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

This study has been terminated.
(The decision was taken solely for business/administrative reasons, no safety considerations entered into this. Ongoing randomized patients to complete.)
Sponsor:
Information provided by:
Axcan Pharma
ClinicalTrials.gov Identifier:
NCT01016262
First received: November 17, 2009
Last updated: July 6, 2011
Last verified: July 2011
  Purpose

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 Intervention Phase
Ulcerative Proctitis
Drug: MAX-002
Drug: Placebo
Drug: Canasa®
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Axcan Pharma:

Primary Outcome Measures:
  • The responder rate at Week 6 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The responder rate at Week 3 [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • Rectal bleeding at Week 6 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Total Inflammatory Bowel Disease Questionnaire (IBDQ) score at Week 6 (health economics evaluation) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Time to relief of tenesmus [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 549
Study Start Date: September 2009
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01016262

  Show 40 Study Locations
Sponsors and Collaborators
Axcan Pharma
Investigators
Study Director: Marielle Cohard-Radice, M.D. Axcan Pharma
  More Information

No publications provided

Responsible Party: Marielle Cohard-Radice Vice President, Clinical Development & Operations, Axcan Pharma inc.
ClinicalTrials.gov Identifier: NCT01016262     History of Changes
Other Study ID Numbers: CD-ME-CAPSITUP508-01
Study First Received: November 17, 2009
Last Updated: July 6, 2011
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Axcan Pharma:
Ulcerative proctitis
Proctocolitis
Inflammatory Bowel Disease
Gastrointestinal Diseases
Colonic Diseases
Mesalamine
5-ASA

Additional relevant MeSH terms:
Proctitis
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Rectal Diseases
Intestinal 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 September 15, 2014