Nortriptyline for Idiopathic Gastroparesis (NORIG)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00765895
First received: October 2, 2008
Last updated: January 22, 2013
Last verified: January 2013
  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 3

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:


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 ]

Enrollment: 130
Study Start Date: January 2009
Study Completion Date: October 2012
Primary Completion Date: October 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
California Pacific Medical Center
San Francisco, California, United States, 94115
Stanford University
Stanford, California, United States, 94305-5187
United States, Michigan
University of Michigan Medical Center
Ann Arbor, Michigan, United States, 48109
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, Pennsylvania
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
United States, Texas
Texas Tech University Health Sciences Center
El Paso, Texas, United States, 79905
Sponsors and Collaborators
Investigators
Study Director: Frank Hamilton, MD, MPH National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  More Information

Additional Information:
No publications provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: January 22, 2013
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 July 22, 2014