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
California Pacific Medical Center California Pacific Medical Center is one of the largest private, not-for-profit,...
Click here to add this to my saved trials
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
Click here to add this to my saved trials
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...
Click here to add this to my saved trials
Click here to add this to my saved trials
Temple University Hospital On January 18, 1892 a three-story house at 3403 North Broad Street...
Click here to add this to my saved trials
Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
Click here to add this to my saved trials
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...
Click here to add this to my saved trials