Nortriptyline for Idiopathic Gastropare… | Clinical Trial

Key information

Conditions

Idiopathic Gastroparesis

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

California Pacific Medical Center, San Francisco, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nortriptyline Hydrochloride

Drug

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

Other names: Nortriptyline HCl, Pamelor

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;

Primary outcomes

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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

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

Nih

Registry information

Official study title

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

Acronym: NORIG

Important dates

Study start: 2009
Primary completion: 2012
Study completion: 2012
First posted: Oct 3, 2008
Registry last updated: May 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed