NCT00090181

Brief Summary

The purpose of this study is to evaluate the efficacy of MK0663 for the treatment of chronic low back pain and to investigate the overall safety and tolerability over four weeks of treatment.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
401

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2004

Shorter than P25 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2004

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 27, 2004

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
Last Updated

February 15, 2022

Status Verified

February 1, 2022

Enrollment Period

9 months

First QC Date

August 25, 2004

Last Update Submit

February 3, 2022

Conditions

Chronic Low Back Pain

Keywords

Arcoxia

Outcome Measures

Primary Outcomes (2)

  • Lower back pain intensity

  • Safety and tolerability

Secondary Outcomes (2)

  • Disability questionnaire

  • Patient global assessment of response to therapy

Interventions

MK0663, etoricoxib / Duration of Treatment: 4 weeksDRUG
Comparator: diclofenac / Duration of Treatment: 4 weeksDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female patients 18 years of age or older, who have Chronic Low Back Pain after the discontinuation of their previous medication for their condition.
  • Patients should have at least 3 months of Low Back Pain.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Zerbini C, Ozturk ZE, Grifka J, Maini M, Nilganuwong S, Morales R, Hupli M, Shivaprakash M, Giezek H; Etoricoxib CLBP Study Group. Efficacy of etoricoxib 60 mg/day and diclofenac 150 mg/day in reduction of pain and disability in patients with chronic low back pain: results of a 4-week, multinational, randomized, double-blind study. Curr Med Res Opin. 2005 Dec;21(12):2037-49. doi: 10.1185/030079905X75069.

    PMID: 16368055BACKGROUND

MeSH Terms

Interventions

EtoricoxibDuration of Therapy

Intervention Hierarchy (Ancestors)

SulfonesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2004

First Posted

August 27, 2004

Study Start

June 1, 2004

Primary Completion

March 1, 2005

Study Completion

March 1, 2005

Last Updated

February 15, 2022

Record last verified: 2022-02