OAK Study
Research type
Research Study
Full title
A Phase 2a, Randomized, Double-blind, Placebo- and Naproxen-controlled, Parallel-group Study to Assess the Analgesic Efficacy of ASP7962 in Patients with Pain Due to Osteoarthritis of the Knee.
IRAS ID
193802
Contact name
Andrew Östör
Contact email
Sponsor organisation
Astellas Pharma Europe B.V.
Eudract number
2014-004996-22
Duration of Study in the UK
0 years, 10 months, 1 days
Research summary
ASP7962 is a test drug that is being developed by the study Sponsor, Astellas Pharma Europe B.V., to treat Osteoarthritis (OA). The purpose of this research study, called the OAK study, is to see if ASP7962 can reduce the pain of OA of the knee and to see if the test dug is safe. ASP7962 works by blocking a pain pathway that is considered important in causing the pain of osteoarthritis.
Approximately 205 adult patients (between 18 and 75 years of age) with OA of the knee will be enroled in this study, which will be conducted at approximately 25 study centres in Europe. Patients will participate in the study for approximately 12 weeks (up to 4 weeks before taking the test drug, 4 weeks while taking the test drug and 4 weeks after stopping the test drug). Patients will be required to make 7 visits to the study centre during this time.
During the 4 weeks when the patient takes the test drug, the patient will receive 1 of 3 possible treatments as follows: ASP7962 (twice daily), Naproxen (twice daily) or placebo (a dummy medication) twice daily to match ASP7962 and placebo twice daily to match naproxen.
Study procedures include: physical examination, blood pressure and heart rate measurements, x-rays of the knees and hips, blood and urine sampling for safety laboratory tests, blood sampling for pharmacokinetic assessments, Electrocardiogram (ECG) monitoring, completion of questionnaires and concomitant medication and adverse events collection.REC name
East of England - Essex Research Ethics Committee
REC reference
15/EE/0452
Date of REC Opinion
5 Feb 2016
REC opinion
Further Information Favourable Opinion