Nortriptyline for Idiopathic Gastroparesis (NORIG)

National Institutes of Health (NIH)

Status and phase

Completed

Phase 3

Conditions

Idiopathic Gastroparesis

Treatments

Drug: Placebo (for nortriptyline)

Drug: Nortriptyline Hydrochloride

Study type

Interventional

Funder types

NIH

Identifiers

NCT00765895

1U01DK073983 (U.S. NIH Grant/Contract)

1U01DK073985 (U.S. NIH Grant/Contract)

U01DK074008 NORIG

1U01DK074008 (U.S. NIH Grant/Contract)

1U01DK074007 (U.S. NIH Grant/Contract)

1U01DK073975 (U.S. NIH Grant/Contract)

1U01DK073974 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Enrollment

130 patients

Sex

All

Ages

21 to 65 years old

Volunteers

No Healthy Volunteers

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