Nortriptyline for Idiopathic Gastroparesis

Phase 3

Completed

Interventions: Drug: Nortriptyline Hydrochloride
Drug: Placebo (for nortriptyline)

Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Nortriptyline	Nortriptyline Hydrochloride	Nortriptyline Hydrochloride dose escalation from 10 mg to 75 mg
Placebo (for nortriptyline)	Placebo (for nortriptyline)	No treatment

Primary Outcome Measures

Name	Time	Method
Decrease From the Baseline GCSI of at Least 50% on Any Two Consecutive Follow-up Visits	at end of treatment, 15 weeks from baseline assessment	A decrease from the baseline Gastroparesis Cardinal Symptom Index (GCSI) score (sum of the 9 individual symptom scores) of at least 50% on any two consecutive follow-up visits during the 15 week treatment period with maximum tolerated study drug dose. The total score ranges from 0-45 with higher scores indicating greater symptom severity.

Secondary Outcome Measures

Name	Time	Method

Locations (7): 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
California Pacific Medical Center
🇺🇸San Francisco, California, United States