GERDNCT01079884
Gastroesophageal Reflux Disease (GERD)/Nighttime Heartburn and Driving Performance
A study testing esomeprazole 40 mg in people with GERD, run by David A. Johnson, MD at 1 site in United States.
Trial summary
The implications of sleep as it relates to the physiology and pathogenesis of a number of diseases has until recently been ignored. With the evolution of sleep laboratories, there is an emerging recognition of the relationship between sleep and various gastrointestinal diseases- in particular gastroesophageal reflux… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- GERD
- What is being tested?
- esomeprazole 40 mg
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Mar 2011
- Phase
- Interventional
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18-60
- Diagnosis of GERD
- Nighttime heartburn
Who cannot join
- Less than 18 years old or older than 60 years of age
- Any conditions other than GERD that could be the primary cause of or a factor in your sleep disturbance. These include but are not limited to: severe anxiety, severe depression, panic attacks, sleep apnea, blocked airways, chronic pulmonary disease requiring oxygen therapy
- Restless leg syndrome
- Excessive need for nighttime urination (more than 2 times per night)
- Insomnia
- Excessive caffeine use (more than 4 standard 8-oz cups of coffee or caffeinated beverages, or 2 12-oz caffeinated sodas per day) or within 3 hours of sleep time
Show all 20Show fewer
- Buerger's disease
- Use of a proton pump inhibitor
- Active gastrointestinal bleeding
- Severe, unresolved or unstable illnesses that the investigator feels would interfere with your participation in the study
- Severe liver disease
- Chronic illness that may cause excessive fatigue or low energy level such as chronic fatigue syndrome, or uncontrolled thyroid disease
- Need for anticoagulation therapy such as warfarin
- Active chemo or radiation therapy for cancer
- Prior gastric by-pass surgery
- History of seizures and/or anti-seizure medications (such as phenytoin or mephenytoin)
- Known hypersensitivity to esomeprazole or antacid tablets such as Tums, or Rolaids
- A history of drug addiction or alcohol abuse within the previous year
- Pregnant or lactating
- HIV+ status
Trial locations and contacts
1 site in 1 country.
United States1 site
Digestive and Liver Disease Specialists
Norfolk, Virginia, 23502
About this study
Official title: Gastroesophageal Reflux Disease, Sleep, and the Relationship to Driving Simulator Performance
The implications of sleep as it relates to the physiology and pathogenesis of a number of diseases has until recently been ignored. With the evolution of sleep laboratories, there is an emerging recognition of the relationship between sleep and various gastrointestinal diseases- in particular gastroesophageal reflux disease (GERD).( 1-5) It seems intuitive that waking/daytime activities or events may affect sleep and that any consequent sleep dysfunction may reciprocally further affect daytime function
Read the detailed description
The implications of sleep as it relates to the physiology and pathogenesis of a number of diseases has until recently been ignored. With the evolution of sleep laboratories, there is an emerging recognition of the relationship between sleep and various gastrointestinal diseases in particular gastroesophageal reflux disease (GERD). Twenty five (25) patients meeting entry criteria will be compared with 25 matching historical control patients who do not have GERD symptoms or sleep disturbance. Patients will record heartburn symptoms and GERD-associated sleep disturbances on a diary card. These patients will be evaluated for baseline functionality GERD symptom scores, PSQI, driving simulator, bed partner questionnaire (optional) and receive 40 mg daily of Nexium® for 4 weeks. Primary outcome variable driving simulator performance will be the relief of nighttime heartburn during the last 7 days of the trial as recorded by the patient on a diary card. Secondary outcome variables include change from baseline to week 4 in the PSQI score, percentage of patients with complete resolution of sleep disturbances, relief of sleep disturbances, and percentage of days without GERD-associated sleep disturbances. Assessment of patients with complete resolution of daytime, night times, and 24-hour heartburn symptoms, and the percentage of patients with relief of daytime and 24-hour heartburn symptoms. The driving simulator performance will be compared at baseline and after 4 weeks of therapy with Nexium®. Also, where available, the bed partner PSQI will be compared at baseline and following treatment of the primary patient with Nexium® for 4 weeks.
- Conditions
- GERD
- Being tested
- esomeprazole 40 mg
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
esomeprazole 40 mgDrug
Also called Nexium
40 mg daily for 4 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
Driving impairment effects measured by the driving simulator (variance of 1.5 feet is abnormal).
All parameters will be assessed by both per protocol and intention to treat assessments.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2010 (estimated)
- Study startJul 2008
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GERDStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- David A. Johnson, MD
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor-investigator, David A. Johnson, MD, Digestive & Liver Disease Specialists
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01079884
- Sponsor's protocol ID
- IRUSESOM0438
- Other IDs
- 08-03-FB-0036
- Status last verified
- Feb 2012
- First submitted
- 2 Mar 2010
- Last updated
- 22 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastroesophageal Reflux Disease, Sleep, and the Relationship to Driving Simulator Performance
- ClinicalTrials.gov ID
- NCT01079884
- Acronym / sponsor ID
- IRUSESOM0438
- Conditions
- GERD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- David A. Johnson, MDUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Jul 2008
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 3 Mar 2010 (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 implications of sleep as it relates to the physiology and pathogenesis of a number of diseases has until recently been ignored. With the evolution of sleep laboratories, there is an emerging recognition of the relationship between sleep and various gastrointestinal diseases- in particular gastroesophageal reflux disease (GERD).( 1-5) It seems intuitive that waking/daytime activities or events may affect sleep and that any consequent sleep dysfunction may reciprocally further affect daytime function
Detailed description
The implications of sleep as it relates to the physiology and pathogenesis of a number of diseases has until recently been ignored. With the evolution of sleep laboratories, there is an emerging recognition of the relationship between sleep and various gastrointestinal diseases in particular gastroesophageal reflux disease (GERD). Twenty five (25) patients meeting entry criteria will be compared with 25 matching historical control patients who do not have GERD symptoms or sleep disturbance. Patients will record heartburn symptoms and GERD-associated sleep disturbances on a diary card. These patients will be evaluated for baseline functionality GERD symptom scores, PSQI, driving simulator, bed partner questionnaire (optional) and receive 40 mg daily of Nexium® for 4 weeks. Primary outcome variable driving simulator performance will be the relief of nighttime heartburn during the last 7 days of the trial as recorded by the patient on a diary card. Secondary outcome variables include change from baseline to week 4 in the PSQI score, percentage of patients with complete resolution of sleep disturbances, relief of sleep disturbances, and percentage of days without GERD-associated sleep disturbances. Assessment of patients with complete resolution of daytime, night times, and 24-hour heartburn symptoms, and the percentage of patients with relief of daytime and 24-hour heartburn symptoms. The driving simulator performance will be compared at baseline and after 4 weeks of therapy with Nexium®. Also, where available, the bed partner PSQI will be compared at baseline and following treatment of the primary patient with Nexium® for 4 weeks.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18-60
- Diagnosis of GERD
- Nighttime heartburn
Key exclusion criteria (20 listed)
- Less than 18 years old or older than 60 years of age
- Any conditions other than GERD that could be the primary cause of or a factor in your sleep disturbance. These include but are not limited to: severe anxiety, severe depression, panic attacks, sleep apnea, blocked airways, chronic pulmonary disease requiring oxygen therapy
- Restless leg syndrome
- Excessive need for nighttime urination (more than 2 times per night)
- Insomnia
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 |
|---|---|---|
| esomeprazole 40 mgAlso: Nexium40 mg daily for 4 weeks | Drug | – |
Primary outcome
Driving impairment effects measured by the driving simulator (variance of 1.5 feet is abnormal).
Time frame: 4 weeks
All parameters will be assessed by both per protocol and intention to treat assessments.
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 22 Feb 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing esomeprazole 40 mg in people with GERD, run by David A. Johnson, MD 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 3 inclusion and 20 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 22 Feb 2012. 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.
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?
Driving impairment effects measured by the driving simulator (variance of 1.5 feet is abnormal). (time frame: 4 weeks). 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 22 Feb 2012.