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

Sponsor
Dr. Falk Pharma GmbH (Industry)
Overall Status
Terminated
CT.gov ID
NCT01038739
Collaborator
(none)
330
Enrollment
1
Location
3
Arms
36
Duration (Months)
9.2
Patients Per Site Per Month

Study Details

Study Description

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
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 Design

Study Type:
Interventional
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 :
Jan 1, 2010
Actual Primary Completion Date :
Jan 1, 2013
Actual Study Completion Date :
Jan 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Proportion of recurrence-free patients at 48 weeks and at 96 weeks: [48/96 weeks]

Secondary Outcome Measures

  1. Time to recurrence [48/96 weeks]

  2. Occurrence of diverticulitis-associated fever [48/96 weeks]

  3. Number of days with left lower quadrant pain [48/96 weeks]

  4. Stool consistency [48/96 weeks]

  5. Severity of diarrhea [48/96 weeks]

  6. Quality of Life (QoL) [48/96 weeks]

  7. Health assessment [48/96 weeks]

  8. Assessment of efficacy by investigator and patient [48/96 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr. Falk Pharma GmbH
ClinicalTrials.gov Identifier:
NCT01038739
Other Study ID Numbers:
  • SAG-51/DIV
  • 2009-015158-39
First Posted:
Dec 24, 2009
Last Update Posted:
Jul 21, 2017
Last Verified:
Jul 1, 2017
Additional relevant MeSH terms:
Diverticulitis
Recurrence
Mesalamine

Study Results

No Results Posted as of Jul 21, 2017