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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:
Information provided by (Responsible Party):
Dr. Falk Pharma GmbH
ClinicalTrials.gov Identifier:
NCT01038739
First received: December 22, 2009
Last updated: May 15, 2014
Last verified: May 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to recurrence [ Time Frame: 48/96 weeks ] [ Designated as safety issue: No ]
  • Occurrence of diverticulitis-associated fever [ Time Frame: 48/96 weeks ] [ Designated as safety issue: No ]
  • Number of days with left lower quadrant pain [ Time Frame: 48/96 weeks ] [ Designated as safety issue: No ]
  • Stool consistency [ Time Frame: 48/96 weeks ] [ Designated as safety issue: No ]
  • Severity of diarrhea [ Time Frame: 48/96 weeks ] [ Designated as safety issue: No ]
  • Quality of Life (QoL) [ Time Frame: 48/96 weeks ] [ Designated as safety issue: No ]
  • Health assessment [ Time Frame: 48/96 weeks ] [ Designated as safety issue: No ]
  • Assessment of efficacy by investigator and patient [ Time Frame: 48/96 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr. Falk Pharma GmbH
ClinicalTrials.gov Identifier: NCT01038739     History of Changes
Other Study ID Numbers: SAG-51/DIV, 2009-015158-39
Study First Received: December 22, 2009
Last Updated: May 15, 2014
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on November 25, 2014