Trial · NCT03544229

A Study to Evaluate the Efficacy and Safety of TAK-906 in Adult Participants With Symptomatic Idiopathic or Diabetic Gastroparesis

NCT03544229, Phase 2, Completed, Millennium Pharmaceuticals, Inc.; results first posted 2022-11-16

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Study to Evaluate the Efficacy and Safety of TAK-906 in Adult Participants With Symptomatic Idiopathic or Diabetic Gastroparesis. Trials, record NCT03544229. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03544229

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Trial

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

Title: A Study to Evaluate the Efficacy and Safety of TAK-906 in Adult Participants With Symptomatic Idiopathic or Diabetic Gastroparesis
NCT number: NCT03544229
Status: Completed
Phases: Phase 2
Enrollment: 242 participants, actual
Lead sponsor: Millennium Pharmaceuticals, Inc.
Conditions: Diabetic Gastroparesis, Idiopathic Gastroparesis
Interventions: TAK-906 Maleate, Placebo
First posted: 2018-06-01
Last updated: 2022-11-16
Other registries' IDs: eudract:2018-001275-21
Results first posted: 2022-11-16

Source ClinicalTrials.gov

Registered outcomes12

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

List	Outcome	Time frame	Description
Primary	Change From Baseline in the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) Composite Score at Week 12 of the Treatment Period	Baseline and Week 12	ANMS GCSI-DD is a patient-reported outcome instrument for a symptom-based clinical trial endpoint in gastroparesis. The ANMS GCSI-DD composite score included score of nausea, early satiety, upper abdominal pain, and postprandial fullness. The severity scores of these symptoms range from 0 (none) to 4 (very severe). The daily composite score was calculated by summing the scores on the 4 symptom items (nausea, early satiety, postprandial fullness, and upper abdominal pain) and then dividing by 4, that is the number of items within the composite score. Thus, the maximum daily composite score was (4 symptoms × maximum score 4 divided by 4) = 16/4 = 4. The ANMS GCSI-DD daily composite score ranged from 0 to 4 with higher scores reflecting greater symptom severity. The negative change from baseline indicates improvement. Mixed-effects Model for Repeated Measures (MMRM) was used for the analysis.
Secondary	Percentage of Participants With at Least 50% Reduction From Baseline in ANMS GCSI-DD Composite Score at Week 12	Baseline and Week 12	ANMS GCSI-DD is a patient-reported outcome instrument for a symptom-based clinical trial endpoint in gastroparesis . The ANMS GCSI-DD composite score included score of nausea, early satiety, upper abdominal pain and postprandial fullness. The severity scores of these symptoms range from 0 (none) to 4 (very severe). The daily composite score was calculated by summing the scores on the 4 symptom items (nausea, early satiety, postprandial fullness, and upper abdominal pain) and then dividing by 4, that is the number of items within the composite score. Thus, the maximum daily composite score was (4 symptoms × maximum score 4 divided by 4) = 16/4 = 4. The ANMS GCSI-DD daily composite score ranged from 0 to 4 with higher scores reflecting greater symptom severity.
Secondary	Change From Baseline in the ANMS GCSI-DD Nausea Symptom Score at Week 12 of the Treatment Period	Baseline and Week 12	ANMS GCSI-DD is a patient-reported outcome instrument for a symptom-based clinical trial endpoint in gastroparesis. The ANMS GCSI-DD assesses nausea, early satiety, postprandial fullness, and upper abdominal pain on a severity score calculated from a 5-point Likert scale. The ANMS GCSI-DD nausea symptom score ranged from 0 to 4 with higher scores reflecting greater symptom severity. The negative change from baseline indicates improvement. MMRM was used for analysis.
Secondary	Change From Baseline in the ANMS GCSI-DD Early Satiety Symptom Score at Week 12 of the Treatment Period	Baseline and Week 12	ANMS GCSI-DD is a patient-reported outcome instrument for a symptom-based clinical trial endpoint in gastroparesis. The ANMS GCSI-DD assesses nausea, early satiety, postprandial fullness, and upper abdominal pain on a severity score calculated from a 5-point Likert scale. The ANMS GCSI-DD early satiety symptom score ranged from 0 to 4 with higher scores reflecting greater symptom severity. The negative change from Baseline indicated improvement. MMRM was used for the analysis.
Secondary	Change From Baseline in the ANMS GCSI-DD Postprandial Fullness Symptom Score at Week 12 of the Treatment Period	Baseline and Week 12	ANMS GCSI-DD is a patient-reported outcome instrument for a symptom-based clinical trial endpoint in gastroparesis. The ANMS GCSI-DD assesses nausea, early satiety, postprandial fullness, and upper abdominal pain on a severity score calculated from a 5-point Likert scale. The ANMS GCSI-DD postprandial fullness symptom score ranged from 0 to 4 with higher scores reflecting greater symptom severity. The negative change from baseline indicates improvement. MMRM was used for the analysis.
Secondary	Change From Baseline in the ANMS GCSI-DD Upper Abdominal Pain Symptom Score at Week 12 of the Treatment Period	Baseline and Week 12	ANMS GCSI-DD is a patient-reported outcome instrument for a symptom-based clinical trial endpoint in gastroparesis. The ANMS GCSI-DD assesses nausea, early satiety, postprandial fullness, and upper abdominal pain on a severity score calculated from a 5-point Likert scale. The ANMS GCSI-DD upper abdominal pain symptom score ranged from 0 to 4 with higher scores reflecting greater symptom severity. The negative change from baseline indicates improvement. MMRM was used for the analysis.
Secondary	Change From Baseline in the ANMS GCSI-DD Recorded Vomiting Frequency at Week 12 of the Treatment Period	Baseline and Week 12	Vomiting frequency was collected as the number of times a participant vomited in a 24-hour period i.e., vomiting episodes using the ANMS GCSI-DD. The daily score was averaged over 7 days. Higher scores indicate more severe symptoms. MMRM was used for the analysis.
Secondary	Change From Baseline in the ANMS GCSI-DD Overall Severity of Gastroparesis Symptoms Score at Week 12 of the Treatment Period	Baseline and Week 12	The overall severity of gastroparesis symptoms is the participant report of the overall severity rating of their symptoms as entered daily in the ANMS GCSI-DD and at time of visit. Severity was rated on a 0 (none) to 4 (very severe) scale. Higher score values indicated more severe symptoms. MMRM was used for the analysis.
Secondary	Change From Baseline in the ANMS GCI-DD Bloating Severity Scale Score at Week 12 of the Treatment Period	Baseline and Week 12	The bloating severity scale was scored from 0 to 4 (where 0 = no symptom and 4 = severe symptom). The daily total score can range from 0 to 4 with higher scores reflecting greater symptom severity. The negative change from baseline indicates improvement. MMRM was used for analysis.
Secondary	Change From Baseline in the ANMS GCSI-DD Total Score at Week 12 of the Treatment Period	Baseline and Week 12	Daily total score was calculated by summing scores on each of the 5 symptom items in ANMS GCSI-DD (nausea, early satiety, postprandial fullness, upper abdominal pain and vomiting) plus the bloating severity item and then dividing by 6. When calculating total score, vomiting frequency was scored from 0 to 4 (where 0=no vomiting and 4=four or more episodes of vomiting). The daily total score can range from 0 to 4 with higher scores reflecting greater symptom severity. MMRM was used for analyses.

1 to 10 of 12Source ClinicalTrials.gov

See all 12 registered outcomes

Outcomes12

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) Composite Score at Week 12 of the Treatment Period	Baseline and Week 12	FAS included all participants who were randomized, received at least 1 dose of study drug, and have a baseline value and at least 1 valid postbaseline value for assessment of primary efficacy.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Percentage of Participants With at Least 50% Reduction From Baseline in ANMS GCSI-DD Composite Score at Week 12	Baseline and Week 12	FAS included all participants who were randomized, received at least 1 dose of study drug, and have a baseline value and at least 1 valid postbaseline value for assessment of primary efficacy.	percentage of participants	NUMBER
SECONDARY	Change From Baseline in the ANMS GCSI-DD Nausea Symptom Score at Week 12 of the Treatment Period	Baseline and Week 12	FAS included all participants who were randomized, received at least 1 dose of study drug, and have a baseline value and at least 1 valid postbaseline value for assessment of primary efficacy. Overall number analyzed is the number of participants with data available for analysis.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in the ANMS GCSI-DD Early Satiety Symptom Score at Week 12 of the Treatment Period	Baseline and Week 12	FAS included all participants who were randomized, received at least 1 dose of study drug, and have a baseline value and at least 1 valid postbaseline value for assessment of primary efficacy. Overall number analyzed is the number of participants with data available for analysis.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in the ANMS GCSI-DD Postprandial Fullness Symptom Score at Week 12 of the Treatment Period	Baseline and Week 12	FAS included all participants who were randomized, received at least 1 dose of study drug, and have a baseline value and at least 1 valid postbaseline value for assessment of primary efficacy. Overall number analyzed is the number of participants with data available for analysis.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in the ANMS GCSI-DD Upper Abdominal Pain Symptom Score at Week 12 of the Treatment Period	Baseline and Week 12	FAS included all participants who were randomized, received at least 1 dose of study drug, and have a baseline value and at least 1 valid postbaseline value for assessment of primary efficacy. Overall number analyzed is the number of participants with data available for analysis.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in the ANMS GCSI-DD Recorded Vomiting Frequency at Week 12 of the Treatment Period	Baseline and Week 12	FAS included all participants who were randomized, received at least 1 dose of study drug, and have a baseline value and at least 1 valid postbaseline value for assessment of primary efficacy. Overall number analyzed is the number of participants with data available for analysis.	vomiting episodes/day	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in the ANMS GCSI-DD Overall Severity of Gastroparesis Symptoms Score at Week 12 of the Treatment Period	Baseline and Week 12	FAS included all participants who were randomized, received at least 1 dose of study drug, and have a baseline value and at least 1 valid postbaseline value for assessment of primary efficacy. Overall number analyzed is the number of participants with data available for analysis.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in the ANMS GCI-DD Bloating Severity Scale Score at Week 12 of the Treatment Period	Baseline and Week 12	FAS included all participants who were randomized, received at least 1 dose of study drug, and have a baseline value and at least 1 valid postbaseline value for assessment of primary efficacy. Overall number analyzed is the number of participants with data available for analysis.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in the ANMS GCSI-DD Total Score at Week 12 of the Treatment Period	Baseline and Week 12	FAS included all participants who were randomized, received at least 1 dose of study drug, and have a baseline value and at least 1 valid postbaseline value for assessment of primary efficacy. Overall number analyzed is the number of participants with data available for analysis.	score on a scale	LEAST_SQUARES_MEAN

1 to 10 of 12Source ClinicalTrials.gov

See all 12 outcomes

Results by group48

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

Outcome	Group	Value	Spread	Units
Change From Baseline in the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) Composite Score at Week 12 of the Treatment Period	Placebo	-1.19	Standard Error 0.120	score on a scale
Change From Baseline in the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) Composite Score at Week 12 of the Treatment Period	TAK-906 Maleate 5 mg	-1.11	Standard Error 0.219	score on a scale
Change From Baseline in the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) Composite Score at Week 12 of the Treatment Period	TAK-906 Maleate 25 mg	-1.17	Standard Error 0.120	score on a scale
Change From Baseline in the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) Composite Score at Week 12 of the Treatment Period	TAK-906 Maleate 50 mg	-1.21	Standard Error 0.116	score on a scale
Percentage of Participants With at Least 50% Reduction From Baseline in ANMS GCSI-DD Composite Score at Week 12	Placebo	42.5		percentage of participants
Percentage of Participants With at Least 50% Reduction From Baseline in ANMS GCSI-DD Composite Score at Week 12	TAK-906 Maleate 5 mg	39.1		percentage of participants
Percentage of Participants With at Least 50% Reduction From Baseline in ANMS GCSI-DD Composite Score at Week 12	TAK-906 Maleate 25 mg	47.2		percentage of participants
Percentage of Participants With at Least 50% Reduction From Baseline in ANMS GCSI-DD Composite Score at Week 12	TAK-906 Maleate 50 mg	41.9		percentage of participants
Change From Baseline in the ANMS GCSI-DD Nausea Symptom Score at Week 12 of the Treatment Period	Placebo	-1.42	Standard Error 0.134	score on a scale
Change From Baseline in the ANMS GCSI-DD Nausea Symptom Score at Week 12 of the Treatment Period	TAK-906 Maleate 5 mg	-1.36	Standard Error 0.245	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	73
Overall Study	STARTED	TAK-906 Maleate 5 mg	23
Overall Study	STARTED	TAK-906 Maleate 25 mg	72
Overall Study	STARTED	TAK-906 Maleate 50 mg	74
Overall Study	COMPLETED	Placebo	67
Overall Study	COMPLETED	TAK-906 Maleate 5 mg	21
Overall Study	COMPLETED	TAK-906 Maleate 25 mg	67
Overall Study	COMPLETED	TAK-906 Maleate 50 mg	72
Overall Study	NOT COMPLETED	Placebo	6
Overall Study	NOT COMPLETED	TAK-906 Maleate 5 mg	2

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events36

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	Headache	Nervous system disorders	Placebo	0	73
other	Headache	Nervous system disorders	TAK-906 5 mg	0	23
other	Headache	Nervous system disorders	TAK-906 25 mg	4	72
other	Headache	Nervous system disorders	TAK-906 50 mg	0	74
other	Nausea	Gastrointestinal disorders	Placebo	0	73
other	Nausea	Gastrointestinal disorders	TAK-906 5 mg	0	23
other	Nausea	Gastrointestinal disorders	TAK-906 25 mg	0	72
other	Nausea	Gastrointestinal disorders	TAK-906 50 mg	4	74
other	Upper respiratory tract infection	Infections and infestations	Placebo	0	73
other	Upper respiratory tract infection	Infections and infestations	TAK-906 5 mg	2	23

1 to 10 of 36Source ClinicalTrials.gov

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Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	73
Total, all-cause mortality	TAK-906 5 mg	0	23
Total, all-cause mortality	TAK-906 25 mg	0	72
Total, all-cause mortality	TAK-906 50 mg	0	74
Total, other adverse events	Placebo	0	73
Total, other adverse events	TAK-906 5 mg	2	23
Total, other adverse events	TAK-906 25 mg	4	72
Total, other adverse events	TAK-906 50 mg	4	74
Total, serious adverse events	Placebo	2	73
Total, serious adverse events	TAK-906 5 mg	0	23

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
34967147	DERIVED	PubMed
37533380	DERIVED	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.

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