Chemotherapy-Induced Nausea and VomitingPhase 1NCT00971633

A Bioequivalence Study of 3 Formulations of Ondansetron in Healthy Adults (0869-095)(COMPLETED)

A Phase 1 study testing Comparator: Treatment A (Zofran, ondansetron), Comparator: Treatment B (Zofran, ondansetron) and Comparator: Treatment C (Zofran, ondansetron) in people with Chemotherapy-Induced Nausea and Vomiting, run by Merck Sharp & Dohme LLC.

Completed

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

Official record

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Trial summary

This study will assess the bioequivalence of a Merck clinical trial formulation of ondansetron compared to a U.S. and non-U.S. marketed formulation of ondansetron. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Chemotherapy-Induced Nausea and Vomiting
What is being tested?: Comparator: Treatment A (Zofran, ondansetron), Comparator: Treatment B (Zofran, ondansetron) and Comparator: Treatment C (Zofran, ondansetron)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: No sites listed yet
Study dates: Nov 2003to Jan 2004
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 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

If female, subject is not pregnant or breast-feeding
Subject is a nonsmoker
Subject is in good general health

Who cannot join

Subject has a history of high blood pressure, asthma, or cardiovascular, liver, neurologic, or kidney disease
Subject is taking prescription or nonprescription drugs that can not be discontinued during the study
Subject is a habitual and heavy consumer of caffeine

About this study

Official title: An Open-Label, Randomized, Single Dose, 3-period Crossover Study to Determine the Bioequivalence of 3 Formulations of Ondansetron in Healthy Young Adult Male and Female Subjects

This study will assess the bioequivalence of a Merck clinical trial formulation of ondansetron compared to a U.S. and non-U.S. marketed formulation of ondansetron.

Conditions: Chemotherapy-Induced Nausea and Vomiting
Being tested: Comparator: Treatment A (Zofran, ondansetron), Comparator: Treatment B (Zofran, ondansetron), Comparator: Treatment C (Zofran, ondansetron)
Medical subject headings: Vomiting

What participants receive

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

Comparator: Treatment A (Zofran, ondansetron)Drug
Also called Zofran, ondansetron
an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) Zofran taken by mouth (PO)
Comparator: Treatment B (Zofran, ondansetron)Drug
Also called Zofran, ondansetron
a single 8 mg tablet of Zofran marketed in the U.K., taken PO
Comparator: Treatment C (Zofran, ondansetron)Drug
Also called Zofran, ondansetron
a single 8 mg tablet of Zofran marketed in the United States (U.S.), taken PO

Study groups in NCT00971633
Study group	Role	What they receive
1	Experimental	Treatment Sequence A-B-C Receives: Drug: Comparator: Treatment A (Zofran, ondansetron); Drug: Comparator: Treatment B (Zofran, ondansetron); Drug: Comparator: Treatment C (Zofran, ondansetron)
2	Experimental	Treatment Sequence B-C-A Receives: Drug: Comparator: Treatment A (Zofran, ondansetron); Drug: Comparator: Treatment B (Zofran, ondansetron); Drug: Comparator: Treatment C (Zofran, ondansetron)
3	Experimental	Treatment Sequence C-A-B Receives: Drug: Comparator: Treatment A (Zofran, ondansetron); Drug: Comparator: Treatment B (Zofran, ondansetron); Drug: Comparator: Treatment C (Zofran, ondansetron)
4	Experimental	Treatment Sequence A-C-B Receives: Drug: Comparator: Treatment A (Zofran, ondansetron); Drug: Comparator: Treatment B (Zofran, ondansetron); Drug: Comparator: Treatment C (Zofran, ondansetron)
5	Experimental	Treatment Sequence B-A-C Receives: Drug: Comparator: Treatment A (Zofran, ondansetron); Drug: Comparator: Treatment B (Zofran, ondansetron); Drug: Comparator: Treatment C (Zofran, ondansetron)
6	Experimental	Treatment Sequence C-B-A Receives: Drug: Comparator: Treatment A (Zofran, ondansetron); Drug: Comparator: Treatment B (Zofran, ondansetron); Drug: Comparator: Treatment C (Zofran, ondansetron)

What is being measured

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

Area Under the Plasma Concentration-Time Curve From Zero to Infinity (AUC) of Ondansetron
Measured: 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, and 24 hours post dose
Maximum Plasma Concentration (Cmax) of Ondansetron
Measured: 24 hours post dose

Timeline

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

Nov 2003Jan 2004

First posted4 Sep 2009 (estimated)
Study startNov 2003
Primary completionDec 2003
Study completionJan 2004

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 Chemotherapy-Induced Nausea and VomitingStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
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: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00971633
Sponsor's protocol ID: 0869-095
Other IDs: 2009_656
Status last verified: Sep 2016
First submitted: 3 Sep 2009
Last updated: 14 Sep 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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

RecruitingPhase 4
BMT-08: A Comparative Effectiveness Study of Transdermal Granisetron to Ondansetron
Nausea With Vomiting Chemotherapy-Induced
RecruitingPhase 2
A Study to Evaluate LY3537021 for the Treatment of Nausea and Vomiting Caused by Chemotherapy in Adults With Cancer
Nausea, Vomiting
RecruitingPhase 2
Personalized Antiemetic Regimen According to Patients' Pharmacogenetic Profile
Breast Cancer
RecruitingObservational study
HR20013 for the Prevention of Nausea and Vomiting in Patients With Cancer: A Real-World Study
Chemotherapy-Induced Nausea and Vomiting (CINV), Nausea
RecruitingPhase 1
A Study to Compare the Bioavailability of Ondansetron Following Nasal (NS003) and IV Administration in Healthy Adults
Chemotherapy-Induced Nausea and Vomiting (CINV), Radiotherapy-induced Nausea and Vomiting (RINV)

All Chemotherapy-Induced Nausea and Vomiting trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Randomized, Single Dose, 3-period Crossover Study to Determine the Bioequivalence of 3 Formulations of Ondansetron in Healthy Young Adult Male and Female Subjects
ClinicalTrials.gov ID: NCT00971633
Acronym / sponsor ID: 0869-095
Conditions: Chemotherapy-Induced Nausea and Vomiting
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Nov 2003
Primary completion: Dec 2003 (actual)
Study completion: Jan 2004 (actual)
First posted: 4 Sep 2009 (estimated)
Results: Posted 26 Aug 2010

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 assess the bioequivalence of a Merck clinical trial formulation of ondansetron compared to a U.S. and non-U.S. marketed formulation of ondansetron.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
1	Experimental	Drug: Comparator: Treatment A (Zofran, ondansetron), Drug: Comparator: Treatment B (Zofran, ondansetron), Drug: Comparator: Treatment C (Zofran, ondansetron)Treatment Sequence A-B-C
2	Experimental	Drug: Comparator: Treatment A (Zofran, ondansetron), Drug: Comparator: Treatment B (Zofran, ondansetron), Drug: Comparator: Treatment C (Zofran, ondansetron)Treatment Sequence B-C-A
3	Experimental	Drug: Comparator: Treatment A (Zofran, ondansetron), Drug: Comparator: Treatment B (Zofran, ondansetron), Drug: Comparator: Treatment C (Zofran, ondansetron)Treatment Sequence C-A-B
4	Experimental	Drug: Comparator: Treatment A (Zofran, ondansetron), Drug: Comparator: Treatment B (Zofran, ondansetron), Drug: Comparator: Treatment C (Zofran, ondansetron)Treatment Sequence A-C-B
5	Experimental	Drug: Comparator: Treatment A (Zofran, ondansetron), Drug: Comparator: Treatment B (Zofran, ondansetron), Drug: Comparator: Treatment C (Zofran, ondansetron)Treatment Sequence B-A-C
6	Experimental	Drug: Comparator: Treatment A (Zofran, ondansetron), Drug: Comparator: Treatment B (Zofran, ondansetron), Drug: Comparator: Treatment C (Zofran, ondansetron)Treatment Sequence C-B-A

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

If female, subject is not pregnant or breast-feeding
Subject is a nonsmoker
Subject is in good general health

Key exclusion criteria (3 listed)

Subject has a history of high blood pressure, asthma, or cardiovascular, liver, neurologic, or kidney disease
Subject is taking prescription or nonprescription drugs that can not be discontinued during the study
Subject is a habitual and heavy consumer of caffeine

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
Comparator: Treatment A (Zofran, ondansetron)Also: Zofran, ondansetronan over-encapsulated single 8 mg tablet of United Kingdom (U.K.) Zofran taken by mouth (PO)	Drug	1, 2, 3, 4, 5, 6
Comparator: Treatment B (Zofran, ondansetron)Also: Zofran, ondansetrona single 8 mg tablet of Zofran marketed in the U.K., taken PO	Drug	1, 2, 3, 4, 5, 6
Comparator: Treatment C (Zofran, ondansetron)Also: Zofran, ondansetrona single 8 mg tablet of Zofran marketed in the United States (U.S.), taken PO	Drug	1, 2, 3, 4, 5, 6

Primary outcome

Area Under the Plasma Concentration-Time Curve From Zero to Infinity (AUC) of Ondansetron
Time frame: 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, and 24 hours post dose
Maximum Plasma Concentration (Cmax) of Ondansetron
Time frame: 24 hours post dose

Results and safety

Results posted to the registry on 26 Aug 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
OE U.K. Tablet Then U.K. Tablet Then U.S. Tablet	2	2
U.K. Tablet Then U.S. Tablet Then OE U.K. Tablet	2	2
U.S. Tablet Then OE U.K. Tablet Then U.K. Tablet	2	2
OE U.K. Tablet Then U.S. Tablet Then U.K. Tablet	2	2
U.K. Tablet Then OE U.K. Tablet Then U.S. Tablet	2	2
U.S. Tablet Then U.K. Tablet Then OE U.K. Tablet	2	2

Primary outcome: Area Under the Plasma Concentration-Time Curve From Zero to Infinity (AUC) of Ondansetron

Time frame: 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, and 24 hours post dose. Least squares mean (Standard Deviation). Unit: nM*hr

Measure	Treatment OE U.K. Tablet n = 12	Treatment U.K. Tablet n = 12	Treatment U.S. Tablet n = 12
Value	644 (240)	712 (233)	649 (255)

Treatment OE U.K. Tablet vs Treatment U.K. Tablet: Geometric Mean Ratio: 0.904 (95% CI 0.796 to 1.028)
Treatment OE U.K. Tablet vs Treatment U.S. Tablet: Geometric Mean Ratio: 0.991 (95% CI 0.873 to 1.126)

Population analysed: All study participants (N=12)

Primary outcome: Maximum Plasma Concentration (Cmax) of Ondansetron

Time frame: 24 hours post dose. Least squares mean (Standard Deviation). Unit: nM

Measure	Treatment OE U.K. Tablet n = 12	Treatment U.K. Tablet n = 12	Treatment U.S. Tablet n = 12
Value	82 (18)	93 (16)	86 (20)

Treatment OE U.K. Tablet vs Treatment U.K. Tablet: Geometric Mean Ratio: 0.886 (95% CI 0.813 to 0.966)
Treatment OE U.K. Tablet vs Treatment U.S. Tablet: Geometric Mean Ratio: 0.951 (95% CI 0.872 to 1.037)

Population analysed: All study participants (N=12)

Adverse events

Time frame: Treatment Period 1, Day 1 to 14 days Post Last Dose of Study Drug in Treatment Period 3, including the 7 day washout in between periods.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment OE U.K. Tablet	0 of 12 (0%)	0 of 12 (0%)	Not reported
Treatment U.K. Tablet	0 of 12 (0%)	0 of 12 (0%)	Not reported
Treatment U.S. Tablet	0 of 12 (0%)	2 of 12 (16.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Chemotherapy-Induced Nausea and Vomiting

RecruitingPhase 4
BMT-08: A Comparative Effectiveness Study of Transdermal Granisetron to Ondansetron
Nausea With Vomiting Chemotherapy-Induced
RecruitingPhase 2
A Study to Evaluate LY3537021 for the Treatment of Nausea and Vomiting Caused by Chemotherapy in Adults With Cancer
Nausea, Vomiting
RecruitingPhase 2
Personalized Antiemetic Regimen According to Patients' Pharmacogenetic Profile
Breast Cancer
RecruitingObservational study
HR20013 for the Prevention of Nausea and Vomiting in Patients With Cancer: A Real-World Study
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RecruitingPhase 1
A Study to Compare the Bioavailability of Ondansetron Following Nasal (NS003) and IV Administration in Healthy Adults
Chemotherapy-Induced Nausea and Vomiting (CINV), Radiotherapy-induced Nausea and Vomiting (RINV)

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?

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 3 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 14 Sep 2016. 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 26 Aug 2010). 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?

Area Under the Plasma Concentration-Time Curve From Zero to Infinity (AUC) of Ondansetron (time frame: 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, and 24 hours post dose). 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 NCT00971633.

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 14 Sep 2016.