Proof of Concept Study Comparing FX006 to Kenalog®-40 in Active Military and Medically Retired Patients With Post-Traumatic Osteoarthritis of the Knee
Information source: Flexion Therapeutics, Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Post-traumatic Osteoarthritis of the Knee
Intervention: FX006 (Drug); Kenalog®-40 (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Flexion Therapeutics, Inc. Overall contact: Jessica Hauben, Phone: 781-305-7773, Email: jhauben@flexiontherapeutics.com
Summary
This study is a double-blind, randomized, parallel group, proof of concept study comparing
FX006 to Kenalog®-40 (triamcinolone acetonide injectable suspension, USP) in active military
and medically retired patients with post-traumatic osteoarthritis of the knee.
Clinical Details
Official title: A Double-Blind, Randomized, Parallel Group, Proof of Concept Study Comparing FX006 to Kenalog®-40 in Active Military and Medically Retired Patients With Post-Traumatic Osteoarthritis of the Knee
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Average change from Baseline in the weekly mean of the average daily (24-hour) pain intensity scores over Weeks 5 to 10
Secondary outcome: Pain Intensity Scores - Secondary Outcome MeasureDecrease in Pain (20%) - Secondary Outcome Measure Decrease in Pain (50%) - Secondary Outcome Measure WOMAC - Secondary Outcome Measure KOOS - Secondary Outcome Measure PGIC & CGIC - Secondary Outcome Measure
Detailed description:
This study is a double-blind, randomized, parallel group, proof of concept study in active
military and medically retired patients with post-traumatic osteoarthritis (PTOA) of the
knee. Approximately 124 eligible patients will be randomized to one of the two treatment
groups (1: 1) and treated with a single intra-articular (IA) injection of:
- 40 mg of FX006
- 40 mg of Kenalog®-40 (triamcinolone acetonide injectable suspension, USP)
Each prospective patient will undergo a screening evaluation to confirm a diagnosis of PTOA
of the knee and concurrence with all other eligibility criteria. Patients will be treated on
Day 1 (Baseline) and will return to the clinic at Weeks 1, 2, 4, 6, 8, 10 and 12 for
evaluation of safety and efficacy.
Eligibility
Minimum age: 20 Years.
Maximum age: 45 Years.
Gender(s): Both.
Criteria:
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 ≤45 years of age
- Active duty and medically retired military personnel with a diagnosis of
post-traumatic OA of the index 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
- Ipsilateral hip OA
- Fibromyalgia, chronic pain syndrome or other concurrent medical or arthritic
conditions which could interfere with the evaluation of the index knee
- History of Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing
spondylitis, arthritis associated with inflammatory bowel disease, sarcoidosis or
amyloidosis
- History of arthritides due to crystals (e. g., gout, pseudogout)
- History of infection in the index knee
- Clinical signs and symptoms of active knee infection or crystal disease of the index
knee
- Knee pain that is not clinically attributable to OA of the knee (e. g., radicular low
back pain and hip pain that is referred to the knee that could cause
misclassification)
- Disease secondary to surgical treatment of Shatzker grade IV, V, or VI tibial plateau
fractures, OTA classification 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) corticosteroids (investigational or marketed) within 3 months of
Screening
- Oral corticosteroids (investigational or marketed) within 1 month of Screening
- Inhaled, intranasal and topical corticosteroids (investigational or marketed) within
2 weeks 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
- Type 1 or Type 2 diabetes requiring insulin
- Women of child-bearing potential not using effective contraception or who are
pregnant or nursing
Locations and Contacts
Jessica Hauben, Phone: 781-305-7773, Email: jhauben@flexiontherapeutics.com
San Antonio Military Medical Center, San Antonio, Texas 78234, United States; Recruiting Kerri Anguiano, Phone: 210-916-4759
Additional Information
Starting date: February 2015
Last updated: June 8, 2015
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