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

April 23, 2008
May 1, 2009
August 2007
June 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00667654 on ClinicalTrials.gov Archive Site
To evaluate safety and efficacy [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Osteoarthritis of the Knee
Drug: 4975
Testing a range of dosing configurations to optimize patient tolerability
Experimental: 1
Single dose with possible dose escalation
Intervention: Drug: 4975
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
June 2008
June 2008   (final data collection date for primary outcome measure)

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.
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00667654
114-02P
No
Shaun Comfort, MD, Anesiva, Inc.
Anesiva, Inc.
Not Provided
Study Director: William C Houghton, MD Anesiva, Inc.
Study Director: Shaun Comfort, MD, MBA Anesiva, Inc.
Anesiva, Inc.
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP