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

Osteoarthritis, Knee Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01291914
• Other study ID #: FX005-2010-001
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: December 2010
• Est. completion date: March 2012

Study information

• Verified date: January 2024
• Source: Pacira Pharmaceuticals, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: March 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• FX005
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)
• Placebo 1 (Carrier)
Single intra-articular injection
• Placebo 2 (Diluent)
Single intra-articular injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pacira Pharmaceuticals, Inc

Countries where clinical trial is conducted

Austria,  Canada,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in the WOMAC A score (pain subscale)		at 4 weeks post treatment
Secondary	Change from baseline in WOMAC A score (pain subscale)		over 4, 8 and 12 weeks post treatment
Secondary	Change from baseline for WOMAC A score (pain subscale)		at 2, 8 and 12 weeks post treatment
Secondary	Change from baseline for WOMAC B score (stiffness subscale)		at 2, 4, 8 and 12 weeks post treatment
Secondary	Change from baseline for WOMAC C score (function subscale)		at 2, 4, 8 and 12 weeks post treatment
Secondary	Change from baseline for WOMAC A1 response (pain on walking)		at 2, 4, 8 and 12 weeks post treatment
Secondary	Change from baseline for WOMAC A1 response (pain on walking)		over 4, 8 and 12 weeks post treatment
Secondary	Change from baseline for WOMAC total score		at 2, 4, 8 and 12 weeks post treatment
Secondary	Change from baseline for ICOAP intermittent pain score		at 2, 4, 8 and 12 weeks post treatment
Secondary	Change from baseline for ICOAP constant pain score		at 2, 4, 8 and 12 weeks post treatment
Secondary	Change from baseline for ICOAP total score		at 2, 4, 8 and 12 weeks post treatment
Secondary	Percent of responders according to the OMERACT-OARSI (Outcome Measures in Rheumatoid Arthritis Clinical Trials-Osteoarthritis Research Society International) criteria		at 4, 8 and 12 weeks post treatment
Secondary	Change in patient's global assessment score		at 4, 8 and 12 weeks post treatment
Secondary	Change in clinical observer's global assessment score		at 4, 8 and 12 weeks post treatment
Secondary	Average weekly consumption of analgesic medications		over 12 weeks post treatment
Secondary	Incidence of treatment emergent adverse events		up to 12 weeks post treatment