Trial Details

Recruiting
Basic Information
Clinical ID c2248
Identifier CTRI/2022/10/046658
Trial Title A Phase II, Multicenter, Randomized, Double-blind, Placebo controlled Clinical study to_evaluate efficacy and safety of PNB-001 as an adjunct to Mesalamine compared to_Mesalamine alone in Subjects with Inflammatory bowel disease
Trial URL Visit Original Page
Study Information
Study Results

No results available
Conditions Health Condition 1: K509- Crohns disease, unspecified_Health Condition 2: K519- Ulcerative colitis, unspecified_
Interventions Intervention1: PNB001 50 mg: One capsule three times daily with water after meals with the stable dose of oral Mesalamine of at least 2.4 gm/day for 4 weeks Intervention2: PNB001 100mg: One capsule three times daily with water after meals with the stable dose of oral Mesalamine of at least 2.4 gm/day for 4 weeks Control Intervention1: Placebo Capsules: One capsule three times daily with water after meals with the stable dose of oral Mesalamine of at least 2.4 gm/day for 4 weeks
Participant Information
Sponsor PNB Vesper Life Science Pvt Ltd
City -
Country/Region India
Enrollment Criteria
Sex Requirement NOT SPECIFIED
Age Requirement -
Study Design
Study Type Interventional
Phase PHASE2
Time Information
Start Date 2025-04-24
Primary Completion Date -
Completion Date -