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Asacol Acute Diverticulitis(DIVA)Study

NCT00554099 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 117

Last updated 2013-04-22

Study results available
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Summary

The purpose of this study is to determine whether Asacol® 2.4 g/day (400 mg Mesalamine) is safe and effective in the treatment of diverticulitis.

Conditions

  • Diverticulitis

Interventions

DRUG

Mesalamine

6 - 400 mg tablets once daily

DRUG

Probiotic

Once capsule daily Bifidobacterium infantis 35624 added at Visit 2 (Day 10 + 4 days)

DRUG

Placebo

6 placebo tablets for first 10 (+4) days followed by once daily placebo tablets.

OTHER

Dietary Advice

Dietary advice

DRUG

Antibiotic for Diverticulitis

Physician recommended antibiotic for Diverticulitis taken for 10-14 days. Antibiotic not specified for study.

Sponsors & Collaborators

  • Warner Chilcott

    lead INDUSTRY

Principal Investigators

  • Ana Balske, MD, PhD · Procter and Gamble

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2010-03-31
Completion
2010-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00554099 on ClinicalTrials.gov