Two Doses Mesalazine Granules Versus Placebo for the Prevention of Recurrence of Diverticulitis
This study has been terminated.
Sponsor:
Dr. Falk Pharma GmbH
Information provided by (Responsible Party):
Dr. Falk Pharma GmbH
ClinicalTrials.gov Identifier:
NCT01038739
First received: December 22, 2009
Last updated: February 12, 2013
Last verified: February 2013
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Diverticulitis |
Drug: Mesalazine Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 |
Resource links provided by NLM:
Further study details as provided by Dr. Falk Pharma GmbH:
Primary Outcome Measures:
- Proportion of recurrence-free patients at 48 weeks and at 96 weeks: [ Time Frame: 48/96 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Time to recurrence [ Time Frame: 48/96 weeks ] [ Designated as safety issue: No ]
- Occurrence of diverticulitis-associated fever [ Time Frame: 48/96 weeks ] [ Designated as safety issue: No ]
- Number of days with left lower quadrant pain [ Time Frame: 48/96 weeks ] [ Designated as safety issue: No ]
- Stool consistency [ Time Frame: 48/96 weeks ] [ Designated as safety issue: No ]
- Severity of diarrhea [ Time Frame: 48/96 weeks ] [ Designated as safety issue: No ]
- Quality of Life (QoL) [ Time Frame: 48/96 weeks ] [ Designated as safety issue: No ]
- Health assessment [ Time Frame: 48/96 weeks ] [ Designated as safety issue: No ]
- Assessment of efficacy by investigator and patient [ Time Frame: 48/96 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 720 |
| Study Start Date: | January 2010 |
| Study Completion Date: | January 2013 |
| Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
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'.
Eligibility| Ages Eligible for Study: | 30 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01038739
Locations
| United States, Florida | |
| 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 |
More Information
No publications provided
| Responsible Party: | Dr. Falk Pharma GmbH |
| ClinicalTrials.gov Identifier: | NCT01038739 History of Changes |
| Other Study ID Numbers: | SAG-51/DIV, 2009-015158-39 |
| Study First Received: | December 22, 2009 |
| Last Updated: | February 12, 2013 |
| Health Authority: | United States: Food and Drug Administration Germany: Federal Institute for Drugs and Medical Devices |
Additional relevant MeSH terms:
|
Diverticulitis Recurrence Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Disease Attributes Pathologic Processes Mesalamine Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 19, 2013