Mesalamine for Uncomplicated Diverticular Disease: a Randomized, Double-blind, Placebo-controlled Study

Sponsor

Dr. Falk Pharma GmbH (Industry)

Overall Status

Completed

CT.gov ID

NCT01627262

Collaborator

(none)

123

Enrollment

Location

Arms

Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colonic Diverticulosis	Drug: Mesalamine Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

123 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2002

Actual Primary Completion Date :

Aug 1, 2004

Actual Study Completion Date :

Apr 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo	Drug: Placebo 3x1000mg placebo granules per day Other Names: Placebo granules
Experimental: Mesalamine	Drug: Mesalamine 3x1000mg mesalamine granules per day Other Names: Salofalk granules

Arm

Intervention/Treatment

Placebo Comparator: Placebo

Drug: Placebo

3x1000mg placebo granules per day

Other Names:

Placebo granules

Experimental: Mesalamine

Drug: Mesalamine

3x1000mg mesalamine granules per day

Other Names:

Salofalk granules

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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