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

Pain Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01688934
• Other study ID #: VND2001
• Status: Completed
• Phase: Phase 2
• First received: September 17, 2012
• Last updated: December 4, 2013
• Start date: September 2012
• Est. completion date: August 2013

Study information

• Verified date: December 2013
• Source: Purdue Pharma LP
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: August 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pain
• Osteoarthritis
• Osteoarthritis, Knee
• Pain

Intervention

Drug:
• V116517 50-mg tablets
Taken orally twice daily
• V116517 30-mg tablets
Taken orally twice daily
• Naproxen 500-mg capsules
Taken orally twice daily
• Placebo
Tablets to match V116517 and/or placebo capsules to match naproxen taken orally twice daily

Locations

Country	Name	City	State
United States	Great Lakes Research Group, Inc.	Bay City	Michigan
United States	Orthopedic Research Institute	Boynton Beach	Florida
United States	PMG Research of Bristol	Bristol	Tennessee
United States	PMG Research of Charlotte, LLC.	Charlotte	North Carolina
United States	Avail Clinical Research, LLC	Deland	Florida
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania
United States	Jacksonville Center for Clinical Research	Jacksonville	Florida
United States	Westside Center for Clinical Research	Jacksonville	Florida
United States	Health Awareness, Inc.	Jupiter	Florida
United States	Analgesic Solutions	Natick	Massachusetts
United States	LION Research	Norman	Oklahoma
United States	Compass Research, LLC	Orlando	Florida
United States	Compass Research East, LLC	Oviedo	Florida
United States	PMG Research of Raleigh, LLC	Raleigh	North Carolina
United States	Wake Research Associates, LLC	Raleigh	North Carolina
United States	Genova Clinical Research, Inc.	Tucson	Arizona
United States	Northwest Indiana Center for Clinical Research	Valparaiso	Indiana
United States	Clinical Research Center of Reading, LLP	Wyomissing	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Purdue Pharma LP

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Western Ontario and McMaster OA Index (WOMAC) Pain Score		Week 4	No
Secondary	WOMAC Physical Function Score		Week 4	No
Secondary	WOMAC Stiffness Score		Week 4	No
Secondary	Modified Brief Pain Inventory - Short Form (mBPI-SF) Severity of Pain and Interference of Pain		Week 4	No
Secondary	Patient Global Impression of Change (PGIC)		Week 4	No
Secondary	Supplemental Analgesic Medication Use		Over 4 weeks	No