Mesalazine Granules vs. Placebo for the Prevention of Recurrence of Diverticulitis

• Sponsor: Dr. Falk Pharma GmbH (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00695643
• Collaborator: (none)
• Enrollment: 345
• Location: 1
• Arms: 2
• Duration (Months): 48
• Patients Per Site Per Month: 7.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Diverticulitis	Drug: Mesalazine; Drug: Placebo	Phase 3

Detailed Description

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 345 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Double-blind, Randomized, Placebo-controlled, Parallel Group, Multi-centre Phase III Clinical Study on the Efficacy and Tolerability of Mesalazine Granules vs. Placebo for the Prevention of Recurrence of Diverticulitis
• Study Start Date: Jan 1, 2008
• Actual Primary Completion Date: Nov 1, 2011
• Actual Study Completion Date: Jan 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A	Drug: Mesalazine; 3 g per day
Placebo Comparator: B	Drug: Placebo; 0 g per day

Outcome Measures

Primary Outcome Measures

1. Proportion of recurrence-free patients within 48 weeks [48 weeks]

Secondary Outcome Measures

1. Time to recurrence []

2. Occurrence of diverticulitis-associated fever [48 weeks]

3. Number of days with left lower quadrant pain [48 weeks]

4. Stool consistency [48 weeks]

5. Severity of diarrhea [48 weeks]

6. Quality of Life (QoL) [48 weeks]

7. Health assessment [48 weeks]

8. Assessment of efficacy by investigator and patient [48 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Diagnosis of left-sided uncomplicated diverticular disease confirmed by ultrasonography or 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) 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Evang. Krankenhaus Kalk, Medical department	Cologne		Germany	51103

Sponsors and Collaborators

• Dr. Falk Pharma GmbH

Investigators

• Principal Investigator: Wolfgang Kruis, Professor, Evang. Krankenhaus Kalk, Medical department

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. Falk Pharma GmbH
• ClinicalTrials.gov Identifier: NCT00695643
• Other Study ID Numbers: SAG-37/DIV; 2007-000680-22
• First Posted: Jun 12, 2008
• Last Update Posted: Jul 24, 2017
• Last Verified: Jul 1, 2017

• Additional relevant MeSH terms: Diverticulitis; Recurrence; Mesalamine

Study Results

No Results Posted as of Jul 24, 2017