Phase 3
N=130
Nortriptyline for Idiopathic Gastroparesis
Idiopathic Gastroparesis
Bottom Line
View on ClinicalTrials.gov: NCT00765895 ↗Enrolled (actual)
130
Serious AEs
4.6%
Results posted
Apr 2015
Primary outcome: Primary: Decrease From the Baseline GCSI of at Least 50% on Any Two Consecutive Follow-up Visits — 15; 14 participants — p=0.86
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Nortriptyline Hydrochloride (Drug); Placebo (for nortriptyline) (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Primary completion
- Oct 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Decrease From the Baseline GCSI of at Least 50% on Any Two Consecutive Follow-up Visits |
15; 14 | 0.86 |
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:
- 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
Data sourced from ClinicalTrials.gov (NCT00765895). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.