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
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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:
|
|
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:
- hypersensitivity or allergy to any tricyclic antidepressant drug
- concomitant therapy with a monoamine oxidase inhibitor (MAOI)
- recent myocardial infarction
- 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
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
| 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 May 19, 2013