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

NCT ID: NCT01429168

Last Updated: 2022-02-18

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2012-08-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Part 1: All Enrolled Participants

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

Group Type: EXPERIMENTAL

Etoricoxib

Intervention Type: DRUG

One 60-mg tablet orally daily

Part 2: Etoricoxib

Group Type: EXPERIMENTAL

Etoricoxib

Intervention Type: DRUG

One 60-mg tablet orally daily

Part 2: Placebo

Group Type: PLACEBO_COMPARATOR

Placebo for etoricoxib

Intervention Type: DRUG

One 60-mg tablet orally daily

Interventions

Etoricoxib

One 60-mg tablet orally daily

Intervention Type: DRUG

Placebo for etoricoxib

One 60-mg tablet orally daily

Intervention Type: DRUG

Other Intervention Names

MK-0663

Eligibility 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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

0663-142

Identifier Type: -

Identifier Source: org_study_id