Mesalamine Pellet Formulation to Maintain Remission of Mild to Moderate Ulcerative Colitis
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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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention |
| 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 |
- Proportion of subjects who were relapse free after 6 months of treatment. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Enrollment: | 305 |
| Study Start Date: | December 2004 |
| Study Completion Date: | October 2007 |
| Primary Completion Date: | May 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: 2
Placebo
|
Drug: Placebo
Matching placebo capsules (4 capsules) were administered orally QD, in the morning
Other Name: placebo
|
|
Active Comparator: 1
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
Other Name: mesalamine pellets
|
Detailed Description:
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:
- Confirmed diagnosis of ulcerative colitis and in remission for at least 1 month.
- Greater than 18 years of age.
Exclusion Criteria:
- Allergy/intolerance to aspirin, mesalamine or other salicylates.
- Prior bowel surgery other than appendectomy.
- Pregnancy, at risk of pregnancy or lactating.
- HIV or hepatitis B or C.
Contacts and Locations More Information
No publications provided by Salix Pharmaceuticals
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Audrey Shaw, Ph.D, Salix Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00744016 History of Changes |
| Other Study ID Numbers: | MPUC3003 |
| Study First Received: | August 27, 2008 |
| Last Updated: | December 21, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Salix Pharmaceuticals:
|
UC Ulcerative colitis IBD Inflammatory bowel disease |
Additional relevant MeSH terms:
|
Colitis Colitis, Ulcerative Ulcer Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Colonic Diseases Intestinal Diseases Inflammatory Bowel Diseases Pathologic Processes Mesalamine |
Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 21, 2013