Heartburn
Conditions
Keywords
Heartburn, antacid, PPI, Lansoprazole, calcium carbonate, magnesium hydroxide, Relief of heartburn following ingestion of a heartburn-inducing meal
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.
Interventions
DRUGCalcium carbonate/magnesium hydroxide/Lansoprazole 15 mg
Tablet
DRUGLansoprazole
Tablet
DRUGCalcium carbonate/magnesium hydroxide
Tablet
DRUGPlacebo
Tablet
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measure: Number of Participants With no Heartburn (Post Treatment) Following Consumption of Heartburn-inducing Meal | 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
| Measure | Time frame | Description |
|---|---|---|
| Measure: Maximum Heartburn Intensity for Those Participants Who Experience Any Heartburn After the Heartburn-inducing Meals | 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 | 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. | 1 day | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Combination Product Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg tablet, single dose | 30 |
| PPI Alone Lansoprazole 15 mg, single dose | 30 |
| Antacid Alone Calcium carbonate/magnesium hydroxide, single dose | 30 |
| Placebo Placebo, single dose | 30 |
| Total | 120 |
Baseline characteristics
| Characteristic | Placebo | Total | PPI Alone | Antacid Alone | Combination Product |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 29 Participants | 119 Participants | 30 Participants | 30 Participants | 30 Participants |
| Age Continuous | 31.9 years STANDARD_DEVIATION 12.6 | 31.7 years STANDARD_DEVIATION 12.1 | 30.4 years STANDARD_DEVIATION 11.1 | 30.9 years STANDARD_DEVIATION 13.3 | 33.7 years STANDARD_DEVIATION 11.5 |
| Region of Enrollment United States | 30 participants | 120 participants | 30 participants | 30 participants | 30 participants |
| Sex: Female, Male Female | 17 Participants | 57 Participants | 14 Participants | 11 Participants | 15 Participants |
| Sex: Female, Male Male | 13 Participants | 63 Participants | 16 Participants | 19 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 30 |
Outcome results
Primary
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.
Time frame: 1 day
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Combination Product | Measure: Number of Participants With no Heartburn (Post Treatment) Following Consumption of Heartburn-inducing Meal | 0 participants |
| PPI Alone | Measure: Number of Participants With no Heartburn (Post Treatment) Following Consumption of Heartburn-inducing Meal | 2 participants |
| Antacid Alone | Measure: Number of Participants With no Heartburn (Post Treatment) Following Consumption of Heartburn-inducing Meal | 1 participants |
| Placebo | Measure: Number of Participants With no Heartburn (Post Treatment) Following Consumption of Heartburn-inducing Meal | 0 participants |
Secondary
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
Time frame: 1 day
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Combination Product | Measure: Maximum Heartburn Intensity for Those Participants Who Experience Any Heartburn After the Heartburn-inducing Meals | 69.3 millimeters |
| PPI Alone | Measure: Maximum Heartburn Intensity for Those Participants Who Experience Any Heartburn After the Heartburn-inducing Meals | 61.2 millimeters |
| Antacid Alone | Measure: Maximum Heartburn Intensity for Those Participants Who Experience Any Heartburn After the Heartburn-inducing Meals | 59.1 millimeters |
| Placebo | Measure: Maximum Heartburn Intensity for Those Participants Who Experience Any Heartburn After the Heartburn-inducing Meals | 56.9 millimeters |
Secondary
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
Time frame: 1 day
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Combination Product | Measure: Maximum Heartburn Intensity for Those Participants Who Experience Any Nighttime Heartburn | 8.2 millimeters |
| PPI Alone | Measure: Maximum Heartburn Intensity for Those Participants Who Experience Any Nighttime Heartburn | 7.0 millimeters |
| Antacid Alone | Measure: Maximum Heartburn Intensity for Those Participants Who Experience Any Nighttime Heartburn | 4.7 millimeters |
| Placebo | Measure: Maximum Heartburn Intensity for Those Participants Who Experience Any Nighttime Heartburn | 4.0 millimeters |
Secondary
Measure: Number of Participants That Reported an Adverse Event for the Combination Product, PPI Alone, Antacid Alone and Placebo.
Time frame: 1 day
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Combination Product | Measure: Number of Participants That Reported an Adverse Event for the Combination Product, PPI Alone, Antacid Alone and Placebo. | 0 participants |
| PPI Alone | Measure: Number of Participants That Reported an Adverse Event for the Combination Product, PPI Alone, Antacid Alone and Placebo. | 1 participants |
| Antacid Alone | Measure: Number of Participants That Reported an Adverse Event for the Combination Product, PPI Alone, Antacid Alone and Placebo. | 0 participants |
| Placebo | Measure: Number of Participants That Reported an Adverse Event for the Combination Product, PPI Alone, Antacid Alone and Placebo. | 0 participants |