Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
130 participants
INTERVENTIONAL
2009-01-31
2012-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Nortriptyline
Nortriptyline Hydrochloride dose escalation from 10 mg to 75 mg
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
Placebo (for nortriptyline)
No treatment
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;
Interventions
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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
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;
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
21 Years
65 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Responsible Party
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Principal Investigators
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Frank Hamilton, MD, MPH
Role: STUDY_DIRECTOR
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Locations
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California Pacific Medical Center
San Francisco, California, United States
Stanford University
Stanford, California, United States
University of Michigan Medical Center
Ann Arbor, Michigan, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Texas Tech University Health Sciences Center
El Paso, Texas, United States
Countries
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References
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Parkman HP, Van Natta ML, Abell TL, McCallum RW, Sarosiek I, Nguyen L, Snape WJ, Koch KL, Hasler WL, Farrugia G, Lee L, Unalp-Arida A, Tonascia J, Hamilton F, Pasricha PJ. Effect of nortriptyline on symptoms of idiopathic gastroparesis: the NORIG randomized clinical trial. JAMA. 2013 Dec 25;310(24):2640-9. doi: 10.1001/jama.2013.282833.
Related Links
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Click here for information on gastroparesis research
Other Identifiers
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U01DK074008 NORIG
Identifier Type: -
Identifier Source: org_study_id
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