NCT01953081

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 30, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

June 14, 2017

Completed
Last Updated

February 18, 2020

Status Verified

February 1, 2020

Enrollment Period

8 months

First QC Date

September 25, 2013

Results QC Date

December 20, 2016

Last Update Submit

February 5, 2020

Conditions

Enteral Feeding Intolerance

Keywords

Enteral feeding

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (7)

  • Tmax

    72 hours

  • AUC

    72 hours

  • Cmax

    72 hours

  • Gastric Emptying by Breath Test

    180 minutes

  • Percentage Gastric Retention by Scintigraphy at 60 Minutes Postdose

    60 minutes

  • +2 more secondary outcomes

Study Arms (2)

TD-8954

EXPERIMENTAL

TD-8954 single infusion for 1 hour and 4 injections of saline every 6 hours

Drug: TD-8954

Metoclopramide

ACTIVE COMPARATOR

Metoclopramide 4 doses every 6 hours for 24 hours and 1 hour infusion of saline

Drug: Metoclopramide

Interventions

TD-8954DRUG
TD-8954
MetoclopramideDRUG
Metoclopramide

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Location

Related Publications (1)

  • 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.

    PMID: 31990087DERIVED

MeSH Terms

Interventions

4-((4-((2-isopropyl-1H-benzoimidazole-4-carbonyl)amino)methyl)piperidin-1-ylmethyl)piperidine-1-carboxylic acid methyl esterMetoclopramide

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic Chemicalspara-AminobenzoatesAminobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsChlorobenzoatesHydroxybenzoate EthersHydroxybenzoatesHydroxy AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenyl EthersPhenols

Results Point of Contact

Title
Dr. Brett Haumann, SVP, Clinical Development
Organization
Theravance Biopharma US, Inc.
BHaumann@theravance.com
650-808-6000

Study Officials

  • Daniel Canafax, PharmD, FCCP

    Theravance Biopharma, US, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2013

First Posted

September 30, 2013

Study Start

January 1, 2014

Primary Completion

September 1, 2014

Study Completion

October 1, 2014

Last Updated

February 18, 2020

Results First Posted

June 14, 2017

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)