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Citation
Tonascia, James (2016). Nortriptyline for Idiopathic Gastroparesis (NORIG) (Version 2) [Dataset] NIDDK Central Repository. https://doi.org/10.58020/pga7-2s51
Data Availability Statement
Data from Nortriptyline for Idiopathic Gastroparesis (NORIG) [(Version 2) https://doi.org/10.58020/pga7-2s51] reported here are available for request at the NIDDK Central Repository (NIDDK-CR) website, Resources for Research (R4R), https://repository.niddk.nih.gov/.
Acknowledgement Statement
The NORIG study was conducted by the study investigators and supported by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The resources from the NORIG (https://doi.org/10.58020/pga7-2s51) study reported here were supplied by NIDDK Central Repository (NIDDK-CR) and are available for request at https://repository.niddk.nih.gov. This manuscript was not prepared under the auspices of the NORIG study and does not necessarily reflect the opinions or views of the NORIG study, NIDDK-CR, or NIDDK.
Data Package Version
Version 2 (Updated on: Mar 21, 2016)
Resource Availability
  • Data Available for Request
  • Specimens Available for Request
Publications
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View publications (23)

General Description

Gastroparesis, a syndrome in which patients experience delayed gastric emptying, is characterized by symptoms such as nausea, vomiting, bloating, abdominal pain, and early satiety. Management of gastroparesis is limited by few effective treatments, many of which function by accelerating gastric emptying. Based on the hypothesis that some symptoms of gastroparesis arise because of neuropathic changes in enteric and sensory nerves, tricyclic antidepressants (TCAs) in low doses have been used as neuromodulators to treat refractory symptoms of nausea, vomiting, and abdominal pain, but there is little evidence to support this use. The Nortriptyline for Idiopathic Gastroparesis (NORIG) study is a multicenter, randomized, clinical trial that was designed by the Gastroparesis Clinical Research Consortium (GpCRC) to test whether treatment with nortriptyline, a TCA with reduced anticholinergic side effects, results in symptomatic improvement in patients with idiopathic gastroparesis.

Individuals between the ages of 21 and 68 years old with moderate to severe symptoms of idiopathic gastroparesis for at least 6 months were enrolled. Participants were randomized to treatment with either nortiptyline or placebo. In both groups, dosing was escalated at 3-week intervals (10, 25, 50, 75 mg) up to 75 mg at 12 weeks. At follow-up study visits, which occurred every 3 weeks, symptom questionnaires were administered to assess gastrointestinal and psychological symptoms, quality of life, and TCA side effects. Electrogastrography (EGG) satiety tests and electrocardiography tests were also performed. Treatment was continued for 15 weeks, at which time study medication dose was tapered to zero with a final assessment at 18 weeks. The primary outcome measure was a decrease from the patient’s baseline Gastroparesis Cardinal Symptom Index (GCSI) score of at least 50% on two consecutive 3 week GCSI assessments over 15 weeks of treatment. Secondary outcome measures included physiological assessments during satiety testing, clinical and psychological symptom scores, and adverse event rates.

Overall symptomatic improvement, as defined by the primary outcome measure, did not differ between the treatment groups: 23% on nortriptyline versus 21% on placebo. Additionally, treatment with nortriptyline showed no improvement in nausea, fullness/satiety, bloating, or quality of life measures. These findings suggest that TCAs may not be effective in the treatment of idiopathic gastroparesis.

Objectives

The NORIG study tested whether treatment with nortriptyline, a TCA with reduced anticholinergic side effects, results in symptomatic improvement in patients with idiopathic gastroparesis.

Outcome Measure

The primary outcome measure was a decrease from the patient’s baseline Gastroparesis Cardinal Symptom Index (GCSI) score of at least 50% on two consecutive 3 week GCSI assessments over 15 weeks of treatment. Secondary outcome measures included physiological assessments during satiety testing, clinical and psychological symptom scores, and adverse event rates.

Eligibility Criteria

Individuals between the ages of 21 and 68 years old who met the following criteria were eligible for the study:

  • Symptoms of gastroparesis for at least 6 months prior to registration, with Gastroparesis Cardinal Symptom Index score ≥ 21 on the 0-45 point scale
  • Documentation of delayed gastric emptying on gastric emptying scintigraphy, defined as greater than 60% retention at 2 hours or greater than 10% retention at 4 hours, within 2 years of registration
  • Negative upper endoscopy or upper GI series within 2 years of registration
  • No contraindications to nortriptyline use
  • Not currently using any of the following medications: TCAs of any kind, daily narcotic analgesics, anticholinergic medications, calcium channel blockers, and erythromycin.

Patients having dyspeptic symptoms with normal gastric emptying or having diabetic gastroparesis or post-surgical gastroparesis including fundoplication were excluded.

Outcome

Overall symptomatic improvement, as defined by the primary outcome measure, did not differ between the treatment groups: 23% on nortriptyline versus 21% on placebo. Additionally, treatment with nortriptyline showed no improvement in nausea, fullness/satiety, bloating, or quality of life measures. These findings suggest that TCAs may not be effective in the treatment of idiopathic gastroparesis.

Research Area

Digestive Diseases

Study Type

Interventional

Study Sites

7

Study Start Date

2009-01

Study End Date

2012-10

Condition

Gastroparesis

Keywords

Gastric Emptying, Tricylcic Antidepressants, Nortripytline, Gastroparesis, Calcium Channel, Gastroparesis Cardinal Symptom Index (GCSI)

NIDDK Division

Division of Digestive Diseases and Nutrition

130
Participants

Target Population
Adults

Sex

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Age

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Race

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Ethnicity

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Public Documents Table
Document Name
Description
Document Type
File Format
Compliance
Download
NORIG Data Dictionary
Data Dictionary used as a collection of metadata - defines the variable contents of each dataset Codebook/Data DictionaryPDF
If you need accessible versions of documents, please email your request to NIDDK-CRsupport@niddk.nih.gov

Permitted Use(s) of the Resources
  • Use is allowed for health, medical, or biomedical research purposes
Non-Public Documents (7)
Non-Public Documents Table
Document Name
Description
Document Type
File Format
NORIG Informed Consent Statement
NORIG Informed Consent Statement provided by the NIH, GpCRC, and NORIGConsent Form TemplatePDF
NORIG Genetic Informed Consent Statement
NORIG Informed Consent Statement for the collection storage, and use of blood samples for current and future genetic research provided by the NIH, GpCRC, and NORIGConsent Form TemplatePDF
Datasets (24)
Datasets Table
Dataset Name
Description
# of Records
# of Variables
File Format(s)
GD1 Form Dataset
Contains data from the Patient Assessment of Gastrointestinal Disorders - Symptom Severity Index form854sas7bdat (64 KB); csv (120.45 KB)
Treatment Randomization Groups Dataset
Contains the randomization groups for the subjects in the NORIG trial130sas7bdat (16 KB); csv (2.05 KB)
RG2 Form Dataset
Contains data from the Registration form130sas7bdat (40 KB); csv (13.83 KB)
PQ1 Form Dataset
Contains data from the Patient Health Questionnaire form367sas7bdat (24 KB); csv (27.75 KB)
SE1 Form Dataset
Contains data from the State-Trait Anxiety Inventory form366sas7bdat (24 KB); csv (9.69 KB)
FH1 Form Dataset
Contains data from the Follow-Up Medical History form725sas7bdat (408 KB); csv (386.49 KB)
BH2 Form Dataset
Contains data from the Baseline Medical History form130sas7bdat (88 KB); csv (71.47 KB)
GE1 Form Dataset
Contains data from the Gastric Emptying Scintigraphy Documentation form130sas7bdat (72 KB); csv (19.71 KB)
IE1 Form Dataset
Contains data from the Interim Event Report form108sas7bdat (56 KB); csv (19.64 KB)
RD1 Form Dataset
Contains data from the Study Drug Dispensing and Return form879sas7bdat (136 KB); csv (92.89 KB)
QF1 Form Dataset
Contains data from the SF-36v2 Health Survey form366sas7bdat (40 KB); csv (57.88 KB)
LR1 Form Dataset
Contains data from the Laboratory Results form243sas7bdat (72 KB); csv (39.5 KB)
GS1 Form Dataset
Contains data from the Gastrointestinal Symptom Rating Scale (GSRS) form854sas7bdat (40 KB); csv (64.47 KB)
PI1 Form Dataset
Contains data from the Brief Pain Inventory form367sas7bdat (72 KB); csv (33.92 KB)
DD1 Form Dataset
Contains data from the Drug Dosing Determination and Dispensing form741sas7bdat (40 KB); csv (47.36 KB)
ST3 Form Dataset
Contains data from the ECG and Satiety Test form278sas7bdat (136 KB); csv (163.71 KB)
EG1 Form Dataset
Contains data from the Upper Endoscopy Documentation form130sas7bdat (56 KB); csv (21.59 KB)
PE2 Form Dataset
Contains data from the Physical Examination form509sas7bdat (248 KB); csv (104.64 KB)
BD1 Form Dataset
Contains data from the Beck Depression Inventory form854sas7bdat (32 KB); csv (28.52 KB)
Specimens (2,295)
Specimens Table
Specimen
Count
Plasma2285
Serum10