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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01627262

Enrollment

123

Registered

2012-06-25

Start date

2002-05-31

Completion date

2006-04-30

Last updated

2016-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colonic Diverticulosis

Keywords

diverticular disease, colonic diverticulosis, mesalamine, placebo, randomized

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.

Interventions

DRUGMesalamine

3x1000mg mesalamine granules per day

DRUGPlacebo

3x1000mg placebo granules per day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

45 Years to 80 Years

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026