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:
Anesiva, Inc.
ClinicalTrials.gov Identifier:
NCT00667654
First received: April 23, 2008
Last updated: May 1, 2009
Last verified: May 2009
  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: 4975
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group 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 Anesiva, Inc.:

Primary Outcome Measures:
  • To evaluate optimal dosing regimens of 4975 using Numerical Rating Scale (NRS) measures of pain at prescribed times [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate safety and efficacy [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]

Enrollment: 54
Study Start Date: August 2007
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Single dose with possible dose escalation
Drug: 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
Genders Eligible for Study:   Both
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
Anesiva, Inc.
Investigators
Study Director: William C Houghton, MD Anesiva, Inc.
Study Director: Shaun Comfort, MD, MBA Anesiva, Inc.
  More Information

No publications provided

Responsible Party: Shaun Comfort, MD, Anesiva, Inc.
ClinicalTrials.gov Identifier: NCT00667654     History of Changes
Other Study ID Numbers: 114-02P
Study First Received: April 23, 2008
Last Updated: May 1, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Anesiva, Inc.:
Osteoarthritis, Knee

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

ClinicalTrials.gov processed this record on August 20, 2014