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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-001275-21 | EudraCT Number | ||
| U1111-1211-2779 | Other Identifier | Universal Trial Number |
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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.
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):
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | TAK-906 maleate placebo-matching capsules, orally, twice daily (BID) for up to 12 weeks. |
|
| TAK-906 Maleate 5 mg | Experimental | TAK-906 maleate 5 mg, capsules, orally, BID for up to 12 weeks. |
|
| TAK-906 Maleate 25 mg | Experimental | TAK-906 maleate 25 mg, capsules, orally, BID for up to 12 weeks. |
|
| TAK-906 Maleate 50 mg | Experimental | TAK-906 maleate 50 mg, capsules, orally, BID for up to 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAK-906 Maleate | Drug | TAK-906 maleate capsules. |
|
| 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 |
| 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. |
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Inclusion Criteria:
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.
Must have confirmed delayed gastric emptying by meeting 1 of the following criteria:
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.
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).
Has a body mass index (BMI) of ≥18 to ≤40 kg/m^2 inclusive.
Participant with diabetes mellitus must have glycosylated hemoglobin (HbA1c) ≤11% at screening and before randomization.
Absence of gastric outlet obstruction confirmed by upper GI, computed tomography or endoscopy.
Exclusion Criteria:
Known secondary causes of gastroparesis including but not limited to Parkinson disease, cancer, viral illness, or connective tissue diseases.
Predominant gastroparetic symptom is epigastric pain, diffuse abdominal pain, or pain associated with bowel movement.
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.
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.
History of intra-pyloric botulinum toxin injection within 3 months of Screening or currently has functioning implantable electric stimulator.
Nasogastric, percutaneous endoscopic gastrostomy, or percutaneous endoscopic jejunostomy feeding tube or inpatient hospitalization for gastroparesis within 2 weeks before the Screening Visit.
Required parenteral nutrition for treatment of gastroparesis within 2 months before the Screening Visit.
Previous diagnosis of gastric bezoar (the presence of retained liquid, bile, or small amounts of poorly organized food residue is permitted).
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.
Elevated serum prolactin (>upper limit of normal [ULN]) at Screening.
Has concurrent hypogonadism, current clinically significant menstrual abnormalities, such as amenorrhea or oligomenorrhea, or other clinical features of hyperprolactinemia such as galactorrhea or gynecomastia.
Has acute or chronic liver disease meeting any of the criteria described below:
Has renal impairment, defined as a lower limit of (estimated glomerular filtration rate [eGFR]) <30 mL/min at screening visit.
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).
Uncontrolled or poorly controlled medical or psychiatric comorbidities which might affect their ability to participate in the study.
Has known COVID-19 infection, or suspected COVID-19 infection (as assessed by the investigator).
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.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Digestive Health Specialists of the Southeast | Dothan | Alabama | 36305 | United States | ||
| Del Sol Research Management |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37533380 | Derived | Tack J, McCallum R, Kuo B, Huh SY, Zhang Y, Chen YJ, Mehrotra S, Parkman HP. Randomized clinical trial: A phase 2b controlled study of the efficacy and safety of trazpiroben (TAK-906) for idiopathic or diabetic gastroparesis. Neurogastroenterol Motil. 2023 Oct;35(10):e14652. doi: 10.1111/nmo.14652. Epub 2023 Aug 3. | |
| 34967147 | Derived |
| Label | URL |
|---|---|
| Related Info | View source |
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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 receive TAK-906 5 mg, 25 mg, 50 mg Maleate or placebo in 1:1:1:1 ratio until protocol amendment 8 was implemented. As pre-specified in protocol amendment 8 further randomization TAK-906 5 mg arm was discontinued and remaining enrolled participants were randomized into TAK-906 25 mg, TAK-906 50 mg Maleate or placebo in 1:1:1 ratio.
Participants with symptomatic idiopathic or diabetic gastroparesis took part in the study at 73 investigative sites in Belgium, Poland, Japan and the United States from 14 October 2018 to 15 July 2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | TAK-906 maleate placebo-matching capsules, orally, twice daily (BID) for up to 12 weeks. |
| FG001 | TAK-906 Maleate 5 mg | TAK-906 maleate 5 mg, capsules, orally, BID for up to 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Jul 13, 2020 | Jun 9, 2022 |
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| Placebo | Drug | TAK-906 maleate placebo-matching capsules. |
|
| 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 |
| Tucson |
| Arizona |
| 85710 |
| United States |
| Del Sol Research Management | Tucson | Arizona | 85745 | United States |
| GW Research | Chula Vista | California | 91910 | United States |
| Trial Connections - New Hope Research Development | Corona | California | 92882 | United States |
| Paragon Rx Clinical - Garden Grove | Garden Grove | California | 92840 | United States |
| Torrance Clinical Research Institute Inc. | Lomita | California | 90717 | United States |
| California Medical Research Associates | Northridge | California | 91324 | United States |
| ISS - Conquest Clinical Research | Orange | California | 92866 | United States |
| Precision Research Institute | San Diego | California | 92114 | United States |
| Connecticut Clinical Research Foundation | Bristol | Connecticut | 06010 | United States |
| ISS - Innovative Research of West Florida | Clearwater | Florida | 33756 | United States |
| Elias Research Associates - Direct Helpers Research Center - Hialeah | Hialeah | Florida | 33012 | United States |
| International Research Associates | Hialeah | Florida | 33012 | United States |
| Palmetto Research | Hialeah | Florida | 33016 | United States |
| Homestead Associates in Research | Homestead | Florida | 33032 | United States |
| Gastroenterology Associates - Crystal River | Inverness | Florida | 34452 | United States |
| Mayo Clinic | Jacksonville | Florida | 32224 | United States |
| Baptist Diabetes Associates Research | Miami | Florida | 33156 | United States |
| PharmaSouth Research | Miami | Florida | 33175 | United States |
| Miami Dade Medical Research Institute | Miami | Florida | 33176 | United States |
| Anchor Medical Research | Miami | Florida | 33186 | United States |
| Advanced Research Institute - New Port Richey | New Port Richey | Florida | 34653 | United States |
| Advanced Medical Research Center | Port Orange | Florida | 32127 | United States |
| Summit Clinical Research | Athens | Georgia | 30607 | United States |
| Digestive Healthcare of Georgia - Atlanta | Atlanta | Georgia | 30309 | United States |
| DM Clinical Research - Southwest Gastroenterology - Oak Lawn | Oak Lawn | Illinois | 60453 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| Tri-State Gastroenterology Associates | Crestview Hills | Kentucky | 41017 | United States |
| Gastro Center of Maryland | Columbia | Maryland | 21045 | United States |
| MGH Digestive Healthcare | Boston | Massachusetts | 02114 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Veterans Affairs Medical Center - West Roxbury | West Roxbury | Massachusetts | 02132 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Clinical Research Institute of Michigan | Chesterfield | Michigan | 48047 | United States |
| Gastroenterology Associates of Western Michigan | Wyoming | Michigan | 49519 | United States |
| Gastrointestinal Associates and Endoscopy Center | Flowood | Mississippi | 39232 | United States |
| Montana Medical Research | Missoula | Montana | 59808 | United States |
| Lovelace Scientific Resources - Albuquerque | Albuquerque | New Mexico | 87108 | United States |
| NY Scientific | Brooklyn | New York | 11235 | United States |
| Long Island Gastrointestinal Research Group | Great Neck | New York | 11023 | United States |
| Atrium Health | Charlotte | North Carolina | 28204 | United States |
| Chevy Chase Clinical Research | Concord | North Carolina | 28025 | United States |
| Fayetteville Gastroenterology Associates | Fayetteville | North Carolina | 28304 | United States |
| Carolina Digestive Diseases | Greenville | North Carolina | 27834 | United States |
| Wake Research Associates | Raleigh | North Carolina | 27612 | United States |
| PMG Research of Salisbury | Salisbury | North Carolina | 28144 | United States |
| Trial Management Associates | Wilmington | North Carolina | 28403 | United States |
| Gastroenterology Associates of the Piedmont | Winston-Salem | North Carolina | 27103 | United States |
| Consultants for Clinical Research | Cincinnati | Ohio | 45219 | United States |
| Providence Health Partners - Center for Clinical Research | Dayton | Ohio | 45439 | United States |
| Elite Research - Lynn Institute of Stillwater | Stillwater | Oklahoma | 74074 | United States |
| Options Health Research | Tulsa | Oklahoma | 74104 | United States |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | United States |
| Digestive Disease Associates - Wyomissin | Wyomissing | Pennsylvania | 19610 | United States |
| ClinSearch | Chattanooga | Tennessee | 37421 | United States |
| Clinical Research Solutions - Jackson | Jackson | Tennessee | 38305 | United States |
| New Phase Research and Development | Knoxville | Tennessee | 37909 | United States |
| Quality Medical Research | Nashville | Tennessee | 37211 | United States |
| Texas Tech University Health Sciences Center - El Paso | El Paso | Texas | 79905 | United States |
| Spring Gastroenterology Associates - Houston | Houston | Texas | 77002 | United States |
| Biopharma Informatic Houston 1 | Houston | Texas | 77043 | United States |
| Biopharma Informatic Houston 2 | Houston | Texas | 77084 | United States |
| Rio Grande Gastroenterology | McAllen | Texas | 78503 | United States |
| Clinical Associates in Research Therapeutics of America | San Antonio | Texas | 78212 | United States |
| Sun Research Institute | San Antonio | Texas | 78215 | United States |
| Gastroenterology Associates of Tidewater | Chesapeake | Virginia | 23320 | United States |
| Universiteit Antwerpen | Edegem | Antwerpen | 2650 | Belgium |
| Universitair Ziekenhuis Leuven | Leuven | Flemish Brabant | 3000 | Belgium |
| Algemeen Ziekenhuis Sint-Lucas | Bruges | West-vlaanderen | 8310 | Belgium |
| AZ Groeninge Campus Kennedylaan | Kortrijk | West-vlaanderen | 8500 | Belgium |
| Hopital Erasme | Brussels | 1070 Bruxelles | Belgium |
| Cliniques Universitaires Saint-Luc | Brussels | 1200 | Belgium |
| Universiteit Gent | Ghent | 9000 | Belgium |
| Tokai Memorial Hospital | Kasugai-shi | Aichi-ken | 487-0031 | Japan |
| Meitetsu Hospital | Nagoya | Aichi-ken | 451-8511 | Japan |
| Chubu-Rosai Hospital | Nagoya | Aichi-ken | 455-8530 | Japan |
| Nagoya City University Hospital | Nagoya | Aichi-ken | 467-8602 | Japan |
| Tokatsu Tsujinaka Hospital | Abiko | Chiba | 270-1168 | Japan |
| Matsuyama Shimin Hospital | Matsuyama | Ehime | 790-0067 | Japan |
| Hatakeyama Clinic | Fukuoka | Fukuoka | 810-0024 | Japan |
| Oishi Clinic | Kasuya-gun | Fukuoka | 811-2310 | Japan |
| Igarashi Internal Medicine Surgery Clinic | Kōriyama | Fukushima | 963-8026 | Japan |
| Asahi University Hospital | Gifu | Gifu | 500-8523 | Japan |
| Nakamura Digestive Organ Internal Medicine Clinic | Bibai | Hokkaido | 072-0012 | Japan |
| Akakura GI Clinic | Sapporo | Hokkairdo | 060-0807 | Japan |
| Hyogo Prefectural Nishinomiya Hospital | Nishinomiya | Hyōgo | 662-0918 | Japan |
| Hyogo College of Medicine Hospital | Nishinomiya | Hyōgo | 663-8501 | Japan |
| Takarazuka City Hospital | Takarazuka-shi | Hyōgo | 665-0827 | Japan |
| Hitachi, Ltd. Hitachinaka General Hospital | Hitachi | Ibaraki | 312-0057 | Japan |
| Minami Akatsuka Clinic | Mito | Ibaraki | 311-4153 | Japan |
| Tsuchiura Beryl Clinic | Tsuchiura | Ibaraki | 300-0062 | Japan |
| Medical Corporation Shintoukai Yokohama Minoru Clinic | Yokohama | Kanagawa | 232-0064 | Japan |
| Takatsuki Red Cross Hospital | Takatsuki-shi | Osaka | 569-1096 | Japan |
| Medical Corporation Kumagaya General Hospital | Kumagaya | Saitama | 360-8567 | Japan |
| Wakasa Clinic | Tokorozawa | Saitama | 359-1151 | Japan |
| Community Hospital Koga Hospital | Yaizu | Shizuoka | 425-0088 | Japan |
| Shimokitazawa Tomo Clinic | Setagaya-Ku | Tokyo | 155-0031 | Japan |
| Morinaga Ueno Clinic | Kumamoto | 860-0863 | Japan |
| Ijinkai Takeda General Hospital | Kyoto | 601-1495 | Japan |
| Okayama Saiseikai General Hospital | Okayama | 700-8511 | Japan |
| Medical Corporation Kamata Clinic | Saitama | 330-0064 | Japan |
| Gastroenterology and Internal Medicine, Oizumi Medical Clinic | Yamagata | 990-0832 | Japan |
| VITAMED Galaj i Cichomski spolka jawna | Bydgoszcz | Kuyavian-Pomeranian Voivodeship | 85-079 | Poland |
| Centrum Medyczne Clw-Med Aneta Cichomska i Joanna uka-Wendrowska sp.j. | Grudziądz | Kuyavian-Pomeranian Voivodeship | 86-300 | Poland |
| Bodyclinic | Warsaw | Masovian Voivodeship | 00-332 | Poland |
| Centrum Medyczne Lukamed Joanna Luka | Chojnice | Pomeranian Voivodeship | 89-600 | Poland |
| Endoskopia | Sopot | 81-756 | Poland |
| Niepubliczny Zaklad Opieki Zdrowotnej - Witamed Poradnia Diabetolo | Kielce | Świętokrzyskie Voivodeship | 25-035 | Poland |
| 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. |
| FG002 | TAK-906 Maleate 25 mg | TAK-906 maleate 25 mg, capsules, orally, BID for up to 12 weeks. |
| FG003 | TAK-906 Maleate 50 mg | TAK-906 maleate 50 mg, capsules, orally, BID for up to 12 weeks. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Randomized Set included all participants who were randomized.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | TAK-906 maleate placebo-matching capsules, orally, BID for up to 12 weeks. |
| BG001 | TAK-906 Maleate 5 mg | TAK-906 maleate 5 mg, capsules, orally, BID for up to 12 weeks. |
| BG002 | TAK-906 Maleate 25 mg | TAK-906 maleate 25 mg, capsules, orally, BID for up to 12 weeks. |
| BG003 | TAK-906 Maleate 50 mg | TAK-906 maleate 50 mg, capsules, orally, BID for up to 12 weeks. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||
| Height | Mean | Standard Deviation | centimetres (cm) |
| |||||||||||||||
| Weight | Mean | Standard Deviation | kilograms (kg) |
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| Body Mass Index (BMI) | BMI was calculated as weight (kg) divided by square of height (m^2). | Mean | Standard Deviation | kg/m^2 |
| ||||||||||||||
| Smoking Classification | Count of Participants | Participants |
| ||||||||||||||||
| ANMS GCSI-DD Composite Score | American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary(ANMS GCSI-DD):patient-reported outcome instrument for symptom-based clinical trial endpoint in gastroparesis. ANMS GCSI-DD composite score: nausea, early satiety, upper abdominal pain and postprandial fullness.Daily composite score was calculated by summing scores on 4 symptom items(nausea, early satiety, postprandial fullness, and upper abdominal pain)/4 (number of items within composite score). ANMS GCSI-DD daily composite score ranged from 0 to 4 with higher scores=greater symptom severity. | 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. | Mean | Full Range | score on a scale |
| |||||||||||||
| ANMS GCSI-DD Nausea Symptom Score | 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. | 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. | Mean | Full Range | score on a scale |
| |||||||||||||
| ANMS GCSI-DD Early Satiety Symptom Score | 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. | 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. | Mean | Full Range | score on a scale |
| |||||||||||||
| ANMS GCSI-DD Postprandial Fullness Symptom Score | 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. | 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. | Mean | Full Range | score on a scale |
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| ANMS GCSI-DD Upper Abdominal Pain Symptom Score | 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. | 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. | Mean | Full Range | score on a scale |
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| ANMS GCSI-DD Recorded Vomiting Frequency | 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. | 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. | Mean | Full Range | vomiting episodes/day |
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| ANMS GCSI-DD Overall Severity of Gastroparesis Symptoms Score | 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. | 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. | Mean | Full Range | score on a scale |
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| Bloating Severity Scale Score | 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. | 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. | Mean | Full Range | score on a scale |
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| ANMS GCSI-DD Total Score | 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. | 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. | Mean | Full Range | score on a scale |
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| PAGI-SYM Total Score | The patient assessment of upper gastrointestinal disorders-symptom severity index (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 patients with upper GI disorders. | 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. | Mean | Full Range | score on a scale |
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| 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 | 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. | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Week 12 |
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| Secondary | 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. | 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. | Posted | Number | percentage of participants | Baseline and Week 12 |
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| Secondary | 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. | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Week 12 |
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| Secondary | 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. | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Week 12 |
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| Secondary | 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. | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Week 12 |
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| Secondary | 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. | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Week 12 |
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| Secondary | 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. | 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. | Posted | Least Squares Mean | Standard Error | vomiting episodes/day | Baseline and Week 12 |
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| Secondary | 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. | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Week 12 |
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| Secondary | 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. | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Week 12 |
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| Secondary | 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. | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Week 12 |
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| Secondary | 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. | 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. | Posted | Least Squares Mean | Standard Error | percentage of weeks | Up to 12 weeks |
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| Secondary | 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. | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Week 12 |
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From the study start up to 30 days after end of treatment (up to approximately 16 weeks)
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. Safety data was collected for all participants evaluable for response.
Not provided
| 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-906 maleate placebo-matching capsules, orally, BID for up to 12 weeks. | 0 | 73 | 2 | 73 | 0 | 73 |
| EG001 | TAK-906 5 mg | TAK-906 maleate 5 mg, capsules, orally, BID for up to 12 weeks. | 0 | 23 | 0 | 23 | 2 | 23 |
| EG002 | TAK-906 25 mg | TAK-906 maleate 25 mg, capsules, orally, BID for up to 12 weeks. | 0 | 72 | 2 | 72 | 4 | 72 |
| EG003 | TAK-906 50 mg | TAK-906 maleate 50 mg, capsules, orally, BID for up to 12 weeks. | 0 | 74 | 2 | 74 | 4 | 74 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 pneumonia | Infections and infestations | MedDRA 24 | Systematic Assessment |
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| Diabetic foot | Skin and subcutaneous tissue disorders | MedDRA 24 | Systematic Assessment |
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| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 24 | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 24 | Systematic Assessment |
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| Intermittent claudication | Vascular disorders | MedDRA 24 | Systematic Assessment |
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| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 24 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 24 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 24 | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Takeda | +1-877-825-3327 | TrialDisclosures@takeda.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 2, 2021 | Jun 9, 2022 | SAP_001.pdf |
Not provided
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Japan |
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| Poland |
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| United States of America |
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| Participant is a Current Smoker |
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| Participant is an Ex-smoker |
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| MMRM | =0.533 | 1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD composite score was <0. | Least Square Mean Difference | 0.01 | Standard Error of the Mean | 0.170 | 2-Sided | 90 | -0.27 | 0.29 | MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default. | Superiority |
| MMRM | =0.447 | 1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD composite score was <0. | Least Square Mean Difference | -0.02 | Standard Error of the Mean | 0.167 | 2-Sided | 90 | -0.30 | 0.25 | MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default. | Superiority |
| TAK-906 Maleate 25 mg |
TAK-906 maleate 25 mg, capsules, orally, BID for up to 12 weeks. |
| OG003 | TAK-906 Maleate 50 mg | TAK-906 maleate 50 mg, capsules, orally, BID for up to 12 weeks. |
|
|
|
| OG003 | TAK-906 Maleate 50 mg | TAK-906 maleate 50 mg, capsules, orally, BID for up to 12 weeks. |
|
|
|
| OG003 | TAK-906 Maleate 50 mg | TAK-906 maleate 50 mg, capsules, orally, BID for up to 12 weeks. |
|
|
|
TAK-906 maleate 25 mg, capsules, orally, BID for up to 12 weeks.
| OG003 | TAK-906 Maleate 50 mg | TAK-906 maleate 50 mg, capsules, orally, BID for up to 12 weeks. |
|
|
|
TAK-906 maleate 25 mg, capsules, orally, BID for up to 12 weeks.
| OG003 | TAK-906 Maleate 50 mg | TAK-906 maleate 50 mg, capsules, orally, BID for up to 12 weeks. |
|
|
|
| TAK-906 Maleate 50 mg |
TAK-906 maleate 50 mg, capsules, orally, BID for up to 12 weeks. |
|
|
|
| OG003 |
| TAK-906 Maleate 50 mg |
TAK-906 maleate 50 mg, capsules, orally, BID for up to 12 weeks. |
|
|
|
| TAK-906 Maleate 50 mg |
TAK-906 maleate 50 mg, capsules, orally, BID for up to 12 weeks. |
|
|
|
| OG003 | TAK-906 Maleate 50 mg | TAK-906 maleate 50 mg, capsules, orally, BID for up to 12 weeks. |
|
|
|
|
|
|
| OG003 | TAK-906 Maleate 50 mg | TAK-906 maleate 50 mg, capsules, orally, BID for up to 12 weeks. |
|
|
|