Clinical trial NCT01038739: 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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Diverticulitis
Lead sponsor: Dr. Falk Pharma GmbH
Sponsor class: INDUSTRY
First posted: 2009-12-24
Enrollment: 330
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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'.

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

Primary outcomes:
measure: Proportion of recurrence-free patients at 48 weeks and at 96 weeks:
timeFrame: 48/96 weeks
Secondary outcomes:
measure: Time to recurrence
timeFrame: 48/96 weeks
measure: Occurrence of diverticulitis-associated fever
timeFrame: 48/96 weeks
measure: Number of days with left lower quadrant pain
timeFrame: 48/96 weeks
measure: Stool consistency
timeFrame: 48/96 weeks
measure: Severity of diarrhea
timeFrame: 48/96 weeks
measure: Quality of Life (QoL)
timeFrame: 48/96 weeks
measure: Health assessment
timeFrame: 48/96 weeks
measure: Assessment of efficacy by investigator and patient
timeFrame: 48/96 weeks
Other outcomes:
Locations:
city: New Smyrna Beach
country: United States
facility: United Medical Research
state: Florida
Study officials:
affiliation: Evang. Krankenhaus Kalk, Medical department
name: Wolfgang Kruis, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.