GastroparesisPhase 4NCT00492622

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

A Phase 4 study testing Immediate-release omeprazole and Delayed-release omeprazole in people with Gastroparesis and Gastroesophageal Reflux Disease, run by University of Louisville at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Gastroparesis, Gastroesophageal Reflux Disease
What is being tested?: Immediate-release omeprazole and Delayed-release omeprazole
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteUnited States
Study dates: Jun 2007to Dec 2008
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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)

Show all 13Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Digestive Health Center, University of Louisville Hospital
Louisville, Kentucky, 40202

Other trials in United States

About this study

Official title: Pharmacokinetics of Immediate-Release vs. Delayed-Release Omeprazole in Patients With Heartburn Associated With Gastroparesis

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.

Read the detailed description

Hypothesis: Immediate-release omeprazole suspension may have a more rapid pharmacokinetic profile and greater overall drug absorption in gastroparesis. This will result in shorter time to maximal drug concentration, greater maximal concentration, and greater total area under the curve of the concentration vs. time plot.

Primary Objective: To compare the pharmacokinetics of omeprazole between immediate-release suspension and delayed-release capsules in patients with heartburn associated with gastroparesis.

Study design: randomized, open-labeled, crossover treatment for 7 days with 10-14 days washout. Pharmacokinetic studies will be performed after 7 days on study drug.

Conditions: Gastroparesis, Gastroesophageal Reflux Disease
Being tested: Immediate-release omeprazole, Delayed-release omeprazole
Keywords: Gastroparesis, Gastroesophageal reflux disease, heartburn
Medical subject headings: Gastroparesis, Gastroesophageal Reflux, Heartburn

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Immediate-release omeprazoleDrug
Immediate-release omeprazole 40 mg qam for 7 days
Delayed-release omeprazoleDrug
Delayed-release omeprazole 40 mg qam for 7 days

Study groups in NCT00492622
Study group	Role	What they receive
Immediate-release omeprazole release first	Experimental	subjects receive immediate release omeprazole for 7 days then delayed release for 7 days Receives: Drug: Immediate-release omeprazole; Drug: Delayed-release omeprazole
Delayed-release omeprazole first	Experimental	subjects receive delayed release omeprazole for 7 days then immediate release for 7 days Receives: Drug: Immediate-release omeprazole; Drug: Delayed-release omeprazole

What is being measured

The primary outcome is the main question the study is designed to answer.

Time to Maximal Omeprazole Concentration (Tmax)
Time to max concentration for Immediate release vs. Delayed release omeprazole
Measured: 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
Maximal Concentration of Omerazole
Maximal concentration of immediate-release vs. delayed-release omeprazole
Measured: 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
Area Under the Curve for Omeprazole Plasma Concentration
The area under the curve for omeprazole concentration-time curve for immediate release and delayed release omeprazole.
Measured: 0 to 5 hrs after the study drug was ingested on treatment day 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2007Dec 2008

First posted27 Jun 2007 (estimated)
Study startJun 2007
Primary completionDec 2008
Study completionDec 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for GastroparesisStudies of the same condition, open and under way.
More trials run by University of LouisvilleThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00492622
Sponsor's protocol ID: 014.07
Status last verified: Jun 2017
First submitted: 26 Jun 2007
Last updated: 28 Jul 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 19925497

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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To Study the Efficacy and Safety of Medtronic 780G Insulin Pump in People With Gastroparesis and Type 1 Diabetes.
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All Gastroparesis trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pharmacokinetics of Immediate-Release vs. Delayed-Release Omeprazole in Patients With Heartburn Associated With Gastroparesis
ClinicalTrials.gov ID: NCT00492622
Acronym / sponsor ID: 014.07
Conditions: Gastroparesis, Gastroesophageal Reflux Disease
Keywords: Gastroparesis, Gastroesophageal reflux disease, heartburn
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: University of LouisvilleUniversity, hospital or other
Collaborators: Bausch Health Americas, Inc.
Study start: Jun 2007
Primary completion: Dec 2008 (actual)
Study completion: Dec 2008 (actual)
First posted: 27 Jun 2007 (estimated)
Results: Posted 28 Jul 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Primary Objective: To compare the pharmacokinetics of omeprazole between immediate-release suspension and delayed-release capsules in patients with heartburn associated with gastroparesis.

Study design: randomized, open-labeled, crossover treatment for 7 days with 10-14 days washout. Pharmacokinetic studies will be performed after 7 days on study drug.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Immediate-release omeprazole release first	Experimental	Drug: Immediate-release omeprazole, Drug: Delayed-release omeprazolesubjects receive immediate release omeprazole for 7 days then delayed release for 7 days
Delayed-release omeprazole first	Experimental	Drug: Immediate-release omeprazole, Drug: Delayed-release omeprazolesubjects receive delayed release omeprazole for 7 days then immediate release for 7 days

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (13 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Immediate-release omeprazoleImmediate-release omeprazole 40 mg qam for 7 days	Drug	Delayed-release omeprazole first, Immediate-release omeprazole release first
Delayed-release omeprazoleDelayed-release omeprazole 40 mg qam for 7 days	Drug	Delayed-release omeprazole first, Immediate-release omeprazole release first

Primary outcome

Time to Maximal Omeprazole Concentration (Tmax)
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
Time to max concentration for Immediate release vs. Delayed release omeprazole
Maximal Concentration of Omerazole
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
Maximal concentration of immediate-release vs. delayed-release omeprazole
Area Under the Curve for Omeprazole Plasma Concentration
Time frame: 0 to 5 hrs after the study drug was ingested on treatment day 7
The area under the curve for omeprazole concentration-time curve for immediate release and delayed release omeprazole.

Results and safety

Results posted to the registry on 28 Jul 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Study Participants	12	12

Primary outcome: Time to Maximal Omeprazole Concentration (Tmax)

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. Mean (Standard Deviation). Unit: minutes

Measure	All Study Participants Immediate Release Arm n = 12	All Study Subjects Delayed Release Arm n = 12
Value	32 (11)	97 (46)

All Study Participants Immediate Release Arm vs All Study Subjects Delayed Release Arm: p < 0.01, paired t-tests

Population analysed: All subjects were included regardless of which formulation they received first.

Primary outcome: Maximal Concentration of Omerazole

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. Mean (Standard Deviation). Unit: ng/mL plasma

Measure	All Study Participants Immediate Release Arm n = 12	All Study Subjects Delayed Release Arm n = 12
Value	1979 (832)	1625 (921)

Population analysed: All subjects were included, regardless of which formulation they received first.

Primary outcome: Area Under the Curve for Omeprazole Plasma Concentration

Time frame: 0 to 5 hrs after the study drug was ingested on treatment day 7. Mean (Standard Deviation). Unit: mg*h/mL

Measure	All Study Participants Immediate Release Arm n = 12	All Study Subjects Delayed Release Arm n = 12
Value	3842 (1618)	3745 (2386)

All Study Participants Immediate Release Arm vs All Study Subjects Delayed Release Arm: p = 0.95, ANOVA

Population analysed: the AUC for each formulation were combined regardless of order given

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Immediate Release Fomeprazole	0 of 12 (0%)	0 of 12 (0%)	0 of 12
Delayed Release Omeprazole	0 of 12 (0%)	0 of 12 (0%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 19925497Wo 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.

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RecruitingObservational study
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Enrolling by invitationObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

John M Wo, MD principal investigator

University of Louisville

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Maximal Omeprazole Concentration (Tmax) (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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00492622, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2017.