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

Phase 2

Completed

• Conditions: Heartburn
• Interventions: Drug: Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg; Drug: Lansoprazole; Drug: Calcium carbonate/magnesium hydroxide; Drug: Placebo

• Registration Number: NCT01037452
• Lead Sponsor: Novartis

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2009-12-22
• Study First Submitted QC: 2009-12-22
• Study First Posted: 2009-12-23
• Primary Completion: 2010-01
• Results First Submitted: 2010-12-14
• Status Verified: 2011-03
• Results First Submitted QC: 2011-03-01
• Last Update Submitted: 2011-03-01
• Results First Posted: 2011-03-28
• Last Update Posted: 2011-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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"

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Combination product	Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg	Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg tablet
PPI alone	Lansoprazole	Lansoprazole
Antacid alone	Calcium carbonate/magnesium hydroxide	Calcium carbonate/magnesium hydroxide
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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