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

Primary Purpose

Osteoarthritis of the Knee

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

CNTX-4975

About this trial

This is an interventional treatment trial for Osteoarthritis of the Knee focused on measuring Osteoarthritis, Knee

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Clinical Phamacology Study Group

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Arm Label

100-200 µg CNTX-4975

300-425 µg CNTX-4975

600-700 µg CNTX-4975

800 µg CNTX-4975

900-1000 µg CNTX-4975

Arm Description

single dose

Total dose delivered as two separate lower doses

Outcomes

Primary Outcome Measures

To evaluate the safety of IA CNTX-4975 as measured by related AEs occurring on day of dosing measures of pain at prescribed times

Secondary Outcome Measures

Evaluate analgesic efficacy, as measured by the PGIC, following IA injection of CNTX-4975

Change from baseline to Week 12 in WOMAC subscale score

Full Information

NCT ID

NCT00667654

First Posted

April 23, 2008

Last Updated

December 5, 2016

Sponsor

Centrexion Therapeutics

1. Study Identification

Unique Protocol Identification Number

NCT00667654

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2016

Overall Recruitment Status

Completed

Study Start Date

August 2007 (undefined)

Primary Completion Date

June 2008 (Actual)

Study Completion Date

August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centrexion Therapeutics

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis of the Knee

Keywords

Osteoarthritis, Knee

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

54 (Actual)

8. Arms, Groups, and Interventions

Arm Title

100-200 µg CNTX-4975

Arm Type

Experimental

Arm Description

single dose

Arm Title

300-425 µg CNTX-4975

Arm Type

Experimental

Arm Description

Total dose delivered as two separate lower doses

Arm Title

600-700 µg CNTX-4975

Arm Type

Experimental

Arm Description

Total dose delivered as two separate lower doses

Arm Title

800 µg CNTX-4975

Arm Type

Experimental

Arm Description

Total dose delivered as two separate lower doses

Arm Title

900-1000 µg CNTX-4975

Arm Type

Experimental

Arm Description

Total dose delivered as two separate lower doses

Intervention Type

Drug

Intervention Name(s)

CNTX-4975

Intervention Description

Testing a range of dosing configurations to optimize patient tolerability

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Evaluate analgesic efficacy, as measured by the PGIC, following IA injection of CNTX-4975

Time Frame

12 Weeks

Title

Change from baseline to Week 12 in WOMAC subscale score

Time Frame

Baseline to 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

William C Houghton, MD

Organizational Affiliation

Anesiva, Inc.

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Shaun Comfort, MD, MBA

Organizational Affiliation

Anesiva, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Clinical Phamacology Study Group

City

Worcester

State/Province

Massachusetts

ZIP/Postal Code

01610

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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