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

Phase 3

Completed

• Conditions: diverticulitis; pouch formations of the intestinal wall; 10013535

• Registration Number: NL-OMON35257
• Lead Sponsor: Dr. Falk Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 70

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 antibiotis and/or dietary modifications within the last 6 months.
3 or more of the following symptoms documented at the start of the most recent attack:
- left lower quadrant pain
- fever (higher than 38°C by rectal measurement)
- altered bowel habit (diarrhea, constipation, passage of mucus, or urgency)
- systemic upset (nausea, lethargy)
CRP > ULN or leucocytosis (> 10 000/mm³) at the start of the most recent attack

Exclusion Criteria

Chronic inflammatory bowel disease.
Complicated diverticular disease (diverticulitis with associated abscess, fistula, obstruction or perforation)
Right-sided diverticulitis.
Presence of symptomatic organic disease of the gastrointestinal tract.
Only patients planned for CT: hyperthyroidism, history of hypersensitivity to iodine or iodinated contrast media, congestive heart failure (NYHA III/IV), multiple myeloma, diabetes with need of drug treatment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Proportion of recurrence-free patients within 48 weeks: Recurrence of<br /><br>diverticulitis, defined as CRP > ULN or after leucocytosis and recurrence of<br /><br>diverticulitis-like symptoms (left lower quadrant pain, fever) with associated<br /><br>clinical, biochemical parameters or confirmation by ultrasonography or computed<br /><br>tomography</p><br>