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NCT03544229 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Efficacy and Safety of TAK-906 in Adult Participants With Symptomatic Idiopathic or Diabetic Gastroparesis
A Phase 2 study of Diabetic Gastroparesis and Idiopathic Gastroparesis, sponsored by Millennium Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 242
- Enrollment target
- 20
- Study locations
NCT03544229: Completed Phase 2 study of Diabetic Gastroparesis and Idiopathic Gastroparesis, sponsored by Millennium Pharmaceuticals.
NCT03544229 is a Phase 2 study of Diabetic Gastroparesis and Idiopathic Gastroparesis that has completed, run by Millennium Pharmaceuticals. The registered enrollment target is 242 participants, above the 127-participant average among 7 other Diabetic Gastroparesis trials with a reported enrollment target (91% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03544229, a Phase 2 study of Diabetic Gastroparesis and Idiopathic Gastroparesis, has completed, sponsored by Millennium Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 242 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
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,
Conditions Studied
Interventions
- DRUG Placebo
- DRUG TAK-906 Maleate
Study Locations (20)
Florida
- ISS - Innovative Research of West Florida - Clearwater
- Elias Research Associates - Direct Helpers Research Center - Hialeah - Hialeah
- International Research Associates - Hialeah
- Palmetto Research - Hialeah
- Homestead Associates in Research - Homestead
- Gastroenterology Associates - Crystal River - Inverness
- Mayo Clinic - Jacksonville
- Baptist Diabetes Associates Research - Miami
- PharmaSouth Research - Miami
California
- GW Research - Chula Vista
- Trial Connections - New Hope Research Development - Corona
- Paragon Rx Clinical - Garden Grove - Garden Grove
- Torrance Clinical Research Institute Inc. - Lomita
- California Medical Research Associates - Northridge
- ISS - Conquest Clinical Research - Orange
- Precision Research Institute - San Diego
Arizona
- Del Sol Research Management - Tucson
- Del Sol Research Management - Tucson
Alabama
- Digestive Health Specialists of the Southeast - Dothan
Connecticut
- Connecticut Clinical Research Foundation - Bristol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 242 participants |
| Start Date | 2018-10-14 |
| Est. Completion | 2021-07-15 |
| Phase | Phase 2 |
What the finished NCT03544229 record still lists
NCT03544229 is an interventional study that assigns participants to a tested intervention. The registered 242 participants enrollment target is mid-sized for trials with a published cap, above the 127-participant average among 7 other Diabetic Gastroparesis trials with a reported enrollment target (91% higher).
The record links to 2 conditions, with Diabetic Gastroparesis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03544229 names 20 study sites across 5 states, led by Florida, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT03544229 about?
NCT03544229 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of TAK-906 in Adult Participants 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.
What is the current status of trial NCT03544229?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 242 participants. The study started on 2018-10-14. Estimated completion is 2021-07-15.
What conditions does trial NCT03544229 study?
This clinical trial studies the following conditions: Diabetic Gastroparesis, Idiopathic Gastroparesis.
What interventions are being tested in trial NCT03544229?
The interventions under investigation include: Placebo (DRUG), TAK-906 Maleate (DRUG).
Who is sponsoring clinical trial NCT03544229?
This trial is sponsored by Millennium Pharmaceuticals, which has 135 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03544229 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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