Efficacy/Safety of Lansoprazole in Patients With Frequent Nighttime Heartburn

Novartis

Status and phase: Completed; Phase 3

Conditions: Frequent Heartburn

Treatments: Drug: Lansoprazole; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00701259

PRSW-GN-305

Details and patient eligibility

About

Heartburn, a burning sensation in the chest or throat, occurs in many individuals when acidic stomach contents move upward into the esophagus from the stomach. This study will investigate the safety and efficacy of lansoprazole 15 mg or 30 mg administered once a day in preventing frequent nighttime heartburn.

Enrollment: 852 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Experiencing heartburn at least 2 days per week during the nighttime period over the past month.
• 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 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: Parallel Assignment

Masking: Triple Blind

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852 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

15 mg lansoprazole

Treatment:

Drug: Lansoprazole

Drug: Lansoprazole

2

Experimental group

Description:

30 mg lansoprazole

Treatment:

Drug: Lansoprazole

Drug: Lansoprazole

3

Placebo Comparator group

Description:

placebo

Treatment:

Drug: placebo