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



Status:Recruiting
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 85
Updated:3/13/2019
Start Date:October 17, 2018
End Date:March 30, 2020
Contact:Takeda Study Registration Call Center
Email:medicalinformation@tpna.com
Phone:+1-877-825-3327

Use our guide to learn which trials are right for you!

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 various 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 280 patients. Participants will be randomly assigned (by
chance, like flipping a coin) to one of the four 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 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

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 40 days after receiving their last dose of study drug for a follow-up
assessment.

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. Should have confirmed delayed gastric emptying at Screening; delayed gastric emptying
by gastric emptying breath test (GEBT) is defined as t1/2 ≥79 minutes (80th
percentile).

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 ≥19 to ≤40 kg/m^2 inclusive

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

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 Visit 2.

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. Uncontrolled or poorly controlled medical or psychiatric comorbidities which might
affect their ability to participate in the study.
We found this trial at
42
sites
Salisbury, North Carolina 28144
?
mi
from
Salisbury, NC
Click here to add this to my saved trials
2441 Ridgecrest Drive
Albuquerque, New Mexico 87108
505-348-9398
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
?
mi
from
Boston, MA
Click here to add this to my saved trials
112 Gainsborough Square
Chesapeake, Virginia 23320
757-547-0798
?
mi
from
Chesapeake, VA
Click here to add this to my saved trials
4201 Belfort Road
Jacksonville, Florida 32216
(408) 293-2336
Mayo Clinic Mayo Clinic's campus in Arizona provides medical care for thousands of people from...
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
1690 Dunlawton Ave # 220
Port Orange, Florida 32127
?
mi
from
Port Orange, FL
Click here to add this to my saved trials
500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
95 Collier Road Northwest
Atlanta, Georgia 30309
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Boston, Massachusetts 02114
?
mi
from
Boston, MA
Click here to add this to my saved trials
Chattanooga, Tennessee 37421
?
mi
from
Chattanooga, TN
Click here to add this to my saved trials
Chesterfield, Michigan 48098
?
mi
from
Chesterfield, MI
Click here to add this to my saved trials
Chula Vista, California 91910
?
mi
from
Chula Vista, CA
Click here to add this to my saved trials
Chula Vista, California 91910
?
mi
from
Chula Vista, CA
Click here to add this to my saved trials
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Concord, North Carolina 28025
?
mi
from
Concord, NC
Click here to add this to my saved trials
Crestview Hills, Kentucky 41017
?
mi
from
Crestview Hills, KY
Click here to add this to my saved trials
?
mi
from
Dayton, OH
Click here to add this to my saved trials
Edegem, Antwerpen
?
mi
from
Edegem,
Click here to add this to my saved trials
?
mi
from
El Paso, TX
Click here to add this to my saved trials
Fayetteville, North Carolina 28304
?
mi
from
Fayetteville, NC
Click here to add this to my saved trials
2510 Lakeland Drive
Flowood, Mississippi 39232
?
mi
from
Flowood, MS
Click here to add this to my saved trials
Germantown, Tennessee 38138
?
mi
from
Germantown, TN
Click here to add this to my saved trials
Great Neck, New York 11023
?
mi
from
Great Neck, NY
Click here to add this to my saved trials
?
mi
from
Hialeah, FL
Click here to add this to my saved trials
Hialeah, Florida 33016
?
mi
from
Hialeah, FL
Click here to add this to my saved trials
?
mi
from
Inverness, FL
Click here to add this to my saved trials
Jackson, Tennessee 38305
?
mi
from
Jackson, TN
Click here to add this to my saved trials
3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
?
mi
from
Kansas City, KS
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
Miami, Florida 33175
?
mi
from
Miami, FL
Click here to add this to my saved trials
Nashville, Tennessee 37211
?
mi
from
Nashville, TN
Click here to add this to my saved trials
?
mi
from
Oak Lawn, IL
Click here to add this to my saved trials
3401 N Broad St
Philadelphia, Pennsylvania
(215) 707-2000
Temple University Hospital On January 18, 1892 a three-story house at 3403 North Broad Street...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
3100 Duraleigh Rd
Raleigh, North Carolina 27612
(919) 781-2514
Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
Rockville, Maryland 20850
?
mi
from
Rockville, MD
Click here to add this to my saved trials
San Diego, California 92115
?
mi
from
San Diego, CA
Click here to add this to my saved trials
Tucson, Arizona 85710
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
Tulsa, Oklahoma 74137
?
mi
from
Tulsa, OK
Click here to add this to my saved trials
West Roxbury, Massachusetts 02132
?
mi
from
West Roxbury, MA
Click here to add this to my saved trials
Wilmington, North Carolina 28403
?
mi
from
Wilmington, NC
Click here to add this to my saved trials
875 Bethesda Road
Winston-Salem, North Carolina 27103
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials
?
mi
from
Wyoming, MI
Click here to add this to my saved trials