Nortriptyline for Idiopathic Gastroparesis

Completed · Phase 3 · Has a placebo group

Conditions studied: Idiopathic Gastroparesis

In brief

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

Key facts

Study ID

NCT00765895

Run by

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

People needed

130

Starts

2009-01-01

Expected to finish

2012-10-01

Last updated by the study team

2020-05-14

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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:
• hypersensitivity or allergy to any tricyclic antidepressant drug
• concomitant therapy with a monoamine oxidase inhibitor (MAOI)
• recent myocardial infarction
• 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

Where it is running

• California Pacific Medical Center — San Francisco, California, United States
• Stanford University — Stanford, California, United States
• University of Michigan Medical Center — Ann Arbor, Michigan, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
• Temple University Hospital — Philadelphia, Pennsylvania, United States
• Texas Tech University Health Sciences Center — El Paso, Texas, United States

Full record on ClinicalTrials.gov

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