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

This study has been terminated.
Information provided by (Responsible Party):
Dr. Falk Pharma GmbH Identifier:
First received: June 10, 2008
Last updated: May 16, 2014
Last verified: May 2014
The purpose of the study is to determine whether mesalazine granules compared to placebo is effective in prevention of recurrence of disease.

Condition Intervention Phase
Drug: Mesalazine
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

Further study details as provided by Dr. Falk Pharma GmbH:

Primary Outcome Measures:
  • Proportion of recurrence-free patients within 48 weeks [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to recurrence [ Designated as safety issue: No ]
  • Occurrence of diverticulitis-associated fever [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Number of days with left lower quadrant pain [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Stool consistency [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Severity of diarrhea [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Quality of Life (QoL) [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Health assessment [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Assessment of efficacy by investigator and patient [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Enrollment: 345
Study Start Date: January 2008
Study Completion Date: January 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: Mesalazine
3 g per day
Placebo Comparator: B Drug: Placebo
0 g per day

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.

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its identifier: NCT00695643

Evang. Krankenhaus Kalk, Medical department
Cologne, Germany, 51103
Sponsors and Collaborators
Dr. Falk Pharma GmbH
Principal Investigator: Wolfgang Kruis, Professor Evang. Krankenhaus Kalk, Medical department
  More Information

Responsible Party: Dr. Falk Pharma GmbH Identifier: NCT00695643     History of Changes
Other Study ID Numbers: SAG-37/DIV  2007-000680-22 
Study First Received: June 10, 2008
Last Updated: May 16, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Digestive System Diseases
Gastrointestinal Diseases
Intraabdominal Infections
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents processed this record on May 22, 2016