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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01037452
First Posted: December 23, 2009
Last Update Posted: March 28, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Novartis
  Purpose
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
Heartburn 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: Triple (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
Tablet
Active Comparator: PPI alone
Lansoprazole
Drug: Lansoprazole
Tablet
Active Comparator: Antacid alone
Calcium carbonate/magnesium hydroxide
Drug: Calcium carbonate/magnesium hydroxide
Tablet
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Tablet

  Eligibility

Information from the National Library of Medicine

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

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"

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01037452


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

Responsible Party: Head, New Therapeutic Opportunities, Novartis
ClinicalTrials.gov Identifier: NCT01037452     History of Changes
Other Study ID Numbers: 145-G-201
First Submitted: December 22, 2009
First Posted: December 23, 2009
Results First Submitted: December 14, 2010
Results First Posted: March 28, 2011
Last Update Posted: March 28, 2011
Last Verified: March 2011

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

Additional relevant MeSH terms:
Heartburn
Signs and Symptoms, Digestive
Signs and Symptoms
Calcium, Dietary
Lansoprazole
Dexlansoprazole
Anti-Ulcer Agents
Calcium Carbonate
Magnesium Hydroxide
Antacids
Bone Density Conservation Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action