Gastroesophageal RefluxPhase 4NCT00237367
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
A Phase 4 study testing rabeprazole and pantoprazole in people with Gastroesophageal Reflux, run by PriCara, Unit of Ortho-McNeil, Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gastroesophageal Reflux
- What is being tested?
- rabeprazole and pantoprazole
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Apr 2005
- 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
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
About this study
Official title: 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.
Read the 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
- Conditions
- Gastroesophageal Reflux
- Being tested
- rabeprazole and pantoprazole
- Keywords
- Gastroesophageal Reflux, GERD, Nighttime heartburn, heartburn, esophagus, esophageal acid exposure, EAE, Aciphex, Pariet, rabeprazole, Protonix, pantoprazole
- Medical subject headings
- Gastroesophageal Reflux, Heartburn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rabeprazole and pantoprazoleDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (1)
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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2005 (estimated)
- Study completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal RefluxStudies 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
- Single blind
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- PriCara, Unit of Ortho-McNeil, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eisai Inc.
- Investigators
- PriCara, Unit of Ortho-McNeil, Inc. Clinical Trial, Study director, PriCara, Unit of Ortho-McNeil, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00237367
- Sponsor's protocol ID
- CR004618
- Status last verified
- Apr 2010
- First submitted
- 7 Oct 2005
- Last updated
- 28 Apr 2010
- Results posted
- No
Publications
Miner P, Delemos B, Xiang J, Lococo J, Ieni J. Effects of a single dose of rabeprazole 20 mg and pantoprazole 40 mg on 24-h intragastric acidity and oesophageal acid exposure: a randomized study in gastro-oesophageal reflux disease patients with a history of nocturnal heartburn. Aliment Pharmacol Ther. 2010 May;31(9):991-1000. doi: 10.1111/j.1365-2036.2010.04255.x. Epub 2010 Feb 2.
PubMed 20132153
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00237367
- Acronym / sponsor ID
- CR004618
- Conditions
- Gastroesophageal Reflux
- Keywords
- Gastroesophageal Reflux, GERD, Nighttime heartburn, heartburn, esophagus, esophageal acid exposure, EAE, Aciphex
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- PriCara, Unit of Ortho-McNeil, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Eisai Inc.
- Study completion
- Apr 2005 (actual)
- First posted
- 12 Oct 2005 (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 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
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 and pantoprazole | Drug | – |
Primary outcome
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
1 secondary outcome
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)
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 28 Apr 2010.
- Derived from this study: PubMed 20132153Miner P, Delemos B, Xiang J, Lococo J, Ieni J. Effects of a single dose of rabeprazole 20 mg and pantoprazole 40 mg on 24-h intragastric acidity and oesophageal acid exposure: a randomized study in gastro-oesophageal reflux disease patients with a history of nocturnal heartburn. Aliment Pharmacol Ther. 2010 May;31(9):991-1000. doi: 10.1111/j.1365-2036.2010.04255.x. Epub 2010 Feb 2.
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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.
PriCara, Unit of Ortho-McNeil, Inc. Clinical Trial study director
PriCara, Unit of Ortho-McNeil, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing rabeprazole and pantoprazole in people with Gastroesophageal Reflux, run by PriCara, Unit of Ortho-McNeil, Inc..
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 8 inclusion and 11 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 28 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
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?
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. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00237367, which also lists 1 linked publication.
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 28 Apr 2010.