HeartburnPhase 2NCT01037452

Proof of Concept Study Efficacy of an Antacid/Lansoprazole Combination for Relief of Heartburn

A Phase 2 study testing Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg, Lansoprazole and Calcium carbonate/magnesium hydroxide in people with Heartburn, run by Novartis at 1 site in United States.

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 investigate the safety and efficacy of an antacid/Lansoprazole combination product for the relief of heartburn after consuming a heartburn-inducing meal. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Heartburn
What is being tested?: Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg, Lansoprazole and Calcium carbonate/magnesium hydroxide
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 120 participants
Where: 1 siteUnited States
Study dates: Dec 2009to Jan 2010
Phase: Phase 2
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Experiencing heartburn in the past month if untreated
Having heartburn that responds to heartburn medication
Be willing to discontinue the use of heartburn treatment for 7 days prior to inclusion in the study.

Who cannot join

Having history of erosive esophagitis or gastroesophageal reflux disease (GERD) diagnosed by a physician and confirmed by testing (endoscopy)
Be unwilling to take only the study medication, and antacid provided as a rescue medication for relief of acute heartburn during the study.
"Other protocol-defined inclusion/exclusion criteria may apply"

Trial locations and contacts

1 site in 1 country.

United States1 site

Study site
Anaheim, California

Other trials in United States

About this study

Official title: A Phase II, Randomized, Double-blind, Placebo-controlled, Parallel Group Proof-of-Concept Trial to Assess Relief of Meal Induced Heartburn by a Combination of Lansoprazole 15 mg and Antacid Versus Lansoprazole 15 mg and Antacid (Calcium Carbonate and Magnesium Hydroxide) Alone

This study will investigate the safety and efficacy of an antacid/Lansoprazole combination product for the relief of heartburn after consuming a heartburn-inducing meal.

Conditions: Heartburn
Being tested: Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg, Lansoprazole, Calcium carbonate/magnesium hydroxide, Placebo
Keywords: Heartburn, antacid, PPI, Lansoprazole, calcium carbonate, magnesium hydroxide, Relief of heartburn following ingestion of a heartburn-inducing meal
Medical subject headings: Heartburn

What participants receive

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

Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mgDrug
Tablet
LansoprazoleDrug
Tablet
Calcium carbonate/magnesium hydroxideDrug
Tablet
PlaceboDrug
Tablet

Study groups in NCT01037452
Study group	Role	What they receive
Combination product	Experimental	Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg tablet Receives: Drug: Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg
PPI alone	Active comparator	Lansoprazole Receives: Drug: Lansoprazole
Antacid alone	Active comparator	Calcium carbonate/magnesium hydroxide Receives: Drug: Calcium carbonate/magnesium hydroxide
Placebo	Placebo comparator	Placebo Receives: Drug: Placebo

What is being measured

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

Measure: Number of Participants With no Heartburn (Post Treatment) Following Consumption of Heartburn-inducing Meal
Participant reported severity of heartburn using a Visual Analog Scale (VAS)directly on CRF every 15 minutes until no heartburn reported or up to 5 hours after 1st heartburn-inducing meal, whichever occurred first. At this point in time, a diary was provided to participants to record any changes in severity of heartburn for 28 hours post treatment.
Measured: 1 day

Secondary outcomes (3)

Measure: Maximum Heartburn Intensity for Those Participants Who Experience Any Heartburn After the Heartburn-inducing Meals
Heartburn severity was measured using a Visual Analog Scale, which was 100 milliimeters long.
0 millimeters: None (no heartburn) 100 millimeters: Most severe
Measured: 1 day
Measure: Maximum Heartburn Intensity for Those Participants Who Experience Any Nighttime Heartburn
Heartburn severity was measured using a Visual Analog Scale, which was 100 milliimeters long.
0 millimeters: None (no heartburn) 100 millimeters: Most severe
Measured: 1 day
Measure: Number of Participants That Reported an Adverse Event for the Combination Product, PPI Alone, Antacid Alone and Placebo.
Measured: 1 day

Timeline

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

Dec 2009Jan 2010

First posted23 Dec 2009 (estimated)
Study startDec 2009
Primary completionJan 2010

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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01037452
Sponsor's protocol ID: 145-G-201
Status last verified: Mar 2011
First submitted: 22 Dec 2009
Last updated: 28 Mar 2011
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?

See locations

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 28 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II, Randomized, Double-blind, Placebo-controlled, Parallel Group Proof-of-Concept Trial to Assess Relief of Meal Induced Heartburn by a Combination of Lansoprazole 15 mg and Antacid Versus Lansoprazole 15 mg and Antacid (Calcium Carbonate and Magnesium Hydroxide) Alone
ClinicalTrials.gov ID: NCT01037452
Acronym / sponsor ID: 145-G-201
Conditions: Heartburn
Keywords: Heartburn, antacid, PPI, Lansoprazole, calcium carbonate, magnesium hydroxide, Relief of heartburn following ingestion of a heartburn-inducing meal
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: NovartisIndustry (pharma, biotech, devices)
Study start: Dec 2009
Primary completion: Jan 2010 (actual)
First posted: 23 Dec 2009 (estimated)
Results: Posted 28 Mar 2011

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 investigate the safety and efficacy of an antacid/Lansoprazole combination product for the relief of heartburn after consuming a heartburn-inducing meal.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 4

Arm	Type	Receives
Combination product	Experimental	Drug: Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mgCalcium carbonate/magnesium hydroxide/Lansoprazole 15 mg tablet
PPI alone	Active comparator	Drug: LansoprazoleLansoprazole
Antacid alone	Active comparator	Drug: Calcium carbonate/magnesium hydroxideCalcium carbonate/magnesium hydroxide
Placebo	Placebo comparator	Drug: PlaceboPlacebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Experiencing heartburn in the past month if untreated
Having heartburn that responds to heartburn medication
Be willing to discontinue the use of heartburn treatment for 7 days prior to inclusion in the study.

Key exclusion criteria (3 listed)

Having history of erosive esophagitis or gastroesophageal reflux disease (GERD) diagnosed by a physician and confirmed by testing (endoscopy)
Be unwilling to take only the study medication, and antacid provided as a rescue medication for relief of acute heartburn during the study.
"Other protocol-defined inclusion/exclusion criteria may apply"

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
Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mgTablet	Drug	Combination product
LansoprazoleTablet	Drug	PPI alone
Calcium carbonate/magnesium hydroxideTablet	Drug	Antacid alone
PlaceboTablet	Drug	Placebo

Primary outcome

Measure: Number of Participants With no Heartburn (Post Treatment) Following Consumption of Heartburn-inducing Meal
Time frame: 1 day
Participant reported severity of heartburn using a Visual Analog Scale (VAS)directly on CRF every 15 minutes until no heartburn reported or up to 5 hours after 1st heartburn-inducing meal, whichever occurred first. At this point in time, a diary was provided to participants to record any changes in severity of heartburn for 28 hours post treatment.

3 secondary outcomes

Measure: Maximum Heartburn Intensity for Those Participants Who Experience Any Heartburn After the Heartburn-inducing Meals
Time frame: 1 day
Measure: Maximum Heartburn Intensity for Those Participants Who Experience Any Nighttime Heartburn
Time frame: 1 day
Measure: Number of Participants That Reported an Adverse Event for the Combination Product, PPI Alone, Antacid Alone and Placebo.
Time frame: 1 day

Results and safety

Results posted to the registry on 28 Mar 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Combination Product	30	30
PPI Alone	30	30
Antacid Alone	30	30
Placebo	30	30

Primary outcome: Measure: Number of Participants With no Heartburn (Post Treatment) Following Consumption of Heartburn-inducing Meal

Time frame: 1 day. Number (95% Confidence Interval). Unit: participants

Measure	Combination Product n = 30	PPI Alone n = 30	Antacid Alone n = 30	Placebo n = 30
Value	0 (0.0 to 11.6)	2 (0.8 to 22.1)	1 (0.1 to 17.2)	0 (0.0 to 11.6)

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Combination Product	0 of 30 (0%)	0 of 30 (0%)	Not reported
PPI Alone	0 of 30 (0%)	0 of 30 (0%)	Not reported
Antacid Alone	0 of 30 (0%)	0 of 30 (0%)	Not reported
Placebo	0 of 30 (0%)	0 of 30 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2011.
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.

Novartis . study director

Novartis

1 site in 1 country: see every site and its status.

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 28 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 28 Mar 2011). 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?

Measure: Number of Participants With no Heartburn (Post Treatment) Following Consumption of Heartburn-inducing Meal (time frame: 1 day). 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 NCT01037452.

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 28 Mar 2011.