Safety and Tolerability of 4975 in the Treatment of Moderate to Severe Knee Pain Due to Osteoarthritis (OA)

December 5, 2016 updated by: Centrexion Therapeutics

A Phase 2, Open-label Study to Evaluate Safety and Tolerability, and to Explore the Efficacy, of Dosing Regimens of Intraarticular 4975 in Patients With Chronic Moderate to Severe Pain of the Knee Associated With Osteoarthritis

This study will evaluate dosing regimens of 4975 in terms of safety and tolerability when delivered as an intra-articular injection in the knee. Secondary objectives will be to explore the efficacy of 4975 in terms of onset, extent and duration of pain relief.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a single site study. The study drug, 4975, will be administered in various dosing regimens by intra-articular injection followed by an observation period of up to 12 weeks. Pain in the treated knee will be assessed before, during and after administration of the study drug.

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 2

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

  • United States
    • Massachusetts
      • Worcester, Massachusetts, United States, 01610
        • Clinical Phamacology Study Group

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

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female patients aged 40 years or over.
  • Body mass index (BMI) of 35 or less.
  • History of OA of the knee for at least 1 year and has experienced pain in the target area for at least six months.
  • X-Ray of the target knee.
  • Willing and able to complete the study procedures.

Exclusion Criteria:

  • Female patients who are pregnant or lactating or who plan to get pregnant.
  • Clinically significant form of joint disease other than OA.
  • Medical condition that could adversely impact the patient's participation, safety or affect the conduct of the study.
  • Prior major trauma in the target knee or major surgeries such as partial or total knee arthroplasty.
  • Arthroscopic surgery on the target knee within 6 months.

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 100-200 µg CNTX-4975
single dose
Drug: CNTX-4975
Testing a range of dosing configurations to optimize patient tolerability
Experimental: 300-425 µg CNTX-4975
Total dose delivered as two separate lower doses
Drug: CNTX-4975
Testing a range of dosing configurations to optimize patient tolerability
Experimental: 600-700 µg CNTX-4975
Total dose delivered as two separate lower doses
Drug: CNTX-4975
Testing a range of dosing configurations to optimize patient tolerability
Experimental: 800 µg CNTX-4975
Total dose delivered as two separate lower doses
Drug: CNTX-4975
Testing a range of dosing configurations to optimize patient tolerability
Experimental: 900-1000 µg CNTX-4975
Total dose delivered as two separate lower doses
Drug: CNTX-4975
Testing a range of dosing configurations to optimize patient tolerability

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate the safety of IA CNTX-4975 as measured by related AEs occurring on day of dosing measures of pain at prescribed times
Time Frame: 12 Weeks
12 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluate analgesic efficacy, as measured by the PGIC, following IA injection of CNTX-4975
Time Frame: 12 Weeks
12 Weeks
Change from baseline to Week 12 in WOMAC subscale score
Time Frame: Baseline to 12 weeks
Baseline to 12 weeks

Collaborators and Investigators

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

Sponsor

Centrexion Therapeutics

Investigators

  • Study Director: William C Houghton, MD, Anesiva, Inc.
  • Study Director: Shaun Comfort, MD, MBA, Anesiva, 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

August 1, 2007

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

April 23, 2008

First Submitted That Met QC Criteria

April 25, 2008

First Posted (Estimate)

April 28, 2008

Study Record Updates

Last Update Posted (Estimate)

December 6, 2016

Last Update Submitted That Met QC Criteria

December 5, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 114-02P

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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