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An Efficacy and Safety Study of PENTASA in Chinese Patients With Left-sided Active Ulcerative Colitis Followed by a 24-Week Open-Label Extension Phase

NCT02368717 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 281

Last updated 2017-10-11

No results posted yet for this study

Summary

The purpose of this study is to investigate the efficacy and safety of 4-week double-blind treatment with PENTASA enema compared with placebo enema in Chinese patients with mild to moderate active left-sided ulcerative colitis, followed by a maximal 28-week open-label extension phase with PENTASA enema and/or PENTASA tablets.

Conditions

Interventions

DRUG

Mesalazine Enema

DRUG

Placebo Enema

Sponsors & Collaborators

  • Ferring Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Clinical Development Support · Ferring Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2017-01-05
Completion
2017-07-25

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT02368717 on ClinicalTrials.gov