Nortriptyline for Idiopathic Gastroparesis

Idiopathic Gastroparesis Clinical Trial

— NORIG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00765895
• Other study ID #: U01DK074008 NORIG
• Secondary ID: 1U01DK0739831U01
• Status: Completed
• Phase: Phase 3
• Start date: January 2009
• Est. completion date: October 2012

Study information

• Verified date: April 2020
• Source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastroparesis
• Idiopathic Gastroparesis

Intervention

Drug:
• Nortriptyline Hydrochloride
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)
Placebo (for nortriptyline), 10 mg, one capsule, po qhs x 3 weeks, f03 visit, 25 mg, one capsule, po qhs x 3 weeks;

Locations

Country	Name	City	State
United States	University of Michigan Medical Center	Ann Arbor	Michigan
United States	Texas Tech University Health Sciences Center	El Paso	Texas
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	California Pacific Medical Center	San Francisco	California
United States	Stanford University	Stanford	California
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Click here for information on gastroparesis research