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

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ClinicalTrials.gov Identifier: NCT03544229
Recruitment Status : Not yet recruiting
First Posted : June 1, 2018
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
Takeda ( Millennium Pharmaceuticals, Inc. )

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetic Gastroparesis Idiopathic Gastroparesis 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 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 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
Estimated Study Start Date : October 19, 2018
Estimated Primary Completion Date : March 30, 2020
Estimated Study Completion Date : March 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TAK-906 Maleate 5 mg
TAK-906 maleate 5 mg, capsules, orally, twice daily 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




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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 Bloating Severity Scale Score at Week 12 [ Time Frame: Baseline and Week 12 ]
    The bloating severity scale score ranges from 0-none to 4-very severe. High scores reflect greater symptom severity.

  8. Change from Baseline in the ANMS GCSI-DD Total Score at Week 12 [ Time Frame: 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.

  9. Percentage of Symptomatic Weeks [ Time Frame: Up to 12 weeks ]
    Symptomatic weeks are weeks with average composite symptom score assessed as >mild [ANMS GCSI-DD Score ≥2]).

  10. Change from Baseline in the Patient Assessment of Upper Gastrointestinal Disorders-Symptom Severity Index (PAGI-SYM) Total Score at Week 12 [ Time Frame: 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.

  11. Change from Baseline in the ANMS GCSI-DD Severity of Gastroparesis Symptoms Score at Week 12 [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03544229


Contacts
Contact: Takeda Study Registration Call Center +1-877-825-3327 medicalinformation@tpna.com

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Sponsors and Collaborators
Millennium Pharmaceuticals, Inc.
Investigators
Study Director: Medical Director Clinical Science Takeda

Responsible Party: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03544229     History of Changes
Other Study ID Numbers: TAK-906-2002
First Posted: June 1, 2018    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Takeda ( Millennium Pharmaceuticals, Inc. ):
Drug Therapy

Additional relevant MeSH terms:
Gastroparesis
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms
Maleic acid
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action