Enteral Feeding IntolerancePhase 1/2NCT01953081
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 study testing TD-8954 and Metoclopramide in people with Enteral Feeding Intolerance, run by Takeda at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Enteral Feeding Intolerance
- What is being tested?
- TD-8954 and Metoclopramide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteAustralia
- Study dates
- Jan 2014to Oct 2014
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Enteral Feeding Intolerance
- Being tested
- TD-8954, Metoclopramide
- Keywords
- Enteral feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TD-8954Drug
MetoclopramideDrug
| Study group | Role | What they receive |
|---|---|---|
| TD-8954 | Experimental | TD-8954 single infusion for 1 hour and 4 injections of saline every 6 hours Receives: Drug: TD-8954 |
| Metoclopramide | Active comparator | Metoclopramide 4 doses every 6 hours for 24 hours and 1 hour infusion of saline Receives: Drug: Metoclopramide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
the number of subjects reporting adverse events by treatment group
Measured: 6 Days
Gastric Retention by Scintigraphy
Number of subjects with retention less than 13% at 180 minutes after dosing.
Measured: 180 minutes
Secondary outcomes (7)
Tmax
Time to maximal concentration in plasma
Measured: 72 hours
AUC
Area under the plasma concentration time curve from 0 to 72 hours after dosing.
Measured: 72 hours
Cmax
Maximum plasma concentration
Measured: 72 hours
Gastric Emptying by Breath Test
Time to 1/2 gastric emptying by breath test
Measured: 180 minutes
Percentage Gastric Retention by Scintigraphy at 60 Minutes Postdose
Mean gastric retention percentage after dosing.
Measured: 60 minutes
Percentage Gastric Retention by Scintigraphy at 120 Minutes Postdose
Mean gastric retention percentage after dosing.
Measured: 120 minutes
Percentage of Gastric Retention by Scintigraphy at 240 Minutes Postdose
Mean gastric retention percentage after dosing.
Measured: 240 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2013 (estimated)
- Study startJan 2014
- Primary completionSep 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Enteral Feeding IntoleranceStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Theravance Biopharma
- Responsible party
- Sponsor
- Investigators
- Daniel Canafax, PharmD, FCCP, Study director, Theravance Biopharma, US, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01953081
- Sponsor's protocol ID
- 0082
- Status last verified
- Feb 2020
- First submitted
- 25 Sep 2013
- Last updated
- 18 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01953081
- Acronym / sponsor ID
- 0082
- Conditions
- Enteral Feeding Intolerance
- Keywords
- Enteral feeding
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Collaborators
- Theravance Biopharma
- Study start
- Jan 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 30 Sep 2013 (estimated)
- Results
- Posted 14 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TD-8954 | Experimental | Drug: TD-8954TD-8954 single infusion for 1 hour and 4 injections of saline every 6 hours |
| Metoclopramide | Active comparator | Drug: MetoclopramideMetoclopramide 4 doses every 6 hours for 24 hours and 1 hour infusion of saline |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TD-8954 | Drug | TD-8954 |
| Metoclopramide | Drug | Metoclopramide |
Primary outcome
Adverse Events
Time frame: 6 Days
the number of subjects reporting adverse events by treatment group
Gastric Retention by Scintigraphy
Time frame: 180 minutes
Number of subjects with retention less than 13% at 180 minutes after dosing.
7 secondary outcomes
Tmax
Time frame: 72 hours
AUC
Time frame: 72 hours
Cmax
Time frame: 72 hours
Gastric Emptying by Breath Test
Time frame: 180 minutes
Percentage Gastric Retention by Scintigraphy at 60 Minutes Postdose
Time frame: 60 minutes
Percentage Gastric Retention by Scintigraphy at 120 Minutes Postdose
Time frame: 120 minutes
Percentage of Gastric Retention by Scintigraphy at 240 Minutes Postdose
Time frame: 240 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31990087Chapman 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Canafax, PharmD, FCCP study director
Theravance Biopharma, US, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TD-8954 and Metoclopramide in people with Enteral Feeding Intolerance, run by Takeda at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: 6 Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01953081, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2020; AzTrials last refreshed its copy on 27 Oct 2026.