Apremilast Therapy for Acute Gouty Arthritis

Conditions

• Acute Gout

Eligibility Criteria

Sex

MALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• apremilast — DRUG
  apremilast 20 mg taken twice daily by mouth
• indomethacin SR — DRUG
  indomethacin SR 75 mg taken twice daily by mouth

Study Details

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.

Key Dates

First listed

Oct 19, 2009

Start date

Apr 30, 2010

Status verified

Mar 2018

Primary completion

Dec 31, 2010

Completion

Dec 31, 2010

Study Design

Enrollment

0 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: apremilast
  Experimental treatment for acute gout
• Active Comparator: indomethacin
  Medication currently used for the treatment of acute gout

Primary Outcome Measure

Subject-reported number of swollen joints, the number of tender joints, the number of warm joints, as well as self-report pain, global assessment, and functional status. Subject-reported time to resolution of symptoms will be measured. [ Time Frame: Day 1, Day 7 and Day 21. ]

Locations (1)

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