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

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Dr. Falk Pharma

Status and phase

Terminated
Phase 3

Conditions

Diverticulitis

Treatments

Drug: Mesalazine
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01038739
SAG-51/DIV
2009-015158-39 (Other Identifier)

Details and patient eligibility

About

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.

Full 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'.

Enrollment

330 patients

Sex

All

Ages

30 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

330 participants in 3 patient groups, including a placebo group

A
Experimental group
Treatment:
Drug: Mesalazine
B
Experimental group
Treatment:
Drug: Mesalazine
C
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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