Brief Summary
The purpose of this study is to evaluate the analgesic efficacy, safety, and tolerability of VM902A twice daily compared to placebo in subjects with moderate to severe chronic pain due to OA of the knee.
Brief Title
A Study to Evaluate the Analgesic Efficacy and Safety of VM902A in Subjects With Osteoarthritis (OA) of the Knee
Completion Date
Completion Date Type
Actual
Conditions
Osteoarthritis Pain of the Knee
Eligibility Criteria
Key Inclusion Criteria Include:
1. Males and females ≥ 40 and ≤ 75 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, stiffness \< 30 min, 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. Note that K-L grades 2 to 3 require the presence of osteophytes, which is required to meet ACR clinical and radiographic criteria for knee OA
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 ≥ 5 and ≤ 9 on an 11-point numerical rating scale (NRS) for the index knee on ≥ 3 consecutive days during the screening period and come in for randomization within 72 hours after qualification is met
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 treatment period, 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 at risk for destructive arthropathy, subjects with a history of osteonecrosis, osteoporotic fracture, rapidly progressive osteoarthritis (RPOA 1 and 2), subchondral insufficiency fracture, and hip/knee dislocations
3. Subjects considered high risk for surgery based upon American Society of Anesthesiologists physical classification system for surgery grading, or subjects who would not be willing to undergo joint replacement surgery if required
4. Subjects with chronic pain conditions other than OA of the knee as their predominant pain condition, including gout (except for subjects with gout that is controlled with diet and/or with stable suppressive treatment with uric acid reducing medication(s) and/or colchicine, and who have not had any attack within the past 2 years), 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
5. Subjects scheduled for surgical interventions of the disease site or any other major surgery during the study conduct period
6. Subjects with a history of a prior joint replacement of the index knee
7. 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.
Other protocol-specific inclusion/exclusion criteria may apply.
1. Males and females ≥ 40 and ≤ 75 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, stiffness \< 30 min, 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. Note that K-L grades 2 to 3 require the presence of osteophytes, which is required to meet ACR clinical and radiographic criteria for knee OA
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 ≥ 5 and ≤ 9 on an 11-point numerical rating scale (NRS) for the index knee on ≥ 3 consecutive days during the screening period and come in for randomization within 72 hours after qualification is met
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 treatment period, 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 at risk for destructive arthropathy, subjects with a history of osteonecrosis, osteoporotic fracture, rapidly progressive osteoarthritis (RPOA 1 and 2), subchondral insufficiency fracture, and hip/knee dislocations
3. Subjects considered high risk for surgery based upon American Society of Anesthesiologists physical classification system for surgery grading, or subjects who would not be willing to undergo joint replacement surgery if required
4. Subjects with chronic pain conditions other than OA of the knee as their predominant pain condition, including gout (except for subjects with gout that is controlled with diet and/or with stable suppressive treatment with uric acid reducing medication(s) and/or colchicine, and who have not had any attack within the past 2 years), 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
5. Subjects scheduled for surgical interventions of the disease site or any other major surgery during the study conduct period
6. Subjects with a history of a prior joint replacement of the index knee
7. 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.
Other protocol-specific inclusion/exclusion criteria may apply.
Inclusion Criteria
Inclusion Criteria Include:
1. Males and females ≥ 40 and ≤ 75 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, stiffness \< 30 min, 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. Note that K-L grades 2 to 3 require the presence of osteophytes, which is required to meet ACR clinical and radiographic criteria for knee OA
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 ≥ 5 and ≤ 9 on an 11-point numerical rating scale (NRS) for the index knee on ≥ 3 consecutive days during the screening period and come in for randomization within 72 hours after qualification is met
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 treatment period, with the exception of study-specific rescue medication.
inclusion/
1. Males and females ≥ 40 and ≤ 75 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, stiffness \< 30 min, 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. Note that K-L grades 2 to 3 require the presence of osteophytes, which is required to meet ACR clinical and radiographic criteria for knee OA
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 ≥ 5 and ≤ 9 on an 11-point numerical rating scale (NRS) for the index knee on ≥ 3 consecutive days during the screening period and come in for randomization within 72 hours after qualification is met
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 treatment period, with the exception of study-specific rescue medication.
inclusion/
Gender
All
Gender Based
false
Keywords
Osteoarthritis
Pain
Osteoarthritis, knee
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
75 Years
Minimum Age
40 Years
NCT Id
NCT02847702
Org Class
Industry
Org Full Name
Purdue Pharma LP
Org Study Id
TKA2001
Overall Status
Terminated
Phases
Phase 2
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Phase 2a, Multicenter, Randomized, Double-blind, Placebo Controlled and Active-controlled, Parallel-group Study Evaluating the Analgesic Efficacy and Safety of VM902A in Subjects With Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee
Primary Outcomes
Outcome Measure
Daily "Average Pain Over the Last 24 Hours" Score at Week 4
Outcome Time Frame
Week 4
Secondary Outcomes
Outcome Time Frame
Week 4
Outcome Measure
Weekly "Average Pain Over the Last 24 Hours" at Week 4
Outcome Time Frame
Week 4
Outcome Measure
Average Daily "Pain Right Now" Score at Week 4
Outcome Time Frame
Week 4
Outcome Measure
Western Ontario and McMaster OA Index (WOMAC) - Total Scores
Outcome Time Frame
Week 4
Outcome Measure
Western Ontario and McMaster OA Index (WOMAC) Pain Severity Subscale Score
Outcome Time Frame
Week 4
Outcome Measure
Western Ontario and McMaster OA Index (WOMAC) Physical Function Subscale Score
Outcome Time Frame
Week 4
Outcome Measure
Western Ontario and McMaster OA Index (WOMAC) Stiffness Subscale Score
Outcome Time Frame
Week 4
Outcome Measure
Modified Brief Pain Inventory-Short Form (mBPI-SF) - Total Scores
Outcome Time Frame
Week 4
Outcome Measure
Modified Brief Pain Inventory-Short Form (mBPI-SF) Pain Severity Subscale Score
Outcome Time Frame
Week 4
Outcome Measure
Modified Brief Pain Inventory-Short Form (mBPI-SF) Pain Interference Subscale Score
Outcome Time Frame
Week 4
Outcome Measure
Medical Outcomes Study 36-item Short-Form Health Survey (SF-36)
Outcome Time Frame
Week 4
Outcome Measure
EuroQol-5D (EQ-5D) to Measure Health Status
Outcome Time Frame
Week 4
Outcome Measure
Patient Global Impression of Change (PGIC) at the End of the Double-blind Period
Outcome Description
The average daily number of tablets of supplemental pain medication taken during the study.
Outcome Time Frame
Days 1 - 28
Outcome Measure
Supplemental Analgesic Medication Use
Outcome Description
The percentage reduction from the baseline mean "average pain over the last 24 hours" score to the week 4 mean pain score from the mBPI-SF pain severity subscale.
Outcome Time Frame
Week 4
Outcome Measure
Responder to Treatment
Outcome Description
Safety assessment to evaluate the impact of VM902A on mood (anxiety and depression)
Outcome Time Frame
Baseline to Week 4
Outcome Measure
Hospital Anxiety and Depression Scale (HADS) Score
Outcome Description
Safety assessment to evaluate the occurrence of treatment-emergent suicidal ideation
Outcome Time Frame
Baseline to Week 4
Outcome Measure
Columbia-Suicide Severity Rating Score (C-SSRS)
Outcome Description
Safety assessment to evaluate symptoms of autonomic dysfunction
Outcome Time Frame
Baseline to Week 4
Outcome Measure
Survey of Autonomic Symptoms (SAS) Score
Outcome Description
Safety assessment to classify the severity of knee OA
Outcome Time Frame
Baseline to Week 4
Outcome Measure
Kellgren-Lawrence Classification (K-L) Score
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
75
Minimum Age Number (converted to Years and rounded down)
40
Investigators
Investigator Type
Principal Investigator
Investigator Name
Naum Shaparin
Investigator Email
nshapari@montefiore.org
Investigator Phone