drugset / Trial / NCT02493712

A Phase 2a, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Trial of IBD98-M

NCT02493712

RandomizedParallel-groupDouble-blindTreatment

Summary

IBD98-M-2002 is a phase 2a , Randomized, Double blind, Placebo-controlled of IBD98-M Delayed Release capsules in subjects with Mild to Moderately Ulcerative Colitis to investigate the clinical efficacy of IBD98-M delayed release capsules (in a fixed combination) over a 6-week treatment period and 2 weeks follow up.

Timeline

Start
2016-01
Primary completion
2018-07
Completion
2019-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Mesalamine Small molecule 800 mg
Subject Mesalamine Small molecule 1200 mg
Subject Sodium Hyaluronate Other / unclassified 92 mg
Subject Sodium Hyaluronate Other / unclassified 138 mg

Indications