Mesalazine Granules vs. Placebo for the Prevention of Recurrence of Diverticulitis
Information source: Dr. Falk Pharma GmbH
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diverticulitis
Intervention: Mesalazine (Drug); Placebo (Drug)
Phase: Phase 3
Status: Terminated
Sponsored by: Dr. Falk Pharma GmbH Official(s) and/or principal investigator(s): Wolfgang Kruis, Professor, Principal Investigator, Affiliation: Evang. Krankenhaus Kalk, Medical department
Summary
The purpose of the study is to determine whether mesalazine granules compared to placebo is
effective in prevention of recurrence of disease.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Proportion of recurrence-free patients within 48 weeks
Secondary outcome: Time to recurrenceOccurrence of diverticulitis-associated fever Number of days with left lower quadrant pain Stool consistency Severity of diarrhea Quality of Life (QoL) Health assessment Assessment of efficacy by investigator and patient
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.
Eligibility
Minimum age: 40 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
Locations and Contacts
Evang. Krankenhaus Kalk, Medical department, Cologne 51103, Germany
Additional Information
Starting date: January 2008
Last updated: May 16, 2014
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