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NCT00284908 · ClinicalTrials.gov registry record · Phase 1
Dose-Effect of S-Tenatoprazole-Na(STU-Na) 30 mg, 60 mg, 90 mg and 120 mg in Healthy Volunteers
A Phase 1 study of Gastroesophageal Reflux and Esophagitis, sponsored by STEBA France.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
- 1
- Study location
NCT00284908 is a Phase 1 study of Gastroesophageal Reflux and Esophagitis that has completed, run by STEBA France. The registered enrollment target is 32 participants, below the 184-participant average among 25 other Gastroesophageal Reflux trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00284908, a Phase 1 study of Gastroesophageal Reflux and Esophagitis, has completed, sponsored by STEBA France.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
- 1
- Study location
Study Summary
S-Tenatoprazole-Na (STU-Na), a new drug currently under clinical development, belongs to a class of drugs, called proton pump inhibitors (PPls). Some PPIs are already commercially available. STU-Na will be used for treatment of acid related diseases (gastroduodenal ulcers, erosive or ulcerative esophagitis due to gastroesophageal reflux disease). This study evaluates the degree of acid suppression by different doses of STU-Na. The degree of acid suppression is considered to be correlated with clinical efficacy. In this study four dosages of STU-Na (30 mg, 60 mg, 90 mg, and 120 mg) will be tested in each volunteer. First, one of the dosages will be orally administered for five days. Then, a nine to sixteen day period without study drug administration will follow prior to the administration of the next dosage, for again five days. Each volunteer will have a total of four study drug administration periods. After the last study drug intake in period 1, 2 and 3 pharmacokinetic blood sampling will be done for four days. After the last study drug intake in period 4 pharmacokinetic blood sampling will be done for five days. Pharmacokinetic blood sampling consists of several blood draws over a pre-determined time period. The pharmacokinetic blood sampling measures the medication concentration in the blood at pre-defined time points. After the last study drug intake in period 1, 2, 3, and 4, gastric acidity will be measured for 24 hours by means of a thin tube that will be inserted into the stomach through the nostril to evaluate the efficacy of the different dosages of STU-Na.
Conditions Studied
Interventions
- DRUG S-Tenatoprazole-Na (STU-Na)
Study Locations (1)
Texas
- Healthcare Discoveries, Inc. - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2006-09 |
| Est. Completion | 2006-11 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00284908
The ClinicalTrials.gov registry entry for NCT00284908 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 184-participant average among 25 other Gastroesophageal Reflux trials with a reported enrollment target (83% lower). The listed sponsor is STEBA France, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Gastroesophageal Reflux appearing as the primary indexed condition, and to 1 intervention - of which S-Tenatoprazole-Na (STU-Na) is the first listed.
NCT00284908 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT00284908 about?
NCT00284908 is a clinical study titled "Dose-Effect of S-Tenatoprazole-Na(STU-Na) 30 mg, 60 mg, 90 mg and 120 mg in Healthy Volunteers". S-Tenatoprazole-Na (STU-Na), a new drug currently under clinical development, belongs to a class of drugs, called proton pump inhibitors (PPls). Some PPIs are already commercially available. STU-Na will be used for treatment of acid related diseases (gastroduodenal ulcers, erosive or ulcerative esop...
What is the current status of trial NCT00284908?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2006-09. Estimated completion is 2006-11.
What conditions does trial NCT00284908 study?
This clinical trial studies the following conditions: Gastroesophageal Reflux, Esophagitis, Stomach Ulcer, Duodenal Ulcer.
What interventions are being tested in trial NCT00284908?
The interventions under investigation include: S-Tenatoprazole-Na (STU-Na) (DRUG).
Who is sponsoring clinical trial NCT00284908?
This trial is sponsored by STEBA France, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00284908 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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