To evaluate efficacy, safety and tolerability of two dose strengths of tacrolimus lipid suspension for injection rectally administered in adult patients with ulcerative colitis
- Conditions
- Health Condition 1: K519- Ulcerative colitis, unspecified
- Registration Number
- CTRI/2015/10/006252
- Lead Sponsor
- Intas Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To examine the efficacy of a four week treatment of two doses of tacrolimus lipid suspension for injection in patients of distal ulcerative colitis refractory to mesalamine treatment.Timepoint: To end of the study
- Secondary Outcome Measures
Name Time Method 1.To evaluate the adverse event (AE) profile of tacrolimus lipid suspension for injection preparations. <br/ ><br>2.To estimate the plasma level of tacrolimus following its local administration.Timepoint: To end of the study