NCT01038739

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
330

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2010

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 24, 2009

Completed
8 days until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

July 21, 2017

Status Verified

July 1, 2017

Enrollment Period

3 years

First QC Date

December 22, 2009

Last Update Submit

July 20, 2017

Conditions

Diverticulitis

Outcome Measures

Primary Outcomes (1)

  • Proportion of recurrence-free patients at 48 weeks and at 96 weeks:

    48/96 weeks

Secondary Outcomes (8)

  • Time to recurrence

    48/96 weeks

  • Occurrence of diverticulitis-associated fever

    48/96 weeks

  • Number of days with left lower quadrant pain

    48/96 weeks

  • Stool consistency

    48/96 weeks

  • Severity of diarrhea

    48/96 weeks

  • +3 more secondary outcomes

Study Arms (3)

A

EXPERIMENTAL
Drug: Mesalazine

B

EXPERIMENTAL
Drug: Mesalazine

C

PLACEBO COMPARATOR
Drug: Placebo

Interventions

MesalazineDRUG

3 g per day

B
PlaceboDRUG

0 g per day

C

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

United Medical Research

New Smyrna Beach, Florida, 32168, United States

Location

Related Publications (3)

  • 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.

    PMID: 28543263RESULT

  • 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.

    PMID: 28707796RESULT

  • 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.

    PMID: 28707787RESULT

MeSH Terms

Conditions

Diverticulitis

Interventions

Mesalamine

Condition Hierarchy (Ancestors)

Diverticular DiseasesGastroenteritisGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

meta-AminobenzoatesAminobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsAminosalicylic AcidsSalicylatesHydroxybenzoatesHydroxy AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenols

Study Officials

  • Wolfgang Kruis, Professor

    Evang. Krankenhaus Kalk, Medical department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2009

First Posted

December 24, 2009

Study Start

January 1, 2010

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

July 21, 2017

Record last verified: 2017-07

Locations

US(1)