Phase 4
N=12
Pharmacokinetics of Immediate-Release vs. Delayed-Release Omeprazole in Gastroparesis
Gastroparesis · Gastroesophageal Reflux Disease
Bottom Line
View on ClinicalTrials.gov: NCT00492622 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcome: Primary: Time to Maximal Omeprazole Concentration (Tmax) — 32; 97 minutes — p=< 0.01
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Immediate-release omeprazole (Drug); Delayed-release omeprazole (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Louisville
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Maximal Omeprazole Concentration (Tmax) |
32; 97 | < 0.01 sig |
| PRIMARY Maximal Concentration of Omerazole |
1979; 1625 | — |
| PRIMARY Area Under the Curve for Omeprazole Plasma Concentration |
3842; 3745 | 0.95 |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00492622). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.