NCT01037452

Brief 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.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

1 active site

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

December 1, 2009

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

December 22, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 23, 2009

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

March 28, 2011

Completed
Last Updated

March 28, 2011

Status Verified

March 1, 2011

Enrollment Period

1 month

First QC Date

December 22, 2009

Results QC Date

December 14, 2010

Last Update Submit

March 1, 2011

Conditions

Heartburn

Keywords

HeartburnantacidPPILansoprazolecalcium carbonatemagnesium hydroxideRelief of heartburn following ingestion of a heartburn-inducing meal

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 day

Secondary Outcomes (3)

  • Measure: Maximum Heartburn Intensity for Those Participants Who Experience Any Heartburn After the Heartburn-inducing Meals

    1 day

  • Measure: Maximum Heartburn Intensity for Those Participants Who Experience Any Nighttime Heartburn

    1 day

  • Measure: Number of Participants That Reported an Adverse Event for the Combination Product, PPI Alone, Antacid Alone and Placebo.

    1 day

Study Arms (4)

Combination product

EXPERIMENTAL

Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg tablet

Drug: Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg

PPI alone

ACTIVE COMPARATOR

Lansoprazole

Drug: Lansoprazole

Antacid alone

ACTIVE COMPARATOR

Calcium carbonate/magnesium hydroxide

Drug: Calcium carbonate/magnesium hydroxide

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mgDRUG

Tablet

Combination product
LansoprazoleDRUG

Tablet

PPI alone
Calcium carbonate/magnesium hydroxideDRUG

Tablet

Antacid alone
PlaceboDRUG

Tablet

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Experiencing heartburn in the past month if untreated
  • Having heartburn that responds to heartburn medication

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Anaheim, California, United States

Location

MeSH Terms

Conditions

Heartburn

Interventions

Calcium CarbonateMagnesium HydroxideLansoprazoledihydroxyaluminum sodium carbonate

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Calcium CompoundsInorganic ChemicalsCarbonatesCarbonic AcidCarbon Compounds, InorganicMineralsHydroxidesAlkaliesAnionsIonsElectrolytesMagnesium Compounds2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title
Head New Therapeutic Opportunities
Organization
Novartis
973-503-8000

Study Officials

  • Novartis .

    Novartis

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 22, 2009

First Posted

December 23, 2009

Study Start

December 1, 2009

Primary Completion

January 1, 2010

Last Updated

March 28, 2011

Results First Posted

March 28, 2011

Record last verified: 2011-03

Locations

US(1)