Gastroesophageal Reflux Clinical Trial
Official title:
Pharmacodynamic Dose-Response 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 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.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05561179 -
Hyaluronic Acid in Patients With Gastroesophageal Reflux Disease
|
N/A | |
| Withdrawn |
NCT02213887 -
Study of the Effects of Pantoprazole on Levels of Prescribed Psychiatric Medications
|
Phase 4 | |
| Completed |
NCT01946971 -
Lansoprazole in Preterm Infants With Gastroesophageal Reflux (GER)
|
Phase 1/Phase 2 | |
| Recruiting |
NCT01825473 -
Study of Erythromycin in GER-Associated Apnea of the Newborn
|
N/A | |
| Completed |
NCT00614536 -
Study of Changes in Reflux Symptoms and Reflux Finding Score According to Rabeprazole Treatment Period
|
Phase 4 | |
| Completed |
NCT00365300 -
Study Evaluating the Efficacy and Safety of Pantoprazole in Infants With Symptomatic Gastroesophageal Reflux Disease (GERD)
|
Phase 3 | |
| Completed |
NCT00373997 -
Esophageal and Laryngeal Tissue Changes in Patients Suspected of Having Laryngopharyngeal Reflux
|
Phase 4 | |
| Completed |
NCT00141960 -
Famotidine in Subjects With Non-erosive Gastroesophageal Reflux Disease
|
Phase 2/Phase 3 | |
| Completed |
NCT00291746 -
Validation of RDQ Questionnaire
|
Phase 4 | |
| Completed |
NCT01167543 -
Relationship and Pathophysiology of Gastroesophageal Reflux and Dental/Periodontal Disease
|
N/A | |
| Completed |
NCT00215787 -
Investigation of the Association Between Nasal Polyposis and Extraesophageal Reflux Disease
|
N/A | |
| Completed |
NCT00226044 -
Rectal and Oral Omeprazole Treatment of Reflux Disease in Infants.
|
Phase 3 | |
| Completed |
NCT00567021 -
German PMS Trial (AWB) to Evaluate Therapy in Reflux Disease and NSAR-Symptoms
|
N/A | |
| Completed |
NCT00181805 -
Natural History of Gastroesophageal Reflux (GER) in Children and Adolescents
|
||
| Completed |
NCT01048840 -
Natural History of Gastroesophageal Reflux (GER) in Children < 12 Years of Age
|
||
| Terminated |
NCT01281553 -
A Study of Cisapride in Patients With Symptomatic Gastro-Oesophageal Reflux Disease
|
Phase 4 | |
| Completed |
NCT05486169 -
Gastroesophageal Reflux Disease After Laparoscopic Sleeve Gastrectomy
|
N/A | |
| Completed |
NCT04034017 -
Gastroesophageal Reflux Disease Among College Students
|
||
| Terminated |
NCT03226054 -
Determining Risk Factors for Successful PPI Weaning
|
N/A | |
| Completed |
NCT03015610 -
Genotype-tailored Treatment of Symptomatic Acid-Reflux in Children With Uncontrolled Asthma
|
Phase 3 |