Working... Menu

Mesalamine Pellet Formulation to Maintain Remission of Mild to Moderate Ulcerative Colitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00744016
Recruitment Status : Completed
First Posted : August 29, 2008
Last Update Posted : December 23, 2009
Information provided by:
Valeant Pharmaceuticals International, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Ulcerative Colitis Drug: Granulated mesalamine Drug: Placebo Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 305 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : December 2004
Actual Primary Completion Date : May 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: 2
Drug: Placebo
Matching placebo capsules (4 capsules) were administered orally QD, in the morning

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

Primary Outcome Measures :
  1. Proportion of subjects who were relapse free after 6 months of treatment. [ Time Frame: 6 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00744016

Layout table for location information
United States, Connecticut
Bristol, Connecticut, United States, 06010
Sponsors and Collaborators
Valeant Pharmaceuticals International, Inc.
Layout table for investigator information
Study Director: Audrey L Shaw, Ph.D. Valeant Pharmaceuticals International, Inc.

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Audrey Shaw, Ph.D, Salix Pharmaceuticals, Inc. Identifier: NCT00744016     History of Changes
Other Study ID Numbers: MPUC3003
First Posted: August 29, 2008    Key Record Dates
Last Update Posted: December 23, 2009
Last Verified: December 2009

Keywords provided by Valeant Pharmaceuticals International, Inc.:
Ulcerative colitis
Inflammatory bowel disease

Additional relevant MeSH terms:
Layout table for MeSH terms
Colitis, Ulcerative
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents