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

NCT02493712 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2021-10-26

Study results available
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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.

Conditions

  • Colitis, Ulcerative

Interventions

DRUG

High dose

6 capsules of IBD98-M, twice a day

DRUG

Low dose

4 capsules of IBD98-M

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • inVentiv Health Clinical

    collaborator OTHER

  • Holy Stone Healthcare Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Silvio Danese · Istituto Clinico Humanitas

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2018-07-31
Completion
2019-04-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02493712 on ClinicalTrials.gov