Efficacy and Safety Study of MAX-002 Suppository Versus Placebo in Mild to Moderate Ulcerative Proctitis

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: NCT01016262
Recruitment Status : Terminated (The decision was taken solely for business/administrative reasons, no safety considerations entered into this. Ongoing randomized patients to complete.)
First Posted : November 19, 2009
Last Update Posted : July 7, 2011
Information provided by:
Axcan Pharma

Brief Summary:

Hypothesis: The responder rate of the MAX-002 will be superior to placebo after 6 weeks of treatment in patients with mild to moderate ulcerative proctitis.

Summary: The primary purpose of this study is to evaluate the efficacy and safety of new mesalamine suppositories (MAX-002) as compared to placebo after 6 weeks of treatment in adults with mild to moderate ulcerative proctitis.

Prior to randomization, all inclusion and exclusion criteria will be verified to confirm eligibility. Patients found to be eligible will be randomized in a 1:1:1 scheme to receive either MAX-002 1 g, Canasa® 1 g, or Placebo suppository once daily at bedtime for 6 weeks in a double-blind fashion. Completers at Study Week 6 will be offered to receive MAX-002 1 g suppositories on a voluntary basis during the next 8 weeks of the open-label phase. Regardless of the treatment groups, all patients will be evaluated through phone calls at Study Weeks 1 and 2 followed by clinical visits at Study Weeks 3, 6, and 14. Study-specific procedures include but are not limited to the following: flexible proctosigmoidoscopy; disease activity assessment; smoking habits description; health-related quality of life; compliance to treatment check and safety evaluations (physical examinations, ECG, vitals signs, clinical laboratory analyses). All patients will complete daily diaries and will be asked general open questions about any occurrence of adverse events/concurrent medical conditions, use of adjunctive therapy/procedure, and their intake of concomitant medication.

Condition or disease Intervention/treatment Phase
Ulcerative Proctitis Drug: MAX-002 Drug: Placebo Drug: Canasa® Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 549 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Double-blind, Controlled, Randomized, Parallel Group Comparison Phase IIIa Treatment Investigation on the Efficacy and Safety of MAX-002 Suppository Versus Placebo and Active Medicine in Mild to Moderate Ulcerative Proctitis
Study Start Date : September 2009
Estimated Primary Completion Date : July 2011
Estimated Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: MAX-002 suppositories Drug: MAX-002
MAX-002 1 g suppositories will be taken once daily at bedtime for 6 weeks during the double-blind phase. Completers at Study Week 6 will be offered to receive, on a voluntary basis, MAX-002 1 g suppositories once daily at bedtime for 8 weeks during the open-label phase.

Placebo Comparator: Placebo suppositories Drug: Placebo
Placebo suppositories will be taken once daily at bedtime for 6 weeks during the double-blind phase.

Active Comparator: Canasa® suppositories Drug: Canasa®
Canasa® 1 g suppositories will be taken once daily at bedtime for 6 weeks during the double-blind phase.

Primary Outcome Measures :
  1. The responder rate at Week 6 [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. The responder rate at Week 3 [ Time Frame: 3 weeks ]
  2. Rectal bleeding at Week 6 [ Time Frame: 6 weeks ]
  3. Total Inflammatory Bowel Disease Questionnaire (IBDQ) score at Week 6 (health economics evaluation) [ Time Frame: 6 weeks ]
  4. Time to relief of tenesmus [ Time Frame: 6 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Main Inclusion Criteria:

  • At screening, patients must have confirmation of mild to moderate UP not extending above the rectum with a total Mayo DAI score between 5 and 10, inclusively.
  • Score of 2 or more for the "Rectal bleeding" and for the "Findings of flexible proctosigmoidoscopy or colonoscopy" sub-scores of the Mayo DAI.

Main Exclusion Criteria:

  • Presence of other digestive diseases interfering with the measurement of any sub-score of the DAI.
  • Known presence or suspicion of malignant disease of the digestive system or presence or history of neoplasms other than carcinoma in situ of the cervix or basal carcinoma of the skin.
  • Chronic use of oral 5-aminosalicylic acid (5-ASA) at a dose greater than 4 g daily, change in the oral 5-ASA dosing, or use of any form of rectal 5-ASA formulations during the 30 days prior to randomization.
  • Significant use of corticosteroids that may have a therapeutic effect on UP, immunosuppressants or biologic response modifiers during the 45 days prior to the date of consent.
  • Use of any rectally administered medicine during the 30 days prior to randomization.
  • Presence of other known clinically significant medical and/or psychological illnesses precluding participation.

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): NCT01016262

  Hide Study Locations
United States, Alabama
Birmingham Gastroenterology Associates P.C.
Birmingham, Alabama, United States, 35209
Digestive Health Specialists of the Southeast
Dothan, Alabama, United States, 36305
United States, Arizona
Desert Sun Gastroenterology
Tucson, Arizona, United States, 85710
United States, Colorado
Rocky Mountain Gastroenterology Associates
Thornton, Colorado, United States, 80229
United States, Connecticut
Litchfield County Gastroenterology and Associates
Torrington, Connecticut, United States, 06790
United States, Florida
Clinical Research of South Florida
Boynton Beach, Florida, United States, 33426
Center for Gastrointestinal Disorders
Hollywood, Florida, United States, 33021
Gastroenterology Group of Naples
Naples, Florida, United States, 34102
Shafran Gastroenterology Center
Winter Park, Florida, United States, 32789
United States, Georgia
Digestive Research Associates
Newman, Georgia, United States, 30263
United States, Indiana
Advanced Pain Care Clinic
Evansville, Indiana, United States, 47714
United States, Mississippi
Gastrointestinal Associates
Jackson, Mississippi, United States, 39202
United States, Missouri
Center for Digestive & Liver Diseases Inc.
Mexico, Missouri, United States, 65265
United States, New Jersey
South Jersey Gastroenterology
Marlton, New Jersey, United States, 08053
United States, New York
Synergy First Medical
Brooklyn, New York, United States, 11230
Research Associates of New York (RANY)
New York, New York, United States, 10075
United States, Ohio
Consultants for Clinical Research
Cincinnati, Ohio, United States, 45219
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Tennessee
Memphis Gastroenterology Group
Germantown, Tennessee, United States, 38138
The First Clinic
Nashville, Tennessee, United States, 37203
United States, Texas
South Texas Research Alliance
Laredo, Texas, United States, 78041
United States, Wisconsin
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, United States, 53215
Canada, British Columbia
Gastroenterology & Hepatology Clinic
Abbotsford, British Columbia, Canada, V2S 3N5
Diamond Health Care Centre
Vancouver, British Columbia, Canada, V5Z 1N9
Canada, Ontario
Surrey GI Clinic Research
Guelph, Ontario, Canada, N1H 3R3
St-Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada, L8N 4A6
DHC Research
Richmond Hill, Ontario, Canada, L4B 3P8
Toronto Digestive Disease Associates Inc. (TDDA)
Vaughan, Ontario, Canada, L4L 4Y7
Canada, Quebec
Hôpital Maisonneuve-Rosemont
Montreal, Quebec, Canada, H1T 2M4
Alpha Recherche Clinique
Quebec, Canada, G2B 5S1
Bialystok, Poland, 15-351
Wojewódzki Szpital Specjalistyczny Oddz. Gastroenterologii
Czestochowa, Poland, 42-200
SPZOZ Uniwersytecki Szpital Kliniczny
Lodz, Poland, 90-153
SPZOZ Uniwersytecki Szpital Kliniczny
Lodz, Poland, 90-549
Wojewodzki Szpital Specjalistyczny
Lublin, Poland, 20-718
SP Szpital Kliniczny
Lublin, Poland, 20-954
Szpital Kolejowy
Pruszków, Poland, 05-800
MEDICOR - Centrum Medyczne
Rzeszow, Poland, 35-068
Endoskopia SP. Z o.o.
Sopot, Poland, 81-756
Gabinet Lekarski LECHMED
Warszawa, Poland, 02-511
Sponsors and Collaborators
Axcan Pharma
Study Director: Marielle Cohard-Radice, M.D. Axcan Pharma

Responsible Party: Marielle Cohard-Radice Vice President, Clinical Development & Operations, Axcan Pharma inc. Identifier: NCT01016262     History of Changes
Other Study ID Numbers: CD-ME-CAPSITUP508-01
First Posted: November 19, 2009    Key Record Dates
Last Update Posted: July 7, 2011
Last Verified: July 2011

Keywords provided by Axcan Pharma:
Ulcerative proctitis
Inflammatory Bowel Disease
Gastrointestinal Diseases
Colonic Diseases

Additional relevant MeSH terms:
Colitis, Ulcerative
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases
Rectal Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Colonic 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