Clinical trial NCT01688934: Analgesic Efficacy and Safety of V116517 in Subjects With Moderate to Severe Chronic Pain Due to Osteoarthritis (OA) of the Knee
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoarthritis, Knee
Pain
Keywords: Pain
Osteoarthritis
Knee
Lead sponsor: Purdue Pharma LP
Sponsor class: INDUSTRY
First posted: 2012-09-20
Enrollment: 230
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Western Ontario and McMaster OA Index (WOMAC) Pain Score
timeFrame: Week 4
Secondary outcomes:
measure: WOMAC Physical Function Score
timeFrame: Week 4
measure: WOMAC Stiffness Score
timeFrame: Week 4
measure: Modified Brief Pain Inventory - Short Form (mBPI-SF) Severity of Pain and Interference of Pain
timeFrame: Week 4
measure: Patient Global Impression of Change (PGIC)
timeFrame: Week 4
measure: Supplemental Analgesic Medication Use
timeFrame: Over 4 weeks
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Genova Clinical Research, Inc.
state: Arizona
city: Boynton Beach
country: United States
facility: Orthopedic Research Institute
state: Florida
city: Deland
country: United States
facility: Avail Clinical Research, LLC
state: Florida
city: Jacksonville
country: United States
facility: Westside Center for Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Jupiter
country: United States
facility: Health Awareness, Inc.
state: Florida
city: Orlando
country: United States
facility: Compass Research, LLC
state: Florida
city: Oviedo
country: United States
facility: Compass Research East, LLC
state: Florida
city: Valparaiso
country: United States
facility: Northwest Indiana Center for Clinical Research
state: Indiana
city: Natick
country: United States
facility: Analgesic Solutions
state: Massachusetts
city: Bay City
country: United States
facility: Great Lakes Research Group, Inc.
state: Michigan
city: Charlotte
country: United States
facility: PMG Research of Charlotte, LLC.
state: North Carolina
city: Raleigh
country: United States
facility: PMG Research of Raleigh, LLC
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates, LLC
state: North Carolina
city: Norman
country: United States
facility: LION Research
state: Oklahoma
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Wyomissing
country: United States
facility: Clinical Research Center of Reading, LLP
state: Pennsylvania
city: Bristol
country: United States
facility: PMG Research of Bristol
state: Tennessee
Study officials:
References: