Pharmacokinetics of Immediate-Release vs. Delayed-Release Omeprazole in Gastroparesis
Completed · Phase 4
Conditions studied: Gastroparesis, Gastroesophageal Reflux Disease
In brief
The purpose of this study is to compare the blood drug levels of two prescribed medications, immediate-release omeprazole 40 mg powder and delayed-release omeprazole 40 mg capsule to determine which drug is better absorbed in patients with a slow stomach emptying (gastroparesis). Delayed-release omeprazole has a protective coating to prevent the drug omeprazole from being neutralized by stomach acid. Immediate-release omeprazole has sodium bicarbonate (antacid) which neutralizes the stomach acid, eliminating the need for a protective coating. Immediate-release omeprazole suspension may have a more rapid pharmacokinetic profile and greater overall drug absorption in gastroparesis.
Key facts
- Study ID
- NCT00492622
- Run by
- University of Louisville
- People needed
- 12
- Starts
- 2007-06-01
- Expected to finish
- 2008-12-01
- Last updated by the study team
- 2017-07-28
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Symptoms of heartburn >2 days per week off antireflux therapy, defined by "a burning feeling rising from the stomach or lower chest up towards the neck"
- Symptoms of gastroparesis >1 month in duration, defined by nausea, vomiting, bloating, dyspepsia, early satiety, or effortless regurgitation.
- Prior abnormal 4-hour gastric emptying scan within the past 3 years
You may not qualify if…
- History of esophageal or gastric surgery
- Severe gastroparesis with any of the following: vomiting with dehydration requiring IV hydration, hospitalization, weight loss >10 % pre-illness weight, requiring feeding jejunostomy tubes
- Presence of gastric electrical stimulator
- Symptoms of retching with vomiting more than 2 days per week
- Diagnosis of diabetes
- Disorders of small bowel motility (such as pseudo-obstruction or dumping syndrome)
- Disorders of small bowel absorption
- Diagnosis of gastric outlet, small bowel or colon mechanical obstruction
- Diagnosis of acid hypersecretory syndrome
- Disorders affecting proton pump inhibitor metabolism (such as liver failure)
- Known allergy or side effects to proton pump inhibitor
- Non-ambulatory patients: bed-ridden, nursing home resident, etc.
- Pregnancy
Where it is running
- Digestive Health Center, University of Louisville Hospital — Louisville, Kentucky, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.