| September 3, 2008 |
| September 3, 2008 |
| May 2005 |
| April 2007 (final data collection date for primary outcome measure) |
| Percentage of patients still in clinical remission at the final/withdrawal examination, with clinical relapse defined as a CAI >4 with an increase of ≥3 points from baseline. [ Time Frame: week 52 or premature withdrawal ] [ Designated as safety issue: No ] |
| Same as current |
| No Changes Posted |
- Time to relapse [ Time Frame: within 52 weeks ] [ Designated as safety issue: No ]
- Proportion of patients in endoscopical remission, defined as a mucosal appearance score of ≤ 1 at final/withdrawal examination. [ Time Frame: week 52 or premature withdrawal ] [ Designated as safety issue: No ]
|
| Same as current |
| |
| Once Daily (OD) Versus Three Times Daily (TID) Dosing With Mesalazine Granules for Prevention of Recurrence of Ulcerative Colitis (UC) |
| Double-Blind, Double-Dummy, Randomised, Multicentre, 12-Months, Comparative Study of 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 Maintenance of Remission in Patients With Ulcerative Colitis |
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 maintenance of remission in patients with ulcerative colitis |
| |
| Phase III |
| Interventional |
| Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
- Colitis, Ulcerative
- Recurrence
|
| Drug: mesalamine granules |
| |
| |
| |
| Completed |
| 648 |
| March 2008 |
| April 2007 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- 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 Criteria:
- 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.
|
| Both |
| 18 Years to 75 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Germany |
| |
| NCT00746447 |
| Dr. Ralph Mueller - Project Manager Clinical Research & Development, Dr. Falk Pharma GmbH |
| SAG-27/UCR, EudraCT No.: 2004-001218-15 |
| Dr. Falk Pharma GmbH |
|
| Study Director: |
Ralph Mueller, Dr. |
Dr. Falk Pharma GmbH |
|
|
| Dr. Falk Pharma GmbH |
| September 2008 |