A Study of Rabeprazole and Pantoprazole on Stomach Acid and Esophageal Acid Exposure in Patients With Gastroesophageal Reflux Disease (GERD) and a History of Nighttime Heartburn
Condition: Gastroesophageal Reflux
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic; Heartburn
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to compare the pharmacodynamics (the way a drug works in the
      body) of rabeprazole and pantoprazole on intragastric acidity and esophageal acid exposure in
      gastroesophageal reflux disease (GERD) patients with nighttime heartburn. Patients will be
      given one dose of each medication with a washout period of 6 to 13 days between doses
      ("washout period" means they will receive no further proton pump inhibitor medication for
      6-13 days, allowing the 1st dose to completely leave their bodies). Rabeprazole is approved
      in the United States for the short-term treatment (4-8 weeks) in the healing and symptomatic
      relief of erosive or ulcerative GERD with symptoms of daytime or nighttime heartburn,
      maintenance of healing of erosive or ulcerative GERD, and treatment of symptomatic GERD. The
      dosage regimen for all GERD indications is 20 mg once a day. Other indications include
      healing of duodenal ulcers, Helicobacter pylori eradication to reduce the risk of duodenal
      ulcer recurrence, and treatment of pathological hypersecretory conditions including
      Zollinger-Ellison Syndrome. The most common side effect of rabeprazole is headache. In
      clinical trials headache was assessed as possibly related to rabeprazole in 2.4% of subjects
      vs. 1.6% for placebo. Pantoprazole at a dose of 40 mg once a day is indicated for the
      short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive
      esophagitis, and the maintenance of healing of erosive esophagitis and reduction in relapse
      rates of daytime and nighttime heartburn symptoms in patients with GERD. Other indications
      include pathological hypersecretory conditions including Zollinger-Ellison Syndrome. The most
      common side effects are headache and diarrhea.
    

Detailed description: 
      The purpose of this study is to compare the effects of a single dose of two drugs,
      rabeprazole and pantoprazole, on reducing the amount of acid in the stomach and esophagus in
      subjects with GERD. This study is conducted at one investigational center. The investigator
      will be blinded (he or she will not know whether the patient is taking rabeprazole or
      pantoprazole). The study is a comparative, randomized, single dose, two-way crossover,
      pharmacodynamic study examining the effectiveness of rabeprazole or pantoprazole on stomach
      acidity and esophageal acid exposure in GERD patients with nighttime heartburn. Patients will
      be randomized (like with the toss of a coin) to one of two sequences in receiving study
      medication; either one dose of rabeprazole in the first treatment period followed by one dose
      of pantoprazole in the second treatment period or one dose of pantoprazole in the first
      treatment period followed by one dose of rabeprazole in the second treatment period. The
      study will measure how the acid levels in the stomach and esophagus change after one dose of
      either study medication. The primary endpoint will be the percent of time that the stomach pH
      is greater than 4 (a pH level considered to be normal) during the 24-hour period after a
      single dose of each study medication. Another endpoint will be the 24-hour esophageal reflux
      time after a single dose of study medication. The esophageal acid exposure is determined by
      measuring how much acid flows backwards from the stomach to the esophagus. Patients will
      participate in two 48-hour treatment periods during which intragastric (stomach) and
      esophageal pH will be recorded at 8-second intervals using a probe inserted through the nose
      and down to the stomach. The two treatment periods will be be separated by a washout period
      of 6 to 13 days. On each day of the treatment periods, patients will be dosed in the morning.
      During each treatment period, patients will receive placebo on Day 1, and active treatment
      (either rabeprazole or pantoprazole) on Day 2. The main objective of the study is to compare
      the effects of a single dose of rabeprazole 20 milligrams to pantoprazole 40 milligrams on
      intragastric acidity and esophageal acid exposure in GERD patients with a history of
      nighttime heartburn and safety will be monitored in the study. Rabeprazole 20 milligram
      tablet once by mouth; pantoprazole 40 milligram tablet once by mouth
    

Intervention name(s): rabeprazole and pantoprazole
Intervention type(s): Drug
Intervention MeSH terms: Rabeprazole; Pantoprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Gastroesophageal Reflux; GERD; Nighttime heartburn; heartburn; esophagus; esophageal acid exposure; EAE; Aciphex; Pariet; rabeprazole; Protonix; pantoprazole