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Mesalazine Granules vs. Placebo for the Prevention of Recurrence of Diverticulitis

Primary Purpose

Diverticulitis

Status
Terminated
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Mesalazine
Placebo
Sponsored by
Dr. Falk Pharma GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diverticulitis

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Evang. Krankenhaus Kalk, Medical department

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

A

B

Arm Description

Outcomes

Primary Outcome Measures

Proportion of recurrence-free patients within 48 weeks

Secondary Outcome Measures

Time to recurrence
Occurrence 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

Full Information

First Posted
June 10, 2008
Last Updated
July 20, 2017
Sponsor
Dr. Falk Pharma GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT00695643
Brief Title
Mesalazine Granules vs. Placebo for the Prevention of Recurrence of Diverticulitis
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 Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Terminated
Study Start Date
January 2008 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dr. Falk Pharma GmbH

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of the study is to determine whether mesalazine granules compared to placebo is effective in prevention of recurrence of disease.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diverticulitis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
345 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Mesalazine
Intervention Description
3 g per day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
0 g per day
Primary Outcome Measure Information:
Title
Proportion of recurrence-free patients within 48 weeks
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
Time to recurrence
Title
Occurrence of diverticulitis-associated fever
Time Frame
48 weeks
Title
Number of days with left lower quadrant pain
Time Frame
48 weeks
Title
Stool consistency
Time Frame
48 weeks
Title
Severity of diarrhea
Time Frame
48 weeks
Title
Quality of Life (QoL)
Time Frame
48 weeks
Title
Health assessment
Time Frame
48 weeks
Title
Assessment of efficacy by investigator and patient
Time Frame
48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wolfgang Kruis, Professor
Organizational Affiliation
Evang. Krankenhaus Kalk, Medical department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Evang. Krankenhaus Kalk, Medical department
City
Cologne
ZIP/Postal Code
51103
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
28543263
Citation
Kruis W, Kardalinos V, Eisenbach T, Lukas M, Vich T, Bunganic I, Pokrotnieks J, Derova J, Kondrackiene J, Safadi R, Tuculanu D, Tulassay Z, Banai J, Curtin A, Dorofeyev AE, Zakko SF, Ferreira N, Bjorck S, Diez Alonso MM, Makela J, Talley NJ, Dilger K, Greinwald R, Mohrbacher R, Spiller R. Randomised clinical trial: mesalazine versus placebo in the prevention of diverticulitis recurrence. Aliment Pharmacol Ther. 2017 Aug;46(3):282-291. doi: 10.1111/apt.14152. Epub 2017 May 23.
Results Reference
result
PubMed Identifier
28707796
Citation
Gracie DJ, Ford AC. Editorial: mesalazine to prevent recurrent acute diverticulitis-the final nail in the coffin. Aliment Pharmacol Ther. 2017 Aug;46(4):461-462. doi: 10.1111/apt.14180. No abstract available.
Results Reference
result
PubMed Identifier
28707787
Citation
Kruis W, Greinwald R. Editorial: mesalazine to prevent recurrent acute diverticulitis-the final nail in the coffin. Authors' reply. Aliment Pharmacol Ther. 2017 Aug;46(4):462-463. doi: 10.1111/apt.14193. No abstract available.
Results Reference
result

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Mesalazine Granules vs. Placebo for the Prevention of Recurrence of Diverticulitis

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