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Apremilast Therapy for Acute Gouty Arthritis

NCT00997581 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2018-04-02

No results posted yet for this study

Summary

The purpose of the study is to learn about a possible new medicine, apremilast, for treating acute gout and compare how it works to indomethacin, a medication that has been used to treat gout for over 50 years.

In order to learn about apremilast, half the participants in this study will receive apremilast and half the participants in this study will receive indomethacin.

This study will measure the severity and duration of acute gout attacks in research participants, as well as measures of quality of life and any side effects or adverse reactions to the medication.

There will be three study visits: a screening/baseline visit on Day 1, a visit to evaluate response to treatment with study medication at Day 7, and a follow-up visit at Day 21.

Conditions

  • Acute Gout

Interventions

DRUG

apremilast

apremilast 20 mg taken twice daily by mouth

DRUG

indomethacin SR

indomethacin SR 75 mg taken twice daily by mouth

Sponsors & Collaborators

  • Celgene Corporation

    collaborator INDUSTRY

  • Dartmouth-Hitchcock Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • United States

Study Locations

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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 NCT00997581 on ClinicalTrials.gov