NCT02611466

A Study to Assess the Analgesic Efficacy of ASP7962 in Patients With Pain Due to Osteoarthritis of the Knee

A Phase 2a, Randomized, Double-blind, Placebo- and Naproxen Controlled, Parallel-group Study to Assess the Analgesic Efficacy of ASP7962 in Patients With Pain Due to Osteoarthritis of the Knee

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 215 (actual)
• Sponsor: Astellas Pharma Europe B.V. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate the analgesic efficacy of ASP7962 relative to placebo. This study will also evaluate the efficacy of ASP7962 relative to placebo on pain on walking, function and stiffness; the time course of efficacy of ASP7962 relative to placebo; the improvement in overall patient status of ASP7962 relative to placebo as well as the safety and tolerability of ASP7962 relative to placebo.

Conditions

• Osteoarthritis of the Knee
• Chronic Lower Back Pain

Interventions

Type	Name	Description
DRUG	ASP7962	Participants receive ASP7962 100 mg orally twice daily, in the morning and evening with or without food (approximately 12 hours).
DRUG	Naproxen	Participants receive naproxen 500 mg orally twice daily, in the morning and evening with or without food (approximately 12 hours).
DRUG	Placebo	Participants receive matching placebo orally twice daily, in the morning and evening with or without food (approximately 12 hours).

Timeline

• Start date: 2016-02-16
• Primary completion: 2017-08-28
• Completion: 2017-09-29
• First posted: 2015-11-20
• Last updated: 2024-10-31

Locations

34 sites across 6 countries: Belgium, Czechia, Germany, Hungary, Spain, United Kingdom