Study of Pantoprazole for Sleepiness Associated With Acid Reflux and Sleep Apnea

This study has been completed.
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00307944
First received: March 27, 2006
Last updated: December 10, 2007
Last verified: December 2007
  Purpose

The purpose of this study is to determine if using Pantoprazole decreases your daytime sleepiness and improves your reaction time when compared to using a placebo (sugar pill).


Condition Intervention Phase
Acid Reflux Disease
Obstructive Sleep Apnea
Drug: Pantoprazole
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Randomized, Placebo-Controlled Trial of Pantoprazole for Sleepiness Associated With Acid Reflux and Obstructive Sleep Disordered Breathing

Resource links provided by NLM:


Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • Difference between treatment groups with regard to change in sleepiness score (ESS)

Secondary Outcome Measures:
  • Difference between treatment groups with regard to change in reaction time testing.
  • Difference between treatment groups with regard to change in total reflux symptom scores.
  • Difference between treatment groups with regard to change in sleep related QOL (FOSQ).

Estimated Enrollment: 68
Study Start Date: August 2004
Estimated Study Completion Date: August 2006
Detailed Description:

Half of the patients enrolled in the study will begin the study taking Pantoprazole. The other half will begin the study taking a placebo (sugar pill). There is an equal chance of being placed in either group.

After two weeks, the patients will stop taking their first batch of medication to allow it to completely leave their bodies. Then the patients will begin taking the other medication so that by the end of the study, each patient will have been treated with pantoprazole for two weeks and placebo for two weeks.

At the end of each two weeks, patients will be asked to complete questionnaires regarding their daytime sleepiness and reflux symptoms. Patients will also complete reaction time testing as a measure of daytime sleepiness.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18 or older
  • Daytime sleepiness (ESS >= 8)
  • Mild to moderate OSD (AHI<=30)
  • Symptoms of GERD
  • Symptoms of acid reflux

Exclusion Criteria:

  • Pregnant or trying to become pregnant
  • Depression or unstable psychiatric disorder
  • Allergy to Pantoprazole
  • Taking a proton pump inhibitor within the last month
  • Taking a histamine-2 receptor blocker within the last month
  • Automobile or industrial accident due to daytime sleepiness
  • Currently taking ketoconazole, itraconazole, ampicillin or iron salts
  • Hypersecretory acid disorder (Zollinger-Ellison Syndrome)
  • Active peptic ulcer disease
  • Severe concomitant disease of another major body system
  • Malignancy in the past 5 years
  • Current abuse of alcohol, medication or drugs
  • Sedative medications
  • Additional treatment for obstructive sleep apnea (i.e. CPAP or surgery)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00307944

Locations
United States, Ohio
University Ear, Nose and Throat Specialists
Cincinnati, Ohio, United States, 45267-0528
Sponsors and Collaborators
University of Cincinnati
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Principal Investigator: David L Steward, MD University Ear, Nose and Throat Specialists
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00307944     History of Changes
Other Study ID Numbers: 04-06-24-04
Study First Received: March 27, 2006
Last Updated: December 10, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Cincinnati:
Acid Reflux
Obstructive Sleep Apnea
Daytime Sleepiness

Additional relevant MeSH terms:
Apnea
Gastroesophageal Reflux
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Pantoprazole
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 29, 2014