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

April 26, 2010 updated by: PriCara, Unit of Ortho-McNeil, Inc.

A Randomized, Two-way Crossover Study of the Effects of a Single Dose of Rabeprazole or Pantoprazole on 24-hour Intragastric Acidity and Esophageal Acid Exposure in GERD Patients With a History of Nocturnal Heartburn

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
52

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of GERD with symptoms for at least 6 months with at least 3 episodes a week and one of those at nighttime
  • in generally good health
  • stop any previous similar (proton pump inhibitor) therapy at least 10 days before screening
  • weigh within normal weight for one's height
  • able to tolerate a nasogastric tube (pH probe assembly that goes through the nose into the stomach) for 48 hours on 2 different occasions
  • esophageal acid exposure of at least 10% on a 24-hour pH monitoring study performed within the 24 months prior to screening
  • Helicobacter pylori (an infection) negative
  • willing to take only TUMS antacid as rescue medicine during the washout period

Exclusion Criteria:

  • History of a serious medical condition
  • significant gastrointestinal illness other than GERD
  • ulcer at any time in the past
  • difficulty swallowing
  • history of gastrointestinal disease (including bleeding)
  • use of any medication that changes acid secretion or gastrointestinal movement in the past 14 days
  • use of any drugs on a list of prohibited drugs within 1 month
  • chronic use of pain relieving medications (NSAIDs or COX-2 inhibitors)
  • pregnant or breast-feeding
  • cancer diagnosis or treatment (except for superficial skin cancers)
  • abusing drugs or alcohol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Pharmacodynamics: intragastric pH measurements, collected every 8 seconds for each 24 hour period after administration of study medication on Day 1 and Day 2 of each study period; percent of the 24-hour period with intragastric pH>4

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Pharmacodynamics: esophageal pH measurements, collected every 8 seconds for each 24 hour period after administration of study drug on Day 1 and Day 2 of each study period; 24-hour esophageal acid reflex time (percent 24-hour period with esophageal pH<4)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
PriCara, Unit of Ortho-McNeil, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eisai Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: PriCara, Unit of Ortho-McNeil, Inc. Clinical Trial, PriCara, Unit of Ortho-McNeil, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2005

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 7, 2005

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 7, 2005

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 12, 2005

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 28, 2010

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2010

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR004618

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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