Ignite Creation Date:
2024-05-05 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001191
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
1999-11-03
Brief Title:
The Use of Oral Omeprazole and Intravenous Pantoprazole in Patients With Hypersecretion of Gastric Acid
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
The Use of Oral Omeprazole and Intravenous Pantoprazole in Patients With Hypersecretion of Gastric Acid
Status:
COMPLETED
Status Verified Date:
2007-12-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients with Zollinger-Ellison Syndrome suffer from ulcers of the upper gastrointestinal tract higher than normal levels of gastric acid and tumors of the pancreas known as non-beta islet cell tumors Patients with Zollinger-Ellison Syndrome require continuous control of their gastric acid secretion If gastric acid levels are permitted to rise higher than normal patients may develop severe ulcers and other complications
This study will attempt to determine the effectiveness of Omeprazole Prilosec in the treatment of patients with Zollinger-Ellison Syndrome Omeprazole is a drug that functions to decrease the amount of gastric acid secreted
Patients for this study will be selected based on a previous diagnosis of Zollinger-Ellison Syndrome andor idiopathic unknown cause high levels of gastric acid secretion The patients will undergo an evaluation including history and physical examination as well as necessary laboratory tests The proper dose of Omeprazole will then be determined in each patient The proper dose of Omeprazole is considered the minimum amount of omeprazole required to lower gastric acid to a safe level
Every year patients participating in this study will undergo a physical examination and history They will be questioned about symptoms associated with Zollinger-Ellison Syndrome Gastric acid levels will be taken and evaluated and patients will undergo an upper gastrointestinal endoscopy
The effectiveness of the treatment will be measured by a clinical history to determine the control of symptoms due to high levels of gastric acid secretion
This study will attempt to determine the effectiveness of Omeprazole Prilosec in the treatment of patients with Zollinger-Ellison Syndrome Omeprazole is a drug that functions to decrease the amount of gastric acid secreted
Patients for this study will be selected based on a previous diagnosis of Zollinger-Ellison Syndrome andor idiopathic unknown cause high levels of gastric acid secretion The patients will undergo an evaluation including history and physical examination as well as necessary laboratory tests The proper dose of Omeprazole will then be determined in each patient The proper dose of Omeprazole is considered the minimum amount of omeprazole required to lower gastric acid to a safe level
Every year patients participating in this study will undergo a physical examination and history They will be questioned about symptoms associated with Zollinger-Ellison Syndrome Gastric acid levels will be taken and evaluated and patients will undergo an upper gastrointestinal endoscopy
The effectiveness of the treatment will be measured by a clinical history to determine the control of symptoms due to high levels of gastric acid secretion
Detailed Description:
Patients with Zollinger-Ellison syndrome require continuous control of their gastric acid secretion or else severe complications of peptic ulcer disease will occur This study investigates the long-term efficacy of the oral gastric acid antisecretory drug Omeprazole which functions as a H - K ATPase inhibitor Long-term safety will also be investigated Also investigated is the ability of the parenteral H-K ATPase inhibitor pantoprazole to control acid secretion short-term when oral Omeprazole cannot be used
In this study the proper maintenance dose of oral Omeprazole will be determined in each patient by determining the minimal dose of drug that reduces acid secretion to safe levels Patients will be examined at least annually for evidence of continued efficacy and safety Efficacy will be assessed by clinical history to assess control of symptoms due to gastric acid hypersecretion measurements of gastric acid secretion while on Omeprazole to determine continued effectiveness of the drug and upper gastrointestinal endoscopy to assess changes in the gastrointestinal mucosa Safety will be determined by assessing clinical and laboratory parameters such as changes in hematologic or clinical chemistry parameters Possible drug induced changes in the gastric mucosa will be assessed by gastric biopsies
With intravenous pantoprazole the ability of the recommended dose of 80 mg three times a day to control acid secretion will be investigated and if this fails 80 mg four times a day will be assessed
In this study the proper maintenance dose of oral Omeprazole will be determined in each patient by determining the minimal dose of drug that reduces acid secretion to safe levels Patients will be examined at least annually for evidence of continued efficacy and safety Efficacy will be assessed by clinical history to assess control of symptoms due to gastric acid hypersecretion measurements of gastric acid secretion while on Omeprazole to determine continued effectiveness of the drug and upper gastrointestinal endoscopy to assess changes in the gastrointestinal mucosa Safety will be determined by assessing clinical and laboratory parameters such as changes in hematologic or clinical chemistry parameters Possible drug induced changes in the gastric mucosa will be assessed by gastric biopsies
With intravenous pantoprazole the ability of the recommended dose of 80 mg three times a day to control acid secretion will be investigated and if this fails 80 mg four times a day will be assessed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 83-DK-0018 | None | None | None |