PainPhase 1NCT00945035

Study of the Bioequivalence of the 20% and 30% Etoricoxib Tablet Formulations (0663-070)

A Phase 1 study testing etoricoxib and Comparator: etoricoxib in people with Pain, run by Organon and Co.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Pain
What is being tested?: etoricoxib and Comparator: etoricoxib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: No sites listed yet
Study dates: Nov 2002to Dec 2002
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

About this study

Official title: An Open-Label, Randomized, 2-Period, Single-Dose, Balanced, Crossover Study in Healthy Subjects to Establish the Bioequivalence of the 20% and 30% Etoricoxib (MK0663) Formulations

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.

Conditions: Pain
Being tested: etoricoxib, Comparator: etoricoxib
Medical subject headings: Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

etoricoxibDrug
Single dose etoricoxib 120 mg 20% final market image tablet in one of two treatment periods.
Comparator: etoricoxibDrug
Single dose etoricoxib 120 mg 30% unmilled, roller compaction tablet in one of two treatment periods.

Study groups in NCT00945035
Study group	Role	What they receive
A	Active comparator	Etoricoxib, 20% tablet Receives: Drug: etoricoxib
B	Active comparator	Etoricoxib, 30% tablet Receives: Drug: Comparator: etoricoxib

What is being measured

The primary outcome is the main question the study is designed to answer.

Plasma Area Under the Curve (AUC(0 to Infinity)) for Etoricoxib
The area under the plasma concentration vs time curve.
Measured: Through 120 Hours Postdose
Peak Plasma Concentration (Cmax) for Etoricoxib
Measured: Through 120 Hours Postdose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2002Dec 2002

First posted23 Jul 2009 (estimated)
Study startNov 2002
Primary completionDec 2002
Study completionDec 2002

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00945035
Sponsor's protocol ID: 0663-070
Other IDs: MK0663-070, 2009_623
Status last verified: Feb 2022
First submitted: 22 Jul 2009
Last updated: 9 Feb 2022
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Randomized, 2-Period, Single-Dose, Balanced, Crossover Study in Healthy Subjects to Establish the Bioequivalence of the 20% and 30% Etoricoxib (MK0663) Formulations
ClinicalTrials.gov ID: NCT00945035
Acronym / sponsor ID: 0663-070
Conditions: Pain
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: Nov 2002
Primary completion: Dec 2002 (actual)
Study completion: Dec 2002 (actual)
First posted: 23 Jul 2009 (estimated)
Results: Posted 17 Nov 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
A	Active comparator	Drug: etoricoxibEtoricoxib, 20% tablet
B	Active comparator	Drug: Comparator: etoricoxibEtoricoxib, 30% tablet

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
etoricoxibSingle dose etoricoxib 120 mg 20% final market image tablet in one of two treatment periods.	Drug	A
Comparator: etoricoxibSingle dose etoricoxib 120 mg 30% unmilled, roller compaction tablet in one of two treatment periods.	Drug	B

Primary outcome

Plasma Area Under the Curve (AUC(0 to Infinity)) for Etoricoxib
Time frame: Through 120 Hours Postdose
The area under the plasma concentration vs time curve.
Peak Plasma Concentration (Cmax) for Etoricoxib
Time frame: Through 120 Hours Postdose

Results and safety

Results posted to the registry on 17 Nov 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Etoricoxib FMI Then Etoricoxib URC	18	18
Etoricoxib URC Then Etoricoxib FMI	18	18

Primary outcome: Plasma Area Under the Curve (AUC(0 to Infinity)) for Etoricoxib

Time frame: Through 120 Hours Postdose. Least squares mean (Standard Deviation). Unit: µg times hr/mL

Measure	Etoricoxib FMI n = 36	Etoricoxib URC n = 36
Value	32.65 (16.20)	33.28 (13.65)

Etoricoxib FMI vs Etoricoxib URC: Least-Squares Mean Ratio: 1.02 (90% CI 0.97 to 1.07)

Population analysed: All healthy adult subjects completed the study and were included in the statistical analysis.

Primary outcome: Peak Plasma Concentration (Cmax) for Etoricoxib

Time frame: Through 120 Hours Postdose. Least squares mean (Standard Deviation). Unit: ng/mL

Measure	Etoricoxib FMI n = 36	Etoricoxib URC n = 36
Value	1964 (701)	2021 (833)

Etoricoxib FMI vs Etoricoxib URC: Least-Squares Mean Ratio: 1.03 (90% CI 0.95 to 1.11)

Population analysed: All healthy adult subjects completed the study and were included in the statistical analysis.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Etoricoxib FMI	0 of 36 (0%)	9 of 36 (25%)	Not reported
Etoricoxib URC	0 of 36 (0%)	12 of 36 (33.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Monitor study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing etoricoxib and Comparator: etoricoxib in people with Pain, run by Organon and Co.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Nov 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Plasma Area Under the Curve (AUC(0 to Infinity)) for Etoricoxib (time frame: Through 120 Hours Postdose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00945035.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2022.