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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Heartburn

Intervention / Treatment
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* Drug: Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg
* Drug: Lansoprazole
* Drug: Calcium carbonate/magnesium hydroxide
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combination product<br>Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg tablet | Drug: Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg<br>* Tablet<br>|
| Active Comparator: PPI alone<br>Lansoprazole | Drug: Lansoprazole<br>* Tablet<br>|
| Active Comparator: Antacid alone<br>Calcium carbonate/magnesium hydroxide | Drug: Calcium carbonate/magnesium hydroxide<br>* Tablet<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 1 day | 
| Measure: Number of Participants That Reported an Adverse Event for the Combination Product, PPI Alone, Antacid Alone and Placebo. |  | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heartburn, antacid, PPI, Lansoprazole, calcium carbonate, magnesium hydroxide, Relief of heartburn following ingestion of a heartburn-inducing meal