Trial · NCT03281577

Effect of TAK-954 on Gastrointestinal and Colonic Transit in Diabetic or Idiopathic Gastroparesis Participants

NCT03281577, Phase 2, Completed, Takeda; results first posted 2020-07-15

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Effect of TAK-954 on Gastrointestinal and Colonic Transit in Diabetic or Idiopathic Gastroparesis Participants. Trials, record NCT03281577. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03281577

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Effect of TAK-954 on Gastrointestinal and Colonic Transit in Diabetic or Idiopathic Gastroparesis Participants
NCT number: NCT03281577
Status: Completed
Phases: Phase 2
Enrollment: 36 participants, actual
Lead sponsor: Takeda
Conditions: Diabetic Gastroparesis, Idiopathic Gastroparesis
Interventions: TAK-954, Placebo
First posted: 2017-09-13
Last updated: 2021-01-07
Results first posted: 2020-07-15

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Percent Change From Baseline in Half-emptying Time (T1/2) of Gastric Solids	Predose and at multiple time-points post-dose (up to 9 hours) on Day 2	Half-emptying time (t1/2) of gastric solids is the time for half of the ingested solids or liquids to leave the stomach. Scintigraphy assessments were used to evaluate the gastric emptying of solids following a radio-labelled meal. A negative percent change from baseline indicated improvement.
Secondary	Colonic Geometric Center	4, 24, and 48 hours post-radiolabeled meal on Day 2	The scintigraphic method was used to measure colonic geometric center following a radio-labelled meal. The geometric center (GC) was the weighted average of counts in the different colonic regions, where 0= no radioactivity in the colon and if radioactivity was detected in the colon, 1=all isotope was in the ascending colon and 5=all isotope was in the stool; a high GC indicated faster colonic transit.
Secondary	Colonic Filling at Hour 6	6 hours post-radiolabel meal on Day 2	Colonic filling was estimated as percentage of the radio-labelled meal that reached the colon at Hour 6.
Secondary	Half-emptying Time (T1/2) of Ascending Colon	Predose and at multiple time-points post-dose (up to 25 hours) on Days 1, 2 and 3	T1/2 of ascending colon emptying was estimated by analysis of proportionate emptying over time of counts from the colon. Scintigraphy assessments were used to evaluate the emptying of solids or liquids from ascending colon following a radio-labelled meal.
Secondary	AUCtau: Area Under the Plasma Concentration-Time Curve From Time 0 to t for TAK-954	Predose and at multiple time-points post-dose (up to 25 hours) on Days 1, 2 and 3
Secondary	Cmax: Maximum Observed Plasma Concentration for TAK-954	Predose and at multiple time-points post-dose (up to 25 hours) on Days 1, 2 and 3
Secondary	Ctrough: Observed Plasma Concentration at the End of a Dosing Interval	At multiple time-points post-dose, up to 9 hours on Day 2 and up to 25 hours on Day 3

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percent Change From Baseline in Half-emptying Time (T1/2) of Gastric Solids	Predose and at multiple time-points post-dose (up to 9 hours) on Day 2	Full analysis set included all randomized participants who received at least 1 dose of study drug. Overall number of participants analyzed is number of participants with data available for analyses.	percent change	MEAN
SECONDARY	Colonic Geometric Center	4, 24, and 48 hours post-radiolabeled meal on Day 2	Full analysis set included all randomized participants who received at least 1 dose of study drug. Number analyzed is the number of participants with evaluable data at the given time point.	score on a scale	MEAN
SECONDARY	Colonic Filling at Hour 6	6 hours post-radiolabel meal on Day 2	Full analysis set included all randomized participants who received at least 1 dose of study drug. Overall number of participants analyzed is number of participants with data available for analyses.	percentage of radio-labelled food	MEAN
SECONDARY	Half-emptying Time (T1/2) of Ascending Colon	Predose and at multiple time-points post-dose (up to 25 hours) on Days 1, 2 and 3	Full analysis set included all randomized participants who received at least 1 dose of study drug. Overall number of participants analyzed is the number of participants with data available for analyses.	hours	MEDIAN
SECONDARY	AUCtau: Area Under the Plasma Concentration-Time Curve From Time 0 to t for TAK-954	Predose and at multiple time-points post-dose (up to 25 hours) on Days 1, 2 and 3	Pharmacokinetic (PK) analysis set included all participants who received at least 1 dose of study drug and had sufficient blood sampling to allow for PK evaluation. Number analyzed is the number of participants with evaluable data at the given time point.	h*ng/mL	MEAN
SECONDARY	Cmax: Maximum Observed Plasma Concentration for TAK-954	Predose and at multiple time-points post-dose (up to 25 hours) on Days 1, 2 and 3	PK analysis set included all participants who received at least 1 dose of study drug and had sufficient blood sampling to allow for PK evaluation. Number analyzed is the number of participants with evaluable data at the given time point.	ng/mL	MEAN
SECONDARY	Ctrough: Observed Plasma Concentration at the End of a Dosing Interval	At multiple time-points post-dose, up to 9 hours on Day 2 and up to 25 hours on Day 3	PK analysis set included all participants who received at least 1 dose of study drug and had sufficient blood sampling to allow for PK evaluation. Number analyzed is the number of participants with evaluable data at the given time point.	ng/mL	MEAN

Source ClinicalTrials.gov

Results by group48

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Percent Change From Baseline in Half-emptying Time (T1/2) of Gastric Solids	Placebo		3.5	Standard Deviation 23.71	percent change
Percent Change From Baseline in Half-emptying Time (T1/2) of Gastric Solids	TAK-954 0.1 mg		-19.8	Standard Deviation 14.43	percent change
Percent Change From Baseline in Half-emptying Time (T1/2) of Gastric Solids	TAK-954 0.3 mg		-25.4	Standard Deviation 20.90	percent change
Percent Change From Baseline in Half-emptying Time (T1/2) of Gastric Solids	TAK-954 1 mg		-25.7	Standard Deviation 23.56	percent change
Colonic Geometric Center	Placebo	Colonic Transit at 4 Hours, Day 2	0.539	Standard Deviation 0.6809	score on a scale
Colonic Geometric Center	TAK-954 0.1 mg	Colonic Transit at 4 Hours, Day 2	1.190	Standard Deviation 0.9083	score on a scale
Colonic Geometric Center	TAK-954 0.3 mg	Colonic Transit at 4 Hours, Day 2	1.737	Standard Deviation 1.0302	score on a scale
Colonic Geometric Center	TAK-954 1 mg	Colonic Transit at 4 Hours, Day 2	1.148	Standard Deviation 0.4138	score on a scale
Colonic Geometric Center	Placebo	Colonic Transit at 24 Hours, Day 2	1.965	Standard Deviation 1.2964	score on a scale
Colonic Geometric Center	TAK-954 0.1 mg	Colonic Transit at 24 Hours, Day 2	3.792	Standard Deviation 1.1441	score on a scale

1 to 10 of 48Source ClinicalTrials.gov

See all 48 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	10
Overall Study	STARTED	TAK-954 0.1 mg	10
Overall Study	STARTED	TAK-954 0.3 mg	9
Overall Study	STARTED	TAK-954 1 mg	7
Overall Study	COMPLETED	Placebo	9
Overall Study	COMPLETED	TAK-954 0.1 mg	10
Overall Study	COMPLETED	TAK-954 0.3 mg	9
Overall Study	COMPLETED	TAK-954 1 mg	6
Overall Study	NOT COMPLETED	Placebo	1
Overall Study	NOT COMPLETED	TAK-954 0.1 mg	0

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events144

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Leukocytosis	Blood and lymphatic system disorders	Placebo	0	10
other	Leukocytosis	Blood and lymphatic system disorders	TAK-954 0.1 mg	0	10
other	Leukocytosis	Blood and lymphatic system disorders	TAK-954 0.3 mg	0	9
other	Leukocytosis	Blood and lymphatic system disorders	TAK-954 1 mg	1	7
other	Eye swelling	Eye disorders	Placebo	0	10
other	Eye swelling	Eye disorders	TAK-954 0.1 mg	0	10
other	Eye swelling	Eye disorders	TAK-954 0.3 mg	0	9
other	Eye swelling	Eye disorders	TAK-954 1 mg	1	7
other	Nausea	Gastrointestinal disorders	Placebo	4	10
other	Nausea	Gastrointestinal disorders	TAK-954 0.1 mg	4	10

1 to 10 of 144Source ClinicalTrials.gov

See all 144 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	10
Total, all-cause mortality	TAK-954 0.1 mg	0	10
Total, all-cause mortality	TAK-954 0.3 mg	0	9
Total, all-cause mortality	TAK-954 1 mg	0	7
Total, other adverse events	Placebo	6	10
Total, other adverse events	TAK-954 0.1 mg	5	10
Total, other adverse events	TAK-954 0.3 mg	6	9
Total, other adverse events	TAK-954 1 mg	6	7
Total, serious adverse events	Placebo	0	10
Total, serious adverse events	TAK-954 0.1 mg	0	10

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
33711180	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03281577

GET https://conductscience.org/api/trials/v1/NCT03281577/results?page=2

API reference For AI assistants