Efficacy and Safety Study of MAX-002 Suppository Versus Placebo and Active Medicine in Mild to Moderate Ulcerative Proctitis
- Conditions
- Proctitis, Ulcerative
- Interventions
- Registration Number
- NCT01016262
- Lead Sponsor
- Forest Laboratories
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 119
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MAX-002 MAX-002 - Placebo Placebo - Canasa® Canasa® -
- Primary Outcome Measures
Name Time Method Percentage of Participants Who Were Responders at Week 6 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).
- Secondary Outcome Measures
Name Time Method Time to Relief of Rectal Bleeding 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.
Time to Relief of Tenesmus 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.
Percentage of Participants Who Were Responders at Week 3 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).
Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 6 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.
Trial Locations
- Locations (39)
Advanced Pain Care Clinic
🇺🇸Evansville, Indiana, United States
MEDICOR - Centrum Medyczne
🇵🇱Rzeszow, Poland
Szpital Kolejowy
🇵🇱Pruszków, Poland
Gabinet Lekarski LECHMED
🇵🇱Warszawa, Poland
Endoskopia SP. Z o.o.
🇵🇱Sopot, Poland
Wojewodzki Szpital Specjalistyczny
🇵🇱Lublin, Poland
SP Szpital Kliniczny
🇵🇱Lublin, Poland
SPZOZ Uniwersytecki Szpital Kliniczny
🇵🇱Lodz, Poland
Digestive Health Specialists of the Southeast
🇺🇸Dothan, Alabama, United States
Toronto Digestive Disease Associates Inc. (TDDA)
🇨🇦Vaughan, Ontario, Canada
Birmingham Gastroenterology Associates P.C.
🇺🇸Birmingham, Alabama, United States
Wisconsin Center for Advanced Research
🇺🇸Milwaukee, Wisconsin, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Desert Sun Gastroenterology
🇺🇸Tucson, Arizona, United States
Rocky Mountain Gastroenterology Associates
🇺🇸Thornton, Colorado, United States
Shafran Gastroenterology Center
🇺🇸Winter Park, Florida, United States
Litchfield County Gastroenterology and Associates
🇺🇸Torrington, Connecticut, United States
Clinical Research of South Florida
🇺🇸Boynton Beach, Florida, United States
Digestive Research Associates
🇺🇸Newnan, Georgia, United States
South Jersey Gastroenterology
🇺🇸Marlton, New Jersey, United States
Center for Digestive & Liver Diseases Inc.
🇺🇸Mexico, Missouri, United States
Synergy First Medical
🇺🇸Brooklyn, New York, United States
Gastrointestinal Associates
🇺🇸Jackson, Mississippi, United States
Research Associates of New York (RANY)
🇺🇸New York, New York, United States
Consultants for Clinical Research
🇺🇸Cincinnati, Ohio, United States
The First Clinic
🇺🇸Nashville, Tennessee, United States
Surrey GI Clinic Research
🇨🇦Guelph, Ontario, Canada
South Texas Research Alliance
🇺🇸Laredo, Texas, United States
St-Joseph's Healthcare Hamilton
🇨🇦Hamilton, Ontario, Canada
Hôpital Maisonneuve-Rosemont
🇨🇦Montreal, Quebec, Canada
DHC Research
🇨🇦Richmond Hill, Ontario, Canada
Alpha Recherche Clinique
🇨🇦Quebec, Canada
GASTROMED s.c.
🇵🇱Bialystok, Poland
Wojewódzki Szpital Specjalistyczny Oddz. Gastroenterologii
🇵🇱Czestochowa, Poland
Gastroenterology Group of Naples
🇺🇸Naples, Florida, United States
Center for Gastrointestinal Disorders
🇺🇸Hollywood, Florida, United States
Memphis Gastroenterology Group
🇺🇸Germantown, Tennessee, United States
Gastroenterology & Hepatology Clinic
🇨🇦Abbotsford, British Columbia, Canada
Diamond Health Care Centre
🇨🇦Vancouver, British Columbia, Canada