Status:
WITHDRAWN
Apremilast Therapy for Acute Gouty Arthritis
Lead Sponsor:
Dartmouth-Hitchcock Medical Center
Collaborating Sponsors:
Celgene Corporation
Conditions:
Acute Gout
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief 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...
Detailed Description
WITHDRAWN
Eligibility Criteria
Inclusion
- Must understand and voluntarily sign the informed consent
- Must have the diagnosis of gout proven by identification of urate crystals from body fluids
- Must be male age \>18 years at the time of consent
- Must be able to adhere to the study visit schedule and other protocol requirements
- Must meet the following laboratory criteria:
- Hemoglobin \> 9.0 g/dL
- White blood cell (WBC) count \> 3000/μL and \< 14,000/μL
- Platelet count \>100,000/μL
- Serum creatinine \< 2.0mg/dL
- Total bilirubin \< 2.0 mg/dL
- Aspartate transaminase (AST) and alanine transaminase (ALT) \<1.5 X upper limit of normal
- Males, including those who have had a vasectomy, must agree to use barrier contraception (latex condom) when engaging in sexual activity with a female of child-bearing potential (FCBP) while on study medications and for 84 days after taking the last does of the medication
Exclusion
- Inability to provide voluntary consent
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he were to participate in the study or confounds the ability to interpret the data from the study
- Females
- Systemic fungal infection
- History of recurrent bacterial infection (at least 3 major infections resulting in hospitalization and/or requiring intravenous antibiotic treatment in the past 2 years
- An active infection at presentation
- Use of any investigational medication within 4 weeks prior to start of study or 5 pharmacokinetic/pharmacodynamic half-lives, whichever is longer
- Any use of corticosteroids, cyclosporine, methotrexate, cyclophosphamide, azathioprine, mycophenolate within 4 weeks prior to start of study
- Any clinically significant abnormality on 12-lead ECG screening
- Malignancy or history of malignancy (except for treated and cured basal-cell skin carcinomas \> 3 years prior to screening)
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00997581
Start Date
April 1 2010
End Date
December 1 2010
Last Update
April 2 2018
Active Locations (1)
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1
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756