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

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ClinicalTrials.gov Identifier: NCT01038739
Recruitment Status : Terminated (Stopped due to futility.)
First Posted : December 24, 2009
Last Update Posted : July 21, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Diverticulitis Drug: Mesalazine Drug: Placebo Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 330 participants
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
Study Start Date : January 2010
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Proportion of recurrence-free patients at 48 weeks and at 96 weeks: [ Time Frame: 48/96 weeks ]

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


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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
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

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

Publications of Results:
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 Posted: December 24, 2009    Key Record Dates
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