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Completed

NCT Number: NCT01627262

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

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

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Key information

Conditions

Colonic Diverticulosis Colonic Diseases Digestive System Diseases Diverticular Diseases Diverticulosis, Colonic Gastroenteritis Gastrointestinal Diseases Intestinal Diseases

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ev. Krankenhaus Kalk, University of Cologne

Cologne, 51103, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mesalamine

Drug

3x1000mg mesalamine granules per day

Other names: Salofalk granules

Placebo

Drug

3x1000mg placebo granules per day

Other names: Placebo granules

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Dr. Falk Pharma GmbH

Industry

Registry information

Official study 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

Important dates

Study start
2002
Primary completion
2004
Study completion
2006
First posted
Jun 25, 2012
Registry last updated
Jan 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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