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

Primary Purpose

Osteoarthritis

Status

Withdrawn

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Etoricoxib

Placebo for etoricoxib

About this trial

This is an interventional treatment trial for Osteoarthritis

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Part 1: All Enrolled Participants

Part 2: Etoricoxib

Part 2: Placebo

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Change in Mean of Daily Pain Scores

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

Full Information

NCT ID

NCT01429168

First Posted

September 2, 2011

Last Updated

February 7, 2022

Sponsor

Organon and Co

1. Study Identification

Unique Protocol Identification Number

NCT01429168

Brief Title

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

Acronym

RESPOND-EUROPE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Withdrawn

Study Start Date

October 2011 (undefined)

Primary Completion Date

August 2012 (Anticipated)

Study Completion Date

August 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Organon and Co

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Part 1: All Enrolled Participants

Arm Type

Experimental

Arm Description

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

Arm Title

Part 2: Etoricoxib

Arm Type

Experimental

Arm Title

Part 2: Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Etoricoxib

Other Intervention Name(s)

MK-0663

Intervention Description

One 60-mg tablet orally daily

Intervention Type

Drug

Intervention Name(s)

Placebo for etoricoxib

Intervention Description

One 60-mg tablet orally daily

Primary Outcome Measure Information:

Title

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

Time Frame

Week 3 to Week 7

Secondary Outcome Measure Information:

Title

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

Time Frame

Week 1 to Week 3

Title

Change in Mean of Daily Pain Scores

Time Frame

Week 1 to Week 7

Title

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

Time Frame

Week 3 to Week 7

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

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.

12. IPD Sharing Statement

Learn more about this trial

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

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