A Phase II, Multicentre, Double-blind, Parallel Group 8 Week Study to Assess the Efficacy and Safety of Two Doses of CNS-242 in Lowering Serum Uric Acid (SUA) and Preventing Gout Attacks in Gout Patients
- Conditions
- Gout/Hyperuricaemia
- Registration Number
- EUCTR2005-001143-31-GB
- Lead Sponsor
- ippon Suisan Kaisha, Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 90
To be eligible for inclusion into the study, each patient must fulfil all of the following criteria:
1. Adults aged at least 18 years.
2. Patients with pharmacologically controlled gout, defined as:
• at least one previous documented clinical diagnosis of an attack, but no attack in the 6 months prior to screening, of acute arthritis of the first metatarsal phalangeal joint of the big toe, tenderness and swelling
3. Levels of SUA = 8 mg/dL at the screening visit, prior to the start of the wash out period. All other clinical laboratory tests within normal ranges and acceptable to the investigator.
4. Patients under a stable anti-hyperuricaemic treatment with allopurinol, probenecid or sulfinpyrazone in the month before screening.
5. Willing and able to give written informed consent prior to any study-specific screening procedures and comply with the study protocol for the duration of the study.
Are the trial subjects under 18?
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Patients are not eligible for this study if they fulfil one or more of the following conditions:
1. Patients who are pregnant or breast-feeding. Women of child-bearing potential must be willing and able to use an adequate method of contraception during the course of the study and must have a negative pregnancy test prior to receiving study drug.
2. Acute gout attack in the 6 months before screening.
3. Use of colchicine in the month prior to screening. Patients meeting this criterion at the screening visit can re-attend for a second screening visit.
4. Use of NSAIDs within 2 weeks of screening. Patients meeting this criterion at the screening visit can re-attend for a second screening visit.
5. Have a clinically relevant history or presence of gastrointestinal, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological or connective tissue diseases or disorders, including hepatic insufficiency (transaminases > 5 x upper limit of normal) and renal insufficiency (CrCl < 30 ml/min) which, in the opinion of the investigator, makes the patient unsuitable for the study.
6. Have a clinically relevant ECG abnormality.
7. Have congestive heart failure, New York Heart Association class III and IV.
8. Have any malignancies in the previous 5 years, with the exception of basal cell carcinoma (excised).
9. Have a clinically relevant surgical history.
10. Have a history of alcoholism or drug abuse.
11. Have used any investigational drug and/or participated in any clinical trial within 3 months of their first admission to this study.
12. Have previously received CNS-242.
13. Patients who, in the opinion of the investigator, are not able to comply with the protocol, are poor medical candidates or pose a psychiatric risk for therapy with an investigational drug.
14. Unwilling or unable to give written informed consent.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method