Clinical Trials Logo

Clinical 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03544229
Study type Interventional
Source Takeda
Contact
Status Completed
Phase Phase 2
Start date October 14, 2018
Completion date July 15, 2021

See also
  Status Clinical Trial Phase
Completed NCT01557296 - Evaluation of Diagnostic Methods and Dietary Treatment of Diabetic Gastroparesis Phase 2
Withdrawn NCT03376399 - Potential Benefits of Sleeve Gastrectomy Surgery on Diabetic Gastroparesis Symptoms
Completed NCT02289846 - Trial of IW-9179 in Patients With Diabetic Gastroparesis (DGP) Phase 2
Not yet recruiting NCT02264587 - Effects and Mechanism of Mosapride Citrate on Diabetic Gastroparesis Phase 4
Recruiting NCT04706832 - Thoracic Splanchnic Magnetic Neuromodulation Therapy (ThorS-MagNT) for Grade 3 Diabetic Gastroparesis: Pilot Study N/A
Not yet recruiting NCT05584462 - Gastroparesis in type2 Diabetic Patient
Enrolling by invitation NCT05812339 - Body Surface Gastric Mapping to Evaluate Patients With Upper Gastrointestinal Symptoms and Controls
Completed NCT02732821 - G-POEM for Treatment of Refractory Gastroparesis
Completed NCT01030341 - Continuous Glucose Monitoring and Insulin Pump Therapy in Diabetic Gastroparesis N/A
Recruiting NCT05832151 - A Study to Evaluate the Efficacy and Safety of CIN-102 (Deudomperidone) in Adults With Diabetic Gastroparesis Phase 2
Completed NCT02025725 - Multicenter Study to Evaluate the Efficacy and Safety of Metoclopramide Nasal Spray in Women With Diabetic Gastroparesis Phase 3
Completed NCT01916460 - Intraluminal Endosonography for Examination of the Structural Changes of the Stomach in Gastroparetic Patients N/A
Completed NCT01469286 - Transcutaneous Electroacupuncture for Gastroparesis Phase 1
Terminated NCT00874133 - The Effect of Acupuncture on Symptoms, Gastric Emptying Rate and Glucose Control in Patients With Diabetic Gastroparesis N/A
Completed NCT01126034 - Improving Metoclopramide Prescribing Practices at Penn Through a Physician-targeted Intervention N/A
Recruiting NCT05273788 - Thoracic Neuromodulation for Diabetic Gastroparesis N/A
Suspended NCT00470795 - Acupuncture for Diabetic Gastroparesis Phase 3
Completed NCT00139893 - A Randomized, Open-label, Two-way Crossover Trial to Determine the Pharmacokinetics of Metoclopramide When Administered as the Orally Disintegrating Tablet Compared to Reglan® Tablets in Subjects With Diabetic Gastroparesis N/A
Recruiting NCT04254549 - Rifaximin in Patients With Diabetic Gastroparesis Phase 2
Not yet recruiting NCT04661215 - Pyloric Sphincter Abnormalities in Patients With Gastroparesis Symptoms