Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 56 of 179 for:    DCLRE1C

A Study to Evaluate the Analgesic Efficacy and Safety of V120083 in Subjects With Osteoarthritis (OA) of the Knee

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03028870
Recruitment Status : Completed
First Posted : January 23, 2017
Results First Posted : November 15, 2018
Last Update Posted : February 12, 2019
Sponsor:
Collaborator:
Shionogi
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Osteo Arthritis Knee Drug: V120083 Drug: Naproxen Drug: Placebo Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 291 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled and Active-controlled, Parallel-group Study Evaluating the Analgesic Efficacy and Safety of V120083 in Subjects With Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee
Actual Study Start Date : March 14, 2017
Actual Primary Completion Date : November 10, 2017
Actual Study Completion Date : November 21, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
Drug Information available for: Naproxen

Arm Intervention/treatment
Experimental: V120083 30 mg
V120083 30-mg capsules taken orally twice daily
Drug: V120083
Capsules

Drug: Placebo
Capsules to match V120083 and/or naproxen

Experimental: V120083 60 mg
V120083 60-mg (2 x 30 mg) capsules taken orally twice daily
Drug: V120083
Capsules

Drug: Placebo
Capsules to match V120083 and/or naproxen

Active Comparator: Naproxen
Naproxen 500-mg capsules taken orally twice daily
Drug: Naproxen
Capsules

Drug: Placebo
Capsules to match V120083 and/or naproxen

Placebo Comparator: Placebo
Capsules to match V120083 and/or naproxen taken orally twice daily
Drug: Placebo
Capsules to match V120083 and/or naproxen




Primary Outcome Measures :
  1. Daily "Average Pain Over the Last 24 Hours" Score at Week 4 [ Time Frame: 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 :
  1. Weekly Change From Baseline Score of "Average Pain Over the Last 24 Hours" From the mBPI-SF Pain Severity Subscale [ Time Frame: 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.

  2. Average Daily "Pain Right Now" Score Collected by e-Diary [ Time Frame: 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.

  3. Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Pain Subscale [ Time Frame: 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.

  4. Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Stiffness Subscale [ Time Frame: 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.

  5. Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Physical Function Subscale [ Time Frame: 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.

  6. Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Total Score [ Time Frame: 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.

  7. Modified Brief Pain Inventory-Short Form (mBPI-SF) - Total Score (All Parts of 6 Questions) [ Time Frame: 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.

  8. Modified Brief Pain Inventory-Short Form (mBPI-SF) Pain Severity Subscale Score [ Time Frame: 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.

  9. Modified Brief Pain Inventory-Short Form (mBPI-SF) Pain Interference Subscale Score [ Time Frame: 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.

  10. Responder to Treatment (Calculated as the Percentage Reduction of "Average Pain Over the Last 24 Hours") at Week 4 [ Time Frame: 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.

  11. Medical Outcomes Study Short Form-36 (SF-36) - Physical Component Summary [ Time Frame: 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.


  12. Medical Outcomes Study Short Form-36 (SF-36) - Mental Component Summary [ Time Frame: 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.


  13. European Quality of Life Scale - 5 Dimensions (EQ-5D-5L) to Measure Health Status [ Time Frame: 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").

  14. Patient Global Impression of Change (PGIC) [ Time Frame: 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.

  15. Supplemental Analgesic Medication Use [ Time Frame: 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.

  16. Number of Participants With Treatment-emergent Suicidal Ideation and Behaviors Assessed by Columbia-Suicide Severity Rating Score (C-SSRS) [ Time Frame: 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.

  17. Change From Baseline to Week 4 in Hospital Anxiety and Depression Scale (HADS) Score [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria Include:

  1. Males and females ≥ 40 and ≤ 80 years of age with moderate to severe chronic OA pain of the knee (lasting several hours daily) as their predominant pain condition for at least 6 months prior to screening
  2. 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, morning stiffness < 30 minutes, crepitus on active motion, and
    • Kellgren-Lawrence (K-L) grade 2 or 3 radiographic evidence at the screening visit as determined by a local radiologist or rheumatologist. If a radiograph is not available, one must be taken and the diagnostic criteria must be confirmed before randomization.
  3. Subjects whose OA pain of the index knee is not adequately treated prior to the screening visit:

    • Subjects must have a self-reported average pain intensity rating of moderate or severe on a verbal rating scale (ie, none, mild, moderate, and severe) over the 7 days prior to the screening visit
  4. The subjects must have "average pain over the last 24 hours" scores ≥ 4 and ≤ 9 on an 11-point numerical rating scale (NRS) for the index knee on ≥ 3 consecutive days during the pain assessment period and come in for randomization within 96 hours after the latest qualifying pain score entry
  5. Subjects who are willing and able to stop taking any/all analgesic medications, including over-the-counter pain medications, opioids, marijuana, and topical analgesics for OA pain for the duration of the study, with the exception of study-specific rescue medication.

Key Exclusion Criteria Include:

  1. Subjects with radiographic evidence of OA with K-L grade 0,1 or 4
  2. Subjects with chronic pain conditions other than OA of the knee as their predominant pain condition, including gout, pseudogout, 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
  3. Subjects scheduled for surgical interventions of the disease site or any other major surgery during the study conduct period
  4. Subjects with a history of a prior joint replacement of the index knee
  5. 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
  6. Subjects with a history of significant trauma to a knee, hip or shoulder within the previous year
  7. Subjects who have significant pain, other than or more than knee pain, including significant hip, back pain, that may confound the analgesic efficacy assessments of this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03028870


  Show 30 Study Locations
Sponsors and Collaborators
Purdue Pharma LP
Shionogi
  Study Documents (Full-Text)

Documents provided by Purdue Pharma LP:
Study Protocol  [PDF] February 16, 2017
Statistical Analysis Plan  [PDF] January 12, 2018


Layout table for additonal information
Responsible Party: Purdue Pharma LP
ClinicalTrials.gov Identifier: NCT03028870     History of Changes
Other Study ID Numbers: VAN2001
First Posted: January 23, 2017    Key Record Dates
Results First Posted: November 15, 2018
Last Update Posted: February 12, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Purdue Pharma LP:
Osteoarthritis
Pain
Osteoarthritis Knee

Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Analgesics
Naproxen
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action