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 |
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
1 Medical Center Blvd
Winston-Salem, North Carolina 27157
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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University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
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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Temple University Hospital On January 18, 1892 a three-story house at 3403 North Broad Street...
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California Pacific Medical Center California Pacific Medical Center is one of the largest private, not-for-profit,...
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Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
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