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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Signs and Symptoms, Digestive
Antacids
Anti-Ulcer Agents
Calcium Carbonate
Calcium, Dietary
Dexlansoprazole
Lansoprazole
Magnesium Hydroxide
Bone Density Conservation Agents
Enzyme Inhibitors
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Proton Pump Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014