FLEXION STUDY

TITLE – PATIENTS WITH OSTEOARTHRITIS OF THE HIP

CATEGORY:

Patients with Osteoarthritis of the hip.

PURPOSE:

  • • To assess the efficacy of study drug on pain following an intra-articular (IA) injection in patients with hip osteoarthritis (OA).
  • • To evaluate Study drug on function, global impression of change, stiffness, quality of life, treatment satisfaction, sleep quality and consumption of rescue medication in patients with hip OA.
  • • To characterize any change in your symptoms and overall condition.
  • • To evaluate the safety of the assess the overall safety of a second injection.
  • • Information regarding safety and side effects that may occur will also be collected.


METHOD OF ADMINISTRATION:

  • • Study drug or saline placebo will be administered as a single IA injection with a 12-week follow-up period in the double-blind phase.
  • • Patients eligible for the second injection in the open-label phase at Week 12 will receive an open-label injection.

INVESTIGATOR:

CHERIAN SAJAN, MD – PRINCIPAL INVESTIGATOR
CESAR A. LASSALLE-NIEVES, M.D. – SUB-INVESTIGATOR

KEY REQUIREMENTS TO QUALIFY FOR THIS STUDY:

  • • Patients 40 to 80 years of age, inclusive, on the day of randomization (Day 1)
  • • Body Mass Index (BMI) ≤ 40 kg/m2
  • • Symptoms (including pain) associated with OA of the index hip for ≥ 3 months prior to Screening visit (patient self-report is acceptable). Moderate to severe index hip pain due to OA for >15 days over the last month (as reported by the patient)

LENGTH/DURATION:

Each subject will be asked to visit the clinic 11 times total over the period 9. Most visits will take approximately 1 to 2 hours.

LOCATION:

1693 Lee Road Winter Park, Fl. 32789

COMPENSATION:

Qualified participants may receive up to $975 for time and travel

WHOM TO CONTACT:

Recruitment Department: 407-203-7936