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

This study has been terminated.
(Stopped due to futility.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01038739
First Posted: December 24, 2009
Last Update Posted: July 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. Falk Pharma GmbH
  Purpose
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.

Condition Intervention Phase
Diverticulitis Drug: Mesalazine Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Double-blind, Dose-response, Randomised, 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 at 48 weeks and at 96 weeks: [ Time Frame: 48/96 weeks ]

Secondary Outcome Measures:
  • Time to recurrence [ Time Frame: 48/96 weeks ]
  • Occurrence of diverticulitis-associated fever [ Time Frame: 48/96 weeks ]
  • Number of days with left lower quadrant pain [ Time Frame: 48/96 weeks ]
  • Stool consistency [ Time Frame: 48/96 weeks ]
  • Severity of diarrhea [ Time Frame: 48/96 weeks ]
  • Quality of Life (QoL) [ Time Frame: 48/96 weeks ]
  • Health assessment [ Time Frame: 48/96 weeks ]
  • Assessment of efficacy by investigator and patient [ Time Frame: 48/96 weeks ]

Enrollment: 330
Study Start Date: January 2010
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: Mesalazine
1.5 g per day
Experimental: B Drug: Mesalazine
3 g per day
Placebo Comparator: C Drug: Placebo
0 g per day

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'.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 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 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
  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): NCT01038739


Locations
United States, Florida
United Medical Research
New Smyrna Beach, Florida, United States, 32168
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: NCT01038739     History of Changes
Other Study ID Numbers: SAG-51/DIV
2009-015158-39 ( Other Identifier: Eudract )
First Submitted: December 22, 2009
First Posted: December 24, 2009
Last Update Posted: July 21, 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