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

NCT02611466 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 215

Last updated 2024-10-31

No results posted yet for this study

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

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).

Sponsors & Collaborators

  • Astellas Pharma Europe B.V.

    lead INDUSTRY

Principal Investigators

  • Medical Officer · Astellas Pharma Europe B.V.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-16
Primary Completion
2017-08-28
Completion
2017-09-29

Countries

  • Belgium
  • Czechia
  • Germany
  • Hungary
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02611466 on ClinicalTrials.gov