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

NCT ID: NCT01016262

Last Updated: 2019-08-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 119 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2011-09-30

Brief Summary

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).

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.

Conditions

Proctitis, Ulcerative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

MAX-002

Group Type: EXPERIMENTAL

MAX-002

Intervention Type: DRUG

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.

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

Canasa®

Group Type: ACTIVE_COMPARATOR

Canasa®

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

Mesalamine; Mesalamine

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Forest Laboratories

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aptalis Medical Information

Role: STUDY_DIRECTOR

Forest Laboratories

Locations

Birmingham Gastroenterology Associates P.C.

Birmingham, Alabama, United States

Digestive Health Specialists of the Southeast

Dothan, Alabama, United States

Desert Sun Gastroenterology

Tucson, Arizona, United States

Rocky Mountain Gastroenterology Associates

Thornton, Colorado, United States

Litchfield County Gastroenterology and Associates

Torrington, Connecticut, United States

Clinical Research of South Florida

Boynton Beach, Florida, United States

Center for Gastrointestinal Disorders

Hollywood, Florida, United States

Gastroenterology Group of Naples

Naples, Florida, United States

Shafran Gastroenterology Center

Winter Park, Florida, United States

Digestive Research Associates

Newnan, Georgia, United States

Advanced Pain Care Clinic

Evansville, Indiana, United States

Gastrointestinal Associates

Jackson, Mississippi, United States

Center for Digestive & Liver Diseases Inc.

Mexico, Missouri, United States

South Jersey Gastroenterology

Marlton, New Jersey, United States

Synergy First Medical

Brooklyn, New York, United States

Research Associates of New York (RANY)

New York, New York, United States

Consultants for Clinical Research

Cincinnati, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

Memphis Gastroenterology Group

Germantown, Tennessee, United States

The First Clinic

Nashville, Tennessee, United States

South Texas Research Alliance

Laredo, Texas, United States

Wisconsin Center for Advanced Research

Milwaukee, Wisconsin, United States

Gastroenterology & Hepatology Clinic

Abbotsford, British Columbia, Canada

Diamond Health Care Centre

Vancouver, British Columbia, Canada

Surrey GI Clinic Research

Guelph, Ontario, Canada

St-Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

DHC Research

Richmond Hill, Ontario, Canada

Toronto Digestive Disease Associates Inc. (TDDA)

Vaughan, Ontario, Canada

Hôpital Maisonneuve-Rosemont

Montreal, Quebec, Canada

Alpha Recherche Clinique

Québec, Quebec, Canada

GASTROMED s.c.

Bialystok, , Poland

Wojewódzki Szpital Specjalistyczny Oddz. Gastroenterologii

Częstochowa, , Poland

SPZOZ Uniwersytecki Szpital Kliniczny

Lodz, , Poland

SPZOZ Uniwersytecki Szpital Kliniczny

Lodz, , Poland

Wojewodzki Szpital Specjalistyczny

Lublin, , Poland

SP Szpital Kliniczny

Lublin, , Poland

Szpital Kolejowy

Pruszków, , Poland

MEDICOR - Centrum Medyczne

Rzeszów, , Poland

Endoskopia SP. Z o.o.

Sopot, , Poland

Gabinet Lekarski LECHMED

Warsaw, , Poland

Countries

United States; Canada; Poland

Other Identifiers

CD-ME-CAPSITUP508-01

Identifier Type: -

Identifier Source: org_study_id