Study Results
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View full resultsBasic Information
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COMPLETED
NA
7 participants
INTERVENTIONAL
2020-11-05
2021-11-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Amitriptyline
Amitriptyline 10 mg daily
Amitriptyline
Amitriptyline tablet
Interventions
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Amitriptyline
Amitriptyline tablet
Eligibility Criteria
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Inclusion Criteria
* Functional heartburn (defined as \<4% of time with reflux on 24 hour pH manometry) 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
* Willingness to take amitriptyline daily for 8 weeks following study visit 1
Exclusion Criteria
* Heavy alcohol use (\> 6 drinks/week for women and \> 13 drinks/week for men) based on subject self-report
* Pregnant, attempting to become pregnant, or breast-feeding
* Dementia or significant memory difficulties as determined by the study team and medical record review
* Severe, unstable psychiatric disease based on subject self-report, study team determination, and/or medical record review
* Bipolar disorder, concurrent treatment with a SSRI or another antidepressant that interacts with tricyclic antidepressants
* Prolonged QTc or severe heart disease
* History of seizure disorder
* Severe liver impairment - e.g., cirrhosis, hepatocellular carcinoma, hepatitis
* Currently taking a tricyclic antidepressant, allergy to tricyclic antidepressants, or another medical contraindication to taking amitriptyline or related medications
* 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
* In the opinion of the investigator, unable to comply with the study protocol or has a condition that would likely interfere with the study
24 Years
64 Years
ALL
Yes
Sponsors
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National Center for Complementary and Integrative Health (NCCIH)
NIH
University of California, Davis
OTHER
Responsible Party
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Principal Investigators
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Michelle Dossett, MD, PhD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of California, Davis
Locations
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University of California Davis Medical Center
Sacramento, California, United States
Countries
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References
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Miner P Jr, Orr W, Filippone J, Jokubaitis L, Sloan S. Rabeprazole in nonerosive gastroesophageal reflux disease: a randomized placebo-controlled trial. Am J Gastroenterol. 2002 Jun;97(6):1332-9. doi: 10.1111/j.1572-0241.2002.05769.x.
Marci CD, Ham J, Moran E, Orr SP. Physiologic correlates of perceived therapist empathy and social-emotional process during psychotherapy. J Nerv Ment Dis. 2007 Feb;195(2):103-11. doi: 10.1097/01.nmd.0000253731.71025.fc.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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1485210
Identifier Type: -
Identifier Source: org_study_id
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