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| Sponsored by: |
Salix Pharmaceuticals |
|---|---|
| Information provided by: | Salix Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00744016 |
Purpose
The purpose of this study is to compare the maintenance of mild to moderate ulcerative colitis remission with six months of treatment with 1.5 grams of mesalamine pellets each day versus placebo.
| Condition | Intervention | Phase |
|---|---|---|
|
Ulcerative Colitis |
Drug: Granulated mesalamine Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double-Blind, Parallel Assignment |
| Official Title: | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Use of Mesalamine Pellet Formulation 1.5G QD to Maintain Remission From Mild to Moderate Ulcerative Colitis |
| Enrollment: | 305 |
| Study Start Date: | December 2004 |
| Arms | Assigned Interventions |
|---|---|
|
2: Placebo Comparator
Placebo
|
Drug: Placebo
Matching placebo capsules (4 capsules) were administered orally QD, in the morning
|
|
1: Active Comparator
Granulated mesalamine
|
Drug: Granulated mesalamine
0.375 g of mesalamine granules were encapsulated in a hard gelatin shell. 1.5 g of eMG (4 capsules) were administered orally QD, in the morning
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This is a phase 3, multicenter, double-blind, randomized, placebo controlled study evaluating the effectiveness and safety of eMG 1.5 g given once daily (QD) compared with placebo in approximately 300 subjects with demonstrated remission from UC. Eligible subjects are randomized in a 2:1 ratio (active:placebo) to receive 1 of 2 treatments: 1.5g eMG QD (four capsules total) or matching placebo capsules QD for 6 months.
The study consists of a Screening phase (completed within 7 days prior to randomization), a Treatment phase (6 months), and a Follow-up visit (2 weeks after end-of-study [EOS] visit). The Treatment phase consists of 4 scheduled study visits: Visit 1 (Baseline)/Randomization (Day 1), Visit 2 (Month 1), Visit 3 (Month 3), Visit 4/EOS (Month 6).
Primary objective:
To compare the maintenance of remission from mild to moderate ulcerative colitis (UC) as measured by rectal bleeding and endoscopic mucosal appearance after 6 months of treatment with encapsulated mesalamine granules (eMG) at 1.5 g QD, as compared with placebo.
Secondary objective:
To compare the safety and tolerability of long-term dosing with eMG at 1.5 g QD as compared with placebo in the maintenance of remission from mild to moderate UC.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| Responsible Party: | Salix Pharmaceuticals, Inc. ( Audrey Shaw, Ph.D ) |
| Study ID Numbers: | MPUC3003 |
| Study First Received: | August 27, 2008 |
| Last Updated: | October 5, 2008 |
| ClinicalTrials.gov Identifier: | NCT00744016 |
| Health Authority: | United States: Food and Drug Administration |
|
UC Ulcerative colitis IBD Inflammatory bowel disease |
|
Digestive System Diseases Mesalamine Gastrointestinal Diseases Ulcer Colonic Diseases Benzocaine |
Inflammatory Bowel Diseases Colitis, Ulcerative Gastroenteritis Intestinal Diseases Colitis |
|
Anti-Inflammatory Agents Pathologic Processes Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses Physiological Effects of Drugs |
Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Central Nervous System Agents Pharmacologic Actions |
