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

NCT01429168 | Withdrawn Phase 4

• 1 other identifier: 0663-142
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Mean Time to Loss of Efficacy in the Double Blind Withdrawal Period (Part 2)

  Week 3 to Week 7

Secondary Outcomes (3)

• Proportion of Participants who Achieve ≥30% Reduction in Pain During Part I

  Week 1 to Week 3

• Change in Mean of Daily Pain Scores

  Week 1 to Week 7

• Proportion of Participants Meeting Criteria for Loss of Efficacy in Part 2

  Week 3 to Week 7

Study Arms (3)

Part 1: All Enrolled Participants

EXPERIMENTAL

All participants will receive open-label etoricoxib 60 mg orally daily during Part 1.

Drug: Etoricoxib

Part 2: Etoricoxib

EXPERIMENTAL

Drug: Etoricoxib

Part 2: Placebo

PLACEBO COMPARATOR

Drug: Placebo for etoricoxib

Interventions

Etoricoxib DRUG

One 60-mg tablet orally daily

Also known as: MK-0663

Part 1: All Enrolled Participants; Part 2: Etoricoxib

Placebo for etoricoxib DRUG

One 60-mg tablet orally daily

Part 2: Placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Organon and Co: lead

MeSH Terms

Conditions

Osteoarthritis

Interventions

Etoricoxib

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Sulfones; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2011
• First Posted: September 5, 2011
• Study Start: October 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: February 18, 2022

Record last verified: 2022-02