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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00667654

Enrollment

Registered

2008-04-28

Start date

2007-08-31

Completion date

2016-08-31

Last updated

2016-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis of the Knee

Keywords

Osteoarthritis, Knee

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.

Interventions

DRUGCNTX-4975

Testing a range of dosing configurations to optimize patient tolerability

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

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.

Design outcomes

Primary

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	12 Weeks

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026