Proof of Concept Study Comparing FX006 to Kenalog®-40 in Patients With Post-Traumatic Osteoarthritis of the Knee

Pacira

Status and phase

Terminated

Phase 2

Conditions

Post-traumatic Osteoarthritis of the Knee

Treatments

Drug: TCA IR 40 mg

Drug: FX006 32 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT02468583

FX006-2014-007

Details and patient eligibility

About

This study was a double-blind, randomized, parallel group, proof of concept study comparing FX006 to Kenalog®-40 (triamcinolone acetonide injectable suspension, USP) in patients with post-traumatic osteoarthritis of the knee.

Full description

This study was a double-blind, randomized, parallel group, proof of concept study patients with post-traumatic osteoarthritis (PTOA) of the knee. Approximately 124 eligible patients were intended to be randomized to one of the two treatment groups (1:1) and treated with a single intra-articular (IA) injection of:

32 mg of FX006
40 mg of Kenalog®-40 (triamcinolone acetonide injectable suspension, USP)

Each prospective patient underwent a screening evaluation to confirm a diagnosis of PTOA of the knee and concurrence with all other eligibility criteria. Patients were be treated on Day 1 (Baseline) and returned to the clinic at Weeks 4, 8 and 12 for evaluation of safety and efficacy.

Enrollment

6 patients

Sex

All

Ages

20 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions
Male or female ≥20 and ≤50 years of age
Diagnosis of post-traumatic OA of the knee
Kellgren-Lawrence (K-L) Grade 2 or 3 in the index knee within 6 months prior to or at Screening
Qualifying mean score on the 24-h average pain score (0-10 numeric rating scale)
Body mass index (BMI) ≤ 40 kg/m2
Willingness to abstain from use of restricted medications and therapies during the study

Exclusion criteria

Prior osteotomy of the index knee
Any condition that could possibly confound the patient's assessment of index knee pain in the judgement of the Investigator (i.e., ipsilateral hip OA, gout, radicular low back pain and hip pain that is referred to the knee that could cause misclassifcation, pain in any other area of the lower extremeties or back that is equal to or greater than the index knee pain)
Fibromyalgia, Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease
History of, or clinical signs and symptoms of active infection of the index knee
Crystal disease of the index knee within one month of Screening
Disease secondary to surgical treatment of Shatzker grade IV, V, or VI tibial plateau fractures (OTA classification C2 or C3); surgical treatment of OTA calssifcation C2 or C3 distal femur fractures; or >2mm of articular incongruity after surgery
IA corticosteroid (investigational or marketed) in any joint within 3 months of Screening
IA hyaluronic acid (investigational or marketed) in the index knee within 6 months of Screening
Intramuscular (IM) or oral corticosteroids (investigational or marketed) within 1 month of Screening
Any other IA investigational drug/biologic within 6 months of Screening
Prior use of FX006
Prior arthroplasty of any type of the index knee or planned/anticipated surgery of the index knee during the study period
Type 1 or Type 2 diabetes requiring insulin
Women of child-bearing potential not using effective contraception or who are pregnant or nursing