Acid Reflux DiseasePhase 4NCT00307944
Study of Pantoprazole for Sleepiness Associated With Acid Reflux and Sleep Apnea
A Phase 4 study testing Pantoprazole in people with Acid Reflux Disease and Obstructive Sleep Apnea, run by University of Cincinnati at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acid Reflux Disease, Obstructive Sleep Apnea
- What is being tested?
- Pantoprazole
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2004to Aug 2006
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 or older
- Daytime sleepiness (ESS >= 8)
- Mild to moderate OSD (AHI<=30)
- Symptoms of GERD
- Symptoms of acid reflux
Who cannot join
- 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
Show all 14Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University Ear, Nose and Throat Specialists
Cincinnati, Ohio, 45267-0528
About this study
Official title: 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).
Read the 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.
- Conditions
- Acid Reflux Disease, Obstructive Sleep Apnea
- Being tested
- Pantoprazole
- Keywords
- Acid Reflux, Obstructive Sleep Apnea, Daytime Sleepiness
- Medical subject headings
- Gastroesophageal Reflux, Sleep Apnea, Obstructive, Disorders of Excessive Somnolence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PantoprazoleDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between treatment groups with regard to change in sleepiness score (ESS)
Secondary outcomes (3)
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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2006 (estimated)
- Study startAug 2004
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acid Reflux DiseaseStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe sponsor's other registered studies.
- 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
- Double blind
- Enrolment
- 68 participants
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer
- Investigators
- David L Steward, MD, Principal investigator, University Ear, Nose and Throat Specialists
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00307944
- Sponsor's protocol ID
- 04-06-24-04
- Status last verified
- Dec 2007
- First submitted
- 27 Mar 2006
- Last updated
- 12 Dec 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Placebo-Controlled Trial of Pantoprazole for Sleepiness Associated With Acid Reflux and Obstructive Sleep Disordered Breathing
- ClinicalTrials.gov ID
- NCT00307944
- Acronym / sponsor ID
- 04-06-24-04
- Conditions
- Acid Reflux Disease, Obstructive Sleep Apnea
- Keywords
- Acid Reflux, Obstructive Sleep Apnea, Daytime Sleepiness
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer
- Study start
- Aug 2004
- Study completion
- Aug 2006
- First posted
- 28 Mar 2006 (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 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).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 or older
- Daytime sleepiness (ESS >= 8)
- Mild to moderate OSD (AHI<=30)
- Symptoms of GERD
- Symptoms of acid reflux
Key exclusion criteria (14 listed)
- 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
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 |
|---|---|---|
| Pantoprazole | Drug | – |
Primary outcome
Difference between treatment groups with regard to change in sleepiness score (ESS)
3 secondary outcomes
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).
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 12 Dec 2007.
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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.
David L Steward, MD principal investigator
University Ear, Nose and Throat Specialists
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pantoprazole in people with Acid Reflux Disease and Obstructive Sleep Apnea, run by University of Cincinnati at 1 site in United States.
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 5 inclusion and 14 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 12 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Difference between treatment groups with regard to change in sleepiness score (ESS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Dec 2007.