Study of FX006 in Patients With Osteoarthritis of the Knee

NCT01487161 | Completed Phase 2 Results

• 1 other identifier: FX006-2011-001
• Study Type: interventional
• Target: 229
• Locations: 3 countries
• Sites: 21

Brief Summary

The purpose of this study was to evaluate the safety, efficacy and pharmacokinetics of FX006 in patients with osteoarthritis of the knee.

Conditions

Osteoarthritis of the Knee

Keywords

osteoarthritis; knee; pain; corticosteroid; intra-articular; injection

Outcome Measures

Primary Outcomes (3)

• Change From Baseline to Week 8 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score for FX006 60 mg vs TCA IR 40 mg

  The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine."

  8 weeks

• Change From Baseline to Week 10 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score for FX006 60 mg vs TCA IR 40 mg

  The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine."

  10 weeks

• Change From Baseline to Week 12 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score for FX006 60 mg vs TCA IR 40 mg

  The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine."

  12 weeks

Secondary Outcomes (13)

• Change From Baseline to Each of Weeks 8, 10, and 12 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score for FX006 10mg and 40 mg vs TCA IR 40 mg

  Weeks 8, 10 and 12

• Change From Baseline to Each of Weeks 1, 2, 3, 4, 5, 6, 7, 9, and 11 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score.

  Weeks 1-7 and Week 9 and 11

• WOMAC A (Pain Subscale) Change From Baseline at Week 8

  8 weeks

• WOMAC A1 (Pain on Walking Question) Change From Baseline at Week 8

  8 weeks

• WOMAC B (Stiffness Subscale) Change From Baseline at Week 8

  8 weeks

Study Arms (4)

FX006 10 mg

EXPERIMENTAL

Single 3 mL intra-articular (IA) injection Extended-Release Formulation

Drug: FX006

FX006 40 mg

EXPERIMENTAL

Single 3 mL intra-articular (IA) injection Extended-Release Formulation

Drug: FX006

FX006 60 mg

EXPERIMENTAL

Single 3mL intra-articular (IA) injection Extended-Release Formulation

Drug: FX006

TCA IR 40 mg

ACTIVE COMPARATOR

Single 1 mL intra-articular (IA) injection Immediate-Release Triamcinolone Acetonide

Drug: TCA IR

Interventions

FX006 DRUG

Single 3 mL intra-articular injection

FX006 10 mg; FX006 40 mg; FX006 60 mg

TCA IR DRUG

Single 1 mL intra-articular injection

Also known as: Kenalog®-40 Injection, Kenacort-A 40, Triamcinolone Acetonide Crystalline Suspension (TAcs)

TCA IR 40 mg

Eligibility Criteria

• Age: 40 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
• Male or female \>=40 years of age
• Diagnosis of unilateral or bilateral OA of the knee for at least 6 months prior to Screening with confirmation of OA according to American College of Rheumatology Criteria for Classification of Idiopathic OA of the Knee (clinical and radiological) based on an X-ray performed within 6 months prior to Screening or during the Screening period
• 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

You may not qualify if:

• 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 joint
• Clinical signs and symptoms of active knee infection or crystal disease of the index knee
• Presence of surgical hardware or other foreign body in the index knee
• Unstable joint (such as a torn anterior cruciate ligament)
• 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
• Oral, inhaled and intranasal corticosteroids (investigational or marketed) within 1 month of Screening
• Prior arthroscopic or open surgery of the index knee within 12 months of Screening
• Planned/anticipated surgery of the index knee during the study period
• Active or history of malignancy within the last 5 years, with the exception of resected basal cell carcinoma, squamous cell carcinoma of the skin, or resected cervical atypia or carcinoma in situ
• Insulin-dependent diabetes

Sponsors & Collaborators

• Pacira Pharmaceuticals, Inc: lead

Study Sites (21)

Unknown Facility

Tucson, Arizona, 85704, United States

Location

Unknown Facility

Duncansville, Pennsylvania, 16635, United States

Location

Unknown Facility

Broadmeadow, New South Wales, Australia

Location

Unknown Facility

Kogarah, New South Wales, Australia

Location

Unknown Facility

St Leonards, New South Wales, Australia

Location

Unknown Facility

Wollongong, New South Wales, Australia

Location

Unknown Facility

Kippa-Ring, Queensland, Australia

Location

Unknown Facility

Maroochydore, Queensland, Australia

Location

Unknown Facility

Sherwood, Queensland, Australia

Location

Unknown Facility

Clayton, Victoria, Australia

Location

Unknown Facility

Malvern East, Victoria, Australia

Location

Unknown Facility

Halifax, Nova Scotia, Canada

Location

Unknown Facility

Etobicoke, Ontario, Canada

Location

Unknown Facility

Newmarket, Ontario, Canada

Location

Unknown Facility

Saint Catherine's, Ontario, Canada

Location

Unknown Facility

Sarnia, Ontario, Canada

Location

Unknown Facility

Thornhill, Ontario, Canada

Location

Unknown Facility

Waterloo, Ontario, Canada

Location

Unknown Facility

Windsor, Ontario, Canada

Location

Unknown Facility

Montreal, Quebec, Canada

Location

Unknown Facility

Sainte-Foy, Quebec, Canada

Location

Related Links

• Journal of Bone \& Joint Surgery - American Volume: 3 June 2015 - Volume 97 - Issue 11 - p 877-888

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis; Pain

Interventions

FX006; Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Scott Kelley, VP of Medical Affairs
• Organization: Flexion Therapeutics

skelley@flexiontherapeutics.com

781-305-7142

Study Officials

• Neil Bodick, MD, PhD

  Flexion Therapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2011
• First Posted: December 7, 2011
• Study Start: June 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: January 24, 2024
• Results First Posted: January 12, 2018

Record last verified: 2024-01

Locations

AU (9); CA (10); US (2)