Trial Outcomes & Findings for Pharmacokinetics of Immediate-Release vs. Delayed-Release Omeprazole in Gastroparesis (NCT NCT00492622)
NCT ID: NCT00492622
Last Updated: 2017-07-28
Results Overview
Time to max concentration for Immediate release vs. Delayed release omeprazole
COMPLETED
PHASE4
12 participants
10, 20, 30, 45, 60, 90, 120, 150, 180, 210, 240 and 300 min after the study drug was ingested on day 7 of treatment
2017-07-28
Participant Flow
Participant milestones
| Measure |
All Study Participants
All participants were randomized to receive all formulations so baseline measures are reported for all participants.
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacokinetics of Immediate-Release vs. Delayed-Release Omeprazole in Gastroparesis
Baseline characteristics by cohort
| Measure |
All Participants
n=12 Participants
|
|---|---|
|
Age, Continuous
|
51 years
STANDARD_DEVIATION 10 • n=99 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
12 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 10, 20, 30, 45, 60, 90, 120, 150, 180, 210, 240 and 300 min after the study drug was ingested on day 7 of treatmentPopulation: All subjects were included regardless of which formulation they received first.
Time to max concentration for Immediate release vs. Delayed release omeprazole
Outcome measures
| Measure |
All Study Participants Immediate Release Arm
n=12 Participants
Immediate-release omeprazole: Immediate-release omeprazole 40 mg qam for 7 days
|
All Study Subjects Delayed Release Arm
n=12 Participants
Delayed-release omeprazole: Delayed-release omeprazole 40 mg qam for 7 days
|
|---|---|---|
|
Time to Maximal Omeprazole Concentration (Tmax)
|
32 minutes
Standard Deviation 11
|
97 minutes
Standard Deviation 46
|
PRIMARY outcome
Timeframe: 10, 20, 30, 45, 60, 90, 120, 150, 180, 210, 240 and 300 min after the study drug was ingested on day 7 of treatmentPopulation: All subjects were included, regardless of which formulation they received first.
Maximal concentration of immediate-release vs. delayed-release omeprazole
Outcome measures
| Measure |
All Study Participants Immediate Release Arm
n=12 Participants
Immediate-release omeprazole: Immediate-release omeprazole 40 mg qam for 7 days
|
All Study Subjects Delayed Release Arm
n=12 Participants
Delayed-release omeprazole: Delayed-release omeprazole 40 mg qam for 7 days
|
|---|---|---|
|
Maximal Concentration of Omerazole
|
1979 ng/mL plasma
Standard Deviation 832
|
1625 ng/mL plasma
Standard Deviation 921
|
PRIMARY outcome
Timeframe: 0 to 5 hrs after the study drug was ingested on treatment day 7Population: the AUC for each formulation were combined regardless of order given
The area under the curve for omeprazole concentration-time curve for immediate release and delayed release omeprazole.
Outcome measures
| Measure |
All Study Participants Immediate Release Arm
n=12 Participants
Immediate-release omeprazole: Immediate-release omeprazole 40 mg qam for 7 days
|
All Study Subjects Delayed Release Arm
n=12 Participants
Delayed-release omeprazole: Delayed-release omeprazole 40 mg qam for 7 days
|
|---|---|---|
|
Area Under the Curve for Omeprazole Plasma Concentration
|
3842 mg*h/mL
Standard Deviation 1618
|
3745 mg*h/mL
Standard Deviation 2386
|
Adverse Events
Immediate Release Fomeprazole
Delayed Release Omeprazole
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place