Nortriptyline for Idiopathic Gastroparesis
Condition: Idiopathic Gastroparesis
MeSH terms: Gastroparesis
Intervention: Nortriptyline Hydrochloride; Placebo (for nortriptyline)
Intervention description: 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), 10 mg, one capsule, po qhs x 3 weeks, f03 visit, 25 mg, one capsule, po qhs x 3 weeks;
Intervention MeSH terms: Nortriptyline
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 130.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: idiopathic gastroparesis

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.
    

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