Gout/Hyperuricaemia
Conditions
Interventions
Product Name: CNS-242
Product Code: CNS-242
Pharmaceutical Form: Tablet
Current Sponsor code: CNS-242
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 200-
Ph
Sponsors
Nippon Suisan Kaisha, Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objectives of this study are: • To assess the efficacy of CNS-242, after 8 weeks’ treatment, in reducing SUA as a surrogate marker of gout (reduction of SUA to a level of 6 mg/dL). • To assess the safety and tolerability of multiple doses of CNS-242 in patients with previous gout attacks and hyperuricaemia. ;Secondary Objective: The secondary objectives of this study are: • To assess the change from baseline in SUA after 8 weeks’ treatment with CNS-242. • To determine and compare the number of patients experiencing acute attacks of gout during 8 weeks’ treatment with CNS-242. • To determine any reduction in tophi after 8 weeks’ treatment with CNS-242. • To determine any reduction in levels of pain during and after 8 weeks’ treatment with CNS 242. • To assess patient quality of life during and after 8 weeks’ treatment with CNS-242. ;Primary end point(s): The efficacy analysis population will be used for the primary analysis of the primary endpoint. The primary endpoint is the proportion of patients with a reduction of SUA to a level of 6 mg/dL or below. It is considered that if more than 50% of patients in either dose group achieve SUA = 6 mg/dL after 8 weeks’ treatment this will be indicative of a pharmacological effect in an accepted surrogate marker for gout, and worth exploring in a more formal dose finding study. Therefore the efficacy of CNS-242 will be examined via null hypotheses for each dose of the form. H0; The proportion of subjects in the CNS-242 dose group with SUA = 6 mg/dL at Visit 5 is < 50%. HA; The proportion of subjects in the CNS-242 dose group with SUA = 6 mg/dL at Visit 5 is = 50%. The proportion of patients with reduction of SUA to a level of 6 mg/dL or below (successes) will be summarised using tables of frequencies and other descriptive statistics. The null hypothesis will be tested by calculating the exact two-sided probability of the actual proportion of successes, given a binomial distribution with expected | — |
Countries
United Kingdom
Outcome results
None listed