Analgesic Efficacy and Safety of V116517 in Subjects With Moderate to Severe Chronic Pain Due to Osteoarthritis (OA) of the Knee

Phase 2

Completed

• Conditions: Osteoarthritis, Knee; Pain
• Interventions: Drug: V116517 50-mg tablets; Drug: V116517 30-mg tablets; Drug: Naproxen 500-mg capsules; Drug: Placebo

• Registration Number: NCT01688934
• Lead Sponsor: Purdue Pharma LP

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-17
• Study First Submitted QC: 2012-09-17
• Study First Posted: 2012-09-20
• Primary Completion: 2013-06
• Study Completion: 2013-08
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-04
• Last Update Posted: 2013-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 230

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
V116517 - 50 mg	V116517 50-mg tablets	V116517 50-mg tablets
V116517 - 50 mg	Placebo	V116517 50-mg tablets
V116517 - 30 mg	V116517 30-mg tablets	V116517 30-mg tablets
V116517 - 30 mg	Placebo	V116517 30-mg tablets
Naproxen 500 mg	Naproxen 500-mg capsules	Naproxen 500-mg capsules
Naproxen 500 mg	Placebo	Naproxen 500-mg capsules
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Western Ontario and McMaster OA Index (WOMAC) Pain Score	Week 4

Secondary Outcome Measures

Name	Time	Method
Patient Global Impression of Change (PGIC)	Week 4
Supplemental Analgesic Medication Use	Over 4 weeks
Modified Brief Pain Inventory - Short Form (mBPI-SF) Severity of Pain and Interference of Pain	Week 4
WOMAC Physical Function Score	Week 4
WOMAC Stiffness Score	Week 4

Trial Locations

Locations (18)

Genova Clinical Research, Inc.; 🇺🇸 Tucson, Arizona, United States

Orthopedic Research Institute; 🇺🇸 Boynton Beach, Florida, United States

Avail Clinical Research, LLC; 🇺🇸 Deland, Florida, United States

Westside Center for Clinical Research; 🇺🇸 Jacksonville, Florida, United States

Jacksonville Center for Clinical Research; 🇺🇸 Jacksonville, Florida, United States

Health Awareness, Inc.; 🇺🇸 Jupiter, Florida, United States

Compass Research, LLC; 🇺🇸 Orlando, Florida, United States

Compass Research East, LLC; 🇺🇸 Oviedo, Florida, United States

Northwest Indiana Center for Clinical Research; 🇺🇸 Valparaiso, Indiana, United States

Analgesic Solutions; 🇺🇸 Natick, Massachusetts, United States

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