Study to Evaluate the Efficacy and Safety of FX006 in Patients With Hip Osteoarthritis

NCT03793010 | Terminated Phase 3 Results FDA Drug

• 1 other identifier: FX006-2018-015
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 32

Brief Summary

This is a two-part, multi-center, randomized, double-blind, placebo-controlled, parallel-group study in patients with hip OA. Approximately 70 patients will be enrolled in Part I and approximately 440 patients will be enrolled in Part II of the study. In each part, patients will be randomized to one of two treatment groups (1:1) and treated with a single IA injection of either 32 mg FX006 or normal saline.

Conditions

Osteoarthritis, Hip

Keywords

Osteoarthritis; Hip; Pain; Intra-articular; Injection

Outcome Measures

Primary Outcomes (1)

• Change in WOMAC A (Pain) Score at Week 12

  The change from baseline on the average Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A (pain) score at Week 12. The average WOMAC A score is calculated by taking the average of five questions with a range from 0 (no pain) to 10 (extreme pain).

  Baseline and Week 12

Secondary Outcomes (2)

• Change in WOMAC C (Function) Score at Week 12

  Baseline and Week 12

• PGIC Score at Week 12

  12 Weeks

Study Arms (2)

FX006

EXPERIMENTAL

FX006 32mg

Drug: FX006

Normal Saline

PLACEBO COMPARATOR

Normal Saline

Drug: Normal saline

Interventions

FX006 DRUG

Single Intra-articular injection

FX006

Normal saline DRUG

Single Intra-articular injection

Normal Saline

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions
• Patients 40 to 80 years of age, inclusive, on the day of randomization (Day 1)
• Body Mass Index (BMI) ≤ 40 kg/m2
• Symptoms associated with OA of the index hip for ≥ 3 months prior to Screening visit
• Currently meet the American College of Radiology (ACR) Criteria (clinical and radiological) for OA of the index hip
• Kellgren-Lawrence (KL) Grade 2 or 3 in the index hip as confirmed by X-ray during Screening visit (centrally read)
• Qualifying mean score on the WOMAC A and C (0-10 NRS scale)
• Agree to maintain the similar activity level throughout the study
• Willingness to abstain from use of restricted medications

You may not qualify if:

• Patients who cannot washout of prohibited medications
• Diagnosed as secondary OA in the index hip including but not limited to articular fracture, major dysplasia or congenital abnormality, osteochondritis dissecans, acromegaly, ochronosis, hemochromatosis, Wilson's disease, or primary osteochondromatosis, etc.
• Ipsilateral chronic knee pain
• Sciatica
• Atrophic osteoarthritis, femoral head necrosis and/or collapse, or subchondral bone insufficiency fracture in the index hip joint determined via central reading
• Current or history of infection in the index hip (e.g. osteomyelitis) or current skin infection at injection site
• Trauma or surgeries (e.g., arthroscopy, knee surgery) of lower limbs within 52 weeks with sequelae, etc.
• History or current evidence of reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease, systemic lupus erythematosus or other autoimmune diseases
• Any planned surgeries in the lower limbs during the study period, or any other surgery during the study period that would require use of a restricted medication
• Presence of surgical hardware or other foreign body in the index hip
• Planned/anticipated surgery of the index hip or any other surgery that would require use of a restricted medication during the study period
• IA corticosteroid of any joint within 3 months of Screening visit (investigational or marketed, including FX006)
• IA treatment of index hip with any of the following agents within 6 months of Screening: any biologic agent or hyaluronic acid (investigational or marketed)
• IV or IM corticosteroids (investigational or marketed) within 3 months of Screening
• Oral corticosteroids (investigational or marketed) within 1 month of Screening

Sponsors & Collaborators

• Pacira Pharmaceuticals, Inc: lead

Study Sites (32)

Arizona Research Center

Phoenix, Arizona, 85053, United States

Location

Noble Clinical Research

Tucson, Arizona, 85704, United States

Location

Hope Clinical Research

Canoga Park, California, 91303, United States

Location

TriWest Research Associates, LLC

El Cajon, California, 92020, United States

Location

BioSolutions Clinical Research Center

La Mesa, California, 91942, United States

Location

Artemis Institute for Clinical Research

San Diego, California, 92103, United States

Location

Mountain View Clinical Research, Inc.

Denver, Colorado, 80209, United States

Location

Chase Medical Research, LLC

Waterbury, Connecticut, 06708, United States

Location

Tampa Bay Medical Research

Clearwater, Florida, 33761, United States

Location

Florida Research Associates, LLC

DeLand, Florida, 32720, United States

Location

Advanced Research for Health Improvement

Naples, Florida, 34102, United States

Location

Medallion Clinical Research Institute, LLC

Naples, Florida, 34102, United States

Location

Oviedo Medical Research

Oviedo, Florida, 32765, United States

Location

Progressive Medical Research

Port Orange, Florida, 32127, United States

Location

Precision Clinical Research, LLC

Sunrise, Florida, 33351, United States

Location

National Pain Research Institute

Winter Park, Florida, 32789, United States

Location

Better Health Clinical Research, Inc

Newnan, Georgia, 30265, United States

Location

Injury Care Research, LLC

Boise, Idaho, 83713, United States

Location

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

Heartland Research Associates

Newton, Kansas, 67114, United States

Location

Excel Clinical Research

Las Vegas, Nevada, 89109, United States

Location

Drug Trials America

Hartsdale, New York, 10530, United States

Location

M3 Wake Research, Inc.

Raleigh, North Carolina, 27612, United States

Location

PMG Research of Wilmington

Wilmington, North Carolina, 28401, United States

Location

University Orthopedics Center

Altoona, Pennsylvania, 16602, United States

Location

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

Clinical Trials of South Carolina

Charleston, South Carolina, 29406, United States

Location

Coastal Carolina Research Center

Charleston, South Carolina, 29406, United States

Location

Wasatch Clinical Research, LLC

Salt Lake City, Utah, 84107, United States

Location

Charlottesville Medical Research

Charlottesville, Virginia, 22911, United States

Location

Spectrum Medical, Inc.

Danville, Virginia, 24541, United States

Location

Northwest Clinical Research Center

Bellevue, Washington, 98007, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Hip; Osteoarthritis; Pain

Interventions

FX006; Saline Solution

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Limitations and Caveats

This study was terminated early by the Sponsor due to occurrences of incomplete study drug administration. Only 15% of the planned study population had enrolled and no statistical evaluations reported due to insufficient sample size.

Results Point of Contact

• Title: David Golod, Vice President, Clinical Operations
• Organization: Flexion Therapeutics, Inc.

dgolod@flexiontherapeutics.com

(781) 305-7572

Study Officials

• Scott Kelley, MD

  Pacira Pharmaceuticals, Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Double-blind, Placebo-controlled, Parallel-group

Study Record Dates

• First Submitted: January 2, 2019
• First Posted: January 4, 2019
• Study Start: December 12, 2018
• Primary Completion: August 7, 2019
• Study Completion: August 7, 2019
• Last Updated: January 24, 2024
• Results First Posted: September 14, 2020

Record last verified: 2024-01

Locations

US (32)