TerminatedNCT00695643Updated Jul 24, 2017

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

A Phase 3 interventional study of Mesalazine and Placebo in Diverticulitis, sponsored by Dr. Falk Pharma GmbH. Terminated at 1 site in Germany. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-07-24.

Sponsored by Dr. Falk Pharma GmbH · Phase 3, Interventional, and Prevention

Phase: Phase 3
Study type: Interventional
Enrollment: 345
Allocation: Randomized
Ages: 40 Years to 80 Years
Sex: All

Study summary

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

Read the 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.

Conditions studied

Diverticulitis

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In context

Diverticulitis

146 studies on the registry are indexed under Diverticulitis; 26 are open to participants now.

This study's enrollment of 345 is above the median of 120 across 71 interventional studies indexed under Diverticulitis.

Browse Diverticulitis studies →

Lead sponsor

Dr. Falk Pharma GmbH is the lead sponsor of 38 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 40 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Study design

Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 345 participants (actual)

Study arms

Experimental
A
Drug: Mesalazine
Placebo comparator
B
Drug: Placebo

Interventions

DrugMesalazine
3 g per day
DrugPlacebo
0 g per day

What researchers measure

Primary outcomes

Proportion of recurrence-free patients within 48 weeks
Time frame: 48 weeks

Secondary outcomes

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

Study locations

1 site

Evang. Krankenhaus Kalk, Medical department
Cologne, 51103, Germany

References and documents

Publications

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. PubMed 28543263 ↗
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. PubMed 28707796 ↗
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. PubMed 28707787 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 24, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00695643
Lead sponsor: Dr. Falk Pharma GmbH
Responsible party: Sponsor
First posted: Jun 12, 2008
Start date: Jan 2008
Primary completion: Nov 2011
Completion: Jan 2012
Last update: Jul 24, 2017

Study contacts

Wolfgang Kruis, Professor

principal investigator · Evang. Krankenhaus Kalk, Medical department

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.

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