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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combination product | Experimental | Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg tablet |
|
| PPI alone | Active Comparator | Lansoprazole |
|
| Antacid alone | Active Comparator | Calcium carbonate/magnesium hydroxide |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg | Drug | Tablet |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 day |
| Measure: Maximum Heartburn Intensity for Those Participants Who Experience Any Nighttime Heartburn |
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Inclusion Criteria:
Exclusion Criteria:
"Other protocol-defined inclusion/exclusion criteria may apply"
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| Name | Affiliation | Role |
|---|---|---|
| Novartis . | Novartis | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anaheim | California | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Combination Product | Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg tablet, single dose |
| FG001 | PPI Alone | Lansoprazole 15 mg, single dose |
| FG002 | Antacid Alone | Calcium carbonate/magnesium hydroxide, single dose |
| FG003 | Placebo | Placebo, single dose |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Combination Product | Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg tablet, single dose |
| BG001 | PPI Alone | Lansoprazole 15 mg, single dose |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | 95% Confidence Interval | participants | 1 day |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Combination Product | Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg tablet, single dose |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head New Therapeutic Opportunities | Novartis | 973-503-8000 |
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| ID | Term |
|---|---|
| D006356 | Heartburn |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002119 | Calcium Carbonate |
| D008276 | Magnesium Hydroxide |
| D064747 | Lansoprazole |
| C016386 | dihydroxyaluminum sodium carbonate |
| ID | Term |
|---|---|
| D017610 | Calcium Compounds |
| D007287 | Inorganic Chemicals |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
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| Lansoprazole |
| Drug |
Tablet |
|
| Calcium carbonate/magnesium hydroxide | Drug | Tablet |
|
| Placebo | Drug | Tablet |
|
Heartburn severity was measured using a Visual Analog Scale, which was 100 milliimeters long. 0 millimeters: None (no heartburn) 100 millimeters: Most severe |
| 1 day |
| Measure: Number of Participants That Reported an Adverse Event for the Combination Product, PPI Alone, Antacid Alone and Placebo. | 1 day |
| BG002 | Antacid Alone | Calcium carbonate/magnesium hydroxide, single dose |
| BG003 | Placebo | Placebo, single dose |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Antacid Alone | Calcium carbonate/magnesium hydroxide, single dose |
| OG003 | Placebo | Placebo, single dose |
|
|
| 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 | Posted | Mean | 95% Confidence Interval | millimeters | 1 day |
|
|
|
| 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 | Posted | Mean | 95% Confidence Interval | millimeters | 1 day |
|
|
|
| Secondary | Measure: Number of Participants That Reported an Adverse Event for the Combination Product, PPI Alone, Antacid Alone and Placebo. | Posted | Number | participants | 1 day |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | PPI Alone | Lansoprazole 15 mg, single dose | 0 | 30 | 0 | 30 |
| EG002 | Antacid Alone | Calcium carbonate/magnesium hydroxide, single dose | 0 | 30 | 0 | 30 |
| EG003 | Placebo | Placebo, single dose | 0 | 30 | 0 | 30 |
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| D017554 |
| Carbon Compounds, Inorganic |
| D008903 | Minerals |
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D017616 | Magnesium Compounds |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |