Nortriptyline for Idiopathic Gastroparesis

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)130 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

130

Conditions

Idiopathic Gastroparesis

Interventions

Nortriptyline HydrochlorideDRUG

Nortriptyline; 10 mg, one capsule, po qhs (by mouth at bedtime each night) x 3 weeks, f03 visit, 25 mg, one capsule, po qhs x 3 weeks, f06 visit, 50 mg, two capsules, po qhs x 3 weeks, f09 visit, 75 mg, three capsules, po qhs x 6 weeks, f15 visit: taper study drug by one capsule a week, off study drug for the last week

Placebo (for nortriptyline)DRUG

Placebo (for nortriptyline), 10 mg, one capsule, po qhs x 3 weeks, f03 visit, 25 mg, one capsule, po qhs x 3 weeks;

Eligibility

Sex: ALLMin age: 21 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

Decrease From the Baseline GCSI of at Least 50% on Any Two Consecutive Follow-up Visits

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.

Time frame: at end of treatment, 15 weeks from baseline assessment

Data from ClinicalTrials.gov

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