DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Nortriptyline for Idiopathic Gastroparesis

Information source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Idiopathic Gastroparesis

Intervention: Nortriptyline Hydrochloride (Drug); Placebo (for nortriptyline) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Official(s) and/or principal investigator(s):
Frank Hamilton, MD, MPH, Study Director, Affiliation: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

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

Eligibility

Minimum age: 21 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

California Pacific Medical Center, San Francisco, California 94115, United States

Stanford University, Stanford, California 94305-5187, United States

University of Michigan Medical Center, Ann Arbor, Michigan 48109, United States

University of Mississippi Medical Center, Jackson, Mississippi 39216, United States

Wake Forest University Health Sciences, Winston-Salem, North Carolina 27157, United States

Temple University Hospital, Philadelphia, Pennsylvania 19140, United States

Texas Tech University Health Sciences Center, El Paso, Texas 79905, United States

Additional Information

Click here for information on gastroparesis research

Starting date: January 2009
Last updated: April 15, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017