Health Condition 1: null- Moderately Active Ulcerative Colitis
Conditions
Interventions
Intervention1: 1) Mesalamine DR Tablets, 800 mg, 1600 mg: TID for 6 weeks
Control Intervention1: 2) Asacol HD®
, 800 mg, 1600 mg: TID for 6 weeks
Control Intervention2: 3) Placebo, 0 mg: daily for 6 weeks
Sponsors
Watson Laboratories Inc
Keith Gallicano
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged 18 or older. 2. Patients with established diagnosis of active ulcerative colitis who have recent relapse within 12 weeks before screening. Newly diagnosed patients with sigmoidoscopy and biopsy report suggestive of active ulcerative colitis within 1 year before screening. 3. Positive Mucosal friability based on the Contact Friability Test conducted at verge. 4. Colonic involvement with ulcerative colitis more than 15 cm from the anal verge. 5. Female or male patients who are surgically sterilized or who are prepared to and agree to practice a barrier form of birth control from screening through 30 days (Females) and 90 days (Males), respectively, from the last dose of study medication. Females who are more than 12 months post-menopausal are also eligible to participate in the study. 6. Able to give written informed consent and to comply with the protocol requirements. 7. Patients who are literate and able and willing to complete a paper diary to enter scores during the 14-to 21 days period immediately before randomization and the entire 6-week treatment period.
Exclusion criteria
Exclusion criteria: 1. Pregnant or nursing females. 2. Patients who have used oral 5-Amino salicylic acid. 3. Patients whom the investigator deems likely to require immunosuppressant therapy. 4. Administration of immunosuppressive agents within the last 6 weeks before randomization. 5. Patients who have used oral corticosteroids within 4 weeks before randomization. 6. Patients taking prescription or over the counter anti-diarrheal agents within 7 days before randomization 7. Use of Antibiotics, other than topical dermatological antibiotics, within 14 days before randomization 8. Patients who receive an experimental drug or procedure within 30days of randomization, or who are likely to receive an experimental drug or procedure during the study through the 30-day period after the final administration of the study medication. 9. Patients with clinically active extra intestinal manifestations. 10. Patients who have had major gastrointestinal surgery except appendectomy and cholecystectomy. 11. Patients with Crohnâ??s disease, isolated proctitis, an intra-abdominal abscess, or a toxic megacolon. 12. Patients who have a history of active malignancies within 5 years. 13. Patients with clinically significant hepatic, renal, neurological, endocrine or other significant disease that may interfere with the assessment of the study endpoints 14. Patients with infectious ulcerative colitis. 15. Active drug and/or drug abuse 16. Known case of HIV infection or testing positive for HIV antibody. 17. Patients with Hepatitis A, B, C, or E infection. 18. Patients with serum creatinine of more than 1.5 times of upper limit of normal or liver enzymes of more than 2 times upper limit of normal at screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the proportion of patients in each of the three treatment groups that achieve overall treatment success at Week 6 defined as clinical improvement from baseline to end of treatment at week 6.Timepoint: | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints are the primary endpoint including patient?s functional assessment as an additional clinical assessment and change in total disease activity index scores from baseline to week 6, with and without patient?s functional assessment.Timepoint: | — |
Countries
India
Contacts
Public ContactMs Suneela Thatte
Outcome results
None listed