- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01429168
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Withdrawn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
Intervention / Treatment
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:
|
EXPERIMENTAL: Part 2: Etoricoxib
|
One 60-mg tablet orally daily
Other Names:
|
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
Terms related to this study
Additional Relevant MeSH Terms
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Arthritis
- Osteoarthritis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Cyclooxygenase 2 Inhibitors
- Etoricoxib
Other Study ID Numbers
- 0663-142
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.
Clinical Trials on Osteoarthritis
-
Sanford HealthActive, not recruitingKnee Osteoarthritis | Hip Osteoarthritis | Shoulder Osteoarthritis | Ankle Osteoarthritis | Wrist OsteoarthritisUnited States
-
University of EdinburghHospital for Special Surgery, New YorkRecruitingKnee Osteoarthritis | Hip Osteoarthritis | Shoulder OsteoarthritisUnited Kingdom
-
Medical University of WarsawUnknownOsteoarthritis | Knee Osteoarthritis | Hip Osteoarthritis | Glenohumeral OsteoarthritisPoland
-
Medical University of WarsawUnknownOsteoarthritis | Knee Osteoarthritis | Hip Osteoarthritis | Glenohumeral OsteoarthritisPoland
-
University of California, San FranciscoStanford University; Robert Wood Johnson FoundationCompletedKnee Osteoarthritis | Hip OsteoarthritisUnited States
-
University of VermontCompletedOsteoarthritis of Knee | Osteoarthritis Of HipUnited States
-
Hospital for Special Surgery, New YorkRoyal Infirmary of EdinburghRecruitingKnee Osteoarthritis | Hip Osteoarthritis | Shoulder OsteoarthritisUnited States, United Kingdom
-
Ottawa Hospital Research InstituteNot yet recruitingKnee Osteoarthritis | Hip Osteoarthritis
-
University Hospital, LilleCompleted
-
Massachusetts General HospitalNewton-Wellesley Hospital; The New England Baptist HospitalCompletedKnee Osteoarthritis | Hip OsteoarthritisUnited States
Clinical Trials on Etoricoxib
-
Organon and CoCompleted
-
Organon and CoCompleted
-
Organon and CoCompleted
-
Organon and CoCompleted
-
Radboud University Medical CenterCompletedOssification, HeterotopicNetherlands
-
Organon and CoCompleted
-
Clinica Virgen MilagrosaMerck Sharp & Dohme LLCTerminatedSoft Tissue Injuries of the Shoulder | Tenosynovitis and Bursitis Affecting the ShoulderPeru
-
University of Erlangen-Nürnberg Medical SchoolMerck Sharp & Dohme LLC; Rush University Medical Center; HELIOS Kliniken GmbHTerminatedPain | Postoperative Pain | Osteoarthritis, HipGermany
-
Núcleo de Estudos em Esportes e Ortopedia, BrazilMerck Sharp & Dohme LLCUnknownSprains and Strains | ContusionsBrazil
-
Organon and CoCompletedAcute Pain Following a Total Abdominal Hysterectomy