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CompletedNCT03281577Updated Jan 7, 2021Results posted

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

A Phase 2 interventional study of TAK-954 and Placebo in Diabetic Gastroparesis and Idiopathic Gastroparesis, sponsored by Takeda. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-01-07.

Sponsored by Takeda · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The purpose of this study is to evaluate the dose-dependent effects of TAK-954 on gastric emptying time of solids in participants with diabetic or idiopathic gastroparesis assessed by scintigraphy.

Read the detailed description

The drug being tested in this study is called TAK-954. TAK-954 is a serotonin (5 HT4) receptor agonist and is being tested to treat people who have diabetic or idiopathic gastroparesis and who previously reported delay in stomach emptying. This study will look at the gastric emptying time of solids in people who take TAK-954 or placebo.

The study will enroll approximately 41 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the four treatment groups-which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need):

  • TAK-954 0.1 mg
  • TAK-954 0.3 mg
  • TAK-954 1 mg
  • Placebo (dummy inactive solution) - this is a solution that looks like the study drug but has no active ingredient.

This single center trial will be conducted in the United States. The duration of treatment is 3 days and the overall period of evaluation is up to 28 days. The participants will be contacted by telephone (Days 10 to 14) for follow-up assessment. There will be another follow-up phone call for women of childbearing potential (Days 38 to 43).

02

Conditions studied

  • Diabetic Gastroparesis
  • Idiopathic Gastroparesis

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Keywords

  • Drug Therapy
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Has diabetes mellitus with symptoms of gastroparesis and previously documented gastric emptying delay or previously documented idiopathic gastroparesis in the last 5 years.
  2. Has a body mass index (BMI) greater than or equal to (>=) 16 and less than or equal to (\<=) 40 kilogram per square meter (kg/m\^2) at the Screening Visit.

Exclusion criteria

Exclusion Criteria:

  1. Has glycosylated hemoglobin (HbA1c) greater than (>) 12 percent (%).
  2. Has other structural diseases/conditions that affect the gastrointestinal (GI) system.
  3. Are unable to withdraw drugs known to alter GI transit 48 hours prior to the study.
  4. Has clinically significant abnormal baseline safety laboratory values.
  5. Has preexisting hepatic disease that meets Child-Pugh Class B (moderate; total score 7 to 9 points) or C (severe; total score 10 to 15 points).

  6. Are without known preexisting hepatic disease who have 1 or more of the following:

    • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2 times the upper limit of normal (ULN).
    • Bilirubin >1.5 times the ULN unless due to Gilbert's syndrome.
    • International normalized ratio (INR) >1.5 unless on anticoagulation therapy.
  7. Has QT intervals with Fridericia correction method (QTcF) interval (>=) 460 millisecond (msec) or with other factors that increase the risk of QT prolongation or arrhythmic events at screening. Note: Participants with bundle branch block and a prolonged QTc interval, or with QTcF between 450 and 460 msec, should be reviewed by the Medical Monitor for potential inclusion.
  8. Has second or third degree atrioventricular (AV) block; AV disassociation; >5 beats of non-sustained VT at a rate >120 beats per minute (bpm); Electrocardiogram (ECG) changes consistent with acute myocardial ischemia or infarction.
  9. Has cardiac history that includes conditions requiring heart rate control (example, atrial fibrillation, atrial flutter, ventricular tachycardia, or other tachyarrhythmias).
  10. Has clinical evidence (including physical examination, ECG, clinical laboratory value and review of the medical history) of significant cardiovascular, respiratory, moderate or severe renal insufficiency (creatinine clearance \<=60 mL/min), hematological, neurological, or psychiatric disease, or other disease that interferes with the objectives of the study.
  11. If female, are pregnant or lactating or intending to become pregnant before participating in this study, during the study, and 4 to 5 days (5 half-lives) PLUS 30 days after last dose of the study drug; or intending to donate ova during such time period.
  12. Are considered by the investigator to be alcoholics not in remission or known substance abusers. Have a history of alcohol consumption exceeding 2 standard drinks per day on average (1 glass is approximately equivalent to: beer [354 milliliter per [mL/] 12 ounces], wine [118 mL/4 ounces], or distilled spirits [29.5 mL/1 ounce] per day).
04

Study design

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

Study arms

  • Placebo comparator
    Placebo

    TAK-954 placebo-matching, 60-minute infusion, intravenously (IV), once daily on Days 1 to 3.

    Drug: Placebo

  • Experimental
    TAK-954 0.1 mg

    TAK-954 0.1 mg, 60-minute infusion, IV, once daily on Days 1 to 3.

    Drug: TAK-954

  • Experimental
    TAK-954 0.3 mg

    TAK-954 1 mg, 60-minute infusion, IV, once daily for up to 3 days.

    Drug: TAK-954

  • Experimental
    TAK-954 1 mg

    TAK-954 1 mg, 60-minute infusion, IV, once daily on Days 1 to 3.

    Drug: TAK-954

Interventions

  • DrugTAK-954

    TAK-954 IV infusion.

  • DrugPlacebo

    TAK-954 placebo-matching IV infusion.

05

What researchers measure

Primary outcomes

  1. Percent Change From Baseline in Half-emptying Time (T1/2) of Gastric Solids

    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.

    Time frame: Predose and at multiple time-points post-dose (up to 9 hours) on Day 2

Secondary outcomes

  1. Colonic Geometric Center

    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.

    Time frame: 4, 24, and 48 hours post-radiolabeled meal on Day 2

  2. Colonic Filling at Hour 6

    Colonic filling was estimated as percentage of the radio-labelled meal that reached the colon at Hour 6.

    Time frame: 6 hours post-radiolabel meal on Day 2

  3. Half-emptying Time (T1/2) of Ascending Colon

    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.

    Time frame: Predose and at multiple time-points post-dose (up to 25 hours) on Days 1, 2 and 3

  4. AUCtau: Area Under the Plasma Concentration-Time Curve From Time 0 to t for TAK-954

    Time frame: Predose and at multiple time-points post-dose (up to 25 hours) on Days 1, 2 and 3

  5. Cmax: Maximum Observed Plasma Concentration for TAK-954

    Time frame: Predose and at multiple time-points post-dose (up to 25 hours) on Days 1, 2 and 3

  6. Ctrough: Observed Plasma Concentration at the End of a Dosing Interval

    Time frame: At multiple time-points post-dose, up to 9 hours on Day 2 and up to 25 hours on Day 3

06

Results

Posted Jul 15, 2020

Participant flow

Participants took part in the study at 1 investigative site in the United States from 02 January 2018 to 12 July 2019.

Participant flow — Overall Study
MilestonePlaceboTAK-954 0.1 mgTAK-954 0.3 mgTAK-954 1 mg
Started101097
Completed91096
Not completed1001
Withdrew: Adverse event0001
Withdrew: Withdrawal by subject1000

Outcome measures

PrimaryPercent Change From Baseline in Half-emptying Time (T1/2) of Gastric Solids

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.

Time frame:
Predose and at multiple time-points post-dose (up to 9 hours) on Day 2
Reported as:
Mean · percent change
Percent Change From Baseline in Half-emptying Time (T1/2) of Gastric Solids
percent changePlaceboTAK-954 0.1 mgTAK-954 0.3 mgTAK-954 1 mg
Percent Change From Baseline in Half-emptying Time (T1/2) of Gastric Solids3.5 ± 23.71-19.8 ± 14.43-25.4 ± 20.90-25.7 ± 23.56
Statistical analysis
  • Placebo vs TAK-954 0.1 mg · ANCOVA · p = 0.0012 (Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% confidence interval (CI) are presented.) · Least squares mean differences: -25.81 · 95% CI -41.757 to -9.858Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as covariate.
  • Placebo vs TAK-954 0.3 mg · ANCOVA · p = 0.0018 (Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.) · Least squares mean differences: -27.52 · 95% CI -45.224 to -9.813Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.
  • Placebo vs TAK-954 1 mg · ANCOVA · p = <.0001 (Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.) · Least squares mean differences: -41.76 · 95% CI -59.616 to -23.902Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.
SecondaryColonic Geometric Center

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.

Time frame:
4, 24, and 48 hours post-radiolabeled meal on Day 2
Reported as:
Mean · score on a scale
Colonic Geometric Center
score on a scalePlaceboTAK-954 0.1 mgTAK-954 0.3 mgTAK-954 1 mg
Colonic Transit at 4 Hours, Day 20.539 ± 0.68091.190 ± 0.90831.737 ± 1.03021.148 ± 0.4138
Colonic Transit at 24 Hours, Day 21.965 ± 1.29643.792 ± 1.14413.468 ± 1.32522.978 ± 1.1382
Colonic Transit at 48 Hours, Day 23.323 ± 1.29484.406 ± 1.11694.550 ± 0.90043.792 ± 1.0382
Statistical analysis
  • Placebo vs TAK-954 0.1 mg · ANCOVA · p = 0.2590 (Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.) · Least squares mean differences: 0.72 · 95% CI -0.364 to 1.795Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.
  • Placebo vs TAK-954 0.3 mg · ANCOVA · p = 0.0280 (Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.) · Least squares mean differences: 1.27 · 95% CI 0.119 to 2.418Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.
  • Placebo vs TAK-954 1 mg · ANCOVA · p = 0.6882 (Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.) · Least squares mean differences: 0.45 · 95% CI -0.757 to 1.660Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.
  • Placebo vs TAK-954 0.1 mg · ANCOVA · p = 0.0062 (Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.) · Least squares mean differences: 1.87 · 95% CI 0.493 to 3.250Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.
  • Placebo vs TAK-954 0.3 mg · ANCOVA · p = 0.1490 (Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.) · Least squares mean differences: 1.19 · 95% CI -0.327 to 2.717Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.
  • Placebo vs TAK-954 1 mg · ANCOVA · p = 0.6285 (Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.) · Least squares mean differences: 0.63 · 95% CI -0.931 to 2.200Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.
  • Placebo vs TAK-954 0.1 mg · ANCOVA · p = 0.0358 (Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.) · Least squares mean differences: 1.29 · 95% CI 0.073 to 2.501Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.
  • Placebo vs TAK-954 0.3 mg · ANCOVA · p = 0.0430 (Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.) · Least squares mean differences: 1.33 · 95% CI 0.035 to 2.621Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.
  • Placebo vs TAK-954 1 mg · ANCOVA · p = 0.9419 (Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.) · Least squares mean differences: 0.25 · 95% CI -1.107 to 1.611Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.
SecondaryColonic Filling at Hour 6

Colonic filling was estimated as percentage of the radio-labelled meal that reached the colon at Hour 6.

Time frame:
6 hours post-radiolabel meal on Day 2
Reported as:
Mean · percentage of radio-labelled food
Colonic Filling at Hour 6
percentage of radio-labelled foodPlaceboTAK-954 0.1 mgTAK-954 0.3 mgTAK-954 1 mg
Colonic Filling at Hour 631.3 ± 25.3855.6 ± 31.3186.4 ± 19.7675.3 ± 31.70
Statistical analysis
  • Placebo vs TAK-954 0.1 mg · ANCOVA · p = 0.0436 (Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.) · Least squares mean differences: 33.12 · 95% CI 0.799 to 65.439Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.
  • Placebo vs TAK-954 0.3 mg · ANCOVA · p = 0.0007 (Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.) · Least squares mean differences: 57.98 · 95% CI 23.555 to 92.396Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.
  • Placebo vs TAK-954 1 mg · ANCOVA · p = 0.0134 (Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.) · Least squares mean differences: 44.44 · 95% CI 8.249 to 80.629Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.
SecondaryHalf-emptying Time (T1/2) of Ascending Colon

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.

Time frame:
Predose and at multiple time-points post-dose (up to 25 hours) on Days 1, 2 and 3
Reported as:
Median · hours
Half-emptying Time (T1/2) of Ascending Colon
hoursPlaceboTAK-954 0.1 mgTAK-954 0.3 mgTAK-954 1 mg
Half-emptying Time (T1/2) of Ascending Colon19.1 (2.6 to 36.0)5.4 (1.9 to 28.8)6.3 (0.6 to 11.0)7.4 (0.9 to 13.6)
Statistical analysis
  • Placebo vs TAK-954 0.1 mg · ANCOVA · p = 0.0789 (Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.) · Least squares mean differences: -10.27 · 95% CI -21.507 to 0.960Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.
  • Placebo vs TAK-954 0.3 mg · ANCOVA · p = 0.0270 (Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.) · Least squares mean differences: -13.28 · 95% CI -25.242 to -1.314Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.
  • Placebo vs TAK-954 1 mg · ANCOVA · p = 0.0750 (Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.) · Least squares mean differences: -11.63 · 95% CI -24.206 to 0.952Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.
SecondaryAUCtau: Area Under the Plasma Concentration-Time Curve From Time 0 to t for TAK-954
Time frame:
Predose and at multiple time-points post-dose (up to 25 hours) on Days 1, 2 and 3
Reported as:
Mean · h*ng/mL
AUCtau: Area Under the Plasma Concentration-Time Curve From Time 0 to t for TAK-954
h*ng/mLTAK-954 0.1 mgTAK-954 0.3 mgTAK-954 1 mg
Day 18.99 ± 2.11025.79 ± 8.34083.75 ± 25.453
Day 212.16 ± 3.03333.94 ± 9.249109.86 ± 31.009
Day 315.72 ± 3.38739.34 ± 12.699125.88 ± 34.586
SecondaryCmax: Maximum Observed Plasma Concentration for TAK-954
Time frame:
Predose and at multiple time-points post-dose (up to 25 hours) on Days 1, 2 and 3
Reported as:
Mean · ng/mL
Cmax: Maximum Observed Plasma Concentration for TAK-954
ng/mLTAK-954 0.1 mgTAK-954 0.3 mgTAK-954 1 mg
Day 11.637 ± 0.39185.346 ± 1.579716.029 ± 2.9239
Day 21.687 ± 0.42275.821 ± 1.944715.517 ± 3.7070
Day 31.705 ± 0.32975.056 ± 1.543017.700 ± 7.1544
SecondaryCtrough: Observed Plasma Concentration at the End of a Dosing Interval
Time frame:
At multiple time-points post-dose, up to 9 hours on Day 2 and up to 25 hours on Day 3
Reported as:
Mean · ng/mL
Ctrough: Observed Plasma Concentration at the End of a Dosing Interval
ng/mLTAK-954 0.1 mgTAK-954 0.3 mgTAK-954 1 mg
Day 20.1969 ± 0.054060.4364 ± 0.203711.6817 ± 0.47072
Day 30.2854 ± 0.103190.6392 ± 0.263712.2620 ± 0.40493

Adverse events

Collected over From first dose up to 30 days post last dose (Up to 46 days). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo0/10 (0%)0/10 (0%)6/10 (60%)
TAK-954 0.1 mg0/10 (0%)0/10 (0%)5/10 (50%)
TAK-954 0.3 mg0/9 (0%)0/9 (0%)6/9 (66.7%)
TAK-954 1 mg0/7 (0%)1/7 (14.3%)6/7 (85.7%)
Most frequent serious events
Most frequent serious events
EventPlaceboTAK-954 0.1 mgTAK-954 0.3 mgTAK-954 1 mg
Pancreatic enzymes increasedInvestigations0/100/100/91/7
Most frequent other events
Showing 10 of 35
Most frequent other events
EventPlaceboTAK-954 0.1 mgTAK-954 0.3 mgTAK-954 1 mg
NauseaGastrointestinal disorders4/104/102/94/7
DiarrhoeaGastrointestinal disorders0/102/101/94/7
HeadacheNervous system disorders0/101/103/91/7
Abdominal painGastrointestinal disorders0/103/100/92/7
Abdominal distensionGastrointestinal disorders2/100/101/92/7
Gastrooesophageal reflux diseaseGastrointestinal disorders1/100/100/92/7
DehydrationMetabolism and nutrition disorders0/100/100/92/7
DizzinessNervous system disorders0/100/101/92/7
Viral infectionInfections and infestations0/102/100/90/7
LeukocytosisBlood and lymphatic system disorders0/100/100/91/7

Baseline characteristics

Safety analysis set included all subjects who receive at least 1 dose of study drug.

Age, Continuous
Age, Continuous(years)PlaceboTAK-954 0.1 mgTAK-954 0.3 mgTAK-954 1 mgTotal
Mean46.2 ± 15.6746.8 ± 12.4542.3 ± 11.8240.3 ± 8.7544.3 ± 12.45
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboTAK-954 0.1 mgTAK-954 0.3 mgTAK-954 1 mgTotal
Female8107530
Male20226
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)PlaceboTAK-954 0.1 mgTAK-954 0.3 mgTAK-954 1 mgTotal
Hispanic or Latino00000
Not Hispanic or Latino999734
Unknown or Not Reported11002
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)PlaceboTAK-954 0.1 mgTAK-954 0.3 mgTAK-954 1 mgTotal
White10109736
Disease History
Disease History(Participants)PlaceboTAK-954 0.1 mgTAK-954 0.3 mgTAK-954 1 mgTotal
Idiopathic Gastroparesis773522
Diabetic Gastroparesis336214
Weight
Weight(kg)PlaceboTAK-954 0.1 mgTAK-954 0.3 mgTAK-954 1 mgTotal
Mean68.3 ± 15.0573.4 ± 14.5776.5 ± 17.9762.5 ± 9.2270.6 ± 15.07
Height
Height(cm)PlaceboTAK-954 0.1 mgTAK-954 0.3 mgTAK-954 1 mgTotal
Mean166.2 ± 9.37160.7 ± 7.27165.7 ± 5.92166.3 ± 7.57164.6 ± 7.74
Body Mass Index (BMI)
Body Mass Index (BMI)(kg/m^2)PlaceboTAK-954 0.1 mgTAK-954 0.3 mgTAK-954 1 mgTotal
Mean24.8 ± 4.8828.4 ± 5.5027.7 ± 5.4422.6 ± 3.1526.1 ± 5.24
07

Study locations

1 site
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
08

References and documents

Publications

  • Chedid V, Brandler J, Arndt K, Vijayvargiya P, Wang XJ, Burton D, Harmsen WS, Siegelman J, Chen C, Chen Y, Almansa C, Dukes G, Camilleri M. Randomised study: effects of the 5-HT4 receptor agonist felcisetrag vs placebo on gut transit in patients with gastroparesis. Aliment Pharmacol Ther. 2021 May;53(9):1010-1020. doi: 10.1111/apt.16304. Epub 2021 Mar 12. PubMed 33711180 ↗

Study documents

  • Study protocol · Dec 19, 2018
  • Statistical analysis plan · Sep 25, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Supporting information: Study protocol, Sap, Icf, Csr

09

Registry details

Key details

Study ID
NCT03281577
Lead sponsor
Takeda
Responsible party
Sponsor
First posted
Sep 13, 2017
Start date
Jan 2, 2018
Primary completion
Jun 7, 2019
Completion
Jul 12, 2019
Results posted
Jul 15, 2020
Last update
Jan 7, 2021

Study contacts

Medical Director Clinical Science
study director · Takeda

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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