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Diabetic GastroparesisPhase 2NCT03544229

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

A Phase 2 study testing TAK-906 Maleate in people with Diabetic Gastroparesis and Idiopathic Gastroparesis, run by Millennium Pharmaceuticals, Inc. at 109 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
TAK-906 Maleate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
242 participants
Where
109 sitesin 4 countries
Study dates
14 Oct 2018to 15 Jul 2021
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • 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
  • Participants without previous confirmation of delayed gastric emptying prior to screening will undergo a GEBT after they have stopped taking prohibited medications.
  • 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).
Show all 9Show fewer
  • 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.

Who cannot join

  • 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.
Show all 22Show fewer
  • 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 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.
  • 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.

Trial locations and contacts

109 sites in 4 countries.

109 sites in 4 countries

United States67 sites

  • Lovelace Scientific Resources - Albuquerque

    Albuquerque, New Mexico, 87108

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Summit Clinical Research

    Athens, Georgia, 30607

  • Digestive Healthcare of Georgia - Atlanta

    Atlanta, Georgia, 30309

  • MGH Digestive Healthcare

    Boston, Massachusetts, 02114

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Connecticut Clinical Research Foundation

    Bristol, Connecticut, 06010

  • NY Scientific

    Brooklyn, New York, 11235

  • Atrium Health

    Charlotte, North Carolina, 28204

  • ClinSearch

    Chattanooga, Tennessee, 37421

  • Gastroenterology Associates of Tidewater

    Chesapeake, Virginia, 23320

  • Clinical Research Institute of Michigan

    Chesterfield, Michigan, 48047

  • GW Research

    Chula Vista, California, 91910

  • Consultants for Clinical Research

    Cincinnati, Ohio, 45219

  • ISS - Innovative Research of West Florida

    Clearwater, Florida, 33756

  • Gastro Center of Maryland

    Columbia, Maryland, 21045

  • Chevy Chase Clinical Research

    Concord, North Carolina, 28025

  • Trial Connections - New Hope Research Development

    Corona, California, 92882

  • Tri-State Gastroenterology Associates

    Crestview Hills, Kentucky, 41017

  • Providence Health Partners - Center for Clinical Research

    Dayton, Ohio, 45439

  • Digestive Health Specialists of the Southeast

    Dothan, Alabama, 36305

  • Texas Tech University Health Sciences Center - El Paso

    El Paso, Texas, 79905

  • Fayetteville Gastroenterology Associates

    Fayetteville, North Carolina, 28304

  • Gastrointestinal Associates and Endoscopy Center

    Flowood, Mississippi, 39232

  • Paragon Rx Clinical - Garden Grove

    Garden Grove, California, 92840

  • Long Island Gastrointestinal Research Group

    Great Neck, New York, 11023

  • Carolina Digestive Diseases

    Greenville, North Carolina, 27834

  • Elias Research Associates - Direct Helpers Research Center - Hialeah

    Hialeah, Florida, 33012

  • International Research Associates

    Hialeah, Florida, 33012

  • Palmetto Research

    Hialeah, Florida, 33016

  • Homestead Associates in Research

    Homestead, Florida, 33032

  • Spring Gastroenterology Associates - Houston

    Houston, Texas, 77002

  • Biopharma Informatic Houston 1

    Houston, Texas, 77043

  • Biopharma Informatic Houston 2

    Houston, Texas, 77084

  • Gastroenterology Associates - Crystal River

    Inverness, Florida, 34452

  • Clinical Research Solutions - Jackson

    Jackson, Tennessee, 38305

  • Mayo Clinic

    Jacksonville, Florida, 32224

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • New Phase Research and Development

    Knoxville, Tennessee, 37909

  • Torrance Clinical Research Institute Inc.

    Lomita, California, 90717

  • Rio Grande Gastroenterology

    McAllen, Texas, 78503

  • Baptist Diabetes Associates Research

    Miami, Florida, 33156

  • PharmaSouth Research

    Miami, Florida, 33175

  • Miami Dade Medical Research Institute

    Miami, Florida, 33176

  • Anchor Medical Research

    Miami, Florida, 33186

  • Montana Medical Research

    Missoula, Montana, 59808

  • Quality Medical Research

    Nashville, Tennessee, 37211

  • Advanced Research Institute - New Port Richey

    New Port Richey, Florida, 34653

  • California Medical Research Associates

    Northridge, California, 91324

  • DM Clinical Research - Southwest Gastroenterology - Oak Lawn

    Oak Lawn, Illinois, 60453

  • ISS - Conquest Clinical Research

    Orange, California, 92866

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140

  • Advanced Medical Research Center

    Port Orange, Florida, 32127

  • Wake Research Associates

    Raleigh, North Carolina, 27612

  • PMG Research of Salisbury

    Salisbury, North Carolina, 28144

  • Clinical Associates in Research Therapeutics of America

    San Antonio, Texas, 78212

  • Sun Research Institute

    San Antonio, Texas, 78215

  • Precision Research Institute

    San Diego, California, 92114

  • Elite Research - Lynn Institute of Stillwater

    Stillwater, Oklahoma, 74074

  • Del Sol Research Management

    Tucson, Arizona, 85710

  • Del Sol Research Management

    Tucson, Arizona, 85745

  • Options Health Research

    Tulsa, Oklahoma, 74104

  • Veterans Affairs Medical Center - West Roxbury

    West Roxbury, Massachusetts, 02132

  • Trial Management Associates

    Wilmington, North Carolina, 28403

  • Gastroenterology Associates of the Piedmont

    Winston-Salem, North Carolina, 27103

  • Gastroenterology Associates of Western Michigan

    Wyoming, Michigan, 49519

  • Digestive Disease Associates - Wyomissin

    Wyomissing, Pennsylvania, 19610

Other trials in United States

Japan29 sites

  • Tokatsu Tsujinaka Hospital

    Abiko, Chiba, 270-1168

  • Nakamura Digestive Organ Internal Medicine Clinic

    Bibai, Hokkaido, 072-0012

  • Hatakeyama Clinic

    Fukuoka, Fukuoka, 810-0024

  • Asahi University Hospital

    Gifu, Gifu, 500-8523

  • Hitachi, Ltd. Hitachinaka General Hospital

    Hitachi, Ibaraki, 312-0057

  • Tokai Memorial Hospital

    Kasugai-shi, Aichi-ken, 487-0031

  • Oishi Clinic

    Kasuya-gun, Fukuoka, 811-2310

  • Igarashi Internal Medicine Surgery Clinic

    Kōriyama, Fukushima, 963-8026

  • Medical Corporation Kumagaya General Hospital

    Kumagaya, Saitama, 360-8567

  • Morinaga Ueno Clinic

    Kumamoto, 860-0863

  • Ijinkai Takeda General Hospital

    Kyoto, 601-1495

  • Matsuyama Shimin Hospital

    Matsuyama, Ehime, 790-0067

  • Minami Akatsuka Clinic

    Mito, Ibaraki, 311-4153

  • Meitetsu Hospital

    Nagoya, Aichi-ken, 451-8511

  • Chubu-Rosai Hospital

    Nagoya, Aichi-ken, 455-8530

  • Nagoya City University Hospital

    Nagoya, Aichi-ken, 467-8602

  • Hyogo Prefectural Nishinomiya Hospital

    Nishinomiya, Hyōgo, 662-0918

  • Hyogo College of Medicine Hospital

    Nishinomiya, Hyōgo, 663-8501

  • Okayama Saiseikai General Hospital

    Okayama, 700-8511

  • Medical Corporation Kamata Clinic

    Saitama, 330-0064

  • Akakura GI Clinic

    Sapporo, Hokkairdo, 060-0807

  • Shimokitazawa Tomo Clinic

    Setagaya-Ku, Tokyo, 155-0031

  • Takarazuka City Hospital

    Takarazuka-shi, Hyōgo, 665-0827

  • Takatsuki Red Cross Hospital

    Takatsuki-shi, Osaka, 569-1096

  • Wakasa Clinic

    Tokorozawa, Saitama, 359-1151

  • Tsuchiura Beryl Clinic

    Tsuchiura, Ibaraki, 300-0062

  • Community Hospital Koga Hospital

    Yaizu, Shizuoka, 425-0088

  • Gastroenterology and Internal Medicine, Oizumi Medical Clinic

    Yamagata, 990-0832

  • Medical Corporation Shintoukai Yokohama Minoru Clinic

    Yokohama, Kanagawa, 232-0064

Other trials in Japan

Belgium7 sites

  • Algemeen Ziekenhuis Sint-Lucas

    Bruges, West-vlaanderen, 8310

  • Hopital Erasme

    Brussels, 1070 Bruxelles

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • Universiteit Antwerpen

    Edegem, Antwerpen, 2650

  • Universiteit Gent

    Ghent, 9000

  • AZ Groeninge Campus Kennedylaan

    Kortrijk, West-vlaanderen, 8500

  • Universitair Ziekenhuis Leuven

    Leuven, Flemish Brabant, 3000

Other trials in Belgium

Poland6 sites

  • VITAMED Galaj i Cichomski spolka jawna

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-079

  • Centrum Medyczne Lukamed Joanna Luka

    Chojnice, Pomeranian Voivodeship, 89-600

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

    Grudziądz, Kuyavian-Pomeranian Voivodeship, 86-300

  • Niepubliczny Zaklad Opieki Zdrowotnej - Witamed Poradnia Diabetolo

    Kielce, Świętokrzyskie Voivodeship, 25-035

  • Endoskopia

    Sopot, 81-756

  • Bodyclinic

    Warsaw, Masovian Voivodeship, 00-332

Other trials in Poland

About this study

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

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.

Read the 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.

Being tested
TAK-906 Maleate, Placebo
Keywords
Drug Therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TAK-906 MaleateDrug

    TAK-906 maleate capsules.

  • PlaceboDrug

    TAK-906 maleate placebo-matching capsules.

Study groups in NCT03544229
Study groupRoleWhat they receive
PlaceboPlacebo comparatorTAK-906 maleate placebo-matching capsules, orally, twice daily (BID) for up to 12 weeks.
Receives: Drug: Placebo
TAK-906 Maleate 5 mgExperimentalTAK-906 maleate 5 mg, capsules, orally, BID for up to 12 weeks.
Receives: Drug: TAK-906 Maleate
TAK-906 Maleate 25 mgExperimentalTAK-906 maleate 25 mg, capsules, orally, BID for up to 12 weeks.
Receives: Drug: TAK-906 Maleate
TAK-906 Maleate 50 mgExperimentalTAK-906 maleate 50 mg, capsules, orally, BID for up to 12 weeks.
Receives: Drug: TAK-906 Maleate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and Week 12

Secondary outcomes (11)

  1. 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.

    Measured: Baseline and Week 12

  2. 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.

    Measured: Baseline and Week 12

  3. 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.

    Measured: Baseline and Week 12

  4. 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.

    Measured: Baseline and Week 12

  5. 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.

    Measured: Baseline and Week 12

  6. 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.

    Measured: Baseline and Week 12

  7. 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.

    Measured: Baseline and Week 12

  8. 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.

    Measured: Baseline and Week 12

  9. 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.

    Measured: Baseline and Week 12

  10. 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.

    Measured: Up to 12 weeks

  11. 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.

    Measured: Baseline and Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2018
  2. Study start14 Oct 2018
  3. Primary completion14 Jun 2021
  4. Study completion15 Jul 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
242 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03544229
Sponsor's protocol ID
TAK-906-2002
Other IDs
2018-001275-21, U1111-1211-2779, 2018
Status last verified
Oct 2022
First submitted
21 May 2018
Last updated
16 Nov 2022
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 37533380

  • 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.

    PubMed 34967147

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TAK-906 Maleate in people with Diabetic Gastroparesis and Idiopathic Gastroparesis, run by Millennium Pharmaceuticals, Inc. at 109 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 109 sites in United States, Japan, Belgium, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Baseline and Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03544229, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2022.

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