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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT01037452
First received: December 22, 2009
Last updated: March 1, 2011
Last verified: March 2011
History of Changes
  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: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: Calcium Heartburn
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01037452

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

No publications provided

Responsible Party: Head, New Therapeutic Opportunities, Novartis
ClinicalTrials.gov 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
Health Authority: United States: Food and Drug Administration

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
Antacids
Calcium Carbonate
Magnesium Hydroxide
Anti-Ulcer Agents
Lansoprazole
Calcium, Dietary
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Gastrointestinal Agents
Therapeutic Uses
Bone Density Conservation Agents
Physiological Effects of Drugs
Anti-Infective Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 22, 2013