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

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.

Study Overview

• Status: Completed
• Conditions: Heartburn
• Intervention / Treatment: Drug: Placebo; Drug: Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg; Drug: Lansoprazole; Drug: Calcium carbonate/magnesium hydroxide

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Tablet
Experimental: Combination product; Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg tablet	Drug: Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg; Tablet
Active Comparator: PPI alone; Lansoprazole	Drug: Lansoprazole; Tablet
Active Comparator: Antacid alone; Calcium carbonate/magnesium hydroxide	Drug: Calcium carbonate/magnesium hydroxide; Tablet

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Novartis
• Investigators: Study Director: Novartis ., Novartis

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): January 1, 2010

Study Registration Dates

• First Submitted: December 22, 2009
• First Submitted That Met QC Criteria: December 22, 2009
• First Posted (Estimate): December 23, 2009

Study Record Updates

• Last Update Posted (Estimate): March 28, 2011
• Last Update Submitted That Met QC Criteria: March 1, 2011
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Keywords: PPI; Lansoprazole; Heartburn; antacid; calcium carbonate; magnesium hydroxide; Relief of heartburn following ingestion of a heartburn-inducing meal
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Heartburn; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Antacids; Dexlansoprazole; Lansoprazole; Calcium; Calcium, Dietary; Calcium Carbonate; Magnesium Hydroxide
• Other Study ID Numbers: 145-G-201