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