Status:
COMPLETED
Nortriptyline for Idiopathic Gastroparesis
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Idiopathic Gastroparesis
Eligibility:
All Genders
21-65 years
Phase:
PHASE3
Brief Summary
The principal objective of this multicenter, randomized, placebo-controlled trial is to evaluate whether treatment with nortriptyline will improve gastroparesis symptoms compared with placebo.
Eligibility Criteria
Inclusion
- 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
- 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:
- hypersensitivity or allergy to any tricyclic antidepressant drug
- concomitant therapy with a monoamine oxidase inhibitor (MAOI)
- recent myocardial infarction
- 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
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT00765895
Start Date
January 1 2009
End Date
October 1 2012
Last Update
May 14 2020
Active Locations (7)
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1
California Pacific Medical Center
San Francisco, California, United States, 94115
2
Stanford University
Stanford, California, United States, 94305-5187
3
University of Michigan Medical Center
Ann Arbor, Michigan, United States, 48109
4
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216