Gastroesophageal Reflux DiseasePhase 4NCT00304421
Comparison of the Nighttime Effects of Two Different Drugs on Subjects With GERD
A Phase 4 study testing rabeprazole and pantoprazole in people with Gastroesophageal Reflux Disease, run by VA Greater Los Angeles Healthcare System at 1 site in United States.
Trial summary
The purpose of the study is to compare the effect of two different drugs, rabeprazole (20 mg) and pantoprazole (40 mg), and their effects on the amount of acid produced by your stomach on evening and at night after standard protein meal. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gastroesophageal Reflux Disease
- What is being tested?
- rabeprazole and pantoprazole
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2004to Sep 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects, 18-65 years of age, inclusive, male or female, of any race, who are willing to undergo testing at the study center.
- Female subjects must not be able to conceive by reason of surgery, radiation, 2 years past the onset of menopause, or an approved method of contraception (e.g., IUD, oral contraceptives for at least one cycle, implant, or double barrier method). Female subjects of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test before medication is dispensed.
- Subjects must have a negative result on the screening for H. pylori by serology, and no history of H. pylori eradication.
- Subjects must have history of GERD with or without antacid use.
- Subjects must be able to tolerate nasogastric tube placement.
Who cannot join
- History of gastric surgery, fundoplication or vagotomy.
- Pyloric stenosis Barrett's esophagus or esophageal stricture.
- Treatment with a histamine H2-receptor antagonist, prostaglandin, or sucralfate within 14 days before enrollment into this study.
- Treatment with rabeprazole, omeprazole, lansoprazole, pantoprazole, esomeprazole, prokinetic agent, or bismuth subsalicylate within 30 days before enrollment into this study.
- Concurrent serious systemic disorders, including renal insufficiency and hepatic insufficiency.
- Subjects with neoplasia or undergoing treatment for cancer (e.g., chemotherapy, radiation.
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- Any condition associated with poor subject compliance (e.g., alcohol abuse, drug abuse).
- History of clinically significant abuse of alcohol defined as (1) patterns of alcohol intake consistent with disruption of normal function in society; (2) history of, or current existence of any indication of difficulty in abstaining from alcohol for the required duration of the present protocol; (3) use of any alcohol within one day of any study period.
- Subjects who have received any investigational agent within the previous 30 days.
- Inability of subject to return for scheduled visits.
- Subjects who, in the opinion of the investigator, are poor medical or psychiatric risks for therapy with an investigational drug.
- History of any hypersensitivity reaction to rabeprazole, pantoprazole or any of their inactive ingredients.
- Any significant evidence at screening of endocrine, cardiovascular, and/or pulmonary disorder.
- Any predisposing condition that might interfere with the absorption, distribution, metabolism, or excretion of drug, or a history of abnormal bleeding tendencies or thrombophlebitis.
- History of HIV, hepatitis B, or hepatitis C infection.
- Subjects who are pregnant or likely to become pregnant during the course of this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Greater Los Angeles Healthcare System
Los Angeles, California, 90073
About this study
Official title: Comparison of the Nighttime Effects of Rabeprazole 20 mg to Pantoprazole 40 mg on Standard Meal Stimulated Gastric Acid Secretion and Intragastric pH in H. Pylori Negative Volunteer Subjects With GERD
The purpose of the study is to compare the effect of two different drugs, rabeprazole (20 mg) and pantoprazole (40 mg), and their effects on the amount of acid produced by your stomach on evening and at night after standard protein meal.
Read the detailed description
Gastric acid secretion can be divided into two phases: the daytime phase and the nocturnal phase. Nocturnal acid reflux is presumably more damaging because of loss of salivary neutralization. The present study is designed to measure effects of rabeprazole and pantoprazole on post-prandial and nocturnal gastric acid secretion and intragastric pH in H. pylori-negative volunteers with gastroesophageal reflux disease. These measurement will be used to compare the degree of inhibition of gastric acid secretion between the two drugs.
- Conditions
- Gastroesophageal Reflux Disease
- Being tested
- rabeprazole, pantoprazole
- Keywords
- Gastroesophageal Reflux Disease, Proton Pump Inhibitors, Gastric pH, Gastric Acid Secretion
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rabeprazoleDrug
pantoprazoleDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To test the hypothesis that during the hours 2000 through 0800 following a single dose administration of medication, the median change from baseline values in gastric acid secretion with 20 mg rabeprazole is significantly less than 40 mg pantoprazole
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2006 (estimated)
- Study startJan 2004
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Greater Los Angeles Healthcare System
- Sponsor type
- US federal agency
- Collaborators
- PriCara, Unit of Ortho-McNeil, Inc., Eisai Inc.
- Investigators
- Joseph Pisegna, MD, Principal investigator, VA Greater Los Angeles Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00304421
- Sponsor's protocol ID
- 0028
- Status last verified
- Sep 2007
- First submitted
- 16 Mar 2006
- Last updated
- 17 Sep 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Nighttime Effects of Rabeprazole 20 mg to Pantoprazole 40 mg on Standard Meal Stimulated Gastric Acid Secretion and Intragastric pH in H. Pylori Negative Volunteer Subjects With GERD
- ClinicalTrials.gov ID
- NCT00304421
- Acronym / sponsor ID
- 0028
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- Gastroesophageal Reflux Disease, Proton Pump Inhibitors, Gastric pH, Gastric Acid Secretion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- VA Greater Los Angeles Healthcare SystemUS federal agency
- Collaborators
- PriCara, Unit of Ortho-McNeil, Inc., Eisai Inc.
- Study start
- Jan 2004
- Study completion
- Sep 2007 (actual)
- First posted
- 17 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to compare the effect of two different drugs, rabeprazole (20 mg) and pantoprazole (40 mg), and their effects on the amount of acid produced by your stomach on evening and at night after standard protein meal.
Detailed description
Gastric acid secretion can be divided into two phases: the daytime phase and the nocturnal phase. Nocturnal acid reflux is presumably more damaging because of loss of salivary neutralization. The present study is designed to measure effects of rabeprazole and pantoprazole on post-prandial and nocturnal gastric acid secretion and intragastric pH in H. pylori-negative volunteers with gastroesophageal reflux disease. These measurement will be used to compare the degree of inhibition of gastric acid secretion between the two drugs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects, 18-65 years of age, inclusive, male or female, of any race, who are willing to undergo testing at the study center.
- Female subjects must not be able to conceive by reason of surgery, radiation, 2 years past the onset of menopause, or an approved method of contraception (e.g., IUD, oral contraceptives for at least one cycle, implant, or double barrier method). Female subjects of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test before medication is dispensed.
- Subjects must have a negative result on the screening for H. pylori by serology, and no history of H. pylori eradication.
- Subjects must have history of GERD with or without antacid use.
- Subjects must be able to tolerate nasogastric tube placement.
Key exclusion criteria (16 listed)
- History of gastric surgery, fundoplication or vagotomy.
- Pyloric stenosis Barrett's esophagus or esophageal stricture.
- Treatment with a histamine H2-receptor antagonist, prostaglandin, or sucralfate within 14 days before enrollment into this study.
- Treatment with rabeprazole, omeprazole, lansoprazole, pantoprazole, esomeprazole, prokinetic agent, or bismuth subsalicylate within 30 days before enrollment into this study.
- Concurrent serious systemic disorders, including renal insufficiency and hepatic insufficiency.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rabeprazole | Drug | – |
| pantoprazole | Drug | – |
Primary outcome
To test the hypothesis that during the hours 2000 through 0800 following a single dose administration of medication, the median change from baseline values in gastric acid secretion with 20 mg rabeprazole is significantly less than 40 mg pantoprazole
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Pisegna, MD principal investigator
VA Greater Los Angeles Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing rabeprazole and pantoprazole in people with Gastroesophageal Reflux Disease, run by VA Greater Los Angeles Healthcare System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To test the hypothesis that during the hours 2000 through 0800 following a single dose administration of medication, the median change from baseline values in gastric acid secretion with 20 mg rabeprazole is significantly less than 40 mg pantoprazole. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2007.