Nortriptyline for Idiopathic Gastroparesis

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

Official Title
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Nortriptyline for Idiopathic Gastroparesis: A Multicenter, Randomized, Double-Masked, Placebo-Controlled Trial (NORIG)

Conditions
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Idiopathic Gastroparesis

Intervention / Treatment
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* Drug: Nortriptyline Hydrochloride
* Drug: Placebo (for nortriptyline)


Participation Criteria
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Eligibility Criteria
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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: 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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nortriptyline<br>Nortriptyline Hydrochloride dose escalation from 10 mg to 75 mg | Drug: Nortriptyline Hydrochloride<br>* 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<br>* Other names: Pamelor;|
| Placebo Comparator: Placebo (for nortriptyline)<br>No treatment | Drug: Placebo (for nortriptyline)<br>* Placebo (for nortriptyline), 10 mg, one capsule, po qhs x 3 weeks, f03 visit, 25 mg, one capsule, po qhs x 3 weeks;<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | at end of treatment, 15 weeks from baseline assessment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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idiopathic gastroparesis