A Study of Rabeprazole and Pantoprazole on Stomach Acid and Esophageal Acid Exposure in Patients … (NCT00237367) | Clinical Trial Compass
CompletedPhase 4
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
52 participants
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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