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
1 other identifier
interventional
54
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Aug 2007
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
April 23, 2008
CompletedFirst Posted
Study publicly available on registry
April 28, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedDecember 6, 2016
December 1, 2016
10 months
April 23, 2008
December 5, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
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
Study Arms (5)
100-200 µg CNTX-4975
EXPERIMENTALsingle dose
300-425 µg CNTX-4975
EXPERIMENTALTotal dose delivered as two separate lower doses
600-700 µg CNTX-4975
EXPERIMENTALTotal dose delivered as two separate lower doses
800 µg CNTX-4975
EXPERIMENTALTotal dose delivered as two separate lower doses
900-1000 µg CNTX-4975
EXPERIMENTALTotal dose delivered as two separate lower doses
Interventions
Testing a range of dosing configurations to optimize patient tolerability
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinical Phamacology Study Group
Worcester, Massachusetts, 01610, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
William C Houghton, MD
Anesiva, Inc.
- STUDY DIRECTOR
Shaun Comfort, MD, MBA
Anesiva, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2008
First Posted
April 28, 2008
Study Start
August 1, 2007
Primary Completion
June 1, 2008
Study Completion
August 1, 2016
Last Updated
December 6, 2016
Record last verified: 2016-12