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

NCT ID: NCT00667654

Last Updated: 2016-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2016-08-31

Brief Summary

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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

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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.

Conditions

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Osteoarthritis of the Knee

Keywords

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Osteoarthritis, Knee

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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100-200 µg CNTX-4975

single dose

Group Type EXPERIMENTAL

CNTX-4975

Intervention Type DRUG

Testing a range of dosing configurations to optimize patient tolerability

300-425 µg CNTX-4975

Total dose delivered as two separate lower doses

Group Type EXPERIMENTAL

CNTX-4975

Intervention Type DRUG

Testing a range of dosing configurations to optimize patient tolerability

600-700 µg CNTX-4975

Total dose delivered as two separate lower doses

Group Type EXPERIMENTAL

CNTX-4975

Intervention Type DRUG

Testing a range of dosing configurations to optimize patient tolerability

800 µg CNTX-4975

Total dose delivered as two separate lower doses

Group Type EXPERIMENTAL

CNTX-4975

Intervention Type DRUG

Testing a range of dosing configurations to optimize patient tolerability

900-1000 µg CNTX-4975

Total dose delivered as two separate lower doses

Group Type EXPERIMENTAL

CNTX-4975

Intervention Type DRUG

Testing a range of dosing configurations to optimize patient tolerability

Interventions

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CNTX-4975

Testing a range of dosing configurations to optimize patient tolerability

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centrexion Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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William C Houghton, MD

Role: STUDY_DIRECTOR

Anesiva, Inc.

Shaun Comfort, MD, MBA

Role: STUDY_DIRECTOR

Anesiva, Inc.

Locations

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Clinical Phamacology Study Group

Worcester, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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114-02P

Identifier Type: -

Identifier Source: org_study_id