Two Doses Mesalazine Granules Versus Placebo for the Prevention of Recurrence of Diverticulitis

Phase 3

Terminated

• Conditions: Diverticulitis
• Interventions: Drug: Placebo; Drug: Mesalazine

• Registration Number: NCT01038739
• Lead Sponsor: Dr. Falk Pharma GmbH

Brief Summary

The purpose of the study is to determine which dose of mesalazine granules compared to placebo is more effective in the prevention of recurrence of disease.

Detailed Description

The primary purpose of the study is to demonstrate the superiority of mesalazine granules compared to placebo in terms of the two primary efficacy variables 'proportion of recurrence-free patients within 48 weeks' and 'proportion of recurrence-free patients within 96 weeks'.

Study Timeline

• Study First Submitted: 2009-12-22
• Study First Submitted QC: 2009-12-23
• Study First Posted: 2009-12-24
• Study Start: 2010-01
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Disposition First Submitted: 2017-06-21
• Disposition First Submitted QC: 2017-06-21
• Disposition First Posted: 2017-06-26
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-20
• Last Update Posted: 2017-07-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 330

Inclusion Criteria

• Diagnosis of left-sided uncomplicated diverticular disease confirmed by computed tomography
• Presence of at least one diverticulum of the left colon
• Most recent attack of left-sided uncomplicated diverticulitis responding to antibiotics and/or dietary modification within the last 6 months
• C-reactive protein (CRP) > upper limit of normal (ULN) or leucocytosis at the start of the most recent attack

Exclusion Criteria

• Complicated diverticular disease
• Right-sided diverticulitis
• Previous colonic surgery
• Presence of symptomatic organic disease of the gastrointestinal tract
• Active colorectal cancer or a history of colorectal cancer
• Hemorrhagic diathesis
• Active peptic ulcer disease, local intestinal infection
• Asthma if careful medical monitoring is not ensured
• Abnormal hepatic function or liver cirrhosis
• Abnormal renal function

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
C	Placebo	-
A	Mesalazine	-
B	Mesalazine	-

Primary Outcome Measures

Name	Time	Method
Proportion of recurrence-free patients at 48 weeks and at 96 weeks:	48/96 weeks

Secondary Outcome Measures

Name	Time	Method
Assessment of efficacy by investigator and patient	48/96 weeks
Severity of diarrhea	48/96 weeks
Health assessment	48/96 weeks
Time to recurrence	48/96 weeks
Occurrence of diverticulitis-associated fever	48/96 weeks
Number of days with left lower quadrant pain	48/96 weeks
Stool consistency	48/96 weeks
Quality of Life (QoL)	48/96 weeks

Trial Locations

Locations (1)

United Medical Research; 🇺🇸 New Smyrna Beach, Florida, United States