NCT00380523

Brief Summary

Allow physicians to test the efficacy of arcoxia in patients with acute pain.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
237

participants targeted

Target at P75+ for phase_4 pain

Timeline
Completed

Started Apr 2005

Shorter than P25 for phase_4 pain

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

April 1, 2005

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 22, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 26, 2006

Completed
Last Updated

February 16, 2022

Status Verified

February 1, 2022

Enrollment Period

1 month

First QC Date

September 22, 2006

Last Update Submit

February 4, 2022

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • Evaluate pain using the verbal analog scale (evaluate pain before starting treatment and then evaluate pain every day after had taken arcoxia up to three days)

Secondary Outcomes (2)

  • Patient satisfaction with the drug therapy using PGART scale

  • Patient satisfaction was obtained at the end of treatment(on third day)

Interventions

MK0663, Arcoxia, etoricoxib / Duration of Treatment: 3 DaysDRUG

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of acute pain susceptible of pharmacological treatment
  • Greater than 18 years of age
  • Voluntary acceptance to participate in the study and signature of the informed consent form

You may not qualify if:

  • Allergy to etoricoxib or any of its components
  • Less than 18 years old
  • Patient is taking anticoagulants
  • Patient that already has taken any drug as analgesic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain

Interventions

EtoricoxibDuration of Therapy

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

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
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2006

First Posted

September 26, 2006

Study Start

April 1, 2005

Primary Completion

May 1, 2005

Study Completion

May 1, 2005

Last Updated

February 16, 2022

Record last verified: 2022-02