A postmarketing surveillance to study how safe, tolerable, preferred and effective is Mesalo foam (Mesalazine rectal foam 1 gm) in treatment of patients with ulcerative colitis.
Phase 4
- Conditions
- Health Condition 1: null- Ulcerative Colitis
- Registration Number
- CTRI/2016/01/006545
- Lead Sponsor
- Cipla Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 120
Inclusion Criteria
1. Subjects willing to give written, signed & dated informed consent for study participation.
2. Subjects of either gender above 18 years of age.
3. Subjects with established mild Ulcerative Colitis.
Exclusion Criteria
1. Known hypersensitivity to salicylates or any of the excipients.
2. Severe impairment of hepatic or renal function.
3. Pregnant and lactating females.
4. Subjects who are currently participating in any other clinical
trial or have participated in any clinical trial in last 30 days of visit
1
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Mean Change in Mayo scores from baseline to weeks 4. <br/ ><br>2. Clinical response <br/ ><br>3. Clinical remission <br/ ><br>4. Acceptance/ preference of the patients with respect to the foam formulation.Timepoint: Throughout the study period.
- Secondary Outcome Measures
Name Time Method 1. Incidence and nature of adverse events <br/ ><br>2. Incidence of drug related adverse eventsTimepoint: Throughout the study period.