Conditions: Heartburn
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 629
Healthy volunteers: no

Brief summary:
The purpose of this study is to investigate the safety and efficacy of rabeprazole sodium 10 mg in treating frequent heartburn.

Detailed description:
This is a multicenter, double-blind, randomized, placebo-controlled study to investigate the safety and efficacy of rabeprazole 10 mg in treating frequent heartburn. The study will last for up to five weeks and consists of the following three phases: a one to two week screening period that includes a one-week, single-blind, placebo run-in phase, a two week double-blind, randomized treatment phase, and a one week single-blind, placebo follow-up phase.

Arms:
arm 1: Oral placebo tablet arm 2: oral rabeprazole 10 mg enteric-coated tablet

Interventions: intervention 1: rabeprazole sodium intervention 2: Placebo
Intervention descriptions: intervention 1: Following a one week single-blind, placebo run-in phase, patients will receive rabeprazole 10 mg orally, once daily, for 14 days during the double-blind, randomized treatment phase. This will be followed by a one week single-blind placebo follow-up phase. intervention 2: Following a one week single-blind, placebo run-in phase, patients will receive placebo orally, once daily, for 14 days during the double-blind, randomized treatment phase. This will be followed by a one week single-blind placebo follow-up phase.

Protocol document: