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

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2b Study to Evaluate the Efficacy and Safety of Twice-Daily Oral Administration of a Peripherally Acting Dopamine Receptor D2/D3 Antagonist, TAK-906 for the Treatment of Adult Subjects With Symptomatic Idiopathic or Diabetic Gastroparesis

The purpose of this study is to assess the efficacy and safety of treatment with 2 dose levels of TAK-906 in adult participants with gastroparesis compared with placebo during 12 weeks of treatment.

Study Overview

• Status: Completed
• Conditions: Diabetic Gastroparesis; Idiopathic Gastroparesis
• Intervention / Treatment: Drug: Placebo; Drug: TAK-906 Maleate

Detailed Description

The drug being tested in this study is called TAK-906. TAK-906 is being tested to treat people who have symptomatic idiopathic or diabetic gastroparesis.

The study will enroll approximately 205 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the three treatment groups (in 1:1:1:1 ratio) which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):

• TAK-906 Maleate 5 mg (After implementation of Amendment 8, participants will not be further randomized to this arm)
• TAK-906 Maleate 25 mg
• TAK-906 Maleate 50 mg Placebo (dummy inactive pill) - this is a capsule that looks like the study drug but has no active ingredient

Prior to Amendment 8, participants were randomized to receive TAK-906 5 mg. After implementation of Amendment 8, participants will not be further randomized to this dose arm. All participants will be asked to take one capsule twice daily, at approximately the same time each day throughout the study.

This multi-center trial will be conducted worldwide. The overall study duration is approximately 17 weeks. Participants will make multiple visits to the clinic, and will be contacted by telephone 30 days after receiving their last dose of study drug for a follow-up assessment.

• Study Type: Interventional
• Enrollment (Actual): 242
• Phase: Phase 2

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1200
    • Cliniques Universitaires Saint-Luc
  • Bruxelles, Belgium, 1070 Bruxelles
    • Hopital Erasme
  • Gent, Belgium, 9000
    • Universiteit Gent
  • Antwerpen
    • Edegem, Antwerpen, Belgium, 2650
      • Universiteit Antwerpen
  • Flemish Brabant
    • Leuven, Flemish Brabant, Belgium, 3000
      • Universitair Ziekenhuis Leuven
  • West-vlaanderen
    • Brugge, West-vlaanderen, Belgium, 8310
      • Algemeen Ziekenhuis Sint-Lucas
    • Kortrijk, West-vlaanderen, Belgium, 8500
      • AZ Groeninge Campus Kennedylaan
• Japan
  • Kumamoto, Japan, 860-0863
    • Morinaga Ueno Clinic
  • Kyoto, Japan, 601-1495
    • Ijinkai Takeda General Hospital
  • Okayama, Japan, 700-8511
    • Okayama Saiseikai General Hospital
  • Saitama, Japan, 330-0064
    • Medical Corporation Kamata Clinic
  • Yamagata, Japan, 990-0832
    • Gastroenterology and Internal Medicine, Oizumi Medical Clinic
  • Aichi
    • Kasugai-shi, Aichi, Japan, 487-0031
      • Tokai Memorial Hospital
    • Nagoya, Aichi, Japan, 455-8530
      • Chubu-Rosai Hospital
    • Nagoya City, Aichi, Japan, 467-8602
      • Nagoya City University Hospital
    • Nagoya-shi, Aichi, Japan, 451-8511
      • Meitetsu Hospital
  • Chiba
    • Abiko, Chiba, Japan, 270-1168
      • Tokatsu Tsujinaka Hospital
  • Ehime
    • Matsuyama, Ehime, Japan, 790-0067
      • Matsuyama Shimin Hospital
  • Fukuoka
    • Fukuoka-shi, Fukuoka, Japan, 810-0024
      • Hatakeyama Clinic
    • Kasuya-gun, Fukuoka, Japan, 811-2310
      • Oishi Clinic
  • Fukushima
    • Koriyama City, Fukushima, Japan, 963-8026
      • Igarashi Internal Medicine Surgery Clinic
  • Gifu
    • Gifu-city, Gifu, Japan, 500-8523
      • Asahi University Hospital
  • Hokkaido
    • Bibai, Hokkaido, Japan, 072-0012
      • Nakamura Digestive Organ Internal Medicine Clinic
  • Hokkairdo
    • Sapporo-Shi, Hokkairdo, Japan, 060-0807
      • Akakura GI Clinic
  • Hyogo
    • Nishinomiya, Hyogo, Japan, 663-8501
      • Hyogo College of Medicine Hospital
    • Nishinomiya, Hyogo, Japan, 662-0918
      • Hyogo Prefectural Nishinomiya Hospital
    • Takarazuka-shi, Hyogo, Japan, 665-0827
      • Takarazuka City Hospital
  • Ibaraki
    • Hitachi, Ibaraki, Japan, 312-0057
      • Hitachi, Ltd. Hitachinaka General Hospital
    • Mito-shi, Ibaraki, Japan, 311-4153
      • Minami Akatsuka Clinic
    • Tsuchiura City, Ibaraki, Japan, 300-0062
      • Tsuchiura Beryl Clinic
  • Kanagawa
    • Yokohama-city, Kanagawa, Japan, 232-0064
      • Medical Corporation Shintoukai Yokohama Minoru Clinic
  • Osaka
    • Takatsuki-shi, Osaka, Japan, 569-1096
      • Takatsuki Red Cross Hospital
  • Saitama
    • Kumagaya, Saitama, Japan, 360-8567
      • Medical Corporation Kumagaya General Hospital
    • Tokorozawa, Saitama, Japan, 359-1151
      • Wakasa Clinic
  • Shizuoka
    • Yaizu, Shizuoka, Japan, 425-0088
      • Community Hospital Koga Hospital
  • Tokyo
    • Setagaya-Ku, Tokyo, Japan, 155-0031
      • Shimokitazawa Tomo Clinic
• Poland
  • Sopot, Poland, 81-756
    • Endoskopia
  • Kujawsko-pomorskie
    • Bydgoszcz, Kujawsko-pomorskie, Poland, 85-079
      • VITAMED Galaj i Cichomski spolka jawna
    • Grudziadz, Kujawsko-pomorskie, Poland, 86-300
      • Centrum Medyczne Clw-Med Aneta Cichomska i Joanna uka-Wendrowska sp.j.
  • Mazowieckie
    • Warszawa, Mazowieckie, Poland, 00-332
      • BodyClinic
  • Pomorskie
    • Chojnice, Pomorskie, Poland, 89-600
      • Centrum Medyczne Lukamed Joanna Luka
  • Swietokrzyskie
    • Kielce, Swietokrzyskie, Poland, 25-035
      • Niepubliczny Zaklad Opieki Zdrowotnej - Witamed Poradnia Diabetolo
• United States
  • Alabama
    • Dothan, Alabama, United States, 36305
      • Digestive Health Specialists of the Southeast
  • Arizona
    • Tucson, Arizona, United States, 85710
      • Del Sol Research Management
    • Tucson, Arizona, United States, 85745
      • Del Sol Research Management
  • California
    • Chula Vista, California, United States, 91910
      • GW Research
    • Corona, California, United States, 92882
      • Trial Connections - New Hope Research Development
    • Garden Grove, California, United States, 92840
      • Paragon Rx Clinical - Garden Grove
    • Lomita, California, United States, 90717
      • Torrance Clinical Research Institute Inc.
    • Northridge, California, United States, 91324
      • California Medical Research Associates
    • Orange, California, United States, 92866
      • ISS - Conquest Clinical Research
    • San Diego, California, United States, 92114
      • Precision Research Institute
  • Connecticut
    • Bristol, Connecticut, United States, 06010
      • Connecticut Clinical Research Foundation
  • Florida
    • Clearwater, Florida, United States, 33756
      • ISS - Innovative Research of West Florida
    • Hialeah, Florida, United States, 33016
      • Palmetto Research
    • Hialeah, Florida, United States, 33012
      • Elias Research Associates - Direct Helpers Research Center - Hialeah
    • Hialeah, Florida, United States, 33012
      • International Research Associates
    • Homestead, Florida, United States, 33032
      • Homestead Associates in Research
    • Inverness, Florida, United States, 34452
      • Gastroenterology Associates - Crystal River
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic
    • Miami, Florida, United States, 33176
      • Miami Dade Medical Research Institute
    • Miami, Florida, United States, 33175
      • PharmaSouth Research
    • Miami, Florida, United States, 33156
      • Baptist Diabetes Associates Research
    • Miami, Florida, United States, 33186
      • Anchor Medical Research
    • New Port Richey, Florida, United States, 34653
      • Advanced Research Institute - New Port Richey
    • Port Orange, Florida, United States, 32127
      • Advanced Medical Research Center
  • Georgia
    • Athens, Georgia, United States, 30607
      • Summit Clinical Research
    • Atlanta, Georgia, United States, 30309
      • Digestive Healthcare of Georgia - Atlanta
  • Illinois
    • Oak Lawn, Illinois, United States, 60453
      • DM Clinical Research - Southwest Gastroenterology - Oak Lawn
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center
  • Kentucky
    • Crestview Hills, Kentucky, United States, 41017
      • Tri-State Gastroenterology Associates
  • Maryland
    • Columbia, Maryland, United States, 21045
      • Gastro Center of Maryland
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States, 02114
      • MGH Digestive Healthcare
    • West Roxbury, Massachusetts, United States, 02132
      • Veterans Affairs Medical Center - West Roxbury
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
    • Chesterfield, Michigan, United States, 48047
      • Clinical Research Institute of Michigan
    • Wyoming, Michigan, United States, 49519
      • Gastroenterology Associates of Western Michigan
  • Mississippi
    • Flowood, Mississippi, United States, 39232
      • Gastrointestinal Associates and Endoscopy Center
  • Montana
    • Missoula, Montana, United States, 59808
      • Montana Medical Research
  • New Mexico
    • Albuquerque, New Mexico, United States, 87108
      • Lovelace Scientific Resources - Albuquerque
  • New York
    • Brooklyn, New York, United States, 11235
      • NY Scientific
    • Great Neck, New York, United States, 11023
      • Long Island Gastrointestinal Research Group
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Atrium Health
    • Concord, North Carolina, United States, 28025
      • Chevy Chase Clinical Research
    • Fayetteville, North Carolina, United States, 28304
      • Fayetteville Gastroenterology Associates
    • Greenville, North Carolina, United States, 27834
      • Carolina Digestive Diseases
    • Raleigh, North Carolina, United States, 27612
      • Wake Research Associates
    • Salisbury, North Carolina, United States, 28144
      • PMG Research of Salisbury
    • Wilmington, North Carolina, United States, 28403
      • Trial Management Associates
    • Winston-Salem, North Carolina, United States, 27103
      • Gastroenterology Associates of the Piedmont
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Consultants for Clinical Research
    • Dayton, Ohio, United States, 45439
      • Providence Health Partners - Center For Clinical Research
  • Oklahoma
    • Stillwater, Oklahoma, United States, 74074
      • Elite Research - Lynn Institute of Stillwater
    • Tulsa, Oklahoma, United States, 74104
      • Options Health Research
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University Hospital
    • Wyomissing, Pennsylvania, United States, 19610
      • Digestive Disease Associates - Wyomissin
  • Tennessee
    • Chattanooga, Tennessee, United States, 37421
      • ClinSearch
    • Jackson, Tennessee, United States, 38305
      • Clinical Research Solutions - Jackson
    • Knoxville, Tennessee, United States, 37909
      • New Phase Research and Development
    • Nashville, Tennessee, United States, 37211
      • Quality Medical Research
  • Texas
    • El Paso, Texas, United States, 79905
      • Texas Tech University Health Sciences Center - El Paso
    • Houston, Texas, United States, 77002
      • Spring Gastroenterology Associates - Houston
    • Houston, Texas, United States, 77043
      • Biopharma Informatic Houston 1
    • Houston, Texas, United States, 77084
      • Biopharma Informatic Houston 2
    • McAllen, Texas, United States, 78503
      • Rio Grande Gastroenterology
    • San Antonio, Texas, United States, 78215
      • Sun Research Institute
    • San Antonio, Texas, United States, 78212
      • Clinical Associates in Research Therapeutics of America
  • Virginia
    • Chesapeake, Virginia, United States, 23320
      • Gastroenterology Associates of Tidewater

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Should have experienced symptoms of gastroparesis (e.g., postprandial fullness, nausea, vomiting, upper abdominal pain, and early satiety for at least 3 months before screening as assessed by a physician.

2. Must have confirmed delayed gastric emptying by meeting 1 of the following criteria:

   1. Confirmed by an accepted diagnostic testing method (Gastric Emptying Breath Test [GEBT], scintigraphy, or wireless motility capsule) that is documented in the participant's medical records prior to screening; OR
   2. Participants without previous confirmation of delayed gastric emptying prior to screening will undergo a GEBT after they have stopped taking prohibited medications.
3. Must have an average composite ANMS GCSI-DD symptom score ≥2 during the 7 days before randomization. The predominant symptom experienced by participants must not be abdominal pain.
4. Must experience nausea: nausea subscale (of ANMS GCSI-DD) symptom score ≥2 at least 4 of 7 days or an average nausea subscale symptom score ≥2 during the 7 days before randomization. Nausea symptoms must not be attributable to a central disorder (e.g. motion sickness, glaucoma, menstrual cycles, migraine headache).
5. Has a body mass index (BMI) of ≥18 to ≤40 kg/m^2 inclusive.
6. Participant with diabetes mellitus must have glycosylated hemoglobin (HbA1c) ≤11% at screening and before randomization.
7. Absence of gastric outlet obstruction confirmed by upper GI, computed tomography or endoscopy.

Exclusion Criteria:

1. Known secondary causes of gastroparesis including but not limited to Parkinson disease, cancer, viral illness, or connective tissue diseases.
2. Predominant gastroparetic symptom is epigastric pain, diffuse abdominal pain, or pain associated with bowel movement.
3. Is taking medications that affect gastric emptying including opioids, glucagon-like peptide-1 analogs (e.g., exenatide, liraglutide), amylin analogs (e.g., pramlintide), and cannabinoids.
4. Prior history of gastric surgery, including but not limited to gastrectomy, gastric bypass, gastric banding, bariatric surgery, pyloroplasty, vagotomy, or fundoplication, which has manipulated the natural anatomy of the stomach.
5. History of intra-pyloric botulinum toxin injection within 3 months of Screening or currently has functioning implantable electric stimulator.
6. Nasogastric, percutaneous endoscopic gastrostomy, or percutaneous endoscopic jejunostomy feeding tube or inpatient hospitalization for gastroparesis within 2 weeks before the Screening Visit.
7. Required parenteral nutrition for treatment of gastroparesis within 2 months before the Screening Visit.
8. Previous diagnosis of gastric bezoar (the presence of retained liquid, bile, or small amounts of poorly organized food residue is permitted).
9. Poor control of diabetes within 30 days prior to randomization, including diabetic ketoacidosis, hypoglycemia requiring medical intervention, admission for control of diabetes or diabetic complications.
10. Elevated serum prolactin (>upper limit of normal [ULN]) at Screening.
11. Has concurrent hypogonadism, current clinically significant menstrual abnormalities, such as amenorrhea or oligomenorrhea, or other clinical features of hyperprolactinemia such as galactorrhea or gynecomastia.

12. Has acute or chronic liver disease meeting any of the criteria described below:

    • Has an alanine aminotransferase (ALT), aspartate aminotransferase (AST) or total bilirubin >2.0 times the ULN.
    • Has pre-existing liver cirrhosis that meets Child-Pugh Class B (moderate; total score 7 to 9 points) or C (severe; total score 10 to 15 points) (see Appendix B).
    • Has acute or chronic hepatitis B or C virus infection, manifesting as one of the following at screening:
    • Positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). NOTE: if a participants tests negative for HBsAg, but positive for HBcAb, the participant would be eligible if the Investigator has documentation of other test results showing that the participant does not have active hepatitis B infection.
    • Participants with positive hepatitis C antibody (HCV IgG) and quantitative HCV polymerase chain reaction (PCR). HCV PCR is performed only if HCV IgG is positive.
13. Has renal impairment, defined as a lower limit of (estimated glomerular filtration rate [eGFR]) <30 mL/min at screening visit.
14. Has active neoplastic disease or history of neoplastic disease within 5 years of screening visit (except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the uterine cervix that has been definitively treated with standard of care approaches).
15. Uncontrolled or poorly controlled medical or psychiatric comorbidities which might affect their ability to participate in the study.
16. Has known COVID-19 infection, or suspected COVID-19 infection (as assessed by the investigator).
17. Signs/symptoms or history of extrapyramidal system disease and other clinically relevant CNS or neuropsychiatric disease including but not limited to tardive dyskinesia, neuroleptic malignant syndrome, acute dystonia, parkinsonian like symptoms, severe mental depression, and history of suicide attempt.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; TAK-906 maleate placebo-matching capsules, orally, twice daily (BID) for up to 12 weeks.	Drug: Placebo; TAK-906 maleate placebo-matching capsules.
Experimental: TAK-906 Maleate 5 mg; TAK-906 maleate 5 mg, capsules, orally, BID for up to 12 weeks.	Drug: TAK-906 Maleate; TAK-906 maleate capsules.
Experimental: TAK-906 Maleate 25 mg; TAK-906 maleate 25 mg, capsules, orally, BID for up to 12 weeks.	Drug: TAK-906 Maleate; TAK-906 maleate capsules.
Experimental: TAK-906 Maleate 50 mg; TAK-906 maleate 50 mg, capsules, orally, BID for up to 12 weeks.	Drug: TAK-906 Maleate; TAK-906 maleate capsules.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	Baseline and Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With at Least 50% Reduction From Baseline in ANMS GCSI-DD Composite Score at 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.	Baseline and Week 12
Change From Baseline in the ANMS GCSI-DD Nausea Symptom Score at Week 12 of the Treatment Period	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.	Baseline and Week 12
Change From Baseline in the ANMS GCSI-DD Early Satiety Symptom Score at Week 12 of the Treatment Period	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.	Baseline and Week 12
Change From Baseline in the ANMS GCSI-DD Postprandial Fullness Symptom Score at Week 12 of the Treatment Period	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.	Baseline and Week 12
Change From Baseline in the ANMS GCSI-DD Upper Abdominal Pain Symptom Score at Week 12 of the Treatment Period	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.	Baseline and Week 12
Change From Baseline in the ANMS GCSI-DD Recorded Vomiting Frequency at Week 12 of the Treatment Period	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.	Baseline and Week 12
Change From Baseline in the ANMS GCSI-DD Overall Severity of Gastroparesis Symptoms Score at Week 12 of the Treatment Period	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.	Baseline and Week 12
Change From Baseline in the ANMS GCI-DD Bloating Severity Scale Score at Week 12 of the Treatment Period	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.	Baseline and Week 12
Change From Baseline in the ANMS GCSI-DD Total Score at Week 12 of the Treatment Period	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.	Baseline and Week 12
Percentage of Symptomatic Weeks	Symptomatic weeks are weeks with average composite symptom score assessed as >mild [ANMS GCSI-DD score ≥2] during 12 weeks of treatment. Analysis of variance (ANOVA) was used for the analysis.	Up to 12 weeks
Change From Baseline in the Patient Assessment of Upper Gastrointestinal Disorders-Symptom Severity Index (PAGI-SYM) Total Score at Week 12 of the Treatment Period	The PAGI-SYM total score is defined as the mean of 6 PAGI-SYM subscale scores from 20 items. A 6-point Likert response scale, ranging from 0 (none) to 5 (very severe), is used to measure symptom severity in participants with upper GI disorders. The negative change from baseline indicates improvement. MMRM was used for analysis.	Baseline and Week 12

Collaborators and Investigators

• Sponsor: Millennium Pharmaceuticals, Inc.

Publications and helpful links

General Publications

• Yamaguchi T, Kudou K, Okamoto H, Chen C, Whiting R, Sekino H. Evaluating the Safety, Tolerability, and Disposition of Trazpiroben, a D2 /D3 Receptor Antagonist: Phase I Single- and Multiple-Ascending Dose Studies in Healthy Japanese Participants. Clin Pharmacol Drug Dev. 2022 Jun;11(6):695-706. doi: 10.1002/cpdd.1057. Epub 2021 Dec 29.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2018
• Primary Completion (Actual): June 14, 2021
• Study Completion (Actual): July 15, 2021

Study Registration Dates

• First Submitted: May 21, 2018
• First Submitted That Met QC Criteria: May 21, 2018
• First Posted (Actual): June 1, 2018

Study Record Updates

• Last Update Posted (Actual): November 16, 2022
• Last Update Submitted That Met QC Criteria: October 24, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Drug Therapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Neurologic Manifestations; Gastrointestinal Diseases; Stomach Diseases; Paralysis; Gastroparesis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Maleic acid
• Other Study ID Numbers: TAK-906-2002; 2018-001275-21 (EudraCT Number); U1111-1211-2779 (Other Identifier: Universal Trial Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: 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.
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No