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

August 23, 2019 updated by: Forest Laboratories

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

This is a prospective, multicenter, double-blind (DB), controlled, randomized, parallel group comparison Phase 3a study to evaluate the efficacy and safety of new mesalamine suppositories (MAX-002) as compared to placebo and active medicine after 6 weeks of treatment in adults with mild to moderate ulcerative proctitis (UP).

Study Overview

Status

Terminated

Detailed Description

The present study consists of screening period (2 weeks before randomization), DB phase (6 weeks), OL phase (8 weeks) and follow-up visits at Week 3, Week 6 and Week 14. Participants who are eligible will be randomized to receive 1g MAX-002, 1g Canasa® and placebo suppository once daily in the DB phase. Participants who complete or discontinue the study at Week 6 will either receive 1g MAX-002 suppositories on a voluntary basis, standard care treatment as per investigator's discretion or no treatment during the next 8 weeks of the OL phase. Total duration of treatment will be of 14 weeks. Efficacy will primarily be evaluated by percentage of participants who show response as per Mayo DAI Score at Week 6. Participants' safety will be monitored throughout the study.

Study Type

Interventional

Enrollment (Actual)

119

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participants who are 18 years old or older
  • Participants with total Mayo DAI score between 5 to 10 at Screening and participants with score of 2 or more for the rectal bleeding and for the findings of flexible proctosigmoidoscopy or colonoscopy sub-scores of the Mayo DAI
  • Participants with confirmed mild to moderate active UP not extending above rectum as evidenced by flexible proctosigmoidoscopy and histopathology assessments
  • Female participants of child-bearing age who have negative serum beta-human chorionic gonadotropin (β-HCG) at the time of entry into the study
  • Female participants of child-bearing age who use medically acceptable form of birth control
  • Participants who are smokers and non-smokers must not change their smoking habits or nicotine use during the DB treatment period
  • Participants who are literate and have legal ability to sign informed consent form

Exclusion Criteria:

  • Participants with other digestive diseases interfering with the measurement of any sub-score of the Mayo DAI
  • Participants with 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
  • Participants with clinically significant electrocardiographic abnormalities that would compromise its participation in the study
  • Participants who are chronically using oral 5-aminosalicylic acid (5-ASA) at a dose greater than 4g 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
  • Participants with significant use of corticosteroids ,immunosuppressant's or biologic response modifiers that may have a therapeutic effect on ulcerative proctitis during the 45 days before the date of consent
  • Participants who use any rectally administered medicine during the 30 days prior to randomization
  • Participants who have contraindication to the use of mesalamine or suppository vehicle, analgesia, flexible proctosigmoidoscopy or colonoscopy
  • Participants who have blood parameters of grade 3 or higher on the common terminology criteria for adverse events (CTCAE) 5-point scale
  • Participants with severe renal or hepatic impairment with parameters of grade 3 or higher on the CTCAE
  • Participants with clinically significant urinary tract obstruction and history of idiopathic pancreatitis
  • Participants with presence of other known clinically significant medical and/or psychological illnesses precluding participation
  • Participants who participate in clinical studies other than observational studies during the 90 days before the date of the informed consent form signature
  • Participants who are unable or unwilling to complete the follow-up evaluations required for the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Matching placebo suppository rectally once daily at bedtime for 6 weeks during the DB phase. Participants will then receive either MAX-002 suppository, standard care treatment or no treatment (as per Investigator's judgment) for 8 weeks during the OL phase.
EXPERIMENTAL: MAX-002
MAX-002 suppository 1 gram (g) rectally once daily at bedtime for 6 weeks during the DB phase. Participants will then receive either MAX-002 suppository, standard care treatment or no treatment (as per Investigator's judgment) for 8 weeks during the open-label (OL) phase.
Other Names:
  • Mesalamine
ACTIVE_COMPARATOR: Canasa®
Canasa® suppository 1 g rectally once daily at bedtime for 6 weeks during the DB phase. Participants will then receive either MAX-002 suppository, standard care treatment or no treatment (as per Investigator's judgment) for 8 weeks during the OL phase.
Other Names:
  • Mesalamine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Were Responders at Week 6
Time Frame: Week 6
Participants were considered as responders if they had total Mayo Disease Activity Index (DAI) score less than 3 points and no individual sub-scores greater than or equal to 2. Mayo DAI is a semi-quantitative scale which consists of 4 sub-scales: stool frequency, rectal bleeding, findings of flexible proctosigmoidoscopy or colonoscopy and physician global assessment, each sub-scale ranged from 0 to 3 (0=normal, 3=severe). The total Mayo DAI score ranges from 0 (normal or inactive disease) to 12 (severe disease).
Week 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Were Responders at Week 3
Time Frame: Week 3
Participants considered as responders if they had total Mayo DAI score less than 3 points and no individual sub-scores greater than or equal to 2. Mayo DAI is a semi-quantitative scale which consists of 4 sub-scales: stool frequency, rectal bleeding, findings of flexible proctosigmoidoscopy or colonoscopy and physician global assessment, each sub-scale ranged from 0 to 3 (0=normal, 3=severe). The total Mayo DAI score ranges from 0 (normal or inactive disease) to 12 (severe disease).
Week 3
Time to Relief of Rectal Bleeding
Time Frame: Day 1 up to Week 6
Time to relief of rectal bleeding was defined as number of days from randomization (Day 1) up to the first date of 3 consecutive days without observation of rectal bleeding during the double-blind phase.
Day 1 up to Week 6
Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 6
Time Frame: Baseline, Week 6
The IBDQ is used to measure disease specific quality of life. The IBDQ consists of a self-administered 32-item questionnaire that evaluates quality of life across 4 domains of wellness: bowel symptoms (10 questions), systemic symptoms (5 questions), social symptoms (5 questions) and emotional function (12 questions). The response to each question is graded on 7-point likert scale, ranging from 1 (worst aspect) to 7 (best aspect). The total IBDQ is computed as the sum of the responses to the individual IBDQ questions. The total score ranges from 32 to 224 with higher scores indicating a better quality of life.
Baseline, Week 6
Time to Relief of Tenesmus
Time Frame: Day 1 up to Week 6
Time to relief of tenesmus (feeling of constantly needing to pass stools, even if the bowels are already empty) was defined as the number of days from randomization (Day 1) up to the first date of 3 consecutive days without observation of tenesmus during the double-blind phase.
Day 1 up to Week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 30, 2009

Primary Completion (ACTUAL)

July 31, 2011

Study Completion (ACTUAL)

September 30, 2011

Study Registration Dates

First Submitted

November 17, 2009

First Submitted That Met QC Criteria

November 18, 2009

First Posted (ESTIMATE)

November 19, 2009

Study Record Updates

Last Update Posted (ACTUAL)

August 28, 2019

Last Update Submitted That Met QC Criteria

August 23, 2019

Last Verified

August 1, 2019

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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