CTRI/2015/10/006252
Completed
Phase 2
A double-blind, randomized, two-arm, parallel, clinical study to evaluate efficacy, safety and tolerability of two dose strengths of tacrolimus lipid suspension for injection rectally administered in adult patients with mild to moderately active left-sided/distal ulcerative colitis including proctosigmoiditis/proctitis refractory to mesalamine treatment - NA
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Health Condition 1: K519- Ulcerative colitis, unspecified
- Sponsor
- Intas Pharmaceuticals Ltd
- Enrollment
- 60
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Documented history of idiopathic ulcerative colitis based on standard endoscopic (colonoscopic) and histological criteria with mild to moderate active disease
- •2\.Subjects with a modified Ulcerative Colitis Disease Activity Index (UCDAI) score of 4\-10
- •3\.Rectal bleeding score of 1 or more
- •4\.Mucosal appearance score of 1 point or more at baseline
Exclusion Criteria
- •1\.Documented history of proximal or universal ulcerative colitis
- •2\.Patients who demonstrate signs and symptoms of fulminant colitis, bowel stricture, toxic megacolon, an anticipated need for blood transfusion for gastrointestinal bleeding, or demonstrate evidence of peritonitis.
- •3\.Prior documented history of evidence of high grade dysplasia on biopsy from endoscopic examinations.
- •4\.Patients stool contains enteric pathogens or Clostridium difficile toxins.
Outcomes
Primary Outcomes
Not specified
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