- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03020550
Correlates of GERD Symptom Severity
Physiologic and Behavioral Correlates of GERD Symptom Severity
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02114
- Massachusetts General Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Adults ages 21-70 years old
- Heartburn symptoms 3 or more days per week with an average daily symptom severity of 3 or more on a 7 day baseline symptom diary
- English language proficiency
- Willingness to be videotaped and connected to physiologic monitoring devices during the visit
Exclusion Criteria:
- Diagnosis of Crohn's disease, systemic sclerosis, known active ulcer disease, gastric cancer, or untreated/active Barrett's esophagitis based on subject self-report and/or medical record review
- Heavy alcohol use (> 6 drinks/week for women and > 13 drinks/week for men)
- Pregnant women.
- Dementia or significant memory difficulties
- Severe, unstable psychiatric disease
- Greater than 15 doses of nonsteroidal anti-inflammatory drugs (NSAIDS) within the prior 30 days (aspirin ≤ 325 mg daily permitted) or ongoing NSAID use at a level deemed likely to interfere with the study
- Failure to complete the baseline symptom diary for at least 6 of 7 days
- Change in GERD treatment regimen within the last 2 weeks (subjects may use antacids, H2 receptor blockers, and/or proton pump inhibitors as long as they are symptomatic on a stable regimen)
- Allergy to adhesives
- Inability to provide informed consent
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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GERD Patients
Subjects with active GERD symptoms.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Association of Change in Patient's GSR From Beginning to End of Study Visit With GERD Symptom Severity 2 Weeks Later
Tidsramme: Beginning to end of study visit (1 hour or less for change in GSR)
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Galvanic skin response (GSR) was measured with a device from ADInstruments during the baseline study visit.
Values ranged from 0.93 - 12 micro-Siemens (μS).
Change in GSR was calculated as mean value of GSR for the first 2 minutes of the study visit minus mean value of GSR for the last 2 minutes of the study visit.
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Beginning to end of study visit (1 hour or less for change in GSR)
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Association of Change in Patient's High Frequency HRV From Beginning to End of Study Visit With GERD Symptom Severity 2 Weeks Later
Tidsramme: Beginning to end of study visit (1 hour or less for change in HRV/RMSSD)
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Heart rate variability (HRV) was measured using a device from ADInstruments gathering data at 256 Hz.
We used the RMSSD (Root Mean Square of the Successive Differences) value as a proxy for high frequency HRV.
Measured values ranged from 0 - 150 msec.
Change in high frequency HRV was calculated as the RMSSD value for the first 5 minutes of the study visit minus the RMSSD value for the last 5 minutes of the study visit.
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Beginning to end of study visit (1 hour or less for change in HRV/RMSSD)
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Correlation Between Concordance in GSR Between Patient and Physician During the Study Visit and Percent Change in Patients' GERD Symptoms Over 2 Weeks
Tidsramme: Beginning to end of study visit (1 hour or less for concordance between patient and physician GSR)
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Concordance in galvanic skin response (GSR) between patient and physician was calculated using an established approach (Marci CD, 2007; PMID 17299296) to create a single index value for the visit.
The natural logarithm of this value was taken to reduce skew.
A value greater than 0 means more than 50% concordance in the data, a value less than zero means less than 50% concordance in the data.
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Beginning to end of study visit (1 hour or less for concordance between patient and physician GSR)
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Post GERD Symptom Severity
Tidsramme: 2 weeks (baseline and 2 week follow-up)
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GERD symptom severity at follow-up was assessed by self-report on a 7-day symptom diary (symptoms collected days 8-14 after the study visit).
Possible daily scores ranged from 0-12 with higher scores indicating more severe symptoms (sum of daytime heartburn, nighttime heartburn, and acid regurgitation symptoms each rated 0-4 in severity [none, mild, moderate, severe, very severe]).
Daily scores across the 7 days were averaged to create the Post GERD symptom severity score.
Adapted from: Miner P, et.
al. Am J Gastroenterol. 2002.
PMID: 12094846.
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2 weeks (baseline and 2 week follow-up)
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Percent Change in Patient's GERD Symptoms
Tidsramme: 2 weeks (baseline and 2 week follow-up)
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Percent change in patient's GERD symptoms was calculated as: (post GERD symptom severity - baseline GERD symptom severity) / baseline GERD symptom severity*100. GERD symptom severity scores were averaged across 7 day baseline and follow-up periods from a symptom diary (adapted from Miner P, 2002; PMID 12094846). Scores ranged from 0-12 with higher scores indicating more severe symptoms (sum of daytime heartburn, nighttime heartburn, and acid regurgitation each rated 0-4 in severity [none, mild, moderate, severe, very severe]). |
2 weeks (baseline and 2 week follow-up)
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Michelle Dossett, MD, PHD, MPH, Massachusetts General Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2016P001628
- 1K23AT009218 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
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