NCT00945035

Brief Summary

This study will establish the bioequivalence of the 20%, milled, roller compaction final market image (FMI) etoricoxib tablets and 30% unmilled, roller compaction (UMC) etoricoxib tablets.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P50-P75 for phase_1 pain

Timeline
Completed

Started Nov 2002

Shorter than P25 for phase_1 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

November 1, 2002

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2002

Completed
6.6 years until next milestone

First Submitted

Initial submission to the registry

July 22, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 23, 2009

Completed
4 months until next milestone

Results Posted

Study results publicly available

November 17, 2009

Completed
Last Updated

February 9, 2022

Status Verified

February 1, 2022

Enrollment Period

1 month

First QC Date

July 22, 2009

Results QC Date

October 13, 2009

Last Update Submit

February 7, 2022

Conditions

Pain

Outcome Measures

Primary Outcomes (2)

  • Plasma Area Under the Curve (AUC(0 to Infinity)) for Etoricoxib

    The area under the plasma concentration vs time curve.

    Through 120 Hours Postdose

  • Peak Plasma Concentration (Cmax) for Etoricoxib

    Through 120 Hours Postdose

Study Arms (2)

A

ACTIVE COMPARATOR

Etoricoxib, 20% tablet

Drug: etoricoxib

B

ACTIVE COMPARATOR

Etoricoxib, 30% tablet

Drug: Comparator: etoricoxib

Interventions

etoricoxibDRUG

Single dose etoricoxib 120 mg 20% final market image tablet in one of two treatment periods.

A
Comparator: etoricoxibDRUG

Single dose etoricoxib 120 mg 30% unmilled, roller compaction tablet in one of two treatment periods.

B

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subject is in good health
  • Subject agrees to follow the study guidelines

You may not qualify if:

  • Subject is a smoker
  • Subject has a history of adverse reactions caused by NSAIDs or allergies/intolerance to NSAIDs
  • Subject is in a situation or has a condition/disease which may interfere with optimal participation in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain

Interventions

Etoricoxib

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SulfonesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Senior Vice President, Global Clinical Development
Organization
Merck, Sharp & Dohme Corp.
ClinicalTrialsDisclosure@merck.com
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 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2009

First Posted

July 23, 2009

Study Start

November 1, 2002

Primary Completion

December 1, 2002

Study Completion

December 1, 2002

Last Updated

February 9, 2022

Results First Posted

November 17, 2009

Record last verified: 2022-02