Overview

Nortriptyline for Idiopathic Gastroparesis

Status:
Completed
Trial end date:
2012-10-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Treatments:
Nortriptyline
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