Nortriptyline for Idiopathic Gastroparesis - Full Text View

Nortriptyline for Idiopathic Gastroparesis (NORIG)

This study is currently recruiting participants.

Verified by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), January 2010

First Received: October 2, 2008 Last Updated: January 21, 2010 History of Changes

Sponsor:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:	NCT00765895

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.

Condition	Intervention	Phase
Idiopathic Gastroparesis	Drug: Nortriptyline Hydrochloride Drug: Nortriptyline-Placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Nortriptyline for Idiopathic Gastroparesis: A Multicenter, Randomized, Double-Masked, Placebo-Controlled Trial (NORIG)

Resource links provided by NLM:

Drug Information available for: Nortriptyline Nortriptyline hydrochloride

U.S. FDA Resources

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:

The primary outcome measure is defined as a decrease from the baseline GCSI score of at least 50% on any 2 consecutive follow-up visits during the 15 week treatment period with maximum tolerated study drug dose. [ Time Frame: 17 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	140
Study Start Date:	January 2009
Estimated Study Completion Date:	April 2011
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Nortriptyline: Active Comparator Nortriptyline Hydrochloride dose escalation from 10 mg to 75 mg	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
2: Placebo Comparator No treatment	Drug: Nortriptyline-Placebo Nortriptyline-placebo, 10 mg, one capsule, po qhs 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, po qhs x 15 wks f15 visit: taper study drug by one capsule a week, off study drug for the last week

Eligibility

Ages Eligible for Study:	21 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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
Contraindications to gastric emptying breath test such as a known allergy to egg, wheat, or algae
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00765895

Contacts

Contact: James Tonascia, PhD	410-955-3704	jtonasci@jhsph.edu
Contact: Aynur Unalp-Arida, MD, PhD	410-614-4851	aunalp@jhsph.edu

Locations

United States, California
California Pacific Medical Center	Recruiting
San Francisco, California, United States, 94115
Contact: William Snape, MD 415-516-9127 snapew@sutterhealth.org
Contact: Courtney Ponsetto, RN 415.600.1138 ponsetc@sutterhealth.org
Sub-Investigator: William Snape, MD
Stanford University	Recruiting
Stanford, California, United States, 94305-5187
Contact: Pankaj J Pasricha, MD 650-725-3362 Pasricha@stanford.edu
Contact: Nighat Ullah (650) 723-3567 nullah@stanford.edu
Principal Investigator: Pankaj J Pasricha, MD
United States, Michigan
University of Michigan Medical Center	Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: William L Hasler, MD 734-936-8644 whasler@umich.edu
Contact: Michelle Atkinson (734) 615-6723 michcast@umich.edu
Principal Investigator: William L Hasler, MD
United States, Mississippi
University of Mississippi Medical Center	Recruiting
Jackson, Mississippi, United States, 39216
Contact: Thomas L Abell, MD 601-815-3463 tabell@medicine.umsmed.edu
Contact: Margaret Smith, RN (601) 984-4540 marsmith@medicine.umsmed.edu
Principal Investigator: Thomas L Abell, MD
United States, North Carolina
Wake Forest University Health Sciences	Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Kenneth L Koch, MD 336-713-7333 kkoch@wfubmc.edu
Contact: Judy Hooker 336-713-7301 jhooker@wfubmc.edu
Principal Investigator: Kenneth L Koch, MD
United States, Pennsylvania
Temple University Hospital	Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Henry P Parkman, MD 215-707-7579 henry.parkman@temple.edu
Contact: Kellie Simmons, RN 215-707-5477 kellie.simmons@temple.edu
Principal Investigator: Henry P Parkman, MD
United States, Texas
Texas Tech University Health Sciences Center	Recruiting
El Paso, Texas, United States, 79905
Contact: Richard W McCallum, MD 915-545-6618 richard.mccallum@ttuhsc.edu
Contact: Irene Sarosiek, MD (915) 545-6626 ext 230 irene.sarosiek@ttuhsc.edu
Principal Investigator: Richard W McCallum, MD

Sponsors and Collaborators

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

Investigators

Study Director:

Frank Hamilton, MD, MPH

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

More Information

Additional Information:

Click here for information on gastroparesis research This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	National Institute of Diabetes and Digestive and Kidney Diseases ( Frank Hamilton, Project Officer )
Study ID Numbers:	DK-GpCRC-2NORIG, 1U01DK073983, 1U01DK073975, 1U01DK073985, 1U01DK074007, 1U01DK073974, 1U01DK074008
Study First Received:	October 2, 2008
Last Updated:	January 21, 2010
ClinicalTrials.gov Identifier:	NCT00765895 History of Changes
Health Authority:	United States: Food and Drug Administration

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

idiopathic gastroparesis

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Psychotropic Drugs
Pharmacologic Actions
Antidepressive Agents, Tricyclic

Paralysis
Signs and Symptoms
Stomach Diseases
Digestive System Diseases
Therapeutic Uses
Nortriptyline
Neurologic Manifestations
Central Nervous System Agents
Antidepressive Agents
Gastroparesis

ClinicalTrials.gov processed this record on February 08, 2010