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

Novartis

Status and phase: Completed; Phase 2

Conditions: Heartburn

Treatments: Drug: Lansoprazole; Drug: Placebo; Drug: Calcium carbonate/magnesium hydroxide; Drug: Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01037452

145-G-201

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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"

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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120 participants in 4 patient groups, including a placebo group

Combination product

Experimental group

Description:

Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg tablet

Treatment:

Drug: Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg

PPI alone

Active Comparator group

Description:

Lansoprazole

Treatment:

Drug: Lansoprazole

Antacid alone

Active Comparator group

Description:

Calcium carbonate/magnesium hydroxide

Treatment:

Drug: Calcium carbonate/magnesium hydroxide

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo