Double-blind, Randomised, Placebo-controlled, Parallel-group, Multi-centre Phase III Clinical Study on the Efficacy and Tolerability of Mesalazine Pellets vs. Placebo in Diverticular Disease

Dr. Falk Pharma GmbH1 site in 1 country123 target enrollmentMay 2002

ConditionsColonic Diverticulosis

InterventionsMesalamine Placebo

DrugsMesalamine Placebo

Overview

Phase: Phase 2
Intervention: Mesalamine
Conditions: Colonic Diverticulosis
Sponsor: Dr. Falk Pharma GmbH
Enrollment: 123
Locations: 1
Primary Endpoint: The change in intensity of lower abdominal pain during the first four weeks of treatment (SPID 0-28)
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine whether mesalamine is effective in the treatment of uncomplicated diverticular disease by reducing the pain.

Registry

clinicaltrials.gov

Start Date

May 2002

End Date

April 2006

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Dr. Falk Pharma GmbH

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Diagnosis of diverticular disease with acute pain without serious complications
•Lower abdominal pain of moderate or severe intensity at least during the last 4 days before study inclusion

Exclusion Criteria

•Chronic inflammatory bowel disease
•Fever or other signs of serious complications.

Arms & Interventions

Mesalamine

Intervention: Mesalamine

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

The change in intensity of lower abdominal pain during the first four weeks of treatment (SPID 0-28)

Time Frame: 4 weeks

The change in intensity of lower abdominal pain during the first four weeks of treatment, defined as the cumulative difference of the daily pain intensity score from the first day of study medication intake (day 1) to week 4