HeartburnPhase 1NCT00944671

A Study to Assess the Bioequivalence of Famotidine/Antacid Combination Tablets Compared to Famotidine/Antacid EZ Chew Tablets (0208C-145)(COMPLETED)

A Phase 1 study testing famotidine (+) calcium carbonate (+) magnesium hydroxide tablet, Comparator: famotidine (+) calcium carbonate (+) magnesium hydroxide EZ Chew tablet without water and Comparator: famotidine (+) calcium carbonate (+) magnesium hydroxide EZ Chew tablet with water in people with Heartburn, run by Johnson & Johnson Consumer and Personal Products Worldwide.

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

A study in 24 healthy subjects to assess the bioequivalence of Famotidine/Antacid EZ Chew tablet taken without water and with water compared to the Famotidine/Antacid tablet taken with water. Subjects will be given a single dose of each treatment separated by 5 to 7 days. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Heartburn
What is being tested?: famotidine (+) calcium carbonate (+) magnesium hydroxide tablet, Comparator: famotidine (+) calcium carbonate (+) magnesium hydroxide EZ Chew tablet without water and Comparator: famotidine (+) calcium carbonate (+) magnesium hydroxide EZ Chew tablet with water
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: No sites listed yet
Study dates: Feb 2008to Mar 2008
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

Female subject is not pregnant or lactating, Females of childbearing potential must use reliable means of contraception during the course of the study
Subject is in good health
Subject is able to abstain from smoking during the 24-hour periods before and during each treatment day

Who cannot join

Subject has a history of stomach ulcers, other Gastrointestinal (GI) diseases or GI surgery
Subject has a history of asthma or severe allergies to drugs or foods
Subject currently uses prescribed or nonprescribed drugs on a regular basis
Subject has a recent history of drug/alcohol abuse
Subject consumes more than 6 cups of coffee per day
Subject has unconventional or extreme dietary habits

Show all 9Show fewer

Subject has donated blood or has been in a clinical trial in which they received an investigational drug during the past 30 days
Subject has a history of allergy or intolerance to antacids
Female subject is known to be pregnant or is not using reliable means of contraception

About this study

Official title: A Single-Dose, Open-Label, Three-Period Crossover Study to Assess the Bioequivalence of Famotidine/Antacid Combination Tablets (FACT) Compared to Famotidine/Antacid EZ Chew Tablet Without Water and Famotidine/Antacid EZ Chew Tablet With Water

Conditions: Heartburn
Being tested: famotidine (+) calcium carbonate (+) magnesium hydroxide tablet, Comparator: famotidine (+) calcium carbonate (+) magnesium hydroxide EZ Chew tablet without water, Comparator: famotidine (+) calcium carbonate (+) magnesium hydroxide EZ Chew tablet with water
Medical subject headings: Heartburn

What participants receive

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

famotidine (+) calcium carbonate (+) magnesium hydroxide tabletDrug
A single dose of famotidine/antacid tablet with 120 mL of water in one of three treatment periods
Comparator: famotidine (+) calcium carbonate (+) magnesium hydroxide EZ Chew tablet without waterDrug
A single dose of famotidine/antacid combination EZ Chew tablet without water in one of three treatment periods
Comparator: famotidine (+) calcium carbonate (+) magnesium hydroxide EZ Chew tablet with waterDrug
A single dose of famotidine/antacid combination EZ Chew tablet with 120 mL of water in one of three treatment periods

Study groups in NCT00944671
Study group	Role	What they receive
A	Active comparator	Famotidine/antacid combination tablet with water Receives: Drug: famotidine (+) calcium carbonate (+) magnesium hydroxide tablet
B	Experimental	Famotidine/Antacid EZ Chew tablet without water Receives: Drug: Comparator: famotidine (+) calcium carbonate (+) magnesium hydroxide EZ Chew tablet without water
C	Experimental	Famotidine/Antacid EZ Chew tablet with water Receives: Drug: Comparator: famotidine (+) calcium carbonate (+) magnesium hydroxide EZ Chew tablet with water

What is being measured

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

Area Under the Curve (AUC(0 to Infinity)) Following Single Dose Administration of Famotidine/Antacid Combination EZ Chew Without Water and Famotidine/Antacid Tablet With Water
Measured: Through 24 hours post-dose (½, 1, 1 ½, 2, 2 ½, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose)
Peak Plasma Concentration (Cmax) of Famotidine Following Single Dose Administration of Famotidine/Antacid Combination EZ Chew Without Water and Famotidine/Antacid Tablet With Water
Measured: Through 24 hours post-dose (½, 1, 1 ½, 2, 2 ½, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose)

Secondary outcomes (2)

Area Under the Curve (AUC(0 to Infinity)) Following Single Dose Administration of Famotidine/Antacid Combination EZ Chew With Water and Famotidine/Antacid Tablet With Water
Measured: Through 24 hours post-dose (½, 1, 1 ½, 2, 2 ½, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose)
Peak Plasma Concentration (Cmax) of Famotidine Following Single Dose Administration of Famotidine/Antacid Combination EZ Chew With Water and Famotidine/Antacid Tablet With Water
Measured: Through 24 hours post-dose (½, 1, 1 ½, 2, 2 ½, 3, 4, 6, 8, 10, 12, 14, 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.

Feb 2008Mar 2008

First posted23 Jul 2009 (estimated)
Study startFeb 2008
Primary completionMar 2008
Study completionMar 2008

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 HeartburnStudies 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: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00944671
Sponsor's protocol ID: 0208C-145
Other IDs: 2009_622
Status last verified: Jun 2015
First submitted: 22 Jul 2009
Last updated: 24 Jun 2015
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

RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Vonoprazan 10 mg Compared to Placebo for Relief of Episodic Heartburn in Participants With Symptomatic Non-Erosive Gastroesophageal Reflux Disease Through 24 Weeks
Symptomatic Non-erosive Gastroesophageal Reflux Disease
Active, not recruitingPhase 3
Domperidone in Treating Patients With Gastrointestinal Disorders
Digestive System Disorder, Dyspepsia
RecruitingObservational study
A Study of the Safety of Vonoprazan Exposure in Pregnant Women and Their Offspring
Erosive Esophagitis, Heartburn
Enrolling by invitationObservational study
The Johns Hopkins Heartburn Center Registry
Gastroesophageal Reflux Disease, Barrett Esophagus
Not yet recruiting
Antireflux Surgery Without Preoperative Esophageal Manometry
GERD, Hiatal Hernia

All Heartburn trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-Dose, Open-Label, Three-Period Crossover Study to Assess the Bioequivalence of Famotidine/Antacid Combination Tablets (FACT) Compared to Famotidine/Antacid EZ Chew Tablet Without Water and Famotidine/Antacid EZ Chew Tablet With Water
ClinicalTrials.gov ID: NCT00944671
Acronym / sponsor ID: 0208C-145
Conditions: Heartburn
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Johnson & Johnson Consumer and Personal Products WorldwideIndustry (pharma, biotech, devices)
Study start: Feb 2008
Primary completion: Mar 2008 (actual)
Study completion: Mar 2008 (actual)
First posted: 23 Jul 2009 (estimated)
Results: Posted 24 Jun 2015

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
A	Active comparator	Drug: famotidine (+) calcium carbonate (+) magnesium hydroxide tabletFamotidine/antacid combination tablet with water
B	Experimental	Drug: Comparator: famotidine (+) calcium carbonate (+) magnesium hydroxide EZ Chew tablet without waterFamotidine/Antacid EZ Chew tablet without water
C	Experimental	Drug: Comparator: famotidine (+) calcium carbonate (+) magnesium hydroxide EZ Chew tablet with waterFamotidine/Antacid EZ Chew tablet with water

Who may qualify

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

Key inclusion criteria (3 listed)

Female subject is not pregnant or lactating, Females of childbearing potential must use reliable means of contraception during the course of the study
Subject is in good health
Subject is able to abstain from smoking during the 24-hour periods before and during each treatment day

Key exclusion criteria (9 listed)

Subject has a history of stomach ulcers, other Gastrointestinal (GI) diseases or GI surgery
Subject has a history of asthma or severe allergies to drugs or foods
Subject currently uses prescribed or nonprescribed drugs on a regular basis
Subject has a recent history of drug/alcohol abuse
Subject consumes more than 6 cups of coffee per day

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
famotidine (+) calcium carbonate (+) magnesium hydroxide tabletA single dose of famotidine/antacid tablet with 120 mL of water in one of three treatment periods	Drug	A
Comparator: famotidine (+) calcium carbonate (+) magnesium hydroxide EZ Chew tablet without waterA single dose of famotidine/antacid combination EZ Chew tablet without water in one of three treatment periods	Drug	B
Comparator: famotidine (+) calcium carbonate (+) magnesium hydroxide EZ Chew tablet with waterA single dose of famotidine/antacid combination EZ Chew tablet with 120 mL of water in one of three treatment periods	Drug	C

Primary outcome

Area Under the Curve (AUC(0 to Infinity)) Following Single Dose Administration of Famotidine/Antacid Combination EZ Chew Without Water and Famotidine/Antacid Tablet With Water
Time frame: Through 24 hours post-dose (½, 1, 1 ½, 2, 2 ½, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose)
Peak Plasma Concentration (Cmax) of Famotidine Following Single Dose Administration of Famotidine/Antacid Combination EZ Chew Without Water and Famotidine/Antacid Tablet With Water
Time frame: Through 24 hours post-dose (½, 1, 1 ½, 2, 2 ½, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose)

2 secondary outcomes

Area Under the Curve (AUC(0 to Infinity)) Following Single Dose Administration of Famotidine/Antacid Combination EZ Chew With Water and Famotidine/Antacid Tablet With Water
Time frame: Through 24 hours post-dose (½, 1, 1 ½, 2, 2 ½, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose)
Peak Plasma Concentration (Cmax) of Famotidine Following Single Dose Administration of Famotidine/Antacid Combination EZ Chew With Water and Famotidine/Antacid Tablet With Water
Time frame: Through 24 hours post-dose (½, 1, 1 ½, 2, 2 ½, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose)

Results and safety

Results posted to the registry on 24 Jun 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Famotidine With Water/EZ Chew Without Water/EZ Chew With Water	4	4
EZ Chew Without Water/EZ Chew With Water/Famotidine With Water	4	4
EZ Chew With Water/Famotidine With Water/EZ Chew Without Water	4	4
Famotidinewith Water/EZ Chew With Water/EZ Chew Without Water	4	4
EZ Chew Without Water/Famotidine With Water/EZ Chew With Water	4	4
EZ Chew With Water/EZ Chew Without Water/Famotidine With Water	4	4

Primary outcome: Area Under the Curve (AUC(0 to Infinity)) Following Single Dose Administration of Famotidine/Antacid Combination EZ Chew Without Water and Famotidine/Antacid Tablet With Water

Time frame: Through 24 hours post-dose (½, 1, 1 ½, 2, 2 ½, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose). Geometric mean (95% Confidence Interval). Unit: ng*hr/mL

Measure	Famotidine/Antacid Combination EZ Chew Tablet Without Water n = 24	Famotidine/Antacid Combination Tablet With Water n = 24
Value	261.2 (227.9 to 299.3)	248.0 (216.4 to 284.2)

Famotidine/Antacid Combination EZ Chew Tablet Without Water vs Famotidine/Antacid Combination Tablet With Water: Geometric Mean Ratio: 1.05 (90% CI 0.98 to 1.13)

Primary outcome: Peak Plasma Concentration (Cmax) of Famotidine Following Single Dose Administration of Famotidine/Antacid Combination EZ Chew Without Water and Famotidine/Antacid Tablet With Water

Time frame: Through 24 hours post-dose (½, 1, 1 ½, 2, 2 ½, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose). Geometric mean (95% Confidence Interval). Unit: ng/mL

Measure	Famotidine/Antacid Combination EZ Chew Tablet Without Water n = 24	Famotidine/Antacid Combination Tablet With Water n = 24
Value	45.5 (39.1 to 52.9)	44.4 (38.1 to 51.7)

Famotidine/Antacid Combination EZ Chew Tablet Without Water vs Famotidine/Antacid Combination Tablet With Water: Geometric Mean Ratio: 1.03 (90% CI 0.93 to 1.13)

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Famotidine/Antacid Combination Tablet With Water	0 of 24 (0%)	3 of 24 (12.5%)	Not reported
Famotidine/Antacid Combination EZ Chew Tablet Without Water	0 of 24 (0%)	4 of 24 (16.7%)	Not reported
Famotidine/Antacid Combination EZ Chew Tablet With Water	0 of 24 (0%)	5 of 24 (20.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Heartburn

RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Vonoprazan 10 mg Compared to Placebo for Relief of Episodic Heartburn in Participants With Symptomatic Non-Erosive Gastroesophageal Reflux Disease Through 24 Weeks
Symptomatic Non-erosive Gastroesophageal Reflux Disease
Active, not recruitingPhase 3
Domperidone in Treating Patients With Gastrointestinal Disorders
Digestive System Disorder, Dyspepsia
RecruitingObservational study
A Study of the Safety of Vonoprazan Exposure in Pregnant Women and Their Offspring
Erosive Esophagitis, Heartburn
Enrolling by invitationObservational study
The Johns Hopkins Heartburn Center Registry
Gastroesophageal Reflux Disease, Barrett Esophagus
Not yet recruiting
Antireflux Surgery Without Preoperative Esophageal Manometry
GERD, Hiatal Hernia

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 9 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 24 Jun 2015. 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 24 Jun 2015). 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 Curve (AUC(0 to Infinity)) Following Single Dose Administration of Famotidine/Antacid Combination EZ Chew Without Water and Famotidine/Antacid Tablet With Water (time frame: Through 24 hours post-dose (½, 1, 1 ½, 2, 2 ½, 3, 4, 6, 8, 10, 12, 14, 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 NCT00944671.

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 24 Jun 2015.