Gastroesophageal Reflux DiseasePhase 2/3NCT00674245
Effect of Pantoprazole 40mg Daily vs Placebo on Power Spectral Analysis of the Sleep EEG of Patients With GERD.
A Phase 2/3 study testing Pantoprazole in people with Gastroesophageal Reflux Disease, run by Southern Arizona VA Health Care System at 1 site in United States.
Trial summary
The purpose of this research study is to determine if treatment with pantoprazole 40 mg daily versus a placebo improves sleep quality in patients with gastroesophageal reflux disease (GERD). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastroesophageal Reflux Disease
- What is being tested?
- Pantoprazole
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Jul 2010
- Phase
- Phase 2/3
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 to 80 yrs of age
- 2 to 3 episodes of GERD/week
- erosive esophagitis or abnormal 24 hr pH
- able to read and understand, complete questionnaires
Who cannot join
- barrett's esophagus or peptic stricture on endoscopy
- normal EGD and normal 24 hour pH
- previous upper GI surgery
- comorbidity (cardiovascular, respiratory, renal, hepatic)
- use of narcotics or pain medication on regular basis
- insomnia, shift work sleep disorder, sleep apnea, restless leg syndrome
- diabetes, scleroderma or neuromuscular disorders
Trial locations and contacts
1 site in 1 country.
United States1 site
Southern Arizona VA Health Care System
Tucson, Arizona, 85723
About this study
Official title: The Effect Of Pantoprazole 40 mg Once Daily Versus Placebo On The Power Spectral Analysis Of The Sleep Electroencephalogram (EEG) Of Patients With Gastroesophageal Reflux Disease (GERD)
The purpose of this research study is to determine if treatment with pantoprazole 40 mg daily versus a placebo improves sleep quality in patients with gastroesophageal reflux disease (GERD). Another purpose is to determine if treatment with pantoprazole 40 mg once daily versus a placebo improves sleep outcomes in patients with gastroesophageal reflux disease using spectral analysis of sleep electroencephalogram (EEG).
Read the detailed description
It appears that the presence of intraesophageal stimuli alone may not be sufficient to elicit symptoms of heartburn. Most acid reflux events (>80%-90%) do not reach conscious level and thus are not perceived.[3] It is yet to be determined what factors enhance our perception of esophageal stimuli and may help to elevate them to the conscious level. In recent years, central and peripheral factors that may enhance our perception of intraesophageal stimuli have been evaluated. Intraduodenal fat infusion was shown to enhance perception of intraesophageal acid in patients with GERD.[4] This study suggested that fat is an important modulator of postprandial GERD symptoms. Central factors, such as stress and psychological comorbidity, also appear to have an important role in symptom generation in patients with GERD, regardless if esophageal inflammation is present or absent.[5-8] Thus, by modulating brain-gut interactions, perception of pathological and probably physiological events in the esophagus of patients with GERD may be altered.
Poor sleep is a central factor that may enhance perception of intraesophageal stimuli and thus elevate them to the conscious level. Several studies have demonstrated that patients with fibromyalgia or irritable bowel syndrome report increased symptoms due to sleep abnormalities.[9, 10] Similar reports in patients with GERD are not available. A subset of patients with GERD experience nocturnal heartburn that may awaken them during the night. In others, despite lack of nocturnal symptoms, sleep abnormalities may occur due to acid reflux events. In both cases, GERD leads to poor sleep, and that in turn may enhance perception of intraesophageal stimuli, leading to reports of increased frequency and severity of perceived GERD symptoms. Thus, poor sleep may be a crucial factor in symptom generation and exacerbation of patients with GERD.
Recently, we have used a novel technique, power spectral analysis of the sleep electroencephalogram (EEG), to assess patients with heartburn and erosive esophagitis and those with heartburn but without erosive esophagitis.[11] We were able to show that among heartburn patients with GERD, EEG spectral power during sleep is shifted towards higher frequencies as compared to heartburn patients without GERD despite similar sleep architecture.
Several recent therapeutic trials in GERD patients have failed to demonstrate improvement in polysomnographic studies despite improvement in GERD-related symptoms and subjective reports of sleep quality.[12] Spectral analysis of the sleep EEG might be a more sensitive tool than polysomnographic study in assessing objective improvement of sleep in patients receiving antireflux treatment.
In summary, sleep disturbances in patients with GERD are poorly recognized and rarely elicited during clinic visits despite their significant impact on patients' quality of life and probably perception of disease severity. Several studies have demonstrated improvement of subjective reports of sleep quality in patients with GERD receiving antireflux treatment. However, the effect of potent antireflux therapy on objective sleep parameters has yet to be demonstrated.
- Conditions
- Gastroesophageal Reflux Disease
- Being tested
- Pantoprazole, placebo
- Keywords
- heartburn, acid reflux, GERD, spectrum analysis, electroencephalogram, esophagitis, peptic
- Medical subject headings
- Gastroesophageal Reflux, Heartburn, Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PantoprazoleDrug
Also called Protonix, PPI
40 mg once daily for 4 weeks
PantoprazoleDrug
Also called Protonix, PPI
40 mg once daily improves sleep quality in patients with GERD.
placeboDrug
Also called sugar pill
40 mg once daily for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Pantoprazole | Active comparator | 40 mg once daily for four weeks improves sleep quality in patients with GERD Receives: Drug: Pantoprazole |
| placebo | Placebo comparator | To determine if treatment with pantoprazole 40 mg once daily vs placebo improves sleep outcome in patients with GERD. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom control after 4 weeks of treatment.
To determine if treatment with pantoprazole 40 mg daily vs placebo improves sleep quality in patients with GERD.
Measured: April 2008 to July 2010
Secondary outcomes (1)
Effect of Pantoprazole 40 mg Daily vs Placebo on the Power Spectral Analysis of the Sleep Electroencephalogram of Patients With GERD.
To determine if treatment with pantoprazole 40 mg once daily vs placebo improves sleep outcome in patients with GERD using spectral analysis of sleep electroencephalogram.
Measured: April 2008-July 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2008 (estimated)
- Study startApr 2008
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal Reflux DiseaseStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southern Arizona VA Health Care System
- Sponsor type
- US federal agency
- Investigators
- Ronnie Fass, MD, Principal investigator, Southern VA Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00674245
- Sponsor's protocol ID
- 08-0001-01 & R&D#00-77
- Status last verified
- Aug 2010
- First submitted
- 5 May 2008
- Last updated
- 19 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Fass R, Fullerton S, Tung S, Mayer EA. Sleep disturbances in clinic patients with functional bowel disorders. Am J Gastroenterol. 2000 May;95(5):1195-2000. doi: 10.1111/j.1572-0241.2000.02009.x.
PubMed 10811327Wiklund IK, Junghard O, Grace E, Talley NJ, Kamm M, Veldhuyzen van Zanten S, Pare P, Chiba N, Leddin DS, Bigard MA, Colin R, Schoenfeld P. Quality of Life in Reflux and Dyspepsia patients. Psychometric documentation of a new disease-specific questionnaire (QOLRAD). Eur J Surg Suppl. 1998;(583):41-9.
PubMed 10027672Orr WC, Goodrich S, Robert J. The effect of acid suppression on sleep patterns and sleep-related gastro-oesophageal reflux. Aliment Pharmacol Ther. 2005 Jan 15;21(2):103-8. doi: 10.1111/j.1365-2036.2005.02310.x.
PubMed 15679759Locke GR 3rd, Talley NJ, Fett SL, Zinsmeister AR, Melton LJ 3rd. Prevalence and clinical spectrum of gastroesophageal reflux: a population-based study in Olmsted County, Minnesota. Gastroenterology. 1997 May;112(5):1448-56. doi: 10.1016/s0016-5085(97)70025-8.
PubMed 9136821Netzer NC, Stoohs RA, Netzer CM, Clark K, Strohl KP. Using the Berlin Questionnaire to identify patients at risk for the sleep apnea syndrome. Ann Intern Med. 1999 Oct 5;131(7):485-91. doi: 10.7326/0003-4819-131-7-199910050-00002.
PubMed 10507956Goldsmith G, Levin JS. Effect of sleep quality on symptoms of irritable bowel syndrome. Dig Dis Sci. 1993 Oct;38(10):1809-14. doi: 10.1007/BF01296103.
PubMed 8404401
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Pantoprazole 40 mg Once Daily Versus Placebo On The Power Spectral Analysis Of The Sleep Electroencephalogram (EEG) Of Patients With Gastroesophageal Reflux Disease (GERD)
- ClinicalTrials.gov ID
- NCT00674245
- Acronym / sponsor ID
- 08-0001-01 & R&D#00-77
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- heartburn, acid reflux, GERD, spectrum analysis, electroencephalogram, esophagitis, peptic
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Southern Arizona VA Health Care SystemUS federal agency
- Study start
- Apr 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 7 May 2008 (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 research study is to determine if treatment with pantoprazole 40 mg daily versus a placebo improves sleep quality in patients with gastroesophageal reflux disease (GERD). Another purpose is to determine if treatment with pantoprazole 40 mg once daily versus a placebo improves sleep outcomes in patients with gastroesophageal reflux disease using spectral analysis of sleep electroencephalogram (EEG).
Detailed description
It appears that the presence of intraesophageal stimuli alone may not be sufficient to elicit symptoms of heartburn. Most acid reflux events (>80%-90%) do not reach conscious level and thus are not perceived.[3] It is yet to be determined what factors enhance our perception of esophageal stimuli and may help to elevate them to the conscious level. In recent years, central and peripheral factors that may enhance our perception of intraesophageal stimuli have been evaluated. Intraduodenal fat infusion was shown to enhance perception of intraesophageal acid in patients with GERD.[4] This study suggested that fat is an important modulator of postprandial GERD symptoms. Central factors, such as stress and psychological comorbidity, also appear to have an important role in symptom generation in patients with GERD, regardless if esophageal inflammation is present or absent.[5-8] Thus, by modulating brain-gut interactions, perception of pathological and probably physiological events in the esophagus of patients with GERD may be altered.
Poor sleep is a central factor that may enhance perception of intraesophageal stimuli and thus elevate them to the conscious level. Several studies have demonstrated that patients with fibromyalgia or irritable bowel syndrome report increased symptoms due to sleep abnormalities.[9, 10] Similar reports in patients with GERD are not available. A subset of patients with GERD experience nocturnal heartburn that may awaken them during the night. In others, despite lack of nocturnal symptoms, sleep abnormalities may occur due to acid reflux events. In both cases, GERD leads to poor sleep, and that in turn may enhance perception of intraesophageal stimuli, leading to reports of increased frequency and severity of perceived GERD symptoms. Thus, poor sleep may be a crucial factor in symptom generation and exacerbation of patients with GERD.
Recently, we have used a novel technique, power spectral analysis of the sleep electroencephalogram (EEG), to assess patients with heartburn and erosive esophagitis and those with heartburn but without erosive esophagitis.[11] We were able to show that among heartburn patients with GERD, EEG spectral power during sleep is shifted towards higher frequencies as compared to heartburn patients without GERD despite similar sleep architecture.
Several recent therapeutic trials in GERD patients have failed to demonstrate improvement in polysomnographic studies despite improvement in GERD-related symptoms and subjective reports of sleep quality.[12] Spectral analysis of the sleep EEG might be a more sensitive tool than polysomnographic study in assessing objective improvement of sleep in patients receiving antireflux treatment.
In summary, sleep disturbances in patients with GERD are poorly recognized and rarely elicited during clinic visits despite their significant impact on patients' quality of life and probably perception of disease severity. Several studies have demonstrated improvement of subjective reports of sleep quality in patients with GERD receiving antireflux treatment. However, the effect of potent antireflux therapy on objective sleep parameters has yet to be demonstrated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pantoprazole | Active comparator | Drug: Pantoprazole40 mg once daily for four weeks improves sleep quality in patients with GERD |
| placebo | Placebo comparator | Drug: placeboTo determine if treatment with pantoprazole 40 mg once daily vs placebo improves sleep outcome in patients with GERD. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 to 80 yrs of age
- 2 to 3 episodes of GERD/week
- erosive esophagitis or abnormal 24 hr pH
- able to read and understand, complete questionnaires
Key exclusion criteria (7 listed)
- barrett's esophagus or peptic stricture on endoscopy
- normal EGD and normal 24 hour pH
- previous upper GI surgery
- comorbidity (cardiovascular, respiratory, renal, hepatic)
- use of narcotics or pain medication on regular basis
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 |
|---|---|---|
| PantoprazoleAlso: Protonix, PPI40 mg once daily for 4 weeks | Drug | Pantoprazole |
| PantoprazoleAlso: Protonix, PPI40 mg once daily improves sleep quality in patients with GERD. | Drug | Pantoprazole |
| placeboAlso: sugar pill40 mg once daily for 4 weeks | Drug | placebo |
Primary outcome
Symptom control after 4 weeks of treatment.
Time frame: April 2008 to July 2010
To determine if treatment with pantoprazole 40 mg daily vs placebo improves sleep quality in patients with GERD.
1 secondary outcome
Effect of Pantoprazole 40 mg Daily vs Placebo on the Power Spectral Analysis of the Sleep Electroencephalogram of Patients With GERD.
Time frame: April 2008-July 2010
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 19 Aug 2010.
- Background: PubMed 10811327Fass R, Fullerton S, Tung S, Mayer EA. Sleep disturbances in clinic patients with functional bowel disorders. Am J Gastroenterol. 2000 May;95(5):1195-2000. doi: 10.1111/j.1572-0241.2000.02009.x.
- Background: PubMed 10027672Wiklund IK, Junghard O, Grace E, Talley NJ, Kamm M, Veldhuyzen van Zanten S, Pare P, Chiba N, Leddin DS, Bigard MA, Colin R, Schoenfeld P. Quality of Life in Reflux and Dyspepsia patients. Psychometric documentation of a new disease-specific questionnaire (QOLRAD). Eur J Surg Suppl. 1998;(583):41-9.
- Background: PubMed 15679759Orr WC, Goodrich S, Robert J. The effect of acid suppression on sleep patterns and sleep-related gastro-oesophageal reflux. Aliment Pharmacol Ther. 2005 Jan 15;21(2):103-8. doi: 10.1111/j.1365-2036.2005.02310.x.
- Background: PubMed 9136821Locke GR 3rd, Talley NJ, Fett SL, Zinsmeister AR, Melton LJ 3rd. Prevalence and clinical spectrum of gastroesophageal reflux: a population-based study in Olmsted County, Minnesota. Gastroenterology. 1997 May;112(5):1448-56. doi: 10.1016/s0016-5085(97)70025-8.
- Background: PubMed 10507956Netzer NC, Stoohs RA, Netzer CM, Clark K, Strohl KP. Using the Berlin Questionnaire to identify patients at risk for the sleep apnea syndrome. Ann Intern Med. 1999 Oct 5;131(7):485-91. doi: 10.7326/0003-4819-131-7-199910050-00002.
- Background: PubMed 8404401Goldsmith G, Levin JS. Effect of sleep quality on symptoms of irritable bowel syndrome. Dig Dis Sci. 1993 Oct;38(10):1809-14. doi: 10.1007/BF01296103.
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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.
Ronnie Fass, MD principal investigator
Southern VA Health Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Pantoprazole in people with Gastroesophageal Reflux Disease, run by Southern Arizona VA Health Care System 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 4 inclusion and 7 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 19 Aug 2010. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Symptom control after 4 weeks of treatment. (time frame: April 2008 to July 2010). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00674245, which also lists 6 linked publications.
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 19 Aug 2010.