Patient-Reported Effectiveness and Safety of Etoricoxib in Osteoarthritis (OA)(0663-113)

NCT00757627 | Completed Phase 4 Results

• 3 other identifiers: 0663-113MK0663-1132008_029
• Study Type: interventional
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to collect disease burden of OA and the effectiveness and patient satisfaction of treatment by Etoricoxib in the normal practice setting.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• The Percentage of Participants Achieving ≥30% Decrease From Baseline in Pain Intensity as Measured by WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) Question 1 "Pain Walking on a Flat Surface" at Week 4

  WOMAC for pain assessment by patient (0-100 mm Visual Analog Scale (VAS) with 0 represent "no pain" and 100 represent "extreme pain")

  Baseline and end of week 4

Secondary Outcomes (9)

• Mean Change From Baseline in Patient WOMAC Domain Scores at Week 4

  Baseline and Week 4

• Physicians' Global Assessment of Patients' Response to Therapy at Baseline Using IGART (Investigator Global Assessment of Response to Therapy)

  Baseline

• Physicians' Global Assessment of Patients' Response to Therapy at Week 4 Using IGART

  Week 4

• Patient Assessment of General Health Outcome by EuroQoL-5 Dimensions (EQ-5D) at Baseline

  Baseline

• Patient Assessment of General Health Outcome by EuroQoL-5 Dimensions (EQ-5D) at Week 4

  Week 4

Study Arms (1)

1

EXPERIMENTAL

Etoricoxib

Drug: etoricoxib

Interventions

etoricoxib DRUG

etoricoxib 60 mg QD for 4 weeks.

Also known as: Arcoxia

1

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must Be Over 20 Years Of Age, Regardless Of Sex
• Must Have A Diagnosis Of OA That Requiring Treatment
• Patients Must Have Taken an NSAID, Cox-2 Or Opioids On The Majority Of Days During The Last 4 Weeks Before Enrollment Who Are Intolerant (Due To Gastrointestinal Adverse Events) Or Inadequately Respond To Current Therapy (Vas \>= 40 mm On A Pain Scale From 0-100 mm)
• Excluding Osteoarthritis, The Patient Is Judged To Be In Otherwise General Good Health Based On Medical History, Physical Examination, And Routine Laboratory Tests
• Must Agree To Participate Voluntarily In The Study
• Must Have The Capacity To Understand And Answer The Questionnaires Used In The Study
• Must Agree To Return For A Follow-Up Visit With The Treating Physician Four Weeks After The Initiation Of Treatment With Etoricoxib
• Patient Is Willing To Sign Informed Consent Form

You may not qualify if:

• Under 20 Years Of Age
• Severe Hepatic Insufficiency (Child-Pugh Score \> 9)
• Advanced Renal Insufficiency (Creatinine Clearance \< 30 Ml/Min)
• Any Contraindication Or Warning Or Precaution As Mentioned In The Approved Study Drug Package Insert
• Gi Ulcer With Active Bleeding Present At Study Enrollment
• Patient Has A Recent History Of Stroke, Myocardial Infarction Or Transient Ischemic Attack (Within The Previous 2 Years)

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (1)

• Lin HY, Cheng TT, Wang JH, Lee CS, Chen MH, Lei V, Lac C, Gammaitoni AR, Smugar SS, Chen WJ. Etoricoxib improves pain, function and quality of life: results of a real-world effectiveness trial. Int J Rheum Dis. 2010 May;13(2):144-50. doi: 10.1111/j.1756-185X.2010.01468.x.

  PMID: 20536599 RESULT

MeSH Terms

Conditions

Pain

Interventions

Etoricoxib

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

Open-labeled, non-controlled

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2008
• First Posted: September 23, 2008
• Study Start: December 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: February 9, 2022
• Results First Posted: May 11, 2010

Record last verified: 2022-02