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A Study of Etoricoxib in Participants With Osteoarthritis Not Responding to Analgesic Drugs (MK-0663-142 AM1) (RESPOND-EUROPE)

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01429168
First received: September 2, 2011
Last updated: December 14, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention Phase
Osteoarthritis
Drug: Etoricoxib
Drug: Placebo for etoricoxib
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: The Randomized Etoricoxib Study in Patients With Osteoarthritis Not Responding to Analgesic Drugs - THE RESPOND-EUROPE STUDY

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Mean Time to Loss of Efficacy in the Double Blind Withdrawal Period (Part 2) [ Time Frame: Week 3 to Week 7 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of Participants who Achieve ≥30% Reduction in Pain During Part I [ Time Frame: Week 1 to Week 3 ] [ Designated as safety issue: No ]
  • Change in Mean of Daily Pain Scores [ Time Frame: Week 1 to Week 7 ] [ Designated as safety issue: No ]
  • Proportion of Participants Meeting Criteria for Loss of Efficacy in Part 2 [ Time Frame: Week 3 to Week 7 ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: October 2011
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part 1: All Enrolled Participants
All participants will receive open-label etoricoxib 60 mg orally daily during Part 1.
Drug: Etoricoxib
One 60-mg tablet orally daily
Other Name: MK-0663
Experimental: Part 2: Etoricoxib Drug: Etoricoxib
One 60-mg tablet orally daily
Other Name: MK-0663
Placebo Comparator: Part 2: Placebo Drug: Placebo for etoricoxib
One 60-mg tablet orally daily

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01429168     History of Changes
Other Study ID Numbers: MK-0663-142
Study First Received: September 2, 2011
Last Updated: December 14, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Analgesics
Etoricoxib
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014