Clinical trial NCT01291914: Study of FX005 for the Treatment of Pain in Patients With Osteoarthritis of the Knee
Official title: A Double-Blind, Randomized,Placebo-Controlled, Two-Phase Study (a Single Ascending Dose Phase Followed by a Proof of Concept Phase) to Assess the Safety, Efficacy and Pharmacokinetics of FX005 for the Treatment of Pain in Osteoarthritis of the Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Osteoarthritis, Knee
Keywords: Osteoarthritis
knee
intra-articular
safety
efficacy
pharmacokinetics
pain
Lead sponsor: Pacira Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2011-02-09
Enrollment: 140
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: The objectives of the study are to assess FX005, as compared to placebo control, for:

* Safety and tolerability
* Analgesic effect
* Pharmacokinetics

Analgesic effect will be assessed using the Western Ontario \& McMaster University Osteoarthritis Index (WOMAC), the Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP) questionnaire, and patient and clinical observer global assessments.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change from baseline in the WOMAC A score (pain subscale)
timeFrame: at 4 weeks post treatment
Secondary outcomes:
measure: Change from baseline in WOMAC A score (pain subscale)
timeFrame: over 4, 8 and 12 weeks post treatment
measure: Change from baseline for WOMAC A score (pain subscale)
timeFrame: at 2, 8 and 12 weeks post treatment
measure: Change from baseline for WOMAC B score (stiffness subscale)
timeFrame: at 2, 4, 8 and 12 weeks post treatment
measure: Change from baseline for WOMAC C score (function subscale)
timeFrame: at 2, 4, 8 and 12 weeks post treatment
measure: Change from baseline for WOMAC A1 response (pain on walking)
timeFrame: at 2, 4, 8 and 12 weeks post treatment
measure: Change from baseline for WOMAC A1 response (pain on walking)
timeFrame: over 4, 8 and 12 weeks post treatment
measure: Change from baseline for WOMAC total score
timeFrame: at 2, 4, 8 and 12 weeks post treatment
measure: Change from baseline for ICOAP intermittent pain score
timeFrame: at 2, 4, 8 and 12 weeks post treatment
measure: Change from baseline for ICOAP constant pain score
timeFrame: at 2, 4, 8 and 12 weeks post treatment
measure: Change from baseline for ICOAP total score
timeFrame: at 2, 4, 8 and 12 weeks post treatment
measure: Percent of responders according to the OMERACT-OARSI (Outcome Measures in Rheumatoid Arthritis Clinical Trials-Osteoarthritis Research Society International) criteria
timeFrame: at 4, 8 and 12 weeks post treatment
measure: Change in patient's global assessment score
timeFrame: at 4, 8 and 12 weeks post treatment
measure: Change in clinical observer's global assessment score
timeFrame: at 4, 8 and 12 weeks post treatment
measure: Average weekly consumption of analgesic medications
timeFrame: over 12 weeks post treatment
measure: Incidence of treatment emergent adverse events
timeFrame: up to 12 weeks post treatment
Other outcomes:
Locations:
city: Graz
country: Austria
city: Wien
country: Austria
city: Penticton
country: Canada
state: British Columbia
city: Newmarket
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Windsor
country: Canada
state: Ontario
city: Sainte-Foy
country: Canada
state: Quebec
city: Santiago de Compostela
country: Spain
state: A Coruna
city: Santander
country: Spain
state: Cantabria
city: A Coruna
country: Spain
city: Barcelona
country: Spain
city: Sevilla
country: Spain
city: Southampton
country: United Kingdom
Study officials:
affiliation: Pacira Pharmaceuticals, Inc
name: Neil Bodick, MD, PhD
role: STUDY_DIRECTOR
References: