Allopurinol Combination Study - NCT01001338-32720 (Clinical Trial 462117)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy462117.aspx
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| City: |
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DeLand |
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State:
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FL |
| Zip Code: |
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32720 |
| Conditions: |
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Gout |
| Purpose: |
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To compare the proportion of subjects whose serum urate (sUA) levels are < 6.0 mg/dL
following 4 weeks of continuous treatment of RDEA594 in combination with allopurinol to
allopurinol alone in subjects with documented inadequate hypouricemic response with standard
doses of allopurinol.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
1. Male or a post-menopausal or surgically sterile female.
2. 18 - 75 years of age.
3. Has been taking allopurinol as the sole urate lowering therapy for hyperuricemia for
at least 3 months at a dose of 300 mg per day without an adequate response.
4. Has a sUA level ≥ 6 mg/dL at screening.
5. Meets criteria for the diagnosis of gout as per the American Rheumatism Association
(ARA) Criteria for the Classification of Acute Arthritis of Primary Gout.
6. Willing and able to give informed consent and adhere to visit/protocol schedules
(informed consent must be given before the first study procedure is performed).
Exclusion Criteria:
1. Consumes more than 14 drinks of alcohol per week (e.g., 1 drink = 5 oz [150 ml] of
wine, 12 oz [360 ml] of beer, or 1.5 oz [45 ml] of hard liquor).
2. History or suspicion of drug abuse.
3. History of documented or suspected kidney stones.
4. History of rheumatoid arthritis or other autoimmune disease.
5. Documented or suspicion of HIV infection.
6. Positive serology to HCV antibodies (Abs), and/or hepatitis B surface antigen
(HBsAg).
7. History of malignancy, except treated non-melanomatous skin cancer or cervical
dysplasia.
8. History of cardiac abnormalities, including abnormal and clinically relevant ECG
changes
9. Any condition predisposing to QT prolongation including pathological Q-wave (defined
as Q-wave >40 msec or depth > 0.4-0.5 mV).
10. Any use of concomitant medications that prolong the QT/QTc interval within the 14
days prior to Baseline (Day 1).
11. QT interval corrected for heart rate according to Fridericia (QTcF) > 450 msec at
Screening or pre-dose at Baseline (Day 1).
12. Uncontrolled hypertension (above 150/95).
13. Inadequate renal function [serum creatinine >1.5 mg/dL or creatinine clearance < 60
mL/min (by Cockroft-Gault formula)].
14. Hemoglobin < 10 g/dL (males) or < 9 g/dL (females).
15. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 x upper
limit of normal (ULN).
16. Gamma glutamyl transferase (GGT) > 3 x ULN.
17. Active peptic ulcer disease requiring treatment.
18. History of xanthinuria, active liver disease, or hepatic dysfunction.
19. Requires therapy with any other urate-lowering medication, other than the study
medications.
20. Requires long-term use of salicylates; diuretics; losartan; azathioprine;
mercaptopurine; theophylline; intravenous colchicine; cyclosporine; cyclophosphamide;
pyrazinamide; sulfamethoxazole; or trimethoprim.
21. Taking medications known as enzyme inducers (see section 3.7 for listing).
22. Reports receiving a strong or moderate inhibitor of CYP3A4 or a P-gp inhibitor within
1 month prior to study drug dosing, due to potential interactions with colchicine.
23. Acute gout flare (exclusive of chronic synovitis/ arthritis) during the
Screening-Period that has not resolved one week prior to the Baseline Visit (Day 0).
24. Pregnant or breast feeding.
25. Has received an investigational medication within 4 weeks prior to the screening
visit for this study.
26. Previously participated in a clinical study involving RDEA806 or RDEA594.
27. Known hypersensitivity or allergy to RDEA594, allopurinol or colchicine or any
components in their formulations.
28. Body mass index (BMI) >40 kg/m2.
29. Taking greater than 1000 mg/day of Vitamin C.
30. Any other medical or psychological condition, which in the opinion of the
Investigator and/or Medical Monitor, might create undue risk to the subject or
interfere with the subject's ability to comply with the protocol requirements, or to
complete the study. |
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| Study is available at: |
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DeLand, FL 32720
United States
Primary Contact:
Jody Welp
Email: jwelp@ardeabio.com
Phone: 858.652.6641 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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