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

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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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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