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

CompletedPhase 2NCT02611466
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
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
Interventions
Sponsor
Astellas Pharma Europe B.V.
Organization
Astellas Pharma Inc
Start date
2016-02-16
Primary completion
2017-08-28
Sex
All
Age range
from 18 Years to 80 Years
Results posted
No results posted in this snapshot
Countries
Belgium, Czechia, Germany, Hungary, Spain, United Kingdom
Total sites listed
34

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Patient has a primary diagnosis of OA of the index knee with symptoms for at least 6 months prior to screening and patient meets American College of Rheumatology clinical classification criteria for OA of the knee, defined by the following: * Knee pain and at least 3 of the following 6: 1. Age \> 50 years 2. Morning stiffness \< 30 minutes 3. Crepitus on active motion 4. Bony tenderness 5. Bony enlargement 6. No palpable warmth of synovium * Patient has a radiographic image of the index knee (according to the minimum quality criteria for radiographic image as set by the central radiology reader) showing evidence of OA with a Kellgren-Lawrence grade ≥2 at screening (based on central reading). * Patient has moderate to severe index knee pain (pain due to OA of the knee at least 5 days per week for the last 3 months prior to screening, as determined by patient's medical history). * Patient is ambulatory and the index knee must not contain any orthopedic and/or prosthetic device. * WOMAC pain subscale score (with a 48-hour recall period) in the index knee ≥ 4 at baseline (visit 2 predose, mean of all questions on pain subscale). * WOMAC physical function subscale score ≥ 4 at baseline (visit 2 predose, mean of all questions on physical function subscale with a 48-hour recall period). * Patient is willing to discontinue all current pain medications during the baseline and treatment periods (until day 57) (except for allowed rescue medications). Low dose aspirin for cardioprophylaxis is allowed. * Patient is compliant with daily pain recording. Compliance with diary completion will be defined as daily average pain ratings on at least 5 days of the baseline period, of which at least 3 days are in the last 4 days prior to visit 2. * Male patient and their female spouse/partners who are of childbearing potential must be using a barrier method and 1 form of highly effective birth control starting at screening and continuing throughout the study period and for 90 days after the final study drug administration. * Male patient must not donate sperm starting at screening and throughout the study period and for 90 days after the final study drug administration. * Female patient must either: * Be of non-childbearing potential: post-menopausal (defined as at least 1 year without any menses) prior to screening, or documented surgically sterile * Or, if of childbearing potential: agree not to try to become pregnant during the study and for 28 days after…

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02611466