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

NCT ID: NCT03544229

Last Updated: 2022-11-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 242 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-14
• Study Completion Date: 2021-07-15

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.

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.

Conditions

Diabetic Gastroparesis; Idiopathic Gastroparesis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

TAK-906 maleate placebo-matching capsules.

TAK-906 Maleate 5 mg

TAK-906 maleate 5 mg, capsules, orally, BID for up to 12 weeks.

Group Type: EXPERIMENTAL

TAK-906 Maleate

Intervention Type: DRUG

TAK-906 maleate capsules.

TAK-906 Maleate 25 mg

TAK-906 maleate 25 mg, capsules, orally, BID for up to 12 weeks.

Group Type: EXPERIMENTAL

TAK-906 Maleate

Intervention Type: DRUG

TAK-906 maleate capsules.

TAK-906 Maleate 50 mg

TAK-906 maleate 50 mg, capsules, orally, BID for up to 12 weeks.

Group Type: EXPERIMENTAL

TAK-906 Maleate

Intervention Type: DRUG

TAK-906 maleate capsules.

Interventions

TAK-906 Maleate

TAK-906 maleate capsules.

Intervention Type: DRUG

Placebo

TAK-906 maleate placebo-matching capsules.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Millennium Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Takeda

Locations

Digestive Health Specialists of the Southeast

Dothan, Alabama, United States

Del Sol Research Management

Tucson, Arizona, United States

Del Sol Research Management

Tucson, Arizona, United States

GW Research

Chula Vista, California, United States

Trial Connections - New Hope Research Development

Corona, California, United States

Paragon Rx Clinical - Garden Grove

Garden Grove, California, United States

Torrance Clinical Research Institute Inc.

Lomita, California, United States

California Medical Research Associates

Northridge, California, United States

ISS - Conquest Clinical Research

Orange, California, United States

Precision Research Institute

San Diego, California, United States

Connecticut Clinical Research Foundation

Bristol, Connecticut, United States

ISS - Innovative Research of West Florida

Clearwater, Florida, United States

Elias Research Associates - Direct Helpers Research Center - Hialeah

Hialeah, Florida, United States

International Research Associates

Hialeah, Florida, United States

Palmetto Research

Hialeah, Florida, United States

Homestead Associates in Research

Homestead, Florida, United States

Gastroenterology Associates - Crystal River

Inverness, Florida, United States

Mayo Clinic

Jacksonville, Florida, United States

Baptist Diabetes Associates Research

Miami, Florida, United States

PharmaSouth Research

Miami, Florida, United States

Miami Dade Medical Research Institute

Miami, Florida, United States

Anchor Medical Research

Miami, Florida, United States

Advanced Research Institute - New Port Richey

New Port Richey, Florida, United States

Advanced Medical Research Center

Port Orange, Florida, United States

Summit Clinical Research

Athens, Georgia, United States

Digestive Healthcare of Georgia - Atlanta

Atlanta, Georgia, United States

DM Clinical Research - Southwest Gastroenterology - Oak Lawn

Oak Lawn, Illinois, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Tri-State Gastroenterology Associates

Crestview Hills, Kentucky, United States

Gastro Center of Maryland

Columbia, Maryland, United States

MGH Digestive Healthcare

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Veterans Affairs Medical Center - West Roxbury

West Roxbury, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Clinical Research Institute of Michigan

Chesterfield, Michigan, United States

Gastroenterology Associates of Western Michigan

Wyoming, Michigan, United States

Gastrointestinal Associates and Endoscopy Center

Flowood, Mississippi, United States

Montana Medical Research

Missoula, Montana, United States

Lovelace Scientific Resources - Albuquerque

Albuquerque, New Mexico, United States

NY Scientific

Brooklyn, New York, United States

Long Island Gastrointestinal Research Group

Great Neck, New York, United States

Atrium Health

Charlotte, North Carolina, United States

Chevy Chase Clinical Research

Concord, North Carolina, United States

Fayetteville Gastroenterology Associates

Fayetteville, North Carolina, United States

Carolina Digestive Diseases

Greenville, North Carolina, United States

Wake Research Associates

Raleigh, North Carolina, United States

PMG Research of Salisbury

Salisbury, North Carolina, United States

Trial Management Associates

Wilmington, North Carolina, United States

Gastroenterology Associates of the Piedmont

Winston-Salem, North Carolina, United States

Consultants for Clinical Research

Cincinnati, Ohio, United States

Providence Health Partners - Center for Clinical Research

Dayton, Ohio, United States

Elite Research - Lynn Institute of Stillwater

Stillwater, Oklahoma, United States

Options Health Research

Tulsa, Oklahoma, United States

Temple University Hospital

Philadelphia, Pennsylvania, United States

Digestive Disease Associates - Wyomissin

Wyomissing, Pennsylvania, United States

ClinSearch

Chattanooga, Tennessee, United States

Clinical Research Solutions - Jackson

Jackson, Tennessee, United States

New Phase Research and Development

Knoxville, Tennessee, United States

Quality Medical Research

Nashville, Tennessee, United States

Texas Tech University Health Sciences Center - El Paso

El Paso, Texas, United States

Spring Gastroenterology Associates - Houston

Houston, Texas, United States

Biopharma Informatic Houston 1

Houston, Texas, United States

Biopharma Informatic Houston 2

Houston, Texas, United States

Rio Grande Gastroenterology

McAllen, Texas, United States

Clinical Associates in Research Therapeutics of America

San Antonio, Texas, United States

Sun Research Institute

San Antonio, Texas, United States

Gastroenterology Associates of Tidewater

Chesapeake, Virginia, United States

Universiteit Antwerpen

Edegem, Antwerpen, Belgium

Universitair Ziekenhuis Leuven

Leuven, Flemish Brabant, Belgium

Algemeen Ziekenhuis Sint-Lucas

Bruges, West-vlaanderen, Belgium

AZ Groeninge Campus Kennedylaan

Kortrijk, West-vlaanderen, Belgium

Hopital Erasme

Brussels, , Belgium

Cliniques Universitaires Saint-Luc

Brussels, , Belgium

Universiteit Gent

Ghent, , Belgium

Tokai Memorial Hospital

Kasugai-shi, Aichi-ken, Japan

Meitetsu Hospital

Nagoya, Aichi-ken, Japan

Chubu-Rosai Hospital

Nagoya, Aichi-ken, Japan

Nagoya City University Hospital

Nagoya, Aichi-ken, Japan

Tokatsu Tsujinaka Hospital

Abiko, Chiba, Japan

Matsuyama Shimin Hospital

Matsuyama, Ehime, Japan

Hatakeyama Clinic

Fukuoka, Fukuoka, Japan

Oishi Clinic

Kasuya-gun, Fukuoka, Japan

Igarashi Internal Medicine Surgery Clinic

Kōriyama, Fukushima, Japan

Asahi University Hospital

Gifu, Gifu, Japan

Nakamura Digestive Organ Internal Medicine Clinic

Bibai, Hokkaido, Japan

Akakura GI Clinic

Sapporo, Hokkairdo, Japan

Hyogo Prefectural Nishinomiya Hospital

Nishinomiya, Hyōgo, Japan

Hyogo College of Medicine Hospital

Nishinomiya, Hyōgo, Japan

Takarazuka City Hospital

Takarazuka-shi, Hyōgo, Japan

Hitachi, Ltd. Hitachinaka General Hospital

Hitachi, Ibaraki, Japan

Minami Akatsuka Clinic

Mito, Ibaraki, Japan

Tsuchiura Beryl Clinic

Tsuchiura, Ibaraki, Japan

Medical Corporation Shintoukai Yokohama Minoru Clinic

Yokohama, Kanagawa, Japan

Takatsuki Red Cross Hospital

Takatsuki-shi, Osaka, Japan

Medical Corporation Kumagaya General Hospital

Kumagaya, Saitama, Japan

Wakasa Clinic

Tokorozawa, Saitama, Japan

Community Hospital Koga Hospital

Yaizu, Shizuoka, Japan

Shimokitazawa Tomo Clinic

Setagaya-Ku, Tokyo, Japan

Morinaga Ueno Clinic

Kumamoto, , Japan

Ijinkai Takeda General Hospital

Kyoto, , Japan

Okayama Saiseikai General Hospital

Okayama, , Japan

Medical Corporation Kamata Clinic

Saitama, , Japan

Gastroenterology and Internal Medicine, Oizumi Medical Clinic

Yamagata, , Japan

VITAMED Galaj i Cichomski spolka jawna

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Centrum Medyczne Clw-Med Aneta Cichomska i Joanna uka-Wendrowska sp.j.

Grudziądz, Kuyavian-Pomeranian Voivodeship, Poland

Bodyclinic

Warsaw, Masovian Voivodeship, Poland

Centrum Medyczne Lukamed Joanna Luka

Chojnice, Pomeranian Voivodeship, Poland

Endoskopia

Sopot, , Poland

Niepubliczny Zaklad Opieki Zdrowotnej - Witamed Poradnia Diabetolo

Kielce, Świętokrzyskie Voivodeship, Poland

Countries

United States; Belgium; Japan; Poland

References

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.

Reference Type: DERIVED

PMID: 37533380 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34967147 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://clinicaltrials.takeda.com/study-detail/5f6b60354db2bf003ab4a062

Related Info

Other Identifiers

2018-001275-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1211-2779

Identifier Type: OTHER

Identifier Source: secondary_id

TAK-906-2002

Identifier Type: -

Identifier Source: org_study_id