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| Sponsored by: |
Salix Pharmaceuticals |
|---|---|
| Information provided by: | Salix Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00767728 |
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: | 256 |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Mesalamine pellets
|
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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2: Placebo Comparator
Placebo
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Drug: Placebo
Matching placebo capsules (4 capsules) were administered orally QD, in the morning.
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This is a Phase 3 study evaluating the effectiveness and safety of eMG 1.5 g given once daily (QD) compared to placebo in subjects with demonstrated remission from UC. Eligible subjects are randomized in a 2:1 ratio (active:placebo) to receive 1 or 2 treatments: 1.5g eMG (4 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 as measured by rectal bleeding and endoscopic mucosal appearance after 6 months of treatment with encapsulated mesalamine granules (eMG) of 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 to 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: | MPUC3004 |
| Study First Received: | September 17, 2008 |
| Last Updated: | October 6, 2008 |
| ClinicalTrials.gov Identifier: | NCT00767728 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
UC ulcerative colitis IBD Inflammatory Bowel Disease |
|
Anti-Inflammatory Agents Gastrointestinal Diseases Mesalamine Ulcer Colonic Diseases Benzocaine Inflammatory Bowel Diseases Colitis, Ulcerative Intestinal Diseases |
Digestive System Diseases Analgesics, Non-Narcotic Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Gastroenteritis Colitis |
|
Anti-Inflammatory Agents Gastrointestinal Diseases Mesalamine Ulcer Physiological Effects of Drugs Colonic Diseases Inflammatory Bowel Diseases Colitis, Ulcerative Intestinal Diseases Pharmacologic Actions Digestive System Diseases |
Pathologic Processes Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Gastroenteritis Central Nervous System Agents Colitis |
