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Calcium carbonate/magnesium hydroxide/Lansoprazole

Phase 2

Heartburn | Small molecule | Gastrointestinal |Novartis AG|Last Updated: Mar 28, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment120

FDA Designations

No designations recorded

Clinical trial landscape

Calcium carbonate/magnesium hydroxide/Lansoprazole · 1 trial · 1 indication

Phase 2 1
NCT01037452Proof of Concept Study Efficacy of an Antacid/Lansoprazole Combination for Relief of HeartburnHeartburn
COMPLETED120 Analytics
PHASE2COMPLETED
Proof of Concept Study Efficacy of an Antacid/Lansoprazole Combination for Relief of Heartburn
Heartburn
NCT01037452120
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Study Endpoints

Primary Endpoints

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

Secondary Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelFACTORIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Combination productEXPERIMENTALCalcium carbonate/magnesium hydroxide/Lansoprazole 15 mg tablet
PPI aloneACTIVE_COMPARATORLansoprazole
Antacid aloneACTIVE_COMPARATORCalcium carbonate/magnesium hydroxide
PlaceboPLACEBO_COMPARATORPlacebo

Interventions

NameTypeDescription
Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mgDRUGTablet
LansoprazoleDRUGTablet
Calcium carbonate/magnesium hydroxideDRUGTablet
PlaceboDRUGTablet
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * 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. Exclusion Criteria: * Having history of erosive esophagitis o...

Countries:United States
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