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| Name | Class |
|---|---|
| Theravance Biopharma | INDUSTRY |
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This study is being conducted to evaluate the safety, tolerability and early efficacy of IV TD 8954 compared to metoclopramide in critically ill subjects, aged 18 to 85 years, who are admitted to the intensive care require mechanical ventilation, and are intolerant to enteral feeding.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TD-8954 | Experimental | TD-8954 single infusion for 1 hour and 4 injections of saline every 6 hours |
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| Metoclopramide | Active Comparator | Metoclopramide 4 doses every 6 hours for 24 hours and 1 hour infusion of saline |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TD-8954 | Drug |
| ||
| Metoclopramide |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | the number of subjects reporting adverse events by treatment group | 6 Days |
| Gastric Retention by Scintigraphy | Number of subjects with retention less than 13% at 180 minutes after dosing. | 180 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax | Time to maximal concentration in plasma | 72 hours |
| AUC | Area under the plasma concentration time curve from 0 to 72 hours after dosing. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Canafax, PharmD, FCCP | Theravance Biopharma, US, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Adelaide Hospital | Adelaide | South Australia | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31990087 | Derived | Chapman MJ, Jones KL, Almansa C, Barnes CN, Nguyen D, Deane AM. Blinded, Double-Dummy, Parallel-Group, Phase 2a Randomized Clinical Trial to Evaluate the Efficacy and Safety of a Highly Selective 5-Hydroxytryptamine Type 4 Receptor Agonist in Critically Ill Patients With Enteral Feeding Intolerance. JPEN J Parenter Enteral Nutr. 2021 Jan;45(1):115-124. doi: 10.1002/jpen.1732. Epub 2020 Jan 28. |
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| ID | Title | Description |
|---|---|---|
| FG000 | TD-8954 | TD-8954 single infusion for 1 hour and 4 injections of saline every 6 hours |
| FG001 | Metoclopramide | Metoclopramide 4 doses every 6 hours for 24 hours and 1 hour infusion of saline |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 72 hours |
| Cmax | Maximum plasma concentration | 72 hours |
| Gastric Emptying by Breath Test | Time to 1/2 gastric emptying by breath test | 180 minutes |
| Percentage Gastric Retention by Scintigraphy at 60 Minutes Postdose | Mean gastric retention percentage after dosing. | 60 minutes |
| Percentage Gastric Retention by Scintigraphy at 120 Minutes Postdose | Mean gastric retention percentage after dosing. | 120 minutes |
| Percentage of Gastric Retention by Scintigraphy at 240 Minutes Postdose | Mean gastric retention percentage after dosing. | 240 minutes |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | TD-8954 | TD-8954 single infusion for 1 hour and 4 injections of saline every 6 hours |
| BG001 | Metoclopramide | Metoclopramide 4 doses every 6 hours for 24 hours and 1 hour infusion of saline |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| 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 | Adverse Events | the number of subjects reporting adverse events by treatment group | Safety Population | Posted | Number | participants | 6 Days |
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| Primary | Gastric Retention by Scintigraphy | Number of subjects with retention less than 13% at 180 minutes after dosing. | ITT | Posted | Number | participants | 180 minutes |
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| Secondary | Tmax | Time to maximal concentration in plasma | PK Analysis set for subjects receiving TD-8954, metoclopramide concentrations were not measured in the metoclopramide group. | Posted | Median | Full Range | hours | 72 hours |
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| Secondary | AUC | Area under the plasma concentration time curve from 0 to 72 hours after dosing. | One subject did not receive the full dose of TD-8954 and was excluded from PK analysis for the TD-8954 group; Metoclopramide concentrations were not measured in the Metoclopramide group. | Posted | Mean | Standard Deviation | pg*hr/mL | 72 hours |
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| Secondary | Cmax | Maximum plasma concentration | One subject did not receive the full dose of TD-8954 and was excluded from PK analysis for the TD-8954 group; Metoclopramide concentrations were not measured in the Metoclopramide group. | Posted | Mean | Standard Deviation | pg/mL | 72 hours |
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| Secondary | Gastric Emptying by Breath Test | Time to 1/2 gastric emptying by breath test | One subject in the TD-8954 group did not receive the full dose of TD-8954 and was excluded from the TD-8954 analysis. | Posted | Mean | Standard Deviation | minutes | 180 minutes |
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| Secondary | Percentage Gastric Retention by Scintigraphy at 60 Minutes Postdose | Mean gastric retention percentage after dosing. | ITT | Posted | Mean | Standard Deviation | percentage of retention | 60 minutes |
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| Secondary | Percentage Gastric Retention by Scintigraphy at 120 Minutes Postdose | Mean gastric retention percentage after dosing. | ITT | Posted | Mean | Standard Deviation | percentage of retention | 120 minutes |
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| Secondary | Percentage of Gastric Retention by Scintigraphy at 240 Minutes Postdose | Mean gastric retention percentage after dosing. | ITT | Posted | Mean | Standard Deviation | percentage of retention | 240 minutes |
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6 Days
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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 | TD-8954 | TD-8954 single infusion for 1 hour and 4 injections of saline every 6 hours TD-8954 | 2 | 7 | 5 | 7 | ||
| EG001 | Metoclopramide | Metoclopramide 4 doses every 6 hours for 24 hours and 1 hour infusion of saline Metoclopramide | 3 | 6 | 2 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cerebral Hemorrhage | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
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| Hemorrhage intracranial | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
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| Subarachnoid hemorrhage | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
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| Disease progression | General disorders | MedDRA (16.0) | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Agitation | Psychiatric disorders | MedDRA (16.0) | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
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| Hyperkalemia | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA (16.0) | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
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| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
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The PI may communicate the trial results generated by the PI, but only after the first publication or presentation of the combined study results generated by all participating sites. The Sponsor can then review trial results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The Sponsor cannot require changes to the communication and cannot extend the embargo.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Brett Haumann, SVP, Clinical Development | Theravance Biopharma US, Inc. | 650-808-6000 | BHaumann@theravance.com |
| ID | Term |
|---|---|
| C581614 | 4-((4-((2-isopropyl-1H-benzoimidazole-4-carbonyl)amino)methyl)piperidin-1-ylmethyl)piperidine-1-carboxylic acid methyl ester |
| D008787 | Metoclopramide |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D062366 | para-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D002723 | Chlorobenzoates |
| D062425 | Hydroxybenzoate Ethers |
| D062385 | Hydroxybenzoates |
| D006880 | Hydroxy Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010647 | Phenyl Ethers |
| D010636 | Phenols |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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