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

The primary objective of this study is to evaluate the analgesic efficacy of 2 dose levels of V116517 versus placebo.

Study Overview

• Status: Completed
• Conditions: Pain; Osteoarthritis, Knee
• Intervention / Treatment: Drug: V116517 50-mg tablets; Drug: V116517 30-mg tablets; Drug: Placebo; Drug: Naproxen 500-mg capsules

• Study Type: Interventional
• Enrollment (Actual): 230
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85704
      • Genova Clinical Research, Inc.
  • Florida
    • Boynton Beach, Florida, United States, 33472
      • Orthopedic Research Institute
    • Deland, Florida, United States, 32720
      • Avail Clinical Research, LLC
    • Jacksonville, Florida, United States, 32205
      • Westside Center for Clinical Research
    • Jacksonville, Florida, United States, 32216
      • Jacksonville Center for Clinical Research
    • Jupiter, Florida, United States, 33458
      • Health Awareness, Inc.
    • Orlando, Florida, United States, 32806
      • Compass Research, LLC
    • Oviedo, Florida, United States, 32765
      • Compass Research East, LLC
  • Indiana
    • Valparaiso, Indiana, United States, 46383
      • Northwest Indiana Center for Clinical Research
  • Massachusetts
    • Natick, Massachusetts, United States, 01760
      • Analgesic Solutions
  • Michigan
    • Bay City, Michigan, United States, 48706
      • Great Lakes Research Group, Inc.
  • North Carolina
    • Charlotte, North Carolina, United States, 28209
      • PMG Research of Charlotte, LLC.
    • Raleigh, North Carolina, United States, 27612
      • Wake Research Associates, LLC
    • Raleigh, North Carolina, United States, 27609
      • PMG Research of Raleigh, LLC
  • Oklahoma
    • Norman, Oklahoma, United States, 73069
      • Lion Research
  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16635
      • Altoona Center for Clinical Research
    • Wyomissing, Pennsylvania, United States, 19610
      • Clinical Research Center of Reading, LLP
  • Tennessee
    • Bristol, Tennessee, United States, 37620
      • PMG Research of Bristol

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Key Inclusion Criteria:

1. Subjects with moderate pain due to OA of the knee as their primary pain condition.

2. 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.

Key Exclusion Criteria:

1. 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.
2. Subjects who cannot or will not agree to stop all concomitant analgesic medications, apart from specified protocol supplemental analgesic medications.
3. Subjects with history of seizures within the past 5 years.
4. Subjects who use opioids more than 4 days per week.

5. Pain-condition-specific exclusions:

   • 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.
6. 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.

7. Active-comparator-related exclusions:

   • 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.

Other protocol specific inclusion/exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Tablets to match V116517 and/or placebo capsules to match naproxen taken orally twice daily
Experimental: V116517 - 50 mg; V116517 50-mg tablets	Drug: V116517 50-mg tablets; Taken orally twice daily; Drug: Placebo; Tablets to match V116517 and/or placebo capsules to match naproxen taken orally twice daily
Experimental: V116517 - 30 mg; V116517 30-mg tablets	Drug: V116517 30-mg tablets; Taken orally twice daily; Drug: Placebo; Tablets to match V116517 and/or placebo capsules to match naproxen taken orally twice daily
Active Comparator: Naproxen 500 mg; Naproxen 500-mg capsules	Drug: Placebo; Tablets to match V116517 and/or placebo capsules to match naproxen taken orally twice daily; Drug: Naproxen 500-mg capsules; Taken orally twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Western Ontario and McMaster OA Index (WOMAC) Pain Score	Week 4

Secondary Outcome Measures

Outcome Measure	Time Frame
Patient Global Impression of Change (PGIC)	Week 4
Supplemental Analgesic Medication Use	Over 4 weeks
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

Collaborators and Investigators

• Sponsor: Purdue Pharma LP

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: September 17, 2012
• First Submitted That Met QC Criteria: September 17, 2012
• First Posted (Estimate): September 20, 2012

Study Record Updates

• Last Update Posted (Estimate): December 5, 2013
• Last Update Submitted That Met QC Criteria: December 4, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Osteoarthritis; Pain; Knee
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Chronic Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Gout Suppressants; Naproxen
• Other Study ID Numbers: VND2001