Phase 2 N=120 Randomized Triple-blind Treatment

Proof of Concept Study Efficacy of an Antacid/Lansoprazole Combination for Relief of Heartburn

Heartburn

Bottom Line

View on ClinicalTrials.gov: NCT01037452 ↗

Enrolled (actual)

120

Serious AEs

0.0%

Results posted

Mar 2011

Primary outcome: Primary: Measure: Number of Participants With no Heartburn (Post Treatment) Following Consumption of Heartburn-inducing Meal — 0; 2; 1; 0 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg (Drug); Lansoprazole (Drug); Calcium carbonate/magnesium hydroxide (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Novartis
Primary completion: Jan 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Measure: Number of Participants With no Heartburn (Post Treatment) Following Consumption of Heartburn-inducing Meal	0; 2; 1; 0	—
SECONDARY Measure: Maximum Heartburn Intensity for Those Participants Who Experience Any Heartburn After the Heartburn-inducing Meals	69.3; 61.2; 59.1; 56.9	—
SECONDARY Measure: Maximum Heartburn Intensity for Those Participants Who Experience Any Nighttime Heartburn	8.2; 7.0; 4.7; 4.0	—
SECONDARY Measure: Number of Participants That Reported an Adverse Event for the Combination Product, PPI Alone, Antacid Alone and Placebo.	0; 1; 0; 0	—

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.

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"

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01037452). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.