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

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.
 
ClinicalTrials.gov Identifier: NCT01037452
Recruitment Status : Completed
First Posted : December 23, 2009
Results First Posted : March 28, 2011
Last Update Posted : March 28, 2011
Sponsor:
Information provided by:
Novartis

Study Description
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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.

Condition or disease Intervention/treatment Phase
Heartburn Drug: Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg Drug: Lansoprazole Drug: Calcium carbonate/magnesium hydroxide Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
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
Study Start Date : December 2009
Actual Primary Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heartburn

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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


  2. 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


  3. Measure: Number of Participants That Reported an Adverse Event for the Combination Product, PPI Alone, Antacid Alone and Placebo. [ Time Frame: 1 day ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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
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United States, California
Anaheim, California, United States
Sponsors and Collaborators
Novartis
Investigators
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Study Director: Novartis . Novartis
More Information
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Responsible Party: Head, New Therapeutic Opportunities, Novartis
ClinicalTrials.gov Identifier: NCT01037452    
Other Study ID Numbers: 145-G-201
First Posted: December 23, 2009    Key Record Dates
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:
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Heartburn
Signs and Symptoms, Digestive
Calcium, Dietary
Lansoprazole
Dexlansoprazole
Calcium Carbonate
Magnesium Hydroxide
Calcium
Calcium-Regulating Hormones and Agents
 Physiological Effects of Drugs
Bone Density Conservation Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antacids