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

Sponsor
Millennium Pharmaceuticals, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03544229
Collaborator
(none)
242
Enrollment
109
Locations
4
Arms
32.9
Actual Duration (Months)
2.2
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: TAK-906 Maleate
  • Drug: TAK-906 Maleate Placebo
 Phase 2

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 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 Design

Study Type:
Interventional
Actual Enrollment :
242 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Oct 17, 2018
Actual Primary Completion Date :
Jun 14, 2021
Actual Study Completion Date :
Jul 14, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: TAK-906 Maleate 5 mg

TAK-906 maleate 5 mg, capsules, orally, twice daily (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, twice daily 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, twice daily for up to 12 weeks.

Drug: TAK-906 Maleate
TAK-906 maleate capsules.
Placebo Comparator: Placebo

TAK-906 maleate placebo-matching capsules, orally, twice daily for up to 12 weeks.

Drug: TAK-906 Maleate Placebo
TAK-906 maleate placebo-matching capsules.

Outcome Measures

Primary Outcome Measures

  1. Change From Baseline in American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) Composite Score at Week 12 [Baseline and Week 12]

    The ANMS GCSI-DD composite score includes 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).

Secondary Outcome Measures

  1. Percentage of Participants with At Least 50% Reduction From Baseline in ANMS GCSI-DD Composite Score at Week 12 [Baseline and Week 12]

    The ANMS GCSI-DD composite score includes 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).

  2. Change from Baseline in the ANMS GCSI-DD Nausea Symptom Score at Week 12 [Baseline and Week 12]

    The ANMS GCSI-DD nausea symptom score ranges from 0-none to 4-very severe. High scores reflect greater symptom severity.

  3. Change from Baseline in the ANMS GCSI-DD Early Satiety Symptom Score at Week 12 [Baseline and Week 12]

    The ANMS GCSI-DD early satiety symptom score ranges from 0-none to 4-very severe. High scores reflect greater symptom severity.

  4. Change from Baseline in the ANMS GCSI-DD Postprandial Fullness Symptom Score at Week 12 [Baseline and Week 12]

    The ANMS GCSI-DD postprandial fullness symptom score ranges from 0-none to 4-very severe. High scores reflect greater symptom severity.

  5. Change from Baseline in the ANMS GCSI-DD Upper Abdominal Pain Symptom Score at Week 12 [Baseline and Week 12]

    The ANMS GCSI-DD upper abdominal pain symptom score ranges from 0-none to 4-very severe. High scores reflect greater symptom severity.

  6. Change from Baseline in the ANMS GCSI-DD Recorded Vomiting Frequency at Week 12 [Baseline and Week 12]

    The vomiting score assesses the number of vomiting episodes during the day.

  7. Change from Baseline in the ANMS GCSI-DD Overall Severity of Gastroparesis Symptoms Score at Week 12 [Baseline and Week 12]

    The ANMS GCSI-DD gastroparesis symptoms score ranges from 0-none to 4-very severe. High scores reflect greater symptom severity.

  8. Change from Baseline in the ANMS GCSI-DD Bloating Severity Scale Score at Week 12 [Baseline and Week 12]

    The ANMS GCSI-DD bloating severity scale score ranges from 0-none to 4-very severe. High scores reflect greater symptom severity.

  9. Change from Baseline in the ANMS GCSI-DD Total Score at Week 12 [Baseline and Week 12]

    The ANMS GCSI-DD total score quantifies the incidence and severity of symptoms, specifically nausea, early satiety, postprandial fullness, upper abdominal pain, bloating, and vomiting.

  10. Percentage of Symptomatic Weeks [Up to 12 weeks]

    Symptomatic weeks are weeks with average composite symptom score assessed as >mild [ANMS GCSI-DD score ≥2] during 12 weeks of treatment.

  11. Change from Baseline in the Patient Assessment of Upper Gastrointestinal Disorders-Symptom Severity Index (PAGI-SYM) Total Score at Week 12 [Baseline and Week 12]

    PAGI-SYM is a 20-item self-reported questionnaire that measures symptom severity of upper gastrointestinal disorders across six subscales (nausea/vomiting, fullness/early satiety, bloating, upper abdominal pain, lower abdominal pain, heartburn/regurgitation). Higher scores indicate higher symptom severity.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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:

  3. 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

  4. Participants without previous confirmation of delayed gastric emptying prior to screening will undergo a GEBT after they have stopped taking prohibited medications.

  5. 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.

  6. 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).

  7. Has a body mass index (BMI) of ≥18 to ≤40 kg/m^2 inclusive.

  8. Participant with diabetes mellitus must have glycosylated hemoglobin (HbA1c) ≤11% at screening and before randomization.

  9. 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.

  1. Has renal impairment, defined as a lower limit of (estimated glomerular filtration rate [eGFR]) <30 mL/min at screening visit.

  2. 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).

  3. Uncontrolled or poorly controlled medical or psychiatric comorbidities which might affect their ability to participate in the study.

  4. Has known COVID-19 infection, or suspected COVID-19 infection (as assessed by the investigator).

  5. 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Digestive Health Specialists of the Southeast Dothan Alabama United States 36305
2 Del Sol Research Management Tucson Arizona United States 85710
3 Del Sol Research Management Tucson Arizona United States 85745
4 GW Research Chula Vista California United States 91910
5 Trial Connections - New Hope Research Development Corona California United States 92882
6 Paragon Rx Clinical - Garden Grove Garden Grove California United States 92840
7 Torrance Clinical Research Institute Inc. Lomita California United States 90717
8 California Medical Research Associates Northridge California United States 91324
9 ISS - Conquest Clinical Research Orange California United States 92866
10 Precision Research Institute San Diego California United States 92114
11 Connecticut Clinical Research Foundation Bristol Connecticut United States 06010
12 ISS - Innovative Research of West Florida Clearwater Florida United States 33756
13 Elias Research Associates - Direct Helpers Research Center - Hialeah Hialeah Florida United States 33012
14 International Research Associates Hialeah Florida United States 33012
15 Palmetto Research Hialeah Florida United States 33016
16 Homestead Associates in Research Homestead Florida United States 33032
17 Gastroenterology Associates - Crystal River Inverness Florida United States 34452
18 Mayo Clinic Jacksonville Florida United States 32224
19 Baptist Diabetes Associates Research Miami Florida United States 33156
20 PharmaSouth Research Miami Florida United States 33175
21 Miami Dade Medical Research Institute Miami Florida United States 33176
22 Anchor Medical Research Miami Florida United States 33186
23 Advanced Research Institute - New Port Richey New Port Richey Florida United States 34653
24 Advanced Medical Research Center Port Orange Florida United States 32127
25 Summit Clinical Research Athens Georgia United States 30607
26 Digestive Healthcare of Georgia - Atlanta Atlanta Georgia United States 30309
27 DM Clinical Research - Southwest Gastroenterology - Oak Lawn Oak Lawn Illinois United States 60453
28 University of Kansas Medical Center Kansas City Kansas United States 66160
29 Tri-State Gastroenterology Associates Crestview Hills Kentucky United States 41017
30 Gastro Center of Maryland Columbia Maryland United States 21045
31 MGH Digestive Healthcare Boston Massachusetts United States 02114
32 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215
33 Veterans Affairs Medical Center - West Roxbury West Roxbury Massachusetts United States 02132
34 University of Michigan Ann Arbor Michigan United States 48109
35 Clinical Research Institute of Michigan Chesterfield Michigan United States 48047
36 Gastroenterology Associates of Western Michigan Wyoming Michigan United States 49519
37 Gastrointestinal Associates and Endoscopy Center Flowood Mississippi United States 39232
38 Montana Medical Research Missoula Montana United States 59808
39 Lovelace Scientific Resources - Albuquerque Albuquerque New Mexico United States 87108
40 NY Scientific Brooklyn New York United States 11235
41 Long Island Gastrointestinal Research Group Great Neck New York United States 11023
42 Atrium Health Charlotte North Carolina United States 28204
43 Chevy Chase Clinical Research Concord North Carolina United States 28025
44 Fayetteville Gastroenterology Associates Fayetteville North Carolina United States 28304
45 Carolina Digestive Diseases Greenville North Carolina United States 27834-3761
46 Wake Research Associates Raleigh North Carolina United States 27612
47 PMG Research of Salisbury Salisbury North Carolina United States 28144
48 Trial Management Associates Wilmington North Carolina United States 28403
49 Gastroenterology Associates of the Piedmont Winston-Salem North Carolina United States 27103
50 Consultants for Clinical Research Cincinnati Ohio United States 45219
51 Providence Health Partners - Center for Clinical Research Dayton Ohio United States 45439
52 Elite Research - Lynn Institute of Stillwater Stillwater Oklahoma United States 74074
53 Options Health Research Tulsa Oklahoma United States 74104
54 Temple University Hospital Philadelphia Pennsylvania United States 19140
55 Digestive Disease Associates - Wyomissin Wyomissing Pennsylvania United States 19610
56 ClinSearch Chattanooga Tennessee United States 37421
57 Clinical Research Solutions - Jackson Jackson Tennessee United States 38305
58 New Phase Research and Development Knoxville Tennessee United States 37909
59 Quality Medical Research Nashville Tennessee United States 37211
60 Texas Tech University Health Sciences Center - El Paso El Paso Texas United States 79905
61 Spring Gastroenterology Associates - Houston Houston Texas United States 77002
62 Biopharma Informatic Houston 1 Houston Texas United States 77043
63 Biopharma Informatic Houston 2 Houston Texas United States 77084
64 Rio Grande Gastroenterology McAllen Texas United States 78503
65 Clinical Associates in Research Therapeutics of America San Antonio Texas United States 78212
66 Sun Research Institute San Antonio Texas United States 78215
67 Gastroenterology Associates of Tidewater Chesapeake Virginia United States 23320
68 Universiteit Antwerpen Edegem Antwerpen Belgium 2650
69 Universitair Ziekenhuis Leuven Leuven Flemish Brabant Belgium 3000
70 Algemeen Ziekenhuis Sint-Lucas Brugge West-vlaanderen Belgium 8310
71 AZ Groeninge Campus Kennedylaan Kortrijk West-vlaanderen Belgium 8500
72 Cliniques Universitaires Saint-Luc Brussels Belgium 1200
73 Hopital Erasme Bruxelles Belgium 1070 Bruxelles
74 Universiteit Gent Gent Belgium 9000
75 Tokai Memorial Hospital Kasugai-shi Aichi Japan 487-0031
76 Nagoya City University Hospital Nagoya City Aichi Japan 467-8602
77 Meitetsu Hospital Nagoya-shi Aichi Japan 451-8511
78 Chubu-Rosai Hospital Nagoya Aichi Japan 455-8530
79 Tokatsu Tsujinaka Hospital Abiko Chiba Japan 270-1168
80 Matsuyama Shimin Hospital Matsuyama Ehime Japan 790-0067
81 Hatakeyama Clinic Fukuoka-shi Fukuoka Japan 810-0024
82 Oishi Clinic Kasuya-gun Fukuoka Japan 811-2310
83 Igarashi Internal Medicine Surgery Clinic Koriyama City Fukushima Japan 963-8026
84 Asahi University Hospital Gifu-city Gifu Japan 500-8523
85 Nakamura Digestive Organ Internal Medicine Clinic Bibai Hokkaido Japan 072-0012
86 Akakura GI Clinic Sapporo-Shi Hokkairdo Japan 060-0807
87 Hyogo Prefectural Nishinomiya Hospital Nishinomiya Hyogo Japan 662-0918
88 Hyogo College of Medicine Hospital Nishinomiya Hyogo Japan 663-8501
89 Takarazuka City Hospital Takarazuka-shi Hyogo Japan 665-0827
90 Hitachi, Ltd. Hitachinaka General Hospital Hitachi Ibaraki Japan 312-0057
91 Minami Akatsuka Clinic Mito-shi Ibaraki Japan 311-4153
92 Tsuchiura Beryl Clinic Tsuchiura City Ibaraki Japan 300-0062
93 Medical Corporation Shintoukai Yokohama Minoru Clinic Yokohama-city Kanagawa Japan 232-0064
94 Takatsuki Red Cross Hospital Takatsuki-shi Osaka Japan 569-1096
95 Medical Corporation Kumagaya General Hospital Kumagaya Saitama Japan 360-8567
96 Wakasa Clinic Tokorozawa Saitama Japan 359-1151
97 Community Hospital Koga Hospital Yaizu Shizuoka Japan 425-0088
98 Shimokitazawa Tomo Clinic Setagaya-Ku Tokyo Japan 155-0031
99 Morinaga Ueno Clinic Kumamoto Japan 860-0863
100 Ijinkai Takeda General Hospital Kyoto Japan 601-1495
101 Okayama Saiseikai General Hospital Okayama Japan 700-8511
102 Medical Corporation Kamata Clinic Saitama Japan 330-0064
103 Gastroenterology and Internal Medicine, Oizumi Medical Clinic Yamagata Japan 990-0832
104 VITAMED Galaj i Cichomski spolka jawna Bydgoszcz Kujawsko-pomorskie Poland 85-079
105 Centrum Medyczne Clw-Med Aneta Cichomska i Joanna uka-Wendrowska sp.j. Grudziadz Kujawsko-pomorskie Poland 86-300
106 Bodyclinic Warszawa Mazowieckie Poland 00-332
107 Centrum Medyczne Lukamed Joanna Luka Chojnice Pomorskie Poland 89-600
108 Niepubliczny Zaklad Opieki Zdrowotnej - Witamed Poradnia Diabetolo Kielce Swietokrzyskie Poland 25-035
109 Endoskopia Sopot Poland 81-756

Sponsors and Collaborators

  • Millennium Pharmaceuticals, Inc.

Investigators

  • Study Director: Medical Director Clinical Science, Takeda

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT03544229
Other Study ID Numbers:
  • TAK-906-2002
  • 2018-001275-21
First Posted:
Jun 1, 2018
Last Update Posted:
Jul 20, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Millennium Pharmaceuticals, Inc.
Drug Therapy
Additional relevant MeSH terms:
Gastroparesis
Maleic acid

Study Results

No Results Posted as of Jul 20, 2021