NCT00142558

Brief Summary

A study to evaluate the effects of etoricoxib and indomethacin in the treatment of acute gout.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2005

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

January 1, 2005

Completed
4 months 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
4 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 2, 2005

Completed
Last Updated

August 15, 2024

Status Verified

February 1, 2022

Enrollment Period

4 months

First QC Date

August 31, 2005

Last Update Submit

August 12, 2024

Conditions

Acute Gout

Keywords

Arcoxia

Outcome Measures

Primary Outcomes (1)

  • Patient assessment of pain (0- to 4- Likert scale)

Secondary Outcomes (4)

  • Patient Global Assessment of Response to Therapy (0- to 4- point scale)

  • Investigator Global Assessment of Response to Therapy (0- to 4- point scale)

  • Tenderness of the study joint (0- to 3-point scale)

  • Swelling of the study joint (0- to 3-point scale)

Interventions

MK0663; etoricoxib / Duration of Treatment: 5 DaysDRUG
Comparator: indomethacin 75 mg sustained release capsule / Duration of Treatment: 5 DaysDRUG

Eligibility Criteria

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

You may qualify if:

  • Males or females at least 18 years of age who have acute gout.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Navarra S, Rubin BR, Yu Q, Smugar SS, Tershakovec AM. Association of baseline disease and patient characteristics with response to etoricoxib and indomethacin for acute gout. Curr Med Res Opin. 2007 Jul;23(7):1685-91. doi: 10.1185/030079907x210750.

    PMID: 17588299DERIVED

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 31, 2005

First Posted

September 2, 2005

Study Start

January 1, 2005

Primary Completion

May 1, 2005

Study Completion

May 1, 2005

Last Updated

August 15, 2024

Record last verified: 2022-02