View Clinical Trial (Medical Research Study)

Nortriptyline for Idiopathic Gastroparesis - NCT00765895-79905(Clinical Trial 344020)



ClinicalConnection.com has recently undergone an update and this page may no longer be up-to-date. Please Search For Clinical Trials to view the most current clinical trials listings.


Signup
City:  El Paso
State:  
TX
Zip Code: 79905
Conditions: Idiopathic Gastroparesis
Purpose: The principal objective of this multicenter, randomized, placebo-controlled trial is to evaluate whether treatment with nortriptyline will improve gastroparesis symptoms compared with placebo.
Study summary:
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
Study is available at: Texas Tech University Health Sciences Center
El Paso, TX 79905
United States

Primary Contact:
Richard W McCallum, MD
Email: richard.mccallum@ttuhsc.edu
Phone: 915-545-6618

Secondary Contact:
James Tonascia, PhD
Email: jtonasci@jhsph.edu
Phone: 410-955-3704
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
Trials Alerts: If you would like to be notified of new clinical trials as they become available please register for a free account.
Data Source: ClinicalTrials.gov
Date Processed: March 22, 2011
Modifications to
this listing:		 Only selected fields are shown, please use the link above to view all information about this clinical trial.