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

Dr. Falk Pharma GmbH123 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

123

Conditions

Colonic Diverticulosis

Interventions

MesalamineDRUG

3x1000mg mesalamine granules per day

PlaceboDRUG

3x1000mg placebo granules per day

Eligibility

Sex: ALLMin age: 45 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Ev. Krankenhaus Kalk, University of Cologne

Cologne, Germany

Outcomes

Primary Outcomes

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

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

Time frame: 4 weeks

Data from ClinicalTrials.gov

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