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Nortriptyline for Idiopathic Gastroparesis (NORIG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00765895
Recruitment Status : Completed
First Posted : October 3, 2008
Results First Posted : April 16, 2015
Last Update Posted : May 14, 2020
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Brief 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.

Condition or disease Intervention/treatment Phase
Idiopathic Gastroparesis Drug: Nortriptyline Hydrochloride Drug: Placebo (for nortriptyline) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Nortriptyline for Idiopathic Gastroparesis: A Multicenter, Randomized, Double-Masked, Placebo-Controlled Trial (NORIG)
Actual Study Start Date : January 2009
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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: Placebo (for nortriptyline)
No treatment
Drug: Placebo (for nortriptyline)
Placebo (for nortriptyline), 10 mg, one capsule, po qhs x 3 weeks, f03 visit, 25 mg, one capsule, po qhs x 3 weeks;

Primary Outcome Measures :
  1. Decrease From the Baseline GCSI of at Least 50% on Any Two Consecutive Follow-up Visits [ Time Frame: at end of treatment, 15 weeks from baseline assessment ]
    A decrease from the baseline Gastroparesis Cardinal Symptom Index (GCSI) score (sum of the 9 individual symptom scores) of at least 50% on any two consecutive follow-up visits during the 15 week treatment period with maximum tolerated study drug dose. The total score ranges from 0-45 with higher scores indicating greater symptom severity.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00765895

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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
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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Study Director: Frank Hamilton, MD, MPH National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Identifier: NCT00765895    
Other Study ID Numbers: U01DK074008 NORIG
1U01DK073983 ( U.S. NIH Grant/Contract )
1U01DK073975 ( U.S. NIH Grant/Contract )
1U01DK073985 ( U.S. NIH Grant/Contract )
1U01DK074007 ( U.S. NIH Grant/Contract )
1U01DK073974 ( U.S. NIH Grant/Contract )
1U01DK074008 ( U.S. NIH Grant/Contract )
First Posted: October 3, 2008    Key Record Dates
Results First Posted: April 16, 2015
Last Update Posted: May 14, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data are available at the NIDDK Central Repository:

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
idiopathic gastroparesis
Additional relevant MeSH terms:
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Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Neurologic Manifestations
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs