Nortriptyline for Idiopathic Gastroparesis



Status:Completed
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:Any
Updated:9/23/2012
Start Date:January 2009
End Date:August 2012
Contact:James Tonascia, PhD
Email:jtonasci@jhsph.edu
Phone:410-955-3704

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Nortriptyline for Idiopathic Gastroparesis: A Multicenter, Randomized, Double-Masked, Placebo-Controlled Trial (NORIG)


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


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
We found this trial at
7
sites
45 Castro Street
San Francisco, California 94114
(415) 600-6000
California Pacific Medical Center California Pacific Medical Center is one of the largest private, not-for-profit,...
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San Francisco, CA
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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Jackson, MS
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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
University of Michigan Health System The University of Michigan is home to one of the...
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Odessa, TX
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3401 N Broad St
Philadelphia, Pennsylvania
(215) 707-2000
Temple University Hospital On January 18, 1892 a three-story house at 3403 North Broad Street...
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Philadelphia, PA
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450 Serra Mall
Stanford, California 94305
(650) 723-2300
Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
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Stanford, CA
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1 Medical Center Blvd
Winston-Salem, North Carolina 27157
336-716-2011
Wake Forest University Health Sciences Welcome to Wake Forest Baptist Medical Center, a fully integrated...
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Winston-Salem, NC
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