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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1200-9396 | Registry Identifier | WHO |
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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.
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):
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | TAK-954 placebo-matching, 60-minute infusion, intravenously (IV), once daily on Days 1 to 3. |
|
| TAK-954 0.1 mg | Experimental | TAK-954 0.1 mg, 60-minute infusion, IV, once daily on Days 1 to 3. |
|
| TAK-954 0.3 mg | Experimental | TAK-954 1 mg, 60-minute infusion, IV, once daily for up to 3 days. |
|
| TAK-954 1 mg | Experimental | TAK-954 1 mg, 60-minute infusion, IV, once daily on Days 1 to 3. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAK-954 | Drug | TAK-954 IV infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Predose and at multiple time-points post-dose (up to 9 hours) on Day 2 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Has glycosylated hemoglobin (HbA1c) greater than (>) 12 percent (%).
Has other structural diseases/conditions that affect the gastrointestinal (GI) system.
Are unable to withdraw drugs known to alter GI transit 48 hours prior to the study.
Has clinically significant abnormal baseline safety laboratory values.
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).
Are without known preexisting hepatic disease who have 1 or more of the following:
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.
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.
Has cardiac history that includes conditions requiring heart rate control (example, atrial fibrillation, atrial flutter, ventricular tachycardia, or other tachyarrhythmias).
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.
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.
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).
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director Clinical Science | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33711180 | Derived | 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. |
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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.
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IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Participants with a diagnosis of diabetic or idiopathic gastroparesis were enrolled and randomized in 1:1:1:1 ratio to receive TAK-954 0.1 mg, 0.3 mg, 1 mg or placebo.
Participants took part in the study at 1 investigative site in the United States from 02 January 2018 to 12 July 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | TAK-954 placebo-matching, 60-minute infusion, intravenously (IV), once daily on Days 1 to 3. |
| FG001 | TAK-954 0.1 mg | TAK-954 0.1 mg, 60-minute infusion, IV, once daily on Days 1 to 3. |
| FG002 | TAK-954 0.3 mg | TAK-954 0.3 mg, 60-minute infusion, IV, once daily on Days 1 to 3. |
| FG003 | TAK-954 1 mg | TAK-954 1 mg, 60-minute infusion, IV, once daily on Days 1 to 3. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety analysis set included all subjects who receive at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | TAK-954 placebo-matching, 60-minute infusion, IV, once daily on Days 1 to 3. |
| BG001 | TAK-954 0.1 mg | TAK-954 0.1 mg, 60-minute infusion, IV, once daily on Days 1 to 3. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | percent change | Predose and at multiple time-points post-dose (up to 9 hours) on Day 2 |
|
From first dose up to 30 days post last dose (Up to 46 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | TAK-954 placebo-matching, 60-minute infusion, IV, once daily on Days 1 to 3. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancreatic enzymes increased | Investigations | MedDRA 22.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | takedadisclosures@takeda.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 19, 2018 | May 28, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 25, 2018 | May 28, 2020 | SAP_001.pdf |
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| Placebo | Drug | TAK-954 placebo-matching IV infusion. |
|
| 4, 24, and 48 hours post-radiolabeled meal on Day 2 |
| Colonic Filling at Hour 6 | Colonic filling was estimated as percentage of the radio-labelled meal that reached the colon at Hour 6. | 6 hours post-radiolabel meal on Day 2 |
| 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. | Predose and at multiple time-points post-dose (up to 25 hours) on Days 1, 2 and 3 |
| 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 |
| 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 |
| 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 |
| Withdrawal by Subject |
|
| BG002 | TAK-954 0.3 mg | TAK-954 0.3 mg, 60-minute infusion, IV, once daily on Days 1 to 3. |
| BG003 | TAK-954 1 mg | TAK-954 1 mg, 60-minute infusion, IV, once daily on Days 1 to 3. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Disease History | Participants were categorized based on whether they have idiopathic gastroparesis or diabetic gastroparesis. | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | kg |
|
| Height | Mean | Standard Deviation | cm |
|
| Body Mass Index (BMI) | BMI=weight (kg)/height (m)^2 | Mean | Standard Deviation | kg/m^2 |
|
| OG001 |
| TAK-954 0.1 mg |
TAK-954 0.1 mg, 60-minute infusion, IV, once daily on Days 1 to 3. |
| OG002 | TAK-954 0.3 mg | TAK-954 0.3 mg, 60-minute infusion, IV, once daily on Days 1 to 3. |
| OG003 | TAK-954 1 mg | TAK-954 1 mg, 60-minute infusion, IV, once daily on Days 1 to 3. |
|
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 4, 24, and 48 hours post-radiolabeled meal on Day 2 |
|
|
|
|
| Secondary | Colonic Filling at Hour 6 | Colonic filling was estimated as percentage of the radio-labelled meal that reached the colon at Hour 6. | 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. | Posted | Mean | Standard Deviation | percentage of radio-labelled food | 6 hours post-radiolabel meal on Day 2 |
|
|
|
|
| Secondary | 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. | 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. | Posted | Median | Full Range | hours | Predose and at multiple time-points post-dose (up to 25 hours) on Days 1, 2 and 3 |
|
|
|
|
| Secondary | AUCtau: Area Under the Plasma Concentration-Time Curve From Time 0 to t for TAK-954 | 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. | Posted | Mean | Standard Deviation | h*ng/mL | 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 | 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. | Posted | Mean | Standard Deviation | ng/mL | 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 | 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. | Posted | Mean | Standard Deviation | ng/mL | At multiple time-points post-dose, up to 9 hours on Day 2 and up to 25 hours on Day 3 |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 6 |
| 10 |
| EG001 | TAK-954 0.1 mg | TAK-954 0.1 mg, 60-minute infusion, IV, once daily on Days 1 to 3. | 0 | 10 | 0 | 10 | 5 | 10 |
| EG002 | TAK-954 0.3 mg | TAK-954 0.3 mg, 60-minute infusion, IV, once daily on Days 1 to 3. | 0 | 9 | 0 | 9 | 6 | 9 |
| EG003 | TAK-954 1 mg | TAK-954 1 mg, 60-minute infusion, IV, once daily on Days 1 to 3. | 0 | 7 | 1 | 7 | 6 | 7 |
| Eye swelling | Eye disorders | MedDRA 22.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Abdominal pain lower | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 22.0 | Systematic Assessment |
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| Chills | General disorders | MedDRA 22.0 | Systematic Assessment |
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| Sensation of foreign body | General disorders | MedDRA 22.0 | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA 22.0 | Systematic Assessment |
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| Infusion site pain | General disorders | MedDRA 22.0 | Systematic Assessment |
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| Drug withdrawal syndrome | General disorders | MedDRA 22.0 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 22.0 | Systematic Assessment |
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| Viral infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
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| Presyncope | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Cold sweat | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
|
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi-site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
|
| Colonic Transit at 24 Hours, Day 2 |
|
|
| Colonic Transit at 48 Hours, Day 2 |
|
|
| Colonic Transit at 4 Hours, Day 2 | ANCOVA | 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 | 2-Sided | 95 | 0.119 | 2.418 | Linear mixed effects model used for analyses using gastroparesis type [diabetic or idiopathic], age, gender, BMI, baseline as a covariate. | Superiority |
| Colonic Transit at 4 Hours, Day 2 | ANCOVA | 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 | 2-Sided | 95 | -0.757 | 1.660 | Linear mixed effects model used for analyses using gastroparesis type [diabetic or idiopathic], age, gender, BMI, baseline as a covariate. | Superiority |
| Colonic Transit at 24 Hours, Day 2 | ANCOVA | 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 | 2-Sided | 95 | 0.493 | 3.250 | Linear mixed effects model used for analyses using gastroparesis type [diabetic or idiopathic], age, gender, BMI, baseline as a covariate. | Superiority |
| Colonic Transit at 24 Hours, Day 2 | ANCOVA | 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 | 2-Sided | 95 | -0.327 | 2.717 | Linear mixed effects model used for analyses using gastroparesis type [diabetic or idiopathic], age, gender, BMI, baseline as a covariate. | Superiority |
| Colonic Transit at 24 Hours, Day 2 | ANCOVA | 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 | 2-Sided | 95 | -0.931 | 2.200 | Linear mixed effects model used for analyses using gastroparesis type [diabetic or idiopathic], age, gender, BMI, baseline as a covariate. | Superiority |
| Colonic Transit at 48 Hours, Day 2 | ANCOVA | 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 | 2-Sided | 95 | 0.073 | 2.501 | Linear mixed effects model used for analyses using gastroparesis type [diabetic or idiopathic], age, gender, BMI, baseline as a covariate. | Superiority |
| Colonic Transit at 48 Hours, Day 2 | ANCOVA | 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 | 2-Sided | 95 | 0.035 | 2.621 | Linear mixed effects model used for analyses using gastroparesis type [diabetic or idiopathic], age, gender, BMI, baseline as a covariate. | Superiority |
| Colonic Transit at 48 Hours, Day 2 | ANCOVA | 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 | 2-Sided | 95 | -1.107 | 1.611 | Linear mixed effects model used for analyses using gastroparesis type [diabetic or idiopathic], age, gender, BMI, baseline as a covariate. | Superiority |
| ANCOVA |
| 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 |
| 2-Sided |
| 95 |
| 23.555 |
| 92.396 |
Linear mixed effects model used for analyses using gastroparesis type [diabetic or idiopathic], age, gender, BMI, baseline as a covariate. |
| Superiority |
| ANCOVA | 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 | 2-Sided | 95 | 8.249 | 80.629 | Linear mixed effects model used for analyses using gastroparesis type [diabetic or idiopathic], age, gender, BMI, baseline as a covariate. | Superiority |
| ANCOVA |
| 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 |
| 2-Sided |
| 95 |
| -25.242 |
| -1.314 |
Linear mixed effects model used for analyses using gastroparesis type [diabetic or idiopathic], age, gender, BMI, baseline as a covariate. |
| Superiority |
| ANCOVA | 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 | 2-Sided | 95 | -24.206 | 0.952 | Linear mixed effects model used for analyses using gastroparesis type [diabetic or idiopathic], age, gender, BMI, baseline as a covariate. | Superiority |
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| Day 3 |
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| Day 2 |
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| Day 3 |
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| Day 3 |
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