Nortriptyline for Idiopathic Gastroparesis - Full Text View

Nortriptyline for Idiopathic Gastroparesis (NORIG)

This study is currently recruiting participants.

Verified October 2011 by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

First Received on October 2, 2008. Last Updated on October 20, 2011 History of Changes

Sponsor:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):	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:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
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:	130
Study Start Date:	January 2009
Estimated Study Completion Date:	August 2012
Estimated Primary Completion Date:	March 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Nortriptyline 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 Other Names: Nortriptyline HCl Pamelor
Placebo Comparator: notriptyline-placebo capsule 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
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: Brian Macapinlac, RN 415-600-1627 greeMacapiB@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: Nara Wooten (734) 615-6723 smao@med.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@umc.edu
Contact: Natalie Moody, RN (601) 984-4540 nmoody@umc.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 (NIDDK)
ClinicalTrials.gov Identifier:	NCT00765895 History of Changes
Other Study ID Numbers:	IND - DK-GpCRC-2NORIG, 1U01DK073983, 1U01DK073975, 1U01DK073985, 1U01DK074007, 1U01DK073974, 1U01DK074008
Study First Received:	October 2, 2008
Last Updated:	October 20, 2011
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:

Gastroparesis
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms
Nortriptyline
Adrenergic Uptake Inhibitors
Adrenergic Agents

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012