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Cobiprostone Prevention of NSAID-induced Gastroduodenal Injury

NCT00597818 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2019-12-26

Study results available
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Summary

The primary purpose of this study is to determine the efficacy and safety of three dose levels of cobiprostone as compared to placebo in OA/RA patients treated with an NSAID for 20 months.

Conditions

Interventions

DRUG

Cobiprostone

18 mcg cobiprostone capsules for oral administration

DRUG

Placebo

Matching placebo capsules for oral administration

DRUG

Non-steroidal anti-inflammatory drug

Any marketed non-steroidal anti-inflammatory drug used by the participants as standard care.

Sponsors & Collaborators

  • Sucampo Pharma Americas, LLC

    lead INDUSTRY

Principal Investigators

  • Global Clinical Leader · Mallinckrodt

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2009-04-30
Completion
2009-05-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT00597818 on ClinicalTrials.gov