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