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

NCT01016262 | Terminated Phase 3 Results

• 1 other identifier: CD-ME-CAPSITUP508-01
• Study Type: interventional
• Target: 119
• Locations: 3 countries
• Sites: 40

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).

Conditions

Proctitis, Ulcerative

Keywords

Ulcerative proctitis; Proctocolitis; Inflammatory Bowel Disease; Gastrointestinal Diseases; Colonic Diseases; Mesalamine; 5-ASA

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Were Responders at 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 Outcomes (4)

• Percentage of Participants Who Were Responders at Week 3

  Week 3

• Time to Relief of Rectal Bleeding

  Day 1 up to Week 6

• Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 6

  Baseline, Week 6

• Time to Relief of Tenesmus

  Day 1 up to Week 6

Study Arms (3)

MAX-002

EXPERIMENTAL

Drug: MAX-002

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Canasa®

ACTIVE COMPARATOR

Drug: Canasa®

Interventions

MAX-002 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.

Also known as: Mesalamine

MAX-002

Placebo 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.

Placebo

Canasa® 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.

Also known as: Mesalamine

Canasa®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Forest Laboratories: lead

Study Sites (40)

Birmingham Gastroenterology Associates P.C.

Birmingham, Alabama, 35209, United States

Location

Digestive Health Specialists of the Southeast

Dothan, Alabama, 36305, United States

Location

Desert Sun Gastroenterology

Tucson, Arizona, 85710, United States

Location

Rocky Mountain Gastroenterology Associates

Thornton, Colorado, 80229, United States

Location

Litchfield County Gastroenterology and Associates

Torrington, Connecticut, 06790, United States

Location

Clinical Research of South Florida

Boynton Beach, Florida, 33426, United States

Location

Center for Gastrointestinal Disorders

Hollywood, Florida, 33021, United States

Location

Gastroenterology Group of Naples

Naples, Florida, 34102, United States

Location

Shafran Gastroenterology Center

Winter Park, Florida, 32789, United States

Location

Digestive Research Associates

Newnan, Georgia, 30263, United States

Location

Advanced Pain Care Clinic

Evansville, Indiana, 47714, United States

Location

Gastrointestinal Associates

Jackson, Mississippi, 39202, United States

Location

Center for Digestive & Liver Diseases Inc.

Mexico, Missouri, 65265, United States

Location

South Jersey Gastroenterology

Marlton, New Jersey, 08053, United States

Location

Synergy First Medical

Brooklyn, New York, 11230, United States

Location

Research Associates of New York (RANY)

New York, New York, 10075, United States

Location

Consultants for Clinical Research

Cincinnati, Ohio, 45219, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Memphis Gastroenterology Group

Germantown, Tennessee, 38138, United States

Location

The First Clinic

Nashville, Tennessee, 37203, United States

Location

South Texas Research Alliance

Laredo, Texas, 78041, United States

Location

Wisconsin Center for Advanced Research

Milwaukee, Wisconsin, 53215, United States

Location

Gastroenterology & Hepatology Clinic

Abbotsford, British Columbia, V2S 3N5, Canada

Location

Diamond Health Care Centre

Vancouver, British Columbia, V5Z 1N9, Canada

Location

Surrey GI Clinic Research

Guelph, Ontario, N1H 3R3, Canada

Location

St-Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

DHC Research

Richmond Hill, Ontario, L4B 3P8, Canada

Location

Toronto Digestive Disease Associates Inc. (TDDA)

Vaughan, Ontario, L4L 4Y7, Canada

Location

Hôpital Maisonneuve-Rosemont

Montreal, Quebec, H1T 2M4, Canada

Location

Alpha Recherche Clinique

Québec, Quebec, G2B 5S1, Canada

Location

GASTROMED s.c.

Bialystok, 15-351, Poland

Location

Wojewódzki Szpital Specjalistyczny Oddz. Gastroenterologii

Częstochowa, 42-200, Poland

Location

SPZOZ Uniwersytecki Szpital Kliniczny

Lodz, 90-153, Poland

Location

SPZOZ Uniwersytecki Szpital Kliniczny

Lodz, 90-549, Poland

Location

Wojewodzki Szpital Specjalistyczny

Lublin, 20-718, Poland

Location

SP Szpital Kliniczny

Lublin, 20-954, Poland

Location

Szpital Kolejowy

Pruszków, 05-800, Poland

Location

MEDICOR - Centrum Medyczne

Rzeszów, 35-068, Poland

Location

Endoskopia SP. Z o.o.

Sopot, 81-756, Poland

Location

Gabinet Lekarski LECHMED

Warsaw, 02-511, Poland

Location

MeSH Terms

Conditions

Proctitis; Ulcer; Proctocolitis; Inflammatory Bowel Diseases; Gastrointestinal Diseases; Colonic Diseases

Interventions

Mesalamine

Condition Hierarchy (Ancestors)

Gastroenteritis; Digestive System Diseases; Rectal Diseases; Intestinal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Colitis; Sigmoid Diseases

Intervention Hierarchy (Ancestors)

meta-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Aminosalicylic Acids; Salicylates; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols

Limitations and Caveats

The study was terminated because of business/administrative reasons and not because of safety considerations.

Results Point of Contact

• Title: Robert Winkler, MD, VP, Clinical Development and Operations
• Organization: Forest Laboratories

1-800-472-2634

Study Officials

• Aptalis Medical Information

  Forest Laboratories

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2009
• First Posted: November 19, 2009
• Study Start: November 30, 2009
• Primary Completion: July 31, 2011
• Study Completion: September 30, 2011
• Last Updated: August 28, 2019
• Results First Posted: August 28, 2019

Record last verified: 2019-08

Locations

US (22); CA (8); PL (10)