JNJ-39439335 in painful osteoarthritis of the knee

• Research type

  Research Study

• Full title

  A Randomized, Double-Blind, Placebo-Controlled Clinical Study of Single Doses of JNJ-39439335 versus Single and Multiple Doses of Naproxen versus Placebo in the Treatment of Painful Osteoarthritis of the Knee: Focus on Treatment Effects and Methodological Advances

• IRAS ID

  21717

• Eudract number

  2009-010961-21

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This study will evaluate a new drug, JNJ-39439335 compared to both placebo (a dummy treatment) and an established treatment (naproxen) in subjects with painful osteoarthritis of the knee. The study will enrol approximately 36 subjects at a single centre in the UK. Each subject will receive a single dose of JNJ-39439335, placebo or naproxen in random order on Days 1,15 and 29, with naproxen or placebo 12 hours after each dosing and twice daily for the next 6 days. The effect of JNJ-39439335, placebo or naproxen on pain pre- and post-exercise will be assessed and safety and tolerability will also be evaluated.

• REC name

  Yorkshire & The Humber - Leeds West Research Ethics Committee

• REC reference

  09/H1307/65

• Date of REC Opinion

  1 Jul 2009

• REC opinion

  Further Information Favourable Opinion