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

Osteoarthritis of the Knee Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00667654
• Other study ID #: 114-02P
• Status: Completed
• Phase: Phase 2
• First received: April 23, 2008
• Last updated: December 5, 2016
• Start date: August 2007
• Est. completion date: August 2016

Study information

• Verified date: December 2016
• Source: Centrexion Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: August 2016
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

Drug:
• CNTX-4975
Testing a range of dosing configurations to optimize patient tolerability

Locations

Country	Name	City	State
United States	Clinical Phamacology Study Group	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Centrexion Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the safety of IA CNTX-4975 as measured by related AEs occurring on day of dosing measures of pain at prescribed times		12 Weeks	Yes
Secondary	Evaluate analgesic efficacy, as measured by the PGIC, following IA injection of CNTX-4975		12 Weeks	No
Secondary	Change from baseline to Week 12 in WOMAC subscale score		Baseline to 12 weeks	No