Gastroesophageal Reflux Disease (GERD) Clinical Trial
Official title:
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Sequential-Panel, Multiple Repeat Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TAK-438 in Healthy Non-Japanese Male Subjects
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of TAK-438 in healthy, non-Japanese men male subjects following a randomized, double blind, placebo controlled, sequential panel, multiple-dose schedule.
The drug being tested in this study is called TAK-438. TAK-438 is being tested to find a
safe and well-tolerated dose. This study looked at pharmacokinetic (effect of the body on
the drug) and pharmacodynamic properties (effect of the drug on the body) as well as look at
lab results and side effects in people who took TAK-438. This study was designed as a
randomized, sequential-panel, multiple repeat dose study.
The study population consisted of 4 Cohorts with 12 participants in each Cohort; with 9
participants randomized to receive a single dose of TAK-438, and 3 participants to receive
placebo. Participants in each Cohort received a single dose of study drug once daily after a
10-hour fast. The starting dose was 10 mg followed by administrations of 20, 40, and 30 mg.
This single-centre trial was conducted in the United Kingdom. The overall time to
participate in this study was up to 37 days. Participants made 2 visits to the clinic for
screening, one 11-day period of confinement to the clinic, and 2 further visits after the
confinement period. All participants were contacted by telephone 7 days after last dose of
study drug for a follow-up assessment.
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03561883 -
Trial of IW-3718 for 8 Weeks in Patients With Persistent Gastroesophageal Reflux Disease (GERD) Receiving Proton Pump Inhibitors (PPIs)
|
Phase 3 | |
| Completed |
NCT02555852 -
Proton Pump Inhibitors and Risk of Community-acquired Pneumonia
|
N/A | |
| Completed |
NCT01406210 -
RESULT (REflux Surgery in Lung Transplantation) Preliminary Study Protocol
|
N/A | |
| Terminated |
NCT01327963 -
Retrospective TIF Study for Treatment of Gastroesophageal Reflux Disease (GERD). The RetroTIF Study
|
N/A | |
| Completed |
NCT01570842 -
Anthropometry in Gastroesophageal Reflux Disease and Esophageal Injury
|
N/A | |
| Terminated |
NCT00587275 -
Safety and Efficacy of AST-120 in Patients With GERD Who Continue to be Symptomatic on a Standard Dose of PPI
|
Phase 2 | |
| Completed |
NCT00228527 -
Esomeprazole for Treatment of GERD in Pediatric Patients
|
Phase 4 | |
| Completed |
NCT00261300 -
Long-term Pantoprazole Trial in Patients With Symptoms of Chronic Acid Peptic Complaints (BY1023/VMG-708)
|
Phase 3 | |
| Recruiting |
NCT04506593 -
Indiana University Gastrointestinal Motility Diagnosis Registry
|
||
| Completed |
NCT00795093 -
Partial Response to Proton Pump Inhibitors (PPI) Treatment: The Cost to Society and the Burden to the Patient - a Study in the US
|
N/A | |
| Completed |
NCT00394472 -
Symptom Improvements in Gastroesophageal Reflux Disease (GERD) Patients
|
Phase 2 | |
| Completed |
NCT00574925 -
Study to Assess Management Strategies for the Use of Esomeprazole (Nexium) in Helicobacter Pylori Infected Patients
|
Phase 4 | |
| Terminated |
NCT02749071 -
An Investigation of the EndoStim® Lower Esophageal Sphincter (LES) Stimulation System for the Treatment of Reflux
|
N/A | |
| Recruiting |
NCT01129713 -
Comparison of Nexium Versus Secretol in the Healing and Controlling of Symptoms in GERD Patients With Severe EE.
|
Phase 1/Phase 2 | |
| Completed |
NCT00734747 -
Safety and Efficacy the Medigus SRS Endoscopic Stapling System in Gastroesophageal Reflux Disease (GERD)
|
Phase 3 | |
| Completed |
NCT00312806 -
Effect of Pantoprazole on the Symptoms of Acid Reflux Disease in Adult Patients (BY1023/M3-341)
|
Phase 3 | |
| Not yet recruiting |
NCT05579587 -
Transoral Incisionless Fundoplication (TIF) for Laryngopharyngeal Reflux (LPR) Patients
|
||
| Recruiting |
NCT02366169 -
Medigus Ultrasonic Surgical Endostapler (MUSE) Registry
|
N/A | |
| Completed |
NCT01374074 -
Racial Disparity in Barrett's Esophagus
|
N/A | |
| Terminated |
NCT00857597 -
Endoscopic Fundoplication Versus Proton Pump Inhibitors for GERD Treatment
|
Phase 3 |