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

NCT00237367 | Completed Phase 4

• 1 other identifier: CR004618
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Gastroesophageal Reflux

Keywords

Gastroesophageal Reflux; GERD; Nighttime heartburn; heartburn; esophagus; esophageal acid exposure; EAE; Aciphex; Pariet; rabeprazole; Protonix; pantoprazole

Outcome Measures

Primary Outcomes (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

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)

Interventions

rabeprazole and pantoprazole DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• PriCara, Unit of Ortho-McNeil, Inc.: lead
• Eisai Inc.: collaborator

Related Publications (1)

• 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.

  PMID: 20132153 DERIVED

MeSH Terms

Conditions

Gastroesophageal Reflux; Heartburn

Interventions

Rabeprazole; Pantoprazole

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• PriCara, Unit of Ortho-McNeil, Inc. Clinical Trial

  PriCara, Unit of Ortho-McNeil, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 7, 2005
• First Posted: October 12, 2005
• Study Completion: April 1, 2005
• Last Updated: April 28, 2010

Record last verified: 2010-04