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Pharmacokinetics of Immediate-Release vs. Delayed-Release Omeprazole in Gastroparesis

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ClinicalTrials.gov Identifier: NCT00492622
Recruitment Status : Completed
First Posted : June 27, 2007
Results First Posted : July 28, 2017
Last Update Posted : July 28, 2017
Sponsor:
Collaborator:
Bausch Health Americas, Inc.
Information provided by (Responsible Party):
University of Louisville

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Gastroparesis
Gastroesophageal Reflux Disease
Interventions Drug: Immediate-release omeprazole
Drug: Delayed-release omeprazole
Enrollment 12
Recruitment Details  
Pre-assignment Details  
Arm/Group Title All Study Participants
Hide Arm/Group Description All participants were randomized to receive all formulations so baseline measures are reported for all participants.
Period Title: Overall Study
Started 12 [1]
Completed 12
Not Completed 0
[1]
all subjects received the immediate release formulation
Arm/Group Title All Participants
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants
51  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
12
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 12 participants
12
 100.0%
1.Primary Outcome
Title Time to Maximal Omeprazole Concentration (Tmax)
Hide Description Time to max concentration for Immediate release vs. Delayed release omeprazole
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects were included regardless of which formulation they received first.
Arm/Group Title All Study Participants Immediate Release Arm All Study Subjects Delayed Release Arm
Hide Arm/Group Description:
Immediate-release omeprazole: Immediate-release omeprazole 40 mg qam for 7 days
Delayed-release omeprazole: Delayed-release omeprazole 40 mg qam for 7 days
Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: minutes
32  (11) 97  (46)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Study Participants Immediate Release Arm, All Study Subjects Delayed Release Arm
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments Primary study objective was to compare the pharmacokinetics of omeprazole between IR and DR omeprazole in patients with GERD associated with gastroparesis.
Statistical Test of Hypothesis P-Value < 0.01
Comments <0.01 is used for determining the level of significance.
Method paired t-tests
Comments [Not Specified]
2.Primary Outcome
Title Maximal Concentration of Omerazole
Hide Description Maximal concentration of immediate-release vs. delayed-release omeprazole
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects were included, regardless of which formulation they received first.
Arm/Group Title All Study Participants Immediate Release Arm All Study Subjects Delayed Release Arm
Hide Arm/Group Description:
Immediate-release omeprazole concentration: Immediate-release omeprazole 40 mg qam for 7 days
Delayed-release omeprazole concentration: Delayed-release omeprazole 40 mg qam for 7 days
Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: ng/mL plasma
1979  (832) 1625  (921)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Study Participants Immediate Release Arm, All Study Subjects Delayed Release Arm
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments Primary study objective was to compare the pharmacokinetics of omeprazole between IR and DR omeprazole in patients with GERD associated with gastroparesis.
Other Statistical Analysis P<0.05 was used as the level of significance with ANOVA for this endpoint.
3.Primary Outcome
Title Area Under the Curve for Omeprazole Plasma Concentration
Hide Description The area under the curve for omeprazole concentration-time curve for immediate release and delayed release omeprazole.
Time Frame 0 to 5 hrs after the study drug was ingested on treatment day 7
Hide Outcome Measure Data
Hide Analysis Population Description
the AUC for each formulation were combined regardless of order given
Arm/Group Title All Study Participants Immediate Release Arm All Study Subjects Delayed Release Arm
Hide Arm/Group Description:
Immediate-release omeprazole: Immediate-release omeprazole 40 mg qam for 7 days
Delayed-release omeprazole: Delayed-release omeprazole 40 mg qam for 7 days
Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: mg*h/mL
3842  (1618) 3745  (2386)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Study Participants Immediate Release Arm, All Study Subjects Delayed Release Arm
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments Primary study objective was to compare the pharmacokinetics of omeprazole between IR and DR omeprazole in patients with GERD associated with gastroparesis.
Statistical Test of Hypothesis P-Value 0.95
Comments An analysis of variance model was used to compare AUC between IR and DR omeprazole using the natural logarithmic transformation. The model included the following factors: treatment, period, sequence and patient nested within the sequence.
Method ANOVA
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Immediate Release Fomeprazole Delayed Release Omeprazole
Hide Arm/Group Description

subjects received immediate release for 7 days then delayed release for 7 days

Immediate-release omeprazole: Immediate-release omeprazole 40 mg qam for 7 days

subjects receive delayed release for 7 days then immediate release for 7 days

Delayed-release omeprazole: Delayed-release omeprazole 40 mg qam for 7 days
All-Cause Mortality
Immediate Release Fomeprazole Delayed Release Omeprazole
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/12 (0.00%) 
Hide Serious Adverse Events
Immediate Release Fomeprazole Delayed Release Omeprazole
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/12 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Immediate Release Fomeprazole Delayed Release Omeprazole
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/12 (0.00%) 
[Not Specified]
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Nancy Alsip
Organization: University Louisville
Phone: 502-852-2905
EMail: nancy.alsip@louisville.edu
Publications of Results:
Wo JM, Eversmann J, Mann S. Pharmacokinetic profile of immediate-release omeprazole in patients with gastro-oesophageal reflux associated with gastroparesis. Aliment Pharmacol Ther. 2010 Feb 15;31(4):516-22. doi: 10.1111/j.1365-2036.2009.04203.x. Epub 2009 Nov 19.
Layout table for additonal information
Responsible Party: University of Louisville
ClinicalTrials.gov Identifier: NCT00492622    
Other Study ID Numbers: 014.07
First Submitted: June 26, 2007
First Posted: June 27, 2007
Results First Submitted: April 6, 2017
Results First Posted: July 28, 2017
Last Update Posted: July 28, 2017