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Calcium carbonate/magnesium hydroxide/Lansoprazole · 1 trial · 1 indication
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.
| Arm | Type | Description |
|---|---|---|
| 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 |
|---|---|---|
| Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg | DRUG | Tablet |
| Lansoprazole | DRUG | Tablet |
| Calcium carbonate/magnesium hydroxide | DRUG | Tablet |
| Placebo | DRUG | Tablet |
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 o...
Calcium carbonate/magnesium hydroxide/lansoprazole is being studied for the relief of heartburn. It combines an antacid with lansoprazole, a proton pump inhibitor, in a single fixed-dose combination product. The program sits in the gastrointestinal therapeutic area and is being developed by Novartis AG under the ticker NVS.
Novartis AG, which trades under the ticker NVS, is the developer of calcium carbonate/magnesium hydroxide/lansoprazole. The company sponsored the clinical work evaluating the combination for heartburn relief. No other developer or partner is associated with the asset in its public trial record.
Calcium carbonate/magnesium hydroxide/lansoprazole is in Phase 2 development. It is an investigational combination product and has not been approved by the FDA. The Phase 2 program has been completed, and the asset is not currently listed with any active clinical trials.
One Phase 2 trial has evaluated calcium carbonate/magnesium hydroxide/lansoprazole: NCT01037452, titled Proof of Concept Study Efficacy of an Antacid/Lansoprazole Combination for Relief of Heartburn. The completed study enrolled 120 participants in the United States, was randomized, double blind, and placebo controlled, and included adults 18 years and older of all sexes.
Lansoprazole is a proton pump inhibitor, a small molecule that suppresses gastric acid secretion. In this fixed-dose combination it is paired with calcium carbonate and magnesium hydroxide, which act as antacids. The combination is designed to address heartburn through both rapid antacid neutralization and sustained acid suppression from the lansoprazole component.