FX005-2010-001 - Treatment of Pain in OA of The Knee

• Research type

  Research Study

• Full title

  A Double-Blind, Randomised, Placebo-Controlled, Two-Phase Study (a Single Ascending Dose Phase Followed by a Proof of Concept Phase) to Assess the Safety, Efficacy and Pharmacokinetics of FX005 (50:50 PLGA) Microspheres for the Treatment of Pain in Osteoarthritis of the Knee

• IRAS ID

  65241

• Contact name

  nigel arden

• Sponsor organisation

  Flexion Therapeutics, Inc.

• Eudract number

  2010-022976-29

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Osteoarthritis (OA) of the knee produces pain which can worsen when carrying out physical activity and will ease with rest. FX005 microspheres intend to treat this pain. The study consists of two phases, a Single Ascending Dose (SAD) Phase followed by a Proof of Concept (PoC) Phase. The study will be conducted in patients, greater than 40 years of age. Patients diagnosed with bilateral OA will be screened for eligibility. The SAD Phase will involve a Screening period (consisting of 2 out-patient visits), an approximate 24-36 hour in-clinic period and 4 additional out-patient visits. Each patient in the SAD Phase will be followed for 6 weeks after treatment. In the SAD Phase, the dose will be escalated through 1, 10, and 45 mg and compared to a placebo. The PoC Phase will start after the safety review for the final dose of the SAD Phase and a review of various blood results through Day 3 from the SAD Phase. The PoC Phase will involve 6 out-patient visits (2 that comprise the Screening period & a further 4 at week 2,4,8 & 12) and 2 follow-up phone calls at day 2 & 3. Each patient will be followed for 12 weeks after treatment. For both SAD & PoC phases, the patients will attend the investigators?? unit at regular intervals for administration of study drugs, vital signs measurements, neurologic and physical examination, clinical laboratory testing, ECG recording and the recording of concomitant medications and adverse events. Blood samples will be taken to determine the levels of FX005 in blood plasma.Evaluation of pain control will be made using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain and physical function subscale questionnaires and also the Patient Global Assessment of Osteoarthritis.The highest, well-tolerated dose in the SAD Phase will be compared to placebo in the PoC Phase.

• REC name

  South Central - Oxford C Research Ethics Committee

• REC reference

  10/H0606/79

• Date of REC Opinion

  11 Jan 2011

• REC opinion

  Further Information Favourable Opinion