A Study of Etoricoxib in Participants With Osteoarthritis Not Responding to Analgesic Drugs (MK-0663-142) (RESPOND-EUROPE)

February 7, 2022 updated by: Organon and Co

The Randomized Etoricoxib Study in Patients With Osteoarthritis Not Responding to Analgesic Drugs - THE RESPOND-EUROPE STUDY

This two-part study will evaluate the effectiveness of etoricoxib in controlling pain in participants with osteoarthritis who are experiencing inadequate response to their current treatments. In Part 1, all participants will receive open-label etoricoxib 60 mg daily. Those participants who experience a clinically meaningful response to etoricoxib 60 mg daily within two weeks will be eligible to enter the double-blind withdrawal period (Part II). Responders entering Part 2 will be randomized in a 1:1 ratio to receive either etoricoxib 60 mg or placebo.

Study Overview

Status

Withdrawn

Conditions

Study Type

Interventional

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of osteoarthritis of the knee or hip that requires treatment
  • American Rheumatism Association (ARA) functional Class I, II or III
  • Receiving a stable dose of a traditional non-steroidal anti-inflammatory drug (NSAID), a Cox-2 selective inhibitor (other than etoricoxib, e.g. celecoxib), opioid therapy or tramadol to treat their osteoarthritis-related pain for at least 2 weeks and willing to maintain treatment during baseline phase
  • Moderate to severe daily pain intensity on his or her current pain regimen
  • Excepting osteoarthritis, patient is judged to be in otherwise general good health based on medical history, physical examination, and routine laboratory tests
  • Negative serum pregnancy test

Exclusion Criteria:

  • Has not experienced at least 3 consecutive days of daily pain intensity >4 on 10-point scale
  • Severe hepatic insufficiency
  • Advanced renal insufficiency
  • Presence of gastro-intestinal ulcer disease with active bleeding or history of the same within the past 6 months or a presence or history of inflammatory bowel disease
  • History of gastric, biliary (including gastric bypass surgery), or small intestinal surgery that results in clinical malabsorption
  • Receiving or will likely require treatment with ≥14 consecutive days or repeated courses of pharmacologic doses of corticosteroids
  • Established ischemic heart disease, peripheral arterial disease, and/or cerebrovascular disease including a history of stroke, myocardial infarction or transient ischemic attack, and recent revascularization procedures
  • Any other contraindications mentioned in the approved study drug European Union (EU) Summary of Product Characteristics (SmPC)
  • Therapy with glucosamine and/or chondroitin sulfate for <6 months prior to study start.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Part 1: All Enrolled Participants
All participants will receive open-label etoricoxib 60 mg orally daily during Part 1.
One 60-mg tablet orally daily
Other Names:
  • MK-0663
EXPERIMENTAL: Part 2: Etoricoxib
One 60-mg tablet orally daily
Other Names:
  • MK-0663
PLACEBO_COMPARATOR: Part 2: Placebo
One 60-mg tablet orally daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean Time to Loss of Efficacy in the Double Blind Withdrawal Period (Part 2)
Time Frame: Week 3 to Week 7
Week 3 to Week 7

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of Participants who Achieve ≥30% Reduction in Pain During Part I
Time Frame: Week 1 to Week 3
Week 1 to Week 3
Change in Mean of Daily Pain Scores
Time Frame: Week 1 to Week 7
Week 1 to Week 7
Proportion of Participants Meeting Criteria for Loss of Efficacy in Part 2
Time Frame: Week 3 to Week 7
Week 3 to Week 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (ANTICIPATED)

August 1, 2012

Study Completion (ANTICIPATED)

August 1, 2012

Study Registration Dates

First Submitted

September 2, 2011

First Submitted That Met QC Criteria

September 2, 2011

First Posted (ESTIMATE)

September 5, 2011

Study Record Updates

Last Update Posted (ACTUAL)

February 18, 2022

Last Update Submitted That Met QC Criteria

February 7, 2022

Last Verified

February 1, 2022

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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