Status:
COMPLETED
Once Daily (OD) Versus Three Times Daily (TID) Dosing With Mesalazine Granules for Prevention of Recurrence of Ulcerative Colitis (UC)
Lead Sponsor:
Dr. Falk Pharma GmbH
Conditions:
Colitis, Ulcerative
Recurrence
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
This study intends to study the efficacy and tolerability of once daily 3.0 g mesalazine granules vs. once daily 1.5 g mesalazine granules vs. three times daily 0.5 g mesalazine granules for maintenan...
Eligibility Criteria
Inclusion
- Signed informed consent,
- Men or women aged 18 to 75 years,
- Historically confirmed diagnosis of ulcerative colitis by endoscopy and histology,
- Patient being in remission, defined (according to Rachmilewitz) as:
- Clinical Activity Index (CAI) \<= 4, and Endoscopic Index (EI) \< 4,
- Extent of inflammation during last acute episode was \>15 cm beyond the anal margin,
- Last acute episode ended within 3 months prior to study entry.
Exclusion
- Crohn's disease,
- Prior bowel resection leading to diarrhoea,
- Toxic megacolon,
- Gastric or duodenal ulcer,
- Haemorrhagic diathesis,
- Presence of symptomatic organic disease of the gastrointestinal tract (with the exception of haemorrhoids or hiatal hernia),
- Active colorectal cancer or a history of colorectal cancer,
- Serious other secondary illnesses of an acute or chronic nature,
- Asthma,
- Severe impairment of renal (e.g., serum creatinine \> 1.5 mg/dl) and/or liver functions (e.g., serum transaminase \[ALT and/or AST\] or alkaline phosphatase \>=2x upper limit of normal \[ULN\]),
- Application of immunosuppressants within 3 months and/or corticosteroids (oral, intravenous \[IV\] or topical rectal) within 30 days prior to baseline,
- Application of non-steroidal anti-inflammatory drugs (NSAIDs) as long term treatment (i.e. \> 6 weeks), other than acetylsalicylic acid (\<= 350 mg/day), or paracetamol,
- Known intolerance/hypersensitivity to salicylic acid and its derivatives or to any of the other constituents of the study drugs,
- Well-founded doubt about the patient's cooperation,
- Existing or intended pregnancy, breast-feeding,
- Women of child-bearing potential without adequate contraceptive protection, e.g., hormonal contraception, intrauterine device (IUD), double-barrier method of contraception (e.g., use of a condom and spermicide), partner has undergone vasectomy and subject is in monogamous relationship. The investigator is responsible for determining whether the subject has adequate birth control for study participation,
- Participation in another clinical trial within the last 30 days,simultaneous participation in another clinical trial, or previous participation in this trial.
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
648 Patients enrolled
Trial Details
Trial ID
NCT00746447
Start Date
May 1 2005
End Date
March 1 2008
Last Update
June 26 2012
Active Locations (1)
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1
Evangelisches Krankenhaus Kalk, Medical Dept.
Cologne, Germany, 51103