A Study to Evaluate the Analgesic Efficacy and Safety of V120083 in Subjects With Osteoarthritis (OA) of the Knee
- Registration Number
- NCT03028870
- Lead Sponsor
- Purdue Pharma LP
- Brief Summary
The purpose of this study is to evaluate the analgesic efficacy of V120083 twice daily compared to placebo in subjects with moderate to severe chronic pain due to OA of the knee.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 291
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description V120083 30 mg Placebo V120083 30-mg capsules taken orally twice daily V120083 60 mg V120083 V120083 60-mg (2 x 30 mg) capsules taken orally twice daily V120083 60 mg Placebo V120083 60-mg (2 x 30 mg) capsules taken orally twice daily Naproxen Placebo Naproxen 500-mg capsules taken orally twice daily Placebo Placebo Capsules to match V120083 and/or naproxen taken orally twice daily V120083 30 mg V120083 V120083 30-mg capsules taken orally twice daily Naproxen Naproxen Naproxen 500-mg capsules taken orally twice daily
- Primary Outcome Measures
Name Time Method Daily "Average Pain Over the Last 24 Hours" Score at Week 4 Week 4 At week 4, subjects were asked to rate their pain on an 11-point numerical scale where 0 = no pain, 10 = pain as bad as you can imagine.
- Secondary Outcome Measures
Name Time Method Modified Brief Pain Inventory-Short Form (mBPI-SF) Pain Interference Subscale Score 4 Weeks The mBPI-SF is a self-administered questionnaire. The pain interference subscale of the mBPI-SF consists of Question 6 which has 7 parts, all of which ask the subjects to rate the impact/interference of their pain on various functions, ie, general activity, mood, walking, normal work, relations with others, sleep, and enjoyment of life on a 0 to 10 NRS where 0 = does not interfere and 10 = completely interferes. The mean interference of pain scores could range from 0 to 10.
Responder to Treatment (Calculated as the Percentage Reduction of "Average Pain Over the Last 24 Hours") at Week 4 Week 4 A subject's response to treatment was defined as the percentage reduction from the baseline "average pain over the last 24 hours" score to the week 4 pain score from the mBPI-SF pain severity subscale. Responders were defined as having \> 0 % reduction; non-responders were defined as having ≤ 0% reduction.
Medical Outcomes Study Short Form-36 (SF-36) - Physical Component Summary 4 Weeks The SF-36 is a generic health survey with 36 items that measure functional health and well-being from the subject's perspective. The survey is summarized into 8 dimensions/scales: physical functioning (PF), role-physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role-emotional (RE), and mental health (MH).
The Physical Component Summary is derived from 4 of the 8 health dimensions (aggregate of PF, RP, BP, and GH scales). The minimum score is 0 and the maximum score is 100. A higher score indicates a better health state.Medical Outcomes Study Short Form-36 (SF-36) - Mental Component Summary 4 Weeks The SF-36 is a generic health survey with 36 items that measure functional health and well-being from the subject's perspective. The survey is summarized into 8 dimensions/scales: physical functioning (PF), role-physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role-emotional (RE), and mental health (MH).
The Mental Component Summary is derived from 4 of the 8 health dimensions,(aggregate of VT, SF, RE, and MH scales). The minimum score is 0 and the maximum score is 100. A higher score indicates a better health state.Average Daily "Pain Right Now" Score Collected by e-Diary 4 Weeks Subjects were asked to rate their pain on an 11-point numerical scale where 0 = no pain, 10 = pain as bad as you can imagine.
Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Pain Subscale 4 Weeks The pain subscale consisted of 5 items: walking; stair climbing; nocturnal; at rest; weight bearing. The score for each item ranged from 0 (none) to 4 (extreme). The pain subscale score was obtained by adding the responses to the 5 items which could range from 0 to 20.
Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Stiffness Subscale 4 Weeks The stiffness subscale consisted of 2 items; morning stiffness and stiffness occurring later in the day. The score for each item ranged from 0 (none) to 4 (extreme) and the stiffness subscale score was obtained by adding the responses to the 2 items which could range from 0 - 8.
Weekly Change From Baseline Score of "Average Pain Over the Last 24 Hours" From the mBPI-SF Pain Severity Subscale Weeks 1, 2 and 4 Subjects were asked to rate their pain on an 11-point numerical scale where 0 = no pain, 10 = pain as bad as you can imagine.
Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Physical Function Subscale 4 Weeks The physical function subscale consisted of 17 items: descending stairs; ascending stairs; rising from sitting; standing; bending to floor; walking on flat surface; getting into or out of car; going shopping; putting on socks; rising from bed; taking off socks; lying in bed; sitting; getting into or out of the bathtub; getting on or off the toilet; heavy domestic duties; light domestic duties. The score for each item ranged from 0 (none) to 4 (extreme) and the physical function subscale score was obtained by adding the responses to the 17 items which could range from 0 to 68.
Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Total Score 4 Weeks The total score of the WOMAC consisted of 24 items (5 items from the pain subscale, 2 items from the stiffness subscale, and 17 items from the physical function subscale). The total score was obtained by adding the scores from these 3 subscales and could range from 0 to 96.
Modified Brief Pain Inventory-Short Form (mBPI-SF) - Total Score (All Parts of 6 Questions) 4 Weeks The mBPI-SF consists of 6 questions and is a self-administered questionnaire used to assess the severity of pain, and the interference of pain on daily functions. Subjects rated their severity of pain / interference of pain on a 0 (no pain / does not interfere) to 10 (as bad as you can imagine / completely interferes) numerical rating scale (NRS) The total score is the sum of all parts of the 6 questions and the total score range is 0 - 110.
Modified Brief Pain Inventory-Short Form (mBPI-SF) Pain Severity Subscale Score 4 Weeks The mBPI-SF is a self-administered questionnaire. The pain severity subscale of the mBPI-SF consists of 4 questions which ask the subjects to rate their severity of pain on a 0 to 10 NRS for worst pain, least pain, average pain, and current pain. The severity of pain was computed as the mean of questions 1-4. The mean severity of pain scores could range from 0 to 10.
European Quality of Life Scale - 5 Dimensions (EQ-5D-5L) to Measure Health Status 4 Weeks EQ-5D-5L is a standardized generic measure of health status for clinical and economic appraisal based on a descriptive system that defines health in terms of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. It includes a visual analogue scale (VAS) with scores ranging from 0 ("worst imaginable health state") to 100 ("best imaginable health state").
Patient Global Impression of Change (PGIC) 4 Weeks The PGIC is an ordinal scale which assesses the change in overall status relative to the start of the study. The scale has only 1 item, which measures global change of overall status by the subject on a 7-point scale (very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse), where 1 = very much improved and 7 = very much worse. The number of subjects responding "very much improved" and "much improved" was summarized by treatment group.
Supplemental Analgesic Medication Use Up to 28 days The average daily number of tablets of supplemental pain medication used during the double-blind period was summarized by treatment group.
Number of Participants With Treatment-emergent Suicidal Ideation and Behaviors Assessed by Columbia-Suicide Severity Rating Score (C-SSRS) Baseline up to 4 Weeks Suicidality was monitored throughout the study using the C-SSRS. The C-SSRS involves a series of probing questions to inquire about possible suicidal thinking and behavior. The composite endpoints (Suicidal Ideation, Suicidal Behavior, Suicidal Ideation or Behavior) included subjects who experienced any one of the events at least once during treatment.
Change From Baseline to Week 4 in Hospital Anxiety and Depression Scale (HADS) Score Week 4 Safety assessment to evaluate the impact of V120083 on mood (anxiety \[HADS-A\] and depression \[HADS-D\]). The score for each subscale ranges from 0 (no anxiety or depression) to 21, with a score of 11 or higher indicating the probable presence of the mood disorder.
Trial Locations
- Locations (29)
New Horizon Research Center
🇺🇸Miami, Florida, United States
New Horizons Clinical Research
🇺🇸Cincinnati, Ohio, United States
Diagnostics Research Group
🇺🇸San Antonio, Texas, United States
Drug Trials America
🇺🇸Hartsdale, New York, United States
Artemis Institute for Clinical Research
🇺🇸San Marcos, California, United States
Palm Beach Research Center
🇺🇸West Palm Beach, Florida, United States
Future Care Solution, LLC
🇺🇸Miami, Florida, United States
Buynak Clinical Research, P.C.
🇺🇸Valparaiso, Indiana, United States
Mountain View Clinical Research, Inc.
🇺🇸Greer, South Carolina, United States
Hassman Research Institute
🇺🇸Berlin, New Jersey, United States
Medication Management, LLC
🇺🇸Greensboro, North Carolina, United States
Burke Primary Care
🇺🇸Morganton, North Carolina, United States
Providence Health Partners - Center for Clinical Research
🇺🇸Dayton, Ohio, United States
FutureSearch Trials of Neurology
🇺🇸Austin, Texas, United States
Alabama Clinical Therapeutics, LLC
🇺🇸Birmingham, Alabama, United States
Terence T. Hart, MD
🇺🇸Tuscumbia, Alabama, United States
Wake Research Associates, LLC
🇺🇸Raleigh, North Carolina, United States
Heartland Research Associates, LLC
🇺🇸Wichita, Kansas, United States
Omega Research Consultants, LLC
🇺🇸Orlando, Florida, United States
Clinical Research of West Florida, Inc.
🇺🇸Tampa, Florida, United States
St. Louis Center for Clinical Research
🇺🇸Saint Louis, Missouri, United States
St. Louis Clinical Trials, LC
🇺🇸Saint Louis, Missouri, United States
Omega Medical Research
🇺🇸Warwick, Rhode Island, United States
Sensible Healthcare, LLC
🇺🇸Ocoee, Florida, United States
Clinical Pharmacology Study Group
🇺🇸Worcester, Massachusetts, United States
Sundance Clinical Research, LLC
🇺🇸Saint Louis, Missouri, United States
Research Institute of the Carolinas of Piedmont Healthcare, PA
🇺🇸Mooresville, North Carolina, United States
Providence Clinical Research
🇺🇸North Hollywood, California, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States