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Home > "A" Clinical Trials Conditions > A Study of Persons with Gout who Do Not Respond to or Are Allergic to Conventional Therapy  A Study of Persons with Gout who Do Not Respond to or Are Allergic to Conventional Therapy
A Study of Persons with Gout who Do Not Respond to or Are Allergic to Conventional Therapy
For Condition: Gout
Status: Recruiting
Sponsor(s): Savient Pharmaceuticals ,
Synopsis: This is a randomized, open-label, multicenter, parallel-groups study of multiple intravenous doses of Puricase, administered intravenously, in 40 patients with symptomatic gout. Subjects must wash out of any uric acid-lowering agents for one week before being dosed, and must refrain from using such agents throughout the study.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/90 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: Subjects to be included in the study are: - Outpatients of either gender, age 18 or older - Diagnosed with symptomatic gout refractory to conventional therapy or unable to tolerate conventional therapy (for example: having one or more tophi and/or having experienced a gout flare within the previous 6 months and/or having chronic, gouty arthritis) - Hyperuricemic: screening serum uric acid must be >=8 mg/dL. - The patient must be willing and able to give informed consent and adhere to visit/protocol schedules (Consent must be given before any study procedures are performed) - Women of childbearing potential must have a negative serum pregnancy test and must use an approved birth control method during their participation in the protocol. Such methods include oral, injectable, or implantable contraceptives; IUDs and barrier contraceptives in combination with spermicide Exclusion Criteria: Subjects to be excluded are those for whom any of the following apply: - Unstable coronary artery disease or uncontrolled hypertension - History of end stage renal disease requiring dialysis - History of liver disease, as defined by baseline serum transaminase elevation >3X the upper limit of normal in the absence of any other known cause - Organ transplant recipient requiring immunosuppressive therapy - Concurrent use of prednisone at a dose >10 mg qd (or equivalent) at or within one week before dosing - Concurrent use of uric acid-lowering agents - Prior treatment with PuricaseĀ® or other recombinant uricase - An acute gout flare within one week prior to first treatment with PuricaseĀ® (exclusive of chronic synovitis/arthritis) requiring use of medication which violates the protocol - glucose-6-phosphate dehydrogenase deficiency - A history of anaphylactic reaction to a recombinant protein or porcine derivatives - Lactation - Has taken an investigational drug within 4 weeks prior to study drug administration or plans to take an investigational agent during the study - Known allergy to urate oxidase or PEGylated products - Has any other medical or psychological condition which, in the opinion of the investigator, might create undue risk to the patient or interfere with the patientās ability to comply with the protocol requirements
Total Enrollment: 40
Location and Contact Information:
Pride Clinical research Associates *Recruiting*
Pittsburgh, Pennsylvania, 15219
United States
Recruiting Lisa Zeman 412-232-7986
University of Chicago Dept of Medicine *Not yet recruiting*
Chicago, Illinois, 60637
United States
Not yet recruiting Harry Jones 773-834-0223
University of California, San Diego *Not yet recruiting*
La Jolla, California, 92037
United States
Not yet recruiting Merita Halilhodzic 858-657-7048
Duke University Medical Center *Recruiting*
Durham, North Carolina, 27710
United States
Recruiting Edna Scarlett 919-684-6150
Center for Rheumatology and Bone Research *Recruiting*
Wheaton, Maryland, 20902
United States
Recruiting Sheila Kim 301-942-6610
Spain Rehabilitation Center *Not yet recruiting*
Birmingham, Alabama, 35294
United States
Not yet recruiting Paula McKenzie 205-932-2981
Oregon Health & Science University Arthritis & Rheumatic Diseases *Not yet recruiting*
Portland, Oregon, 97239
United States
Not yet recruiting Lindsey Brown 503-494-5571
Additional Information:
Study ID Numbers: C0403;
Study Start Date: March 2004
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00080210
Other Gout Studies:
1. A Study of Persons with Gout who Do Not Respond to or Are Allergic to Conventional Therapy
Related Studies:
Other Gout Clinical Trials
Other California Clinical Trials
Other La Jolla Clinical Trials
A Study of Persons with Gout who Do Not Respond to or Are Allergic to Conventional Therapy
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