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

January 22, 2024 updated by: Pacira Pharmaceuticals, Inc

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
140

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria
      • Wien, Austria
  • Canada
    • British Columbia
      • Penticton, British Columbia, Canada
    • Ontario
      • Newmarket, Ontario, Canada
      • Toronto, Ontario, Canada
      • Windsor, Ontario, Canada
    • Quebec
      • Sainte-Foy, Quebec, Canada
  • Spain
      • A Coruna, Spain
      • Barcelona, Spain
      • Sevilla, Spain
    • A Coruna
      • Santiago de Compostela, A Coruna, Spain
    • Cantabria
      • Santander, Cantabria, Spain
  • United Kingdom
      • Southampton, United Kingdom

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: FX005
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 Comparator: Placebo 1 (Carrier)
Drug: Placebo 1 (Carrier)
Single intra-articular injection
Placebo Comparator: Placebo 2 (Diluent)
Drug: Placebo 2 (Diluent)
Single intra-articular injection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change from baseline in the WOMAC A score (pain subscale)
Time Frame: at 4 weeks post treatment
at 4 weeks post treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change from baseline in WOMAC A score (pain subscale)
Time Frame: over 4, 8 and 12 weeks post treatment
over 4, 8 and 12 weeks post treatment
Change from baseline for WOMAC A score (pain subscale)
Time Frame: at 2, 8 and 12 weeks post treatment
at 2, 8 and 12 weeks post treatment
Change from baseline for WOMAC B score (stiffness subscale)
Time Frame: at 2, 4, 8 and 12 weeks post treatment
at 2, 4, 8 and 12 weeks post treatment
Change from baseline for WOMAC C score (function subscale)
Time Frame: at 2, 4, 8 and 12 weeks post treatment
at 2, 4, 8 and 12 weeks post treatment
Change from baseline for WOMAC A1 response (pain on walking)
Time Frame: at 2, 4, 8 and 12 weeks post treatment
at 2, 4, 8 and 12 weeks post treatment
Change from baseline for WOMAC A1 response (pain on walking)
Time Frame: over 4, 8 and 12 weeks post treatment
over 4, 8 and 12 weeks post treatment
Change from baseline for WOMAC total score
Time Frame: at 2, 4, 8 and 12 weeks post treatment
at 2, 4, 8 and 12 weeks post treatment
Change from baseline for ICOAP intermittent pain score
Time Frame: at 2, 4, 8 and 12 weeks post treatment
at 2, 4, 8 and 12 weeks post treatment
Change from baseline for ICOAP constant pain score
Time Frame: at 2, 4, 8 and 12 weeks post treatment
at 2, 4, 8 and 12 weeks post treatment
Change from baseline for ICOAP total score
Time Frame: at 2, 4, 8 and 12 weeks post treatment
at 2, 4, 8 and 12 weeks post treatment
Percent of responders according to the OMERACT-OARSI (Outcome Measures in Rheumatoid Arthritis Clinical Trials-Osteoarthritis Research Society International) criteria
Time Frame: at 4, 8 and 12 weeks post treatment
at 4, 8 and 12 weeks post treatment
Change in patient's global assessment score
Time Frame: at 4, 8 and 12 weeks post treatment
at 4, 8 and 12 weeks post treatment
Change in clinical observer's global assessment score
Time Frame: at 4, 8 and 12 weeks post treatment
at 4, 8 and 12 weeks post treatment
Average weekly consumption of analgesic medications
Time Frame: over 12 weeks post treatment
over 12 weeks post treatment
Incidence of treatment emergent adverse events
Time Frame: up to 12 weeks post treatment
up to 12 weeks post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pacira Pharmaceuticals, Inc

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Neil Bodick, MD, PhD, Pacira Pharmaceuticals, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 4, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2011

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 9, 2011

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 24, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FX005-2010-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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