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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 Measure

Decrease 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

Page last updated: August 23, 2015

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