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Nortriptyline for Idiopathic Gastroparesis (NORIG)

Primary Purpose

Idiopathic Gastroparesis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Nortriptyline Hydrochloride
Placebo (for nortriptyline)
Sponsored by
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Gastroparesis focused on measuring idiopathic gastroparesis

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • California Pacific Medical Center
  • Stanford University
  • University of Michigan Medical Center
  • University of Mississippi Medical Center
  • Wake Forest University Health Sciences
  • Temple University Hospital
  • Texas Tech University Health Sciences Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Nortriptyline

Placebo (for nortriptyline)

Arm Description

Nortriptyline Hydrochloride dose escalation from 10 mg to 75 mg

No treatment

Outcomes

Primary Outcome Measures

Decrease From the Baseline GCSI of at Least 50% on Any Two Consecutive Follow-up Visits
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.

Secondary Outcome Measures

Full Information

First Posted
October 2, 2008
Last Updated
April 30, 2020
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT00765895
Brief Title
Nortriptyline for Idiopathic Gastroparesis
Acronym
NORIG
Official Title
Nortriptyline for Idiopathic Gastroparesis: A Multicenter, Randomized, Double-Masked, Placebo-Controlled Trial (NORIG)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
January 2009 (Actual)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Gastroparesis
Keywords
idiopathic gastroparesis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nortriptyline
Arm Type
Active Comparator
Arm Description
Nortriptyline Hydrochloride dose escalation from 10 mg to 75 mg
Arm Title
Placebo (for nortriptyline)
Arm Type
Placebo Comparator
Arm Description
No treatment
Intervention Type
Drug
Intervention Name(s)
Nortriptyline Hydrochloride
Other Intervention Name(s)
Nortriptyline HCl, Pamelor
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo (for nortriptyline)
Intervention Description
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 Measure Information:
Title
Decrease From the Baseline GCSI of at Least 50% on Any Two Consecutive Follow-up Visits
Description
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.
Time Frame
at end of treatment, 15 weeks from baseline assessment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank Hamilton, MD, MPH
Organizational Affiliation
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Official's Role
Study Director
Facility Information:
Facility Name
California Pacific Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5187
Country
United States
Facility Name
University of Michigan Medical Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Texas Tech University Health Sciences Center
City
El Paso
State/Province
Texas
ZIP/Postal Code
79905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data are available at the NIDDK Central Repository: https://repository.niddk.nih.gov/studies/norig/?query=norig
IPD Sharing URL
https://repository.niddk.nih.gov/studies/norig/?query=norig
Citations:
PubMed Identifier
24368464
Citation
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.
Results Reference
derived
Links:
URL
https://jhuccs1.us/gpcrc/
Description
Click here for information on gastroparesis research

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Nortriptyline for Idiopathic Gastroparesis

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