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

This study has been completed.
Information provided by:
Novartis Identifier:
First received: December 22, 2009
Last updated: March 1, 2011
Last verified: March 2011
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.

Condition Intervention Phase
Drug: Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg
Drug: Lansoprazole
Drug: Calcium carbonate/magnesium hydroxide
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Measure: Number of Participants With no Heartburn (Post Treatment) Following Consumption of Heartburn-inducing Meal [ Time Frame: 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:
  • Measure: Maximum Heartburn Intensity for Those Participants Who Experience Any Heartburn After the Heartburn-inducing Meals [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: 1 day ]

Enrollment: 120
Study Start Date: December 2009
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Combination product
Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg tablet
Drug: Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg
Active Comparator: PPI alone
Drug: Lansoprazole
Active Comparator: Antacid alone
Calcium carbonate/magnesium hydroxide
Drug: Calcium carbonate/magnesium hydroxide
Placebo Comparator: Placebo
Drug: Placebo


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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"

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Please refer to this study by its identifier: NCT01037452

United States, California
Anaheim, California, United States
Sponsors and Collaborators
Study Director: Novartis . Novartis
  More Information

Responsible Party: Head, New Therapeutic Opportunities, Novartis Identifier: NCT01037452     History of Changes
Other Study ID Numbers: 145-G-201
Study First Received: December 22, 2009
Results First Received: December 14, 2010
Last Updated: March 1, 2011

Keywords provided by Novartis:
calcium carbonate
magnesium hydroxide
Relief of heartburn following ingestion of a heartburn-inducing meal

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms
Calcium, Dietary
Anti-Ulcer Agents
Calcium Carbonate
Magnesium Hydroxide
Bone Density Conservation Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on April 26, 2017