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