A Study to Evaluate the Analgesic Efficacy and Safety of VM902A in Subjects With Osteoarthritis (OA) of the Knee

Phase 2

Terminated

• Conditions: Osteoarthritis Pain of the Knee
• Interventions: Drug: VM902A 200-mg Capsules; Drug: VM902A 400-mg Capsules; Drug: Naproxen 500-mg Capsules; Drug: Placebo

• Registration Number: NCT02847702
• Lead Sponsor: Purdue Pharma LP

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-07-25
• Study First Submitted QC: 2016-07-25
• Study First Posted: 2016-07-28
• Study Start: 2016-08
• Primary Completion: 2016-11-22
• Study Completion: 2016-11-22
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-20
• Last Update Posted: 2017-11-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VM902A 200 mg	VM902A 200-mg Capsules	VM902A 200-mg Capsules
VM902A 200 mg	Placebo	VM902A 200-mg Capsules
VM902A 400 mg	VM902A 400-mg Capsules	VM902A 400-mg Capsules (2 x 200-mg capsules)
VM902A 400 mg	Placebo	VM902A 400-mg Capsules (2 x 200-mg capsules)
Naproxen	Naproxen 500-mg Capsules	Naproxen 500-mg Capsules
Naproxen	Placebo	Naproxen 500-mg Capsules
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Daily "Average Pain Over the Last 24 Hours" Score at Week 4	Week 4

Secondary Outcome Measures

Name	Time	Method
Weekly "Average Pain Over the Last 24 Hours" at Week 4	Week 4
Average Daily "Pain Right Now" Score at Week 4	Week 4
Western Ontario and McMaster OA Index (WOMAC) - Total Scores	Week 4
Western Ontario and McMaster OA Index (WOMAC) Pain Severity Subscale Score	Week 4
Western Ontario and McMaster OA Index (WOMAC) Physical Function Subscale Score	Week 4
Western Ontario and McMaster OA Index (WOMAC) Stiffness Subscale Score	Week 4
Modified Brief Pain Inventory-Short Form (mBPI-SF) - Total Scores	Week 4
Modified Brief Pain Inventory-Short Form (mBPI-SF) Pain Severity Subscale Score	Week 4
Modified Brief Pain Inventory-Short Form (mBPI-SF) Pain Interference Subscale Score	Week 4
Medical Outcomes Study 36-item Short-Form Health Survey (SF-36)	Week 4
EuroQol-5D (EQ-5D) to Measure Health Status	Week 4
Patient Global Impression of Change (PGIC) at the End of the Double-blind Period	Week 4
Supplemental Analgesic Medication Use	Days 1 - 28	The average daily number of tablets of supplemental pain medication taken during the study.
Responder to Treatment	Week 4	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.
Hospital Anxiety and Depression Scale (HADS) Score	Baseline to Week 4	Safety assessment to evaluate the impact of VM902A on mood (anxiety and depression)
Columbia-Suicide Severity Rating Score (C-SSRS)	Baseline to Week 4	Safety assessment to evaluate the occurrence of treatment-emergent suicidal ideation
Survey of Autonomic Symptoms (SAS) Score	Baseline to Week 4	Safety assessment to evaluate symptoms of autonomic dysfunction
Kellgren-Lawrence Classification (K-L) Score	Baseline to Week 4	Safety assessment to classify the severity of knee OA

Trial Locations

Locations (1)

Investigational Site; 🇺🇸 South Jordan, Utah, United States