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

Diverticulitis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00695643
• Other study ID #: SAG-37/DIV
• Secondary ID: 2007-000680-22
• Status: Terminated
• Phase: Phase 3
• First received: June 10, 2008
• Last updated: July 20, 2017
• Start date: January 2008
• Est. completion date: January 2012

Study information

• Verified date: July 2017
• Source: Dr. Falk Pharma GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 345
• Est. completion date: January 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diverticulitis
• Recurrence

Intervention

Drug:
• Mesalazine
3 g per day
• Placebo
0 g per day

Locations

Country	Name	City	State
Germany	Evang. Krankenhaus Kalk, Medical department	Cologne

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Falk Pharma GmbH

Country where clinical trial is conducted

Germany, 

References & Publications (3)

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. — View 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. — View 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, Björck S, Diez Alonso MM, Mäkelä J, Talley NJ, Dilger K, Gre — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of recurrence-free patients within 48 weeks		48 weeks
Secondary	Time to recurrence
Secondary	Occurrence of diverticulitis-associated fever		48 weeks
Secondary	Number of days with left lower quadrant pain		48 weeks
Secondary	Stool consistency		48 weeks
Secondary	Severity of diarrhea		48 weeks
Secondary	Quality of Life (QoL)		48 weeks
Secondary	Health assessment		48 weeks
Secondary	Assessment of efficacy by investigator and patient		48 weeks