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Prevention of Recurrence of Diverticulitis

NCT00545103 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 592

Last updated 2021-06-11

Study results available
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Summary

The purpose of this study is to determine whether SPD476 is effective in reducing recurrence of diverticulitis.

Conditions

  • Diverticulitis

Interventions

DRUG

SPD476, MMX™ mesalazine, 1.2g extended release tablet

SPD476 1.2g administered Once Daily (QD)

DRUG

SPD476, MMX™ mesalazine, 2.4g extended release tablet

SPD476 2.4g administered Once Daily (QD)

DRUG

SPD476, MMX™ mesalazine, 4.8g extended release tablet

SPD476 4.8g administered Once Daily (QD)

DRUG

Placebo

Placebo administered Once Daily (QD)

Sponsors & Collaborators

  • Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-06
Primary Completion
2011-11-28
Completion
2011-11-28

Countries

  • United States
  • Brazil
  • Canada
  • Finland
  • Germany
  • Hungary
  • Italy
  • Netherlands
  • Romania
  • South Africa

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 NCT00545103 on ClinicalTrials.gov