DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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 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

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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017