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| ID | Type | Description | Link |
|---|---|---|---|
| 1U01DK073983 | U.S. NIH Grant/Contract | View source | |
| 1U01DK073975 | U.S. NIH Grant/Contract | View source | |
| 1U01DK073985 | U.S. NIH Grant/Contract | View source | |
| 1U01DK074007 | U.S. NIH Grant/Contract | View source | |
| 1U01DK073974 | U.S. NIH Grant/Contract | View source | |
| 1U01DK074008 | U.S. NIH Grant/Contract | View source |
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The principal objective of this multicenter, randomized, placebo-controlled trial is to evaluate whether treatment with nortriptyline will improve gastroparesis symptoms compared with placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nortriptyline | Active Comparator | Nortriptyline Hydrochloride dose escalation from 10 mg to 75 mg |
|
| Placebo (for nortriptyline) | Placebo Comparator | No treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nortriptyline Hydrochloride | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at end of treatment, 15 weeks from baseline assessment |
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Inclusion Criteria:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Frank Hamilton, MD, MPH | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Pacific Medical Center | San Francisco | California | 94115 | United States | ||
| Stanford University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24368464 | Derived | 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. |
| Label | URL |
|---|---|
| Click here for information on gastroparesis research | View source |
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Data are available at the NIDDK Central Repository: https://repository.niddk.nih.gov/studies/norig/?query=norig
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Placebo | No treatment 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | intention to treat | Posted | Number | 95% Confidence Interval | participants | at end of treatment, 15 weeks from baseline assessment |
|
Duration of treatment. 15 weeks and for 3 weeks after treatment ended ( 18 weeks total)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| allergic reaction | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nervous system | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark Van Natta | Johns Hopkins Data Coordinating Centers | 410-614-1362 | mvannat1@jhu.edu |
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| ID | Term |
|---|---|
| D009661 | Nortriptyline |
| ID | Term |
|---|---|
| D003986 | Dibenzocycloheptenes |
| D001567 | Benzocycloheptenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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|
|
| Placebo (for nortriptyline) | Drug | Placebo (for nortriptyline), 10 mg, one capsule, po qhs x 3 weeks, f03 visit, 25 mg, one capsule, po qhs x 3 weeks; |
|
| Stanford |
| California |
| 94305-5187 |
| United States |
| University of Michigan Medical Center | Ann Arbor | Michigan | 48109 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | United States |
| Texas Tech University Health Sciences Center | El Paso | Texas | 79905 | United States |
| BG001 | Placebo | No treatment 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body mass index | Mean | Standard Deviation | kg/m^2 |
|
| proton-pump inhibitor taken in last month | Number of participants reporting that they used a proton-pump inhibitor drug in the last month. | Number | participants |
|
| benzodiazepine taken in last month | Number of participants reporting that they used a benzodiazepine drug in the last month. | Number | participants |
|
| prokinetic taken in last month | Number of participants reporting that they took a prokinetic drug in the last month. | Number | participants |
|
| antiemetics taken in last month | Number of participants reporting that they took an antiemetic drug in the last month. | Number | participants |
|
| selective serotonin reuptake inhibitor taken in last month | Number of participants reporting that they took a selective serotonin receptor reuptake inhibitor drug in the last month. | Number | participants |
|
| GSCI total score | Sum of all 9 GCSI items (sum of nausea, satiety, and bloating subscores). Score ranges from 0-45;higher scores meaning more severe symptoms. | Mean | Standard Deviation | units on a scale |
|
| GSCI- nausea sub score | Sum of 3 GCSI items: nausea, retching and vomiting symptoms. Each symptom score ranges from 0-5, with a total nausea subscore range from 0-15, with higher scores meaning worse symptom severity. | Mean | Standard Deviation | units on a scale |
|
| GSCI- satiety sub score | Sum of 4 GSCI items: fullness, not able to finish a normal size meal, feeling excessivley full and loss of appetite symptoms. The sub-score ranges from 0-20, with higher scores meaning worse symptom severity. | Mean | Standard Deviation | units on a scale |
|
| GSCI- bloating sub score | Sum of 2 GCSI items: bloating and stomach visibly larger symptoms. Each symptom score ranges from 0-5, with a total bloating subscore range from 0-10. Higher scores mean more severe symptoms. | Mean | Standard Deviation | units on a scale |
|
| PAGI-SYM- upper abdominal pain sub score | Sum of 2 PAGI-SYM items: upper abdominal pain and upper abdominal discomfort symptoms. Each symptom score ranges from 0-5, with a total upper abdominal pain score range from 0-10. Higher scores mean more severe symptoms. | Mean | Standard Deviation | units on a scale |
|
| PAGI-SYM- lower abdominal pain sub score | Sum 2 PAGI-SYM items: lower abdominal pain and lower abdominal discomfort symptoms. Each symptom score ranges from 0-5, with a total lower abdominal pain score range from 0-10. Higher scores mean more severe symptoms. | Mean | Standard Deviation | units on a scale |
|
| PAGI-SYM- GERD sub score | Sum of 7 PAGI-SYM items rating heartburn, discomfort in the chest, regurgitation/reflux and bitter acid taste in your mouth symptoms. Each symptom score ranges from 0-5, with a total GERD score range from 0-35. Higher scores mean more severe symptoms. | Mean | Standard Deviation | units on a scale |
|
| GI symptoms constipation sub score | The constipation symptom score ranges from 0-5, higher scores mean more severe symptoms. | Mean | Standard Deviation | units on a scale |
|
| GI symptom diarrhea sub score | The diarrhea score ranges from 0-5; higher scores mean more severe symptoms. | Mean | Standard Deviation | units on a scale |
|
| PAGI-SYM nausea/vomiting predominant symptom | Number of participants reporting either nausea or vomiting as their predominant symptom on the PAGI-SYM. | Number | participants |
|
| clinical global patient impression score | A Clinical Global Patient Impression (CGPI) question quantified overall relief of symptoms. This question asked, "Compared to the way you usually felt before entering the study,how would you rate your relief of symptoms during the past week?" Items coded -3 (very considerably worse) to 3 (completely better). Lower scores mean worsening of symptoms. | Mean | Standard Deviation | units on a scale |
|
| Gastroparesis Symptom Rating Scale score | Gastrointestinal Symptom Rating Scale (GSRS) assesses gastrointestinal symptoms seen in irritable bowel syndrome and peptic ulcer disease. The mean of 15 items coded 1 (no discomfort) to 7 (very severe discomfort). Higher scores mean worse symptoms. | Mean | Standard Deviation | units on a scale |
|
| SF-36 Quality of Life - Physical component | he SF-36 consists of scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. | Mean | Standard Deviation | units on a scale |
|
| SF-36 Quality of Life -Mental component | he SF-36 consists of scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. | Mean | Standard Deviation | units on a scale |
|
| Beck Depression Inventory- total score | Sum of 21 BDI items coded 0 (absence) to 3 (severe) with a total score range of 0-63. Higher scores mean greater depression symptom severity. | Mean | Standard Deviation | units on a scale |
|
| Beck Depression Inventory- severe depression score | Number of participants with a total score greater than 28 on the Beck Depression Inventory, or scoring a "2" or "3" on either of two items (pessimism and suicidal thoughts) which are indicative of severe depression. | Number | participants |
|
| Brief Pain Inventory- severity score | Mean of 4 Brief Pain Inventory items, where each item is coded 0 (no pain) to 10 (pain as bad as you can imagine) with higher scores meaning greater pain. | Mean | Standard Deviation | units on a scale |
|
| Brief Pain Inventory- interference score | Mean of 7 Brief Pain Inventory items where each item is coded 0 (does not interfere) to 10 (completely interferes) with higher scores indicating a higher degree to which pain interferes with daily life. | Mean | Standard Deviation | units on a scale |
|
| State Trait Anxiety Inventory- State Anxiety score | The STAI measures anxiety - state anxiety, or anxiety about an event. The sum of 20 items coded 1 (not at all) to 4 (very much so) for a total score range of 0-80. Higher scores are positively correlated with higher levels of anxiety. | Mean | Standard Deviation | units on a scale |
|
| State Trait Anxiety Inventory- Trait Anxiety score | The STAI measures trait anxiety, or anxiety level as a personal characteristic. The sum of 20 items coded 1 (almost never) to 4 (almost always)gives a total score range of 0-80. Higher scores are positively correlated with higher levels of trait anxiety. | Mean | Standard Deviation | units on a scale |
|
| Patient Health Questionnaire-15 | The Patient Health Questionnaire (PHQ) is a multiple-choice self-report inventory that is used as a screening and diagnostic tool for somatic symptoms. The sum of 15 items coded 0 (not bothered at all) to 2 (bothered a lot); total score range 0-30).Higher scores indicate higher somatic symptoms. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Placebo | No treatment 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 |
|
|
|
| 5 |
| 65 |
| 18 |
| 65 |
| EG001 | Placebo | No treatment 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 | 1 | 65 | 23 | 65 |
| vomiting | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Nausea and vomiting | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| cardiac event | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| abdominal pain | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| gastrointestinal events | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| cardiac | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| rash | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| renal and urinary events | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| ocular events | Eye disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| swelling of hands and feet | General disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| psychiatric | Psychiatric disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| endocrine | Endocrine disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| weight gain/loss | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| general disorders | General disorders | CTCAE (3.0) | Non-systematic Assessment | insomnia |
|
| pain | General disorders | CTCAE (3.0) | Non-systematic Assessment |
|
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| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |