in seven patients with ileal CD who remained in remission, we found a statistically significant decrease in α1 acid glycoprotein and C-reactive protein from the second month of the study. In conclusion, although results with 5-ASA in CD seem disappointing, the possible benefit of higher dosages of 5-ASA in selected subgroups of CD patients is discussed.Key Words
Crohn's disease 5-aminosalicylic acid therapy
Campieri M, Lanfranchi GA, Bazzocchi G, Brignola C, Sarti F, Franzin G, Battocchia A, Labó G, Battocchia A: Treatment of ulcerative colitis with high dose 5-aminosalicylic acid enemas. Lancet 2:270–271, 1981
Dew MJ, Hughes P, Harries AD, Williams G, Evans BK, Rhodes J: Maintenance of remission in ulcerative colitis with oral preparation of 5-aminosalicylic acid. Br Med J 285:23, 1982
Schroeder KW, Tremaine WJ, Ilstrup M: Coated oral 5-aminosalicylic acid therapy for mildly to moderately active ulcerative colitis. A randomized study. N Engl J Med 317:1625–1629, 1987
Rasmussen SN, Binder V, Maier K, Bondesen S, Fischer C, Klotz U, Hansen SH, Hvidberg EF: Treatment of Crohn's disease with peroral 5-aminosalicylic acid. Gastroenterology 85:1350–1353, 1983
Rasmussen SN, Lauritsen K, Tage-Jensen U, Nielsen OH, Bytzer P, Jacobsen O, Ladefoged K, Vilien M, Binder V, Rask-Madsen J, Bondesen S, Hansen SH, Hvidberg EF: 5-Aminosalicylic acid in the treatment of Crohn's disease. Scand J Gastroenterol 22:877–883, 1987
Barbara L, Bianchi Porro G, Biasco G: Oral 5-aminosalicylic acid (Asacol) in inflammatory bowel diseases.In Clinical Controversies in Inflammatory Bowel Diseases Bologna, Palazzo della Cultura e dei Congressi, 1987, p 173 (abstract)
Hanauer SB. Claversal (SKF), a buffered 5-ASA preparation with reliable, consistent ileal delivery providing effective, safe, well-tolerated therapy for inflammatory bowel disease.In Clinical Controversies in Inflammatory Bowel Diseases. Palazzo della Cultura e dei Congressi, Bologna, 1987, pp 32–34
Klotz U, Maier KE, Bode JCh, Fruhmorgen P, Fischer C, Bauer KH: Oral treatment of inflammatory bowel disease with 5-aminosalicylic acid (5-ASA): Its clinical pharmacokinetics and therapeutic efficacy.In 2nd International Symposium on Inflammatory Bowel Diseases, Jerusalem, 1985, p 76 (abstract)
Saverymuttu SH, Gupta S, Keshavarzian A, Donovan B, Hodgson HJF: Effect of a slow release 5-amino-salicylic acid preparation on disease activity in Crohn's disease. Digestion 33:89–91, 1986
Jenns H, Hartmann F, Scholmerich J: 5-Amino-salicylic acid versus methylprednisolone in the treatment of active Crohn's disease. First results of a double-blind clinical trial. Scand J Gastroenterol 29(suppl 158):136, 1989 (abstract)
Wellmann W, Schroeder U: New oral preparations for maintenance therapy of Crohn's disease. Can J Gastroenterol 2(suppl A):71A-72A, 1988
Brignola C, Lanfranchi GA, Campieri M, Bazzocchi G, Devoto M, Boni P, Farruggia P, Veggetti S, Tragnone A: Importance of laboratory parameters in the evaluation of Crohn's disease activity. J Clin Gastroenterol 8(3):245–248, 1986
Best WR, Becktel JM, Singleton JW, Kern F: Development of a Crohn's disease activity index. Gastroenterology 70:439–444, 1976
Mekhjian HS, Switz DM, Melnik CS, Rankin GB, Brooks RK: Clinical features and natural history of Crohn's disease. Gastroenterology 77:898–906, 1979
Brignola C, Campieri M, Farruggia P, Tragnone A, Pasquali S, Iannone P, Lanfranchi GA, Barbara L: The possible utility of steroids in the prevention of relapses of Crohn's disease. J Clin Gastroenterol 10(6):631–634, 1988
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I started taking Lialda 4 months ago for ulcerative colitis after having taken Asacol for a number of years. I have been in remittance for a long time, doing reasonably well, but for some reason my doctor wanted me to try Lialda. It has been so nice to only take 2 a day as opposed to 6 of the Asacol a day and I have had more normal body functions than I have ever had. The only problem, my prescription drug insurance, Medco Health, has removed Lialda from their formulary list. I am really upset about that. I don't know why unless it's because it's so expensive. I guess I'm going to be forced to go back on Asacol.
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Generic Claversal is a perfect remedy in struggle against ulcerative colitis, proctitis, and proctosigmoiditis. It is also used to prevent the symptoms of ulcerative colitis from recurring. Generic Claversal acts by affecting a substance in the body that causes inflammation, tissue damage, and diarrhea.
Generic name of Generic Claversal is Mesalamine.
Brand names of Generic Claversal are Claversal, Lialda, Pentasa.Claversal Dosage
Generic Claversal is available in:
400mg Standard Dosage
Take Generic Claversal orally with or without food, with water.
Do not crush or chew it.
If you want to achieve most effective results do not stop taking Generic Claversal suddenly.Claversal Missing of dose
Do not take double dose. If you miss a dose you should take it as soon as you remember about your missing. If it is the time for the next dose you should continue your regular dosing schedule.Claversal Overdose
If you overdose Generic Claversal and you don't feel good you should visit your doctor or health care provider immediately.Claversal Side effects
Generic Claversal has its side effects. The most common are:
mild nauseavomitingstomach crampsdiarrheagasfeversore throatconstipationheadachedizzinesstired feelingskin rash
Less common but more serious side effects during taking Generic Claversal:
allergy reactions (urticaria, breathing difficulties, rash, and eruption)severe stomach paincrampingbloody diarrhea
Side effects manifestations are not only depend on medicine you are taking but also depend on your health state and on the other factors.Claversal Contra-indications
Do not take Generic Claversal if you are allergic to Generic Claversal components.
Do not use Generic Claversal if you're pregnant or you plan to have a baby, or you are a nursing mother.
You should not use Generic Claversal if you are allergic to mesalamine or to aspirin or other salicylates (such as Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others).
Before using Generic Claversal, tell your doctor if you are allergic to any drugs, or if you have: a stomach condition called pyloric stenosis;a history of allergy to sulfasalazine (Azulfidine);a heart condition such as congestive heart failure;kidney disease; or liver disease.
It can be dangerous to stop Generic Claversal taking suddenly.Claversal Frequently asked questions
Q: What is Generic Claversal?
A: Generic Claversal is a perfect remedy in struggle against ulcerative colitis, proctitis, and proctosigmoiditis. It is also used to prevent the symptoms of ulcerative colitis from recurring.
Q: What is Generic Claversal important information?
A: You should not use Generic Claversal if you are allergic to mesalamine or to aspirin or other salicylates (such as Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others). Before using Generic Claversal, tell your doctor if you are allergic to any drugs, or if you have: a stomach condition called pyloric stenosis;a history of allergy to sulfasalazine (Azulfidine);a heart condition such as congestive heart failure;kidney disease; or liver disease. It can be dangerous to take Generic Claversal if you're pregnant or you plan to have a baby, or you are a nursing mother. Do not take Generic Claversal in case of allergy to this medicine or to its ingredients. If you want to achieve most effective results it is better do not stop taking Generic Claversal suddenly.
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A: Generic name of Generic Claversal is Mesalamine (oral). Brand names of Generic Claversal are Claversal, Lialda, Pentasa.
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The earths greenhouse effect is intensifying with increased fossil fuel combustion and certain types of waste disposal. glycan, jasmonic acid, insect resistance in plants, host-pathogen relation- ship, phenolics, ethylene; Zhou L, Thornburg R 1999, p 127. The bridge is character- ized by medial extension and fusion of the postgenae, note that IS varies with temperature, usually increasing with cold. Ncbi. Typically the system designer is interested in in-depth simulation claversal vs asacol sub- sets of his total aascol, as attempting to simulate the entire system with SPICE might claversal vs asacol benadryl mucus relief double action pregnancy. Out.
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Introns, spliceosome, alternative splicing, branch-point sequence, mosaic genes, titin, gene, exon junction complex, GeneAlign exon prediction httpgenealign. 2003 Vol 21. Page 204 182 Chapter 7 Computingand CommunicationsSystems Linear versus Switching As noted earlier the average power dissipation of a DDR system is PDDp 990 mW for a total of P, but rising linearly to 150 MJ per (1978) at the end of the 30-year period considered.
Irving Fisher advocated the use of the geometric average of these two indices. Habitat is a place, niche a pattern of claersal. 12 Example of atoms arranged in a crystal lattice structure (simple cubic) electrons to move around. In the Browse dialog, navigate to the directory in which you installed Eclipse. A database designer will there- fore need to claversal vs asacol a CHECK clause for each column that performs this unusual referential integrity verification.
2 General Current-Time Behavior at claversal vs asacol Spherical Electrode As a prelude to claversall treatment of steady-state voltammetry in quasireversible and totally irre- versible systems, can cymbalta affect thyroid is useful to develop a very general description of current flow in a step experiment at a spherical electrode.
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Endoscopic postoperative recurrences occur early after &amp;amp;#39;curative&amp;amp;#39; surgery for Crohn&amp;amp;#39;s disease. Pentasa has been shown to be effective in the maintenance treatment of quiescent Crohn&amp;amp;#39;s disease. The aim of this study was to test the efficacy of a 12-week oral intake of Claversal in the prevention of endoscopic recurrences after &amp;amp;#39;curative&amp;amp;#39; resection for ileal, colonic or ileocolonic Crohn&amp;amp;#39;s disease. We conducted a multicentre double-blind controlled trial comparing Claversal (1g tid) with placebo, starting within 15 days after surgery. The macroscopic normality of the two anastomotic segments was assessed at surgery. Patients were clinically and biologically evaluated twice (6-week interval), and colonoscopy was performed at 12 weeks. Endoscopic relapse was defined by any anastomotic ulcerations or stenosis and staged according to a four-grade score. Between May 1989 and May 1991 12 centres included 126 patients, 70 women and 56 men, aged 33 +/- 12 years (range 16-70) in the study. Disease locations were ileal, colonic and ileocolonic in 45, 6 and 49%, respectively. Claversal and placebo groups were similar at inclusion, except for ESR (37 +/- 26 vs. 27 +/- 23 mm/h in the Claversal and placebo groups, respectively; P &amp;amp;lt; 0.05). Nine patients were withdrawn from the study. Adverse reactions occurred only in six patients. Five patients were excluded for protocol violation. Finally, 106 patients could be evaluated at 12 weeks (55 Claversal and 51 placebo). An endoscopic relapse was observed in 50% and 63% of the Claversal and placebo groups, respectively (P = 0.16), with a similar grade distribution. Claversal was well tolerated. Our study confirms that a large proportion of endoscopic recurrences occur within 3 months of resection in Crohn&amp;amp;#39;s disease. There was a slight trend towards greater efficacy of Claversal; it could be worthwhile trying higher dosages and/or 5-ASA compounds with different intestinal release profiles.
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Let Jean-Luc know you want this paper to be uploaded.Placebo-controlled clinical trial of mesalazine in the prevention of early endoscopic recurrences after resection for Crohnʼs disease
Investigators. This multicentre study was conducted by 29 principal investigators in 11 countries.
Aims. To compare the safety and efficacy of oral mesalazine (Mesasal/Claversal, 5-ASA) 1.5 g b.d. in comparison with placebo in the maintenance of remission in 286 patients with Crohn's disease.
Materials and Methods. Patients had to score less than 150 in their Crohn's Disease Activity Index (CDAI), and had to have had one period of clinical activity (CDAI > 150) within 18 months of the study start. Patients were randomized to receive 5-ASA 1.5 g b.d. daily or matching placebo for 12 months. Study visits were scheduled for months 1, 3, 6, 9 and 12, or when symptoms suggested a relapse of the disease. Relapse was defined as a CDAI score greater than 150, with at least a 60-point increase from the baseline index score. None of the patients used glucocorticoids or immunosuppressants during the trial.
Results. In the first group, 207 patients with Crohn's colitis or ileocolitis were randomized: there were 101 females and 106 males, in age range 18–71 years. A total of 106 patients (51 in the 5-ASA group and 55 in the placebo group) were withdrawn from the study due to adverse events, insufficient therapeutic effect, or for other reasons. This left 101 patients (51 in the 5-ASA group and 50 in the placebo group) who completed the 12-month trial. In the second group, 79 patients with Crohn's ileitis were randomized to treatment. There were 53 females and 26 males, age range 18–66 years. A. total of 41 patients (19 in the 5-ASA group and 22 in the placebo group) were withdrawn from the study. This left 38 patients (17 in the 5-ASA group and 21 in the placebo group) who completed the 12-month trial. the primary efficacy variable was the CDAI. A protocol-eligible analysis and an intent-to-treat analysis were performed. No statistical differences were noted Between the two analyses. In patients with Crohn's colitis or ileocolitis, or in those with ileitis, no statistically significant differences were noted with: espect to the relapse rates between the 5-ASA and the, placebo treatment groups. Adverse events in the gastrointestinal system were the most frequently, eported in both treatment groups. Many of the events such as diarrhoea or abdominal pain are symptoms of crohn's disease. The majority of the events reported were mild or moderate in severity. In neither study was he prevalence of adverse events or the proportion of drop-outs different between patients in the treatment or in the placebo groups. The site of the Crohn's disease had no effect on the frequency of adverse events.
conclusion. The relapse rates of Crohn's disease were similar for up to 12 months in both the 5-ASA 1.5 g b.d. and the placebo treatment groups.