CompletedNCT01953081Updated Feb 18, 2020Results posted

A Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of a Single Dose of Intravenous TD-8954 Compared With Metoclopramide in Critically Ill Patients With Enteral Feeding Intolerance

A Phase 1/2 interventional study of TD-8954 and Metoclopramide in Enteral Feeding Intolerance, sponsored by Takeda. Completed at 1 site in Australia. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2020-02-18.

Sponsored by Takeda · Phase 1/2, Interventional, and Treatment

Phase: Phase 1/2
Study type: Interventional
Enrollment: 13
Allocation: Randomized
Ages: 18 Years to 85 Years
Sex: All

Study summary

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.

Conditions studied

Enteral Feeding Intolerance

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Critical Illness 1,881

Keywords

Enteral feeding

In context

Critical Illness

1,881 studies on the registry are indexed under Critical Illness; 461 are open to participants now.

This study's enrollment of 13 is below the median of 90 across 979 interventional studies indexed under Critical Illness.

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Lead sponsor

Takeda is the lead sponsor of 1,002 studies on the registry; 92 are open to participants now.

Of its 173 completed or terminated interventional studies of FDA-regulated products, 149 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 85 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Intubated, on mechanical ventilation, and anticipated to remain on mechanical ventilation for 2 days after enrollment into the study
Receiving enteral feeding and assessed to have developed EFI, as defined by a GRV measurement ≥250 mL within the 24 hours before randomization

Exclusion criteria

Exclusion Criteria:

History of diabetic or idiopathic gastroparesis
Screening blood glucose >15 mmol/L (270 mg/dL) while receiving insulin
Impaired renal function, as defined by estimated glomerular filtration rate (eGFR) \<30 mL/min, as determined by the Cockcroft-Gault formula -Bilirubin concentration in blood >2 times the upper limit of normal
ALT or AST >3 times upper limit of normal
Alkaline phosphatase >2 times upper limit of normal
Contraindication to enteral feeding
Opioid or other drug overdose as the primary reason for admission to Intensive Care Unit (ICU)
Receipt of a drug that can be used as a gastric prokinetic agent
Receipt of agents known to directly influence the 5 HT4/acetylcholine prokinetic mechanism

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 13 participants (actual)

Study arms

Experimental
TD-8954
TD-8954 single infusion for 1 hour and 4 injections of saline every 6 hours
Drug: TD-8954
Active comparator
Metoclopramide
Metoclopramide 4 doses every 6 hours for 24 hours and 1 hour infusion of saline
Drug: Metoclopramide

Interventions

DrugTD-8954
DrugMetoclopramide

What researchers measure

Primary outcomes

Adverse Events
the number of subjects reporting adverse events by treatment group
Time frame: 6 Days
Gastric Retention by Scintigraphy
Number of subjects with retention less than 13% at 180 minutes after dosing.
Time frame: 180 minutes

Secondary outcomes

Tmax
Time to maximal concentration in plasma
Time frame: 72 hours
AUC
Area under the plasma concentration time curve from 0 to 72 hours after dosing.
Time frame: 72 hours
Cmax
Maximum plasma concentration
Time frame: 72 hours
Gastric Emptying by Breath Test
Time to 1/2 gastric emptying by breath test
Time frame: 180 minutes
Percentage Gastric Retention by Scintigraphy at 60 Minutes Postdose
Mean gastric retention percentage after dosing.
Time frame: 60 minutes
Percentage Gastric Retention by Scintigraphy at 120 Minutes Postdose
Mean gastric retention percentage after dosing.
Time frame: 120 minutes
Percentage of Gastric Retention by Scintigraphy at 240 Minutes Postdose
Mean gastric retention percentage after dosing.
Time frame: 240 minutes

Results

Posted Jun 14, 2017

Participant flow

Participant flow — Overall Study
Milestone	TD-8954	Metoclopramide
Started	7	6
Completed	5	3
Not completed	2	3

Outcome measures

PrimaryAdverse Events

the number of subjects reporting adverse events by treatment group

Time frame:: 6 Days
Reported as:: Number · participants

Adverse Events
participants	TD-8954	Metoclopramide
Adverse Events	5	4

PrimaryGastric Retention by Scintigraphy

Number of subjects with retention less than 13% at 180 minutes after dosing.

Time frame:: 180 minutes
Reported as:: Number · participants

Gastric Retention by Scintigraphy
participants	TD-8954	Metoclopramide
Gastric Retention by Scintigraphy	6	3

SecondaryTmax

Time to maximal concentration in plasma

Time frame:: 72 hours
Reported as:: Median · hours

Tmax
hours	TD-8954	Metoclopramide
Tmax	0.500 (0.500 to 1.00)	—

SecondaryAUC

Area under the plasma concentration time curve from 0 to 72 hours after dosing.

Time frame:: 72 hours
Reported as:: Mean · pg*hr/mL

AUC
pg*hr/mL	TD-8954	Metoclopramide
AUC	23200 ± 9240	—

SecondaryCmax

Maximum plasma concentration

Time frame:: 72 hours
Reported as:: Mean · pg/mL

Cmax
pg/mL	TD-8954	Metoclopramide
Cmax	5040 ± 1780	—

SecondaryGastric Emptying by Breath Test

Time to 1/2 gastric emptying by breath test

Time frame:: 180 minutes
Reported as:: Mean · minutes

Gastric Emptying by Breath Test
minutes	TD-8954	Metoclopramide
Gastric Emptying by Breath Test	135.7 ± 41.61	132.5 ± 53.87

SecondaryPercentage Gastric Retention by Scintigraphy at 60 Minutes Postdose

Mean gastric retention percentage after dosing.

Time frame:: 60 minutes
Reported as:: Mean · percentage of retention

Percentage Gastric Retention by Scintigraphy at 60 Minutes Postdose
percentage of retention	TD-8954	Metoclopramide
Percentage Gastric Retention by Scintigraphy at 60 Minutes Postdose	29.6 ± 36.28	43.3 ± 30.14

SecondaryPercentage Gastric Retention by Scintigraphy at 120 Minutes Postdose

Mean gastric retention percentage after dosing.

Time frame:: 120 minutes
Reported as:: Mean · percentage of retention

Percentage Gastric Retention by Scintigraphy at 120 Minutes Postdose
percentage of retention	TD-8954	Metoclopramide
Percentage Gastric Retention by Scintigraphy at 120 Minutes Postdose	19.6 ± 36.10	32.3 ± 28.32

SecondaryPercentage of Gastric Retention by Scintigraphy at 240 Minutes Postdose

Mean gastric retention percentage after dosing.

Time frame:: 240 minutes
Reported as:: Mean · percentage of retention

Percentage of Gastric Retention by Scintigraphy at 240 Minutes Postdose
percentage of retention	TD-8954	Metoclopramide
Percentage of Gastric Retention by Scintigraphy at 240 Minutes Postdose	11.1 ± 24.85	16.3 ± 25.64

Adverse events

Collected over 6 Days. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
TD-8954	—	2/7 (28.6%)	5/7 (71.4%)
Metoclopramide	—	3/6 (50%)	2/6 (33.3%)

Most frequent serious events

Most frequent serious events
Event	TD-8954	Metoclopramide
Hemorrhage intracranialNervous system disorders	0/7	1/6
Subarachnoid hemorrhageNervous system disorders	0/7	1/6
Disease progressionGeneral disorders	0/7	1/6
Cerebral HemorrhageNervous system disorders	1/7	0/6
Respiratory failureRespiratory, thoracic and mediastinal disorders	1/7	0/6

Most frequent other events

Most frequent other events
Event	TD-8954	Metoclopramide
DiarrheaGastrointestinal disorders	0/7	1/6
HypertensionVascular disorders	0/7	1/6
AgitationPsychiatric disorders	1/7	0/6
HyperkalemiaMetabolism and nutrition disorders	1/7	0/6
PneumoniaInfections and infestations	1/7	0/6
VomitingGastrointestinal disorders	1/7	0/6
Decubitus ulcerSkin and subcutaneous tissue disorders	1/7	0/6

Baseline characteristics

Age, Continuous
Age, Continuous(years)	TD-8954	Metoclopramide	Total
Mean	54.0 ± 25.29	55.5 ± 13.37	54.7 ± 19.9

Sex: Female, Male
Sex: Female, Male(Participants)	TD-8954	Metoclopramide	Total
Female	1	2	3
Male	6	4	10

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	TD-8954	Metoclopramide	Total
American Indian or Alaska Native	0	0	0
Asian	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	0	0	0
White	7	6	13
More than one race	0	0	0
Unknown or Not Reported	0	0	0

Region of Enrollment
Region of Enrollment(Participants)	TD-8954	Metoclopramide	Total
Australia	7	6	13

Study locations

1 site

Royal Adelaide Hospital
Adelaide, South Australia, Australia

References and documents

Publications

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. PubMed 31990087 ↗

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 18, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01953081
Lead sponsor: Takeda
Collaborators: Theravance Biopharma
Responsible party: Sponsor
First posted: Sep 30, 2013
Start date: Jan 2014
Primary completion: Sep 2014
Completion: Oct 2014
Results posted: Jun 14, 2017
Last update: Feb 18, 2020

Study contacts

Daniel Canafax, PharmD, FCCP

study director · Theravance Biopharma, US, Inc.

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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A Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of a Single Dose of Intravenous TD-8954 Compared With Metoclopramide in Critically Ill Patients With Enteral Feeding Intolerance

Study summary

Conditions studied

Browse trials for

Keywords

In context

Critical Illness

Lead sponsor

Who can participate

✓Inclusion criteria

✕Exclusion criteria

Study design

Study arms

Interventions

What researchers measure

Primary outcomes

Secondary outcomes

Results

Participant flow

Outcome measures

Adverse events

Baseline characteristics

Study locations

References and documents

Publications

Individual participant data

Updates

Registry details

Key details

Study contacts

Oversight

Not currently enrolling

Follow this study

Discussion

Other studies in this condition

Other studies from this sponsor

Inclusion criteria

Exclusion criteria