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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centrexion Therapeutics
ClinicalTrials.gov Identifier:
NCT00667654
First received: April 23, 2008
Last updated: December 5, 2016
Last verified: December 2016
  Purpose
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.

Condition Intervention Phase
Osteoarthritis of the Knee Drug: CNTX-4975 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Centrexion Therapeutics:

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 [ Time Frame: 12 Weeks ]

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

Enrollment: 54
Study Start Date: August 2007
Study Completion Date: August 2016
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00667654

Locations
United States, Massachusetts
Clinical Phamacology Study Group
Worcester, Massachusetts, United States, 01610
Sponsors and Collaborators
Centrexion Therapeutics
Investigators
Study Director: William C Houghton, MD Anesiva, Inc.
Study Director: Shaun Comfort, MD, MBA Anesiva, Inc.
  More Information

Responsible Party: Centrexion Therapeutics
ClinicalTrials.gov Identifier: NCT00667654     History of Changes
Other Study ID Numbers: 114-02P
Study First Received: April 23, 2008
Last Updated: December 5, 2016

Keywords provided by Centrexion Therapeutics:
Osteoarthritis, Knee

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on June 22, 2017