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

Primary Purpose

Diverticulitis

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Mesalazine
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

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

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

Sites / Locations

  • United Medical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

A

B

C

Arm Description

Outcomes

Primary Outcome Measures

Proportion of recurrence-free patients at 48 weeks and at 96 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
December 22, 2009
Last Updated
July 20, 2017
Sponsor
Dr. Falk Pharma GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT01038739
Brief Title
Two Doses Mesalazine Granules Versus Placebo for the Prevention of Recurrence of Diverticulitis
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 Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Terminated
Why Stopped
Stopped due to futility.
Study Start Date
January 2010 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (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 which dose of mesalazine granules compared to placebo is more effective in the prevention of recurrence of disease.
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'.

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
330 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Experimental
Arm Title
C
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Mesalazine
Intervention Description
3 g per day
Intervention Type
Drug
Intervention Name(s)
Mesalazine
Intervention Description
1.5 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 at 48 weeks and at 96 weeks:
Time Frame
48/96 weeks
Secondary Outcome Measure Information:
Title
Time to recurrence
Time Frame
48/96 weeks
Title
Occurrence of diverticulitis-associated fever
Time Frame
48/96 weeks
Title
Number of days with left lower quadrant pain
Time Frame
48/96 weeks
Title
Stool consistency
Time Frame
48/96 weeks
Title
Severity of diarrhea
Time Frame
48/96 weeks
Title
Quality of Life (QoL)
Time Frame
48/96 weeks
Title
Health assessment
Time Frame
48/96 weeks
Title
Assessment of efficacy by investigator and patient
Time Frame
48/96 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 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 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
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
United Medical Research
City
New Smyrna Beach
State/Province
Florida
ZIP/Postal Code
32168
Country
United States

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

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