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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01688934
• Date of registration: 17/09/2012
• Prospective Registration: No
• Primary sponsor: Purdue Pharma LP
• Public title: Analgesic Efficacy and Safety of V116517 in Subjects With Moderate to Severe Chronic Pain Due to Osteoarthritis (OA) of the Knee
• Scientific title: 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
• Date of first enrolment: September 2012
• Target sample size: 230
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01688934
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

United States

Key inclusion & exclusion criteria

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.



Age minimum: 40 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Pain

Osteoarthritis, Knee

Intervention(s)

Drug: V116517 30-mg tablets

Drug: Naproxen 500-mg capsules

Drug: V116517 50-mg tablets

Drug: Placebo

Primary Outcome(s)

Western Ontario and McMaster OA Index (WOMAC) Pain Score [Time Frame: Week 4]

Secondary Outcome(s)

WOMAC Stiffness Score [Time Frame: Week 4]

Supplemental Analgesic Medication Use [Time Frame: Over 4 weeks]

Patient Global Impression of Change (PGIC) [Time Frame: Week 4]

WOMAC Physical Function Score [Time Frame: Week 4]

Modified Brief Pain Inventory - Short Form (mBPI-SF) Severity of Pain and Interference of Pain [Time Frame: Week 4]

Secondary ID(s)

VND2001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors