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Flexion Study

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, MD – 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


Annular Disc Tears

  • 18yrs and older
  • Single or multilevel lumbar disc tears
  • Prior discography, MRI needed
  • No active litigation related to lumbar pain

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