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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
History of Changes

March 27, 2006
December 10, 2007
August 2004
Not Provided
Difference between treatment groups with regard to change in sleepiness score (ESS)
Same as current
Complete list of historical versions of study NCT00307944 on ClinicalTrials.gov Archive Site
  • 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).
Same as current
Not Provided
Not Provided
 
Study of Pantoprazole for Sleepiness Associated With Acid Reflux and Sleep Apnea
Randomized, Placebo-Controlled Trial of Pantoprazole for Sleepiness Associated With Acid Reflux and Obstructive Sleep Disordered Breathing

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).

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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Acid Reflux Disease
  • Obstructive Sleep Apnea
Drug: Pantoprazole
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
68
August 2006
Not Provided

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)
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00307944
04-06-24-04
Not Provided
Not Provided
University of Cincinnati
Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: David L Steward, MD University Ear, Nose and Throat Specialists
University of Cincinnati
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP