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NCT01390714 · ClinicalTrials.gov registry record · Phase 1
Pharmacodynamic and Pharmacokinetic Study of E3710 Following Oral Administration to Healthy, Male, Japanese Subjects
A Phase 1 study of Gastroesophageal Reflux Disease, sponsored by Eisai Co..
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT01390714: Completed Phase 1 study of Gastroesophageal Reflux Disease, sponsored by Eisai Co..
NCT01390714 is a Phase 1 study of Gastroesophageal Reflux Disease that has completed, run by Eisai Co.. The registered enrollment target is 30 participants, below the 355-participant average among 25 other Gastroesophageal Reflux Disease trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01390714, a Phase 1 study of Gastroesophageal Reflux Disease, has completed, sponsored by Eisai Co..
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to investigate the pharmacodynamics (PD) and pharmacokinetics of E3710 following oral administration to Healthy Male Japanese Subjects
Primary Outcome
Summary statistics of the measurements and changes from pre-dose values to post-dose values of intragastric pH 1-, pH 2-, pH 3-, pH 4-, pH 5-, and pH 6 holding time, mean of the intragastric pH and median of intragastric pH are to be calculated by dose. In addition, the mean and median intragastric pH for the hours 1-14 and 14-24 (8:00-22:00 and 22:00-8:00) should be calculated for baseline and each pH-recording period.
Conditions Studied
Interventions
- DRUG E3710
Study Locations (1)
California
- - Glendale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2011-07 |
| Est. Completion | 2011-10 |
| Phase | Phase 1 |
What the finished NCT01390714 record still lists
NCT01390714 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 355-participant average among 25 other Gastroesophageal Reflux Disease trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Gastroesophageal Reflux Disease appearing as the primary indexed condition, and to 1 intervention - of which E3710 is the first listed.
NCT01390714 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT01390714 about?
NCT01390714 is a clinical study titled "Pharmacodynamic and Pharmacokinetic Study of E3710 Following Oral Administration to Healthy, Male, Japanese Subjects". The purpose of this study is to investigate the pharmacodynamics (PD) and pharmacokinetics of E3710 following oral administration to Healthy Male Japanese Subjects
What is the current status of trial NCT01390714?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2011-07. Estimated completion is 2011-10.
What conditions does trial NCT01390714 study?
This clinical trial studies the following conditions: Gastroesophageal Reflux Disease.
What interventions are being tested in trial NCT01390714?
The interventions under investigation include: E3710 (DRUG).
Who is sponsoring clinical trial NCT01390714?
This trial is sponsored by Eisai Co., which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01390714 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Gastroesophageal Reflux Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01390714's enrollment target sits among peer trials
30 22nd of 25 higher than 4 of 25 other Gastroesophageal Reflux Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Gastroesophageal Reflux Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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