Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:00 PM
Ignite Modification Date:
2025-12-24 @ 2:00 PM
NCT ID:
NCT00765895
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
65 Years
Study:
NCT00765895
Study Brief:
Protocol Section:
NCT00765895