Expired Study
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Stanford, California 94305


Purpose:

The principal objective of this multicenter, randomized, placebo-controlled trial is to evaluate whether treatment with nortriptyline will improve gastroparesis symptoms compared with placebo.


Criteria:

Inclusion Criteria: - Age 21 through 65 years old at registration - Documentation of delayed gastric emptying on gastric emptying scintigraphy within 2 years of registration, defined as greater than 60% retention at 2 hours or greater than 10% retention at 4 hours - Symptoms of gastroparesis for at least 6 months (does not have to be contiguous) prior to registration with Gastroparesis Cardinal Symptom Index (GCSI) score of 21 or greater - Negative upper endoscopy or upper GI series within 2 years of registration Exclusion Criteria: - Normal gastric emptying confirmed with scintigraphy - Diabetic gastroparesis or post-surgical gastroparesis including fundoplication - Another active disorder which could explain symptoms in the opinion of the investigator - History of significant cardiac arrhythmias and/or prolonged QTc - History of seizures - Use of narcotics more than 3 days per week - Use of tricyclic antidepressants for refractory symptoms of gastroparesis within 6 weeks prior to randomization - Use of strongly anticholinergic medications - Use of calcium channel blockers - Use of erythromycin - Clear history of failed trial of nortriptyline use for gastroparetic symptoms - Symptoms of primary depression or suicidal ideation - Contraindications to nortriptyline: 1. hypersensitivity or allergy to any tricyclic antidepressant drug 2. concomitant therapy with a monoamine oxidase inhibitor (MAOI) 3. recent myocardial infarction 4. glaucoma - Pregnancy or nursing - Any other condition, which in the opinion of the investigator would impede compliance or hinder completion of the study - Use of a G tube, J tube,or a central catheter for nutrition - Use of a gastric electrical stimulator - Failure to give informed consent


NCT ID:

NCT00765895


Primary Contact:

Study Director
Frank Hamilton, MD, MPH
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)


Backup Contact:

N/A


Location Contact:

Stanford, California 94305
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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