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

Diverticulitis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01038739
• Other study ID #: SAG-51/DIV
• Secondary ID: 2009-015158-39
• Status: Terminated
• Phase: Phase 3
• First received: December 22, 2009
• Last updated: July 20, 2017
• Start date: January 2010
• Est. completion date: January 2013

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 which dose of mesalazine granules compared to placebo is more effective in the prevention of recurrence of disease.

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'.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 330
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diverticulitis
• Recurrence

Intervention

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

Locations

Country	Name	City	State
United States	United Medical Research	New Smyrna Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Falk Pharma GmbH

Country where clinical trial is conducted

United States, 

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 at 48 weeks and at 96 weeks:		48/96 weeks
Secondary	Time to recurrence		48/96 weeks
Secondary	Occurrence of diverticulitis-associated fever		48/96 weeks
Secondary	Number of days with left lower quadrant pain		48/96 weeks
Secondary	Stool consistency		48/96 weeks
Secondary	Severity of diarrhea		48/96 weeks
Secondary	Quality of Life (QoL)		48/96 weeks
Secondary	Health assessment		48/96 weeks
Secondary	Assessment of efficacy by investigator and patient		48/96 weeks