Proof of Concept Study Efficacy of an Antacid/Lansoprazole Combination for Relief of Heartburn
Primary Purpose
Heartburn
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg
Lansoprazole
Calcium carbonate/magnesium hydroxide
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Heartburn focused on measuring Heartburn, antacid, PPI, Lansoprazole, calcium carbonate, magnesium hydroxide, Relief of heartburn following ingestion of a heartburn-inducing meal
Eligibility 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"
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Combination product
PPI alone
Antacid alone
Placebo
Arm Description
Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg tablet
Lansoprazole
Calcium carbonate/magnesium hydroxide
Placebo
Outcomes
Primary Outcome Measures
Measure: Number of Participants With no Heartburn (Post Treatment) Following Consumption of Heartburn-inducing Meal
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
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01037452
Brief Title
Proof of Concept Study Efficacy of an Antacid/Lansoprazole Combination for Relief of Heartburn
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 Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heartburn
Keywords
Heartburn, antacid, PPI, Lansoprazole, calcium carbonate, magnesium hydroxide, Relief of heartburn following ingestion of a heartburn-inducing meal
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Combination product
Arm Type
Experimental
Arm Description
Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg tablet
Arm Title
PPI alone
Arm Type
Active Comparator
Arm Description
Lansoprazole
Arm Title
Antacid alone
Arm Type
Active Comparator
Arm Description
Calcium carbonate/magnesium hydroxide
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg
Intervention Description
Tablet
Intervention Type
Drug
Intervention Name(s)
Lansoprazole
Intervention Description
Tablet
Intervention Type
Drug
Intervention Name(s)
Calcium carbonate/magnesium hydroxide
Intervention Description
Tablet
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tablet
Primary Outcome Measure Information:
Title
Measure: Number of Participants With no Heartburn (Post Treatment) Following Consumption of Heartburn-inducing Meal
Description
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.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Measure: Maximum Heartburn Intensity for Those Participants Who Experience Any Heartburn After the Heartburn-inducing Meals
Description
Heartburn severity was measured using a Visual Analog Scale, which was 100 milliimeters long.
0 millimeters: None (no heartburn) 100 millimeters: Most severe
Time Frame
1 day
Title
Measure: Maximum Heartburn Intensity for Those Participants Who Experience Any Nighttime Heartburn
Description
Heartburn severity was measured using a Visual Analog Scale, which was 100 milliimeters long.
0 millimeters: None (no heartburn) 100 millimeters: Most severe
Time Frame
1 day
Title
Measure: Number of Participants That Reported an Adverse Event for the Combination Product, PPI Alone, Antacid Alone and Placebo.
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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"
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis .
Organizational Affiliation
Novartis
Official's Role
Study Director
Facility Information:
City
Anaheim
State/Province
California
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Proof of Concept Study Efficacy of an Antacid/Lansoprazole Combination for Relief of Heartburn
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