Analgesic Efficacy and Safety of V116517 in Subjects With Moderate to Severe Chronic Pain Due to Osteoarthritis (OA) of the Knee
A Phase 2, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Study Evaluating the Analgesic Efficacy and Safety of V116517 in Subjects With Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee
1 other identifier
interventional
230
1 country
18
Brief Summary
The primary objective of this study is to evaluate the analgesic efficacy of 2 dose levels of V116517 versus placebo.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2012
Shorter than P25 for phase_2
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 17, 2012
CompletedFirst Posted
Study publicly available on registry
September 20, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedDecember 5, 2013
December 1, 2013
9 months
September 17, 2012
December 4, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Western Ontario and McMaster OA Index (WOMAC) Pain Score
Week 4
Secondary Outcomes (5)
WOMAC Physical Function Score
Week 4
WOMAC Stiffness Score
Week 4
Modified Brief Pain Inventory - Short Form (mBPI-SF) Severity of Pain and Interference of Pain
Week 4
Patient Global Impression of Change (PGIC)
Week 4
Supplemental Analgesic Medication Use
Over 4 weeks
Study Arms (4)
V116517 - 50 mg
EXPERIMENTALV116517 50-mg tablets
V116517 - 30 mg
EXPERIMENTALV116517 30-mg tablets
Naproxen 500 mg
ACTIVE COMPARATORNaproxen 500-mg capsules
Placebo
PLACEBO COMPARATORPlacebo
Interventions
Tablets to match V116517 and/or placebo capsules to match naproxen taken orally twice daily
Eligibility Criteria
You may qualify if:
- Subjects with moderate pain due to OA of the knee as their primary pain condition.
- Subjects with diagnostic criteria for primary pain condition (American college of Rheumatology \[ACR\] clinical and radiographic criteria):
- At least 1 of the following in addition to knee pain: age \>50, stiffness \<30 min, crepitus on active motion, and
- Kellgren-Lawrence (K-L) grade ≥ 2 radiographic evidence within the past 2 years.
You may not qualify if:
- Subjects with chronic pain conditions other than OA of the knee as their predominant pain condition, including gout, pseudo gout, psoriatic arthritis, active Lyme disease, rheumatoid arthritis or any other inflammatory arthritis, fibromyalgia, neuropathic pain conditions, bursitis, or acute injury or signs of active infection in the target pain area.
- Subjects who cannot or will not agree to stop all concomitant analgesic medications, apart from specified protocol supplemental analgesic medications.
- Subjects with history of seizures within the past 5 years.
- Subjects who use opioids more than 4 days per week.
- Subjects who received local pain-control procedures, including intra- articular steroid injection in the study knee or intramuscular steroid injection at any site within 6 weeks of entering the study or hyaluronate injection in the study knee within 12 weeks of entering the study.
- Subjects who have had arthroscopy on either knee or hip within 6 months of entering the study, or open surgery on either knee or hip within 12 months of entering the study.
- Subjects who are allergic to or cannot tolerate naproxen or acetaminophen, including history of NSAID-induced asthma, or nasal polyps;
- Subjects with history of bleeding disorders or history of documented gastrointestinal ulcer disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Purdue Pharma LPlead
Study Sites (18)
Genova Clinical Research, Inc.
Tucson, Arizona, 85704, United States
Orthopedic Research Institute
Boynton Beach, Florida, 33472, United States
Avail Clinical Research, LLC
DeLand, Florida, 32720, United States
Westside Center for Clinical Research
Jacksonville, Florida, 32205, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216, United States
Health Awareness, Inc.
Jupiter, Florida, 33458, United States
Compass Research, LLC
Orlando, Florida, 32806, United States
Compass Research East, LLC
Oviedo, Florida, 32765, United States
Northwest Indiana Center for Clinical Research
Valparaiso, Indiana, 46383, United States
Analgesic Solutions
Natick, Massachusetts, 01760, United States
Great Lakes Research Group, Inc.
Bay City, Michigan, 48706, United States
PMG Research of Charlotte, LLC.
Charlotte, North Carolina, 28209, United States
PMG Research of Raleigh, LLC
Raleigh, North Carolina, 27609, United States
Wake Research Associates, LLC
Raleigh, North Carolina, 27612, United States
LION Research
Norman, Oklahoma, 73069, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
Clinical Research Center of Reading, LLP
Wyomissing, Pennsylvania, 19610, United States
PMG Research of Bristol
Bristol, Tennessee, 37620, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 17, 2012
First Posted
September 20, 2012
Study Start
September 1, 2012
Primary Completion
June 1, 2013
Study Completion
August 1, 2013
Last Updated
December 5, 2013
Record last verified: 2013-12