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

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ClinicalTrials.gov Identifier: NCT00695643
Recruitment Status : Terminated
First Posted : June 12, 2008
Last Update Posted : July 24, 2017
Sponsor:
Information provided by (Responsible Party):

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  (Clinical Trial)
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 : January 2008
Primary Completion Date : November 2011
Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 [ Time Frame: 48 weeks ]

Secondary Outcome Measures :
  1. Time to recurrence
  2. Occurrence of diverticulitis-associated fever [ Time Frame: 48 weeks ]
  3. Number of days with left lower quadrant pain [ Time Frame: 48 weeks ]
  4. Stool consistency [ Time Frame: 48 weeks ]
  5. Severity of diarrhea [ Time Frame: 48 weeks ]
  6. Quality of Life (QoL) [ Time Frame: 48 weeks ]
  7. Health assessment [ Time Frame: 48 weeks ]
  8. Assessment of efficacy by investigator and patient [ Time Frame: 48 weeks ]

Eligibility Criteria

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00695643


Locations
Germany
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
More Information

Publications:
Responsible Party: Dr. Falk Pharma GmbH
ClinicalTrials.gov Identifier: NCT00695643     History of Changes
Other Study ID Numbers: SAG-37/DIV
2007-000680-22 ( EudraCT Number )
First Posted: June 12, 2008    Key Record Dates
Last Update Posted: July 24, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Recurrence
Diverticulitis
Disease Attributes
Pathologic Processes
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mesalamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents