Study of FX005 for the Treatment of Pain in Patients With Osteoarthritis of the Knee

NCT01291914 | Completed Phase 1 DMC

• 1 other identifier: FX005-2010-001
• Study Type: interventional
• Target: 140
• Locations: 4 countries
• Sites: 13

Brief Summary

The purpose of this study is to evaluate the safety, efficacy and pharmacokinetics of FX005 for the treatment of pain in patients with osteoarthritis of the knee.

Conditions

Osteoarthritis, Knee

Keywords

Osteoarthritis; knee; intra-articular; safety; efficacy; pharmacokinetics; pain

Outcome Measures

Primary Outcomes (1)

• Change from baseline in the WOMAC A score (pain subscale)

  at 4 weeks post treatment

Secondary Outcomes (15)

• Change from baseline in WOMAC A score (pain subscale)

  over 4, 8 and 12 weeks post treatment

• Change from baseline for WOMAC A score (pain subscale)

  at 2, 8 and 12 weeks post treatment

• Change from baseline for WOMAC B score (stiffness subscale)

  at 2, 4, 8 and 12 weeks post treatment

• Change from baseline for WOMAC C score (function subscale)

  at 2, 4, 8 and 12 weeks post treatment

• Change from baseline for WOMAC A1 response (pain on walking)

  at 2, 4, 8 and 12 weeks post treatment

Study Arms (3)

FX005

EXPERIMENTAL

Drug: FX005

Placebo 1 (Carrier)

PLACEBO COMPARATOR

Drug: Placebo 1 (Carrier)

Placebo 2 (Diluent)

PLACEBO COMPARATOR

Drug: Placebo 2 (Diluent)

Interventions

FX005 DRUG

Single Ascending Dose (SAD) Phase Cohorts: 1, 10 or 45 mg intra-articular injection; Proof of Concept Phase: Maximum, well-tolerated dose intra-articular injection (determined during SAD Phase)

FX005

Placebo 1 (Carrier) DRUG

Single intra-articular injection

Placebo 1 (Carrier)

Placebo 2 (Diluent) DRUG

Single intra-articular injection

Placebo 2 (Diluent)

Eligibility Criteria

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

You may qualify if:

• Male or female ≥40 years of age
• Diagnosis of unilateral or bilateral osteoarthritis of the knee for at least 6 months; confirmation of osteoarthritis according to American College of Rheumatology Criteria (clinical and radiological)
• Kellgren-Lawrence grades II or III
• Mean score for the WOMAC A subscale (pain) between 2.0 and 3.5 for the index knee
• Score of 2-3 for the WOMAC A1 score (pain on walking) for the index knee
• Body mass index ≤ 40 kg/m2
• Willingness to abstain from use of restricted medications during the study
• Willingness and ability to comply with the study procedures and visit schedule

You may not qualify if:

• Kellgren-Lawrence Grade 0, I or IV radiographic stage of the index knee
• Clinically apparent tense effusion in index knee
• Presence of surgical hardware or other foreign body in the index knee
• Clinical signs and symptoms of active knee infection or crystal disease
• Intra-articular corticosteroid within 3 months of Screening
• Intra-articular hyaluronic acid within 6 months of Screening
• Other intra-articular therapy within 3 months 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
• History of malignancy or other serious, non-malignant, significant, acute or chronic medical (e.g.. uncontrolled diabetes) or active psychiatric illness
• Skin breakdown at the knee where the injection would take place
• Women who are pregnant, nursing or likely to become pregnant during the time of the study
• Women of child-bearing potential (not surgically sterile or post-menopausal for at least 1 year) not using effective contraception

Sponsors & Collaborators

• Pacira Pharmaceuticals, Inc: lead

Study Sites (13)

Unknown Facility

Graz, Austria

Location

Unknown Facility

Vienna, Austria

Location

Unknown Facility

Penticton, British Columbia, Canada

Location

Unknown Facility

Newmarket, Ontario, Canada

Location

Unknown Facility

Toronto, Ontario, Canada

Location

Unknown Facility

Windsor, Ontario, Canada

Location

Unknown Facility

Sainte-Foy, Quebec, Canada

Location

Unknown Facility

Santiago de Compostela, A Coruna, Spain

Location

Unknown Facility

Santander, Cantabria, Spain

Location

Unknown Facility

A Coruña, Spain

Location

Unknown Facility

Barcelona, Spain

Location

Unknown Facility

Seville, Spain

Location

Unknown Facility

Southampton, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis; Pain

Interventions

Carrier State

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Public Health; Environment and Public Health

Study Officials

• Neil Bodick, MD, PhD

  Pacira Pharmaceuticals, Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• 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: February 4, 2011
• First Posted: February 9, 2011
• Study Start: December 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: March 1, 2012
• Last Updated: January 24, 2024

Record last verified: 2024-01

Locations

CA (5); GB (1); ES (5); AU (2)