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| Name | Class |
|---|---|
| Mayo Clinic | OTHER |
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To evaluate the effects of tradipitant relative to placebo on satiation, gastric volume, gastric accommodation, and gastric emptying in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tradipitant | Experimental | Oral Capsule |
|
| Placebo | Placebo Comparator | Oral Capsule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tradipitant | Drug | Tradipitant Capsule |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting Gastric Volume as Measured by Single Photon Emission Computed Tomography (SPECT) | Fasting Gastric volume | 9 Days |
| Accommodation Volume as Measured by SPECT | Gastric Accommodation post 300mL Ensure | 9 Days |
| Satiation Expressed as Volume to Fullness as Measured by Satiation Test | 9 Days | |
| Gastric Emptying Half-time of Solids as Measured by Scintigraphy | Gastric Emptying Solids, T50%, Min | 9 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vanda Pharmaceuticals | Vanda Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanda Investigational Site | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35644931 | Derived | Khanna L, Zheng T, Atieh J, Torres M, Busciglio I, Carlin JL, Xiao M, Harmsen WS, Camilleri M. Clinical trial: a single-centre, randomised, controlled trial of tradipitant on satiation, gastric functions, and serum drug levels in healthy volunteers. Aliment Pharmacol Ther. 2022 Jul;56(2):224-230. doi: 10.1111/apt.17065. Epub 2022 May 29. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tradipitant | Oral Capsule Tradipitant: Tradipitant Capsule |
| FG001 | Placebo | Oral Capsule Placebo: Placebo Capsule |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tradipitant | Oral Capsule Tradipitant: Tradipitant Capsule |
| BG001 | Placebo | Oral Capsule Placebo: Placebo Capsule |
| 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 | Fasting Gastric Volume as Measured by Single Photon Emission Computed Tomography (SPECT) | Fasting Gastric volume | Completed subjects | Posted | Median | Inter-Quartile Range | mL | 9 Days |
|
|
9 days
Safety population includes all subjects enrolled. Efficacy data includes all subjects completed.
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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 | Tradipitant | Oral Capsule Tradipitant: Tradipitant Capsule | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| fatigue | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vanda Pharmaceuticals | Vanda Pharmaceuticals | 202-734-3400 | clinicaltrials@vandapharma.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 10, 2021 | Mar 19, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 10, 2021 | Mar 19, 2024 | SAP_001.pdf |
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A single center, randomized, double-blind, placebo-controlled study to evaluate the effects of tradipitant on satiation, gastric volume, gastric accommodation and gastric emptying in healthy volunteers
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| Drug |
Placebo Capsule |
|
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Primary | Accommodation Volume as Measured by SPECT | Gastric Accommodation post 300mL Ensure | Completed subjects | Posted | Median | Inter-Quartile Range | mL | 9 Days |
|
|
|
| Primary | Satiation Expressed as Volume to Fullness as Measured by Satiation Test | Completed subjects | Posted | Median | Inter-Quartile Range | mL | 9 Days |
|
|
|
| Primary | Gastric Emptying Half-time of Solids as Measured by Scintigraphy | Gastric Emptying Solids, T50%, Min | Completed subjects | Posted | Median | Inter-Quartile Range | minutes | 9 Days |
|
|
|
| 13 |
| 0 |
| 13 |
| 4 |
| 13 |
| EG001 | Placebo | Oral Capsule Placebo: Placebo Capsule | 0 | 14 | 0 | 14 | 4 | 14 |
| peripheral swelling | General disorders | Systematic Assessment |
|
| swelling face | General disorders | Systematic Assessment |
|
| abdominal pain | General disorders | Systematic Assessment |
|
| diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| somnolence | Nervous system disorders | Systematic Assessment |
|
| headache | Nervous system disorders | Systematic Assessment |
|
| disturbance in attention | Nervous system disorders | Systematic Assessment |
|
| dizziness postural | Nervous system disorders | Systematic Assessment |
|
| restless leg syndrome | Nervous system disorders | Systematic Assessment |
|
| depressed mood | Psychiatric disorders | Systematic Assessment |
|
| libido decreased | Psychiatric disorders | Systematic Assessment |
|
| increased appetite | Metabolism and nutrition disorders | Systematic Assessment |
|
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