Proctitis, Ulcerative Clinical Trial
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
| Verified date | August 2019 |
| Source | Forest Laboratories |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| Status | Terminated |
| Enrollment | 119 |
| Est. completion date | September 30, 2011 |
| Est. primary completion date | July 31, 2011 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 (ß-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 |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Gastroenterology & Hepatology Clinic | Abbotsford | British Columbia |
| Canada | Surrey GI Clinic Research | Guelph | Ontario |
| Canada | St-Joseph's Healthcare Hamilton | Hamilton | Ontario |
| Canada | Hôpital Maisonneuve-Rosemont | Montreal | Quebec |
| Canada | Alpha Recherche Clinique | Quebec | |
| Canada | DHC Research | Richmond Hill | Ontario |
| Canada | Diamond Health Care Centre | Vancouver | British Columbia |
| Canada | Toronto Digestive Disease Associates Inc. (TDDA) | Vaughan | Ontario |
| Poland | GASTROMED s.c. | Bialystok | |
| Poland | Wojewódzki Szpital Specjalistyczny Oddz. Gastroenterologii | Czestochowa | |
| Poland | SPZOZ Uniwersytecki Szpital Kliniczny | Lodz | |
| Poland | SPZOZ Uniwersytecki Szpital Kliniczny | Lodz | |
| Poland | SP Szpital Kliniczny | Lublin | |
| Poland | Wojewodzki Szpital Specjalistyczny | Lublin | |
| Poland | Szpital Kolejowy | Pruszków | |
| Poland | MEDICOR - Centrum Medyczne | Rzeszow | |
| Poland | Endoskopia SP. Z o.o. | Sopot | |
| Poland | Gabinet Lekarski LECHMED | Warszawa | |
| United States | Birmingham Gastroenterology Associates P.C. | Birmingham | Alabama |
| United States | Clinical Research of South Florida | Boynton Beach | Florida |
| United States | Synergy First Medical | Brooklyn | New York |
| United States | Consultants for Clinical Research | Cincinnati | Ohio |
| United States | Cleveland Clinic | Cleveland | Ohio |
| United States | Digestive Health Specialists of the Southeast | Dothan | Alabama |
| United States | Advanced Pain Care Clinic | Evansville | Indiana |
| United States | Memphis Gastroenterology Group | Germantown | Tennessee |
| United States | Center for Gastrointestinal Disorders | Hollywood | Florida |
| United States | Gastrointestinal Associates | Jackson | Mississippi |
| United States | South Texas Research Alliance | Laredo | Texas |
| United States | South Jersey Gastroenterology | Marlton | New Jersey |
| United States | Center for Digestive & Liver Diseases Inc. | Mexico | Missouri |
| United States | Wisconsin Center for Advanced Research | Milwaukee | Wisconsin |
| United States | Gastroenterology Group of Naples | Naples | Florida |
| United States | The First Clinic | Nashville | Tennessee |
| United States | Research Associates of New York (RANY) | New York | New York |
| United States | Digestive Research Associates | Newnan | Georgia |
| United States | Rocky Mountain Gastroenterology Associates | Thornton | Colorado |
| United States | Litchfield County Gastroenterology and Associates | Torrington | Connecticut |
| United States | Desert Sun Gastroenterology | Tucson | Arizona |
| United States | Shafran Gastroenterology Center | Winter Park | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Forest Laboratories |
United States, Canada, Poland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Percentage of Participants Who Were Responders at 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 | |
| Secondary | Time to Relief of Rectal Bleeding | 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 | |
| Secondary | Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) Score at 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 | |
| Secondary | Time to Relief of Tenesmus | 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 |