Human ExperimentationPhase 3NCT01005719

Study to Compare Gastric Inhibition of Two Proton Pump Inhibitors (CL2008-18)(P07815)(COMPLETED)

A Phase 3 study testing Zegerid and Prevacid® in people with Human Experimentation, run by Bayer.

Completed

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

Trial summary

This study will determine differences between Proton Pump Inhibitors (PPI) formulations relative to their effects on gastric acidity. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Human Experimentation
What is being tested?: Zegerid and Prevacid®
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 63 participants
Where: No sites listed yet
Study dates: Sep 2009to Jan 2010
Phase: Phase 3
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 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy non-Asian, male or non-lactating, non-pregnant female participants who are 18-65 years of age.
Clinical laboratory test must be within normal limits or clinically acceptable to the Investigator/Sponsor.
Participants must have normal or clinically acceptable physical exam and ECG.
Participants must be free of any clinically significant disease that requires a physician's care and/or would interfere with study evaluations, procedures, or participation.
Able to understand and comply with study procedures required and able and willing to provide written informed consent prior to any study procedures being performed.

Who cannot join

History of hypersensitivity, allergy or intolerance to omeprazole, or other proton pump inhibitors
History of peptic ulcer disease or other acid related gastrointestinal symptoms or heartburn with a frequency of more than one/month.
Positive H. pylori breath test at screening.
Participation in any study of an investigational treatment in the 30 days before Screening or participation in another study at any time during the period of this study
Any significant medical illness that would contraindicate participation in the study
Gastrointestinal disorder or surgery leading to impaired drug absorption

Show all 12Show fewer

Any significant mental illness, such as schizophrenia or bipolar disorder
History (in the past year) suggestive of alcohol or drug abuse or dependence, or excessive alcohol use (>2 units per day on average; for example >2 bottles of beer, >2 glasses of wine, >2 ounces of liquor/spirits), or excessive alcohol use during the study
Any abnormal Screening laboratory value that is clinically significant in the investigator's opinion
Currently using or use of any prescription or over the counter (OTC) medications that affect gastrointestinal function, including first generation antihistamines (e.g. diphenhydramine) and anticholinergic agents within 7 days prior to 1st treatment administration.
Currently using, or use within 14 days of first treatment administration, or having a history of frequent use of antacids, OTC or Prescription (Rx) H2 receptor antagonists, or OTC or Rx use of proton pump inhibitors.
Positive urine drug/alcohol test at Screening.

About this study

Official title: Randomized, Crossover, Pharmacodynamic Study Comparing the Effects of Two Proton Pump Inhibitors

This study will determine differences between Proton Pump Inhibitors (PPI) formulations relative to their effects on gastric acidity.

Conditions: Human Experimentation
Being tested: Zegerid, Prevacid®

What participants receive

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

ZegeridDrug
Also called omeprazole/sodium bicarbonate, SCH 900934
Zegerid (20 mg omeprazole/ 1100 mg sodium bicarbonate) taken with approximately 2 oz of water once daily for 7 days.
Prevacid®Drug
Also called lansoprazole
Prevacid (15 mg lansoprazole) taken with approximately 2 oz of water once daily for 7 days.

Study groups in NCT01005719
Study group	Role	What they receive
Zegerid	Experimental	Participants receiving Zegerid (omeprazole/sodium bicarbonate) in Periods 1, 2 or 3. All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order. All participants also took approximately 2 oz of water with their medication. Receives: Drug: Zegerid
Prevacid®	Active comparator	Participants receiving Prevacid® (lansoprazole) in Periods 1, 2 or 3. All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order. All participants also took approximately 2 oz of water with their medication. Receives: Drug: Prevacid®
No treatment	No intervention	Participants receiving No treatment in Periods 1, 2 or 3. All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order. All participants took approximately 2 oz of water once daily for 7 days.

What is being measured

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

Achievement of Sustained Difference in Inhibition of Intragastric Acidity Based on Median pH Values Between the Two Active Study Treatments at Steady-state on Day 7
Median intragastric pH scores were collected at 5 minute intervals after treatment dose. The achievement of sustained difference was the earliest time for which a statistically significant difference was observed in the median intragastric pH scores for 3 consecutive 5-minute intervals. The earliest 3 time points for which a statistically significant difference was observed between the median intragastric pH values for the two active treatments for three consecutive 5-minute intervals are shown here.
Measured: Treatment dose to 4-hr post-dose on Day 7

Secondary outcomes (17)

Achievement of Sustained Difference in Inhibition of Intragastric Acidity Based on Median pH Values Between the Two Active Study Treatments at Steady-state on Day 1
Median intragastric pH scores were collected at 5 minute intervals after treatment dose. The achievement of sustained difference was the earliest time for which a statistically significant difference was observed in the median intragastric pH scores for 3 consecutive 5-minute intervals. The earliest 3 time points for which a statistically significant difference was observed between the median intragastric pH values for the two active treatments for three consecutive 5-minute intervals are shown here.
Measured: Treatment dose to 4-hr post-dose on Day 1
The Difference in the Onset of Action Based on Median pH Values Between the Two Active Treatments Compared to No Treatment on Day 1 and Day 7
Median intragastric pH scores were collected at 5 minute intervals after treatment dose. The difference in the onset of action was the earliest 5 minute interval (from start of interval to end of interval) for which each active treatment presented a statistically significantly advantage over No treatment based on median pH values. The earliest 5 minute interval showing the difference in onset of action is reported here.
Measured: Treatment dose to 4-hr post-dose on Day 1 and Day 7
Median Time to Achieve Intragastric pH > = 3.5 for a 10-Minute Period
The time required to achieve an intragastric pH ≥3.5 that is reached for 10 consecutive minutes after drug administration on the 1st and 7th days of dosing.
Measured: Treatment dose to 4-hr post-dose on Day 1 and Day 7
Percentage Time Intragastric pH >4 During the First 4 Hours After Dosing on Day 7
Measured: Treatment dose to 4 hours Post-dose on Day 7
Median 24-hr Intragastric pH on Day 7
The median intragastric pH values were recorded over a 24-hr period.
Measured: Treatment dose to 24-hour post-dose on Day 7
Percentage of Time Intragastric is pH >4 Over 24-hour Period on Day 7
Measured: Treatment dose to 24-hour post-dose on Day 7
Percentage of Time Intragastric pH >3.5 Over 24-hour Period on Day 7
Measured: Treatment dose to 24-hours post-dose on Day 7
Number of Participants With Intragastric pH >4 for More Than 50% of the Time on Day 7
Number of participants maintaining intragastric pH > 4 for at least 12 hrs at
steady-state on Day 7
Measured: Treatment dose to 24-hour post-dose on Day 7
Number of Participants With Intragastric pH >3.5 for More Than 50% of the Time on Day 7
Number of participants maintaining intragastric pH > 3.5 for at least 12 hrs at
steady-state on Day 7
Measured: Treatment dose to 24-hour post-dose on Day 7
Percentage of Time Intragastric pH >4 Over the Nocturnal Period on Day 7
Measured: Treatment dose to 24-hour post-dose on Day 7
Time to Achieve Sustained Intragastric pH > 3.5 at Steady-state on Day 7
The first time to sustain median pH > 3.5 for at least 3 successive 5-minute periods within the first 2 hours after dosing with Zegerid Capsules, and Prevacid Capsules, or No treatment on the 7th day of respective treatments. If this condition was not met for any time point within the first 2 hours following dosing, a score of 120 minutes was imputed.
Measured: Treatment dose to 2-hours post-dose on Day 7
Time to Onset of Inhibition of Acid Secretion on Day 1
The onset of inhibition of acid secretion was the first time to sustain median pH >3.5 for each of the twenty-four successive 5-minute periods. If this condition was not met for any time point within the first 4 hours following dosing, a score of 240 minutes was imputed.
Measured: Treatment dose to onset of event on Day 1
Number of Participants Maintaining Intragastric pH > 4 for at Least 12 Hours on Day 1
Measured: Treatment dose to 24-hr post-dose on Day 1
Number of Participants Maintaining Intragastric pH > 3.5 for at Least 12 Hours on Day 1
Measured: Treatment dose to 24-hr post-dose on Day 1
Percentage of Time Intragastric pH >4 Over the Nocturnal Period on Day 1
Measured: Treatment dose to 24-hour post-dose on Day 1
Percentage of Time Intragastric pH >4 During the First 4 Hours on Day 1
Measured: Treatment dose to 4-hours post-dose on Day 1
Time to Achieve Sustained Advantage Over No Treatment During the First 4 Hours After Dosing
The earliest time during the first 4 hours after dosing that the median
pH for the treatment is over 1 unit higher than that for the No treatment during the next three 5 minute intervals. (When this condition does not occur, the time to sustained advantage will be imputed as 4 hours.)
Measured: Treatment dose to event on Day 1 and Day 7

Timeline

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

Sep 2009Jan 2010

First posted2 Nov 2009 (estimated)
Study startSep 2009
Primary completionJan 2010
Study completionJan 2010

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.
Other trials for Human ExperimentationStudies of the same condition, open and under way.
More trials run by BayerThe 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 63 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01005719
Sponsor's protocol ID: 18135
Other IDs: CL2008-18, P07815
Status last verified: Feb 2015
First submitted: 30 Oct 2009
Last updated: 11 Mar 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 11 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, Crossover, Pharmacodynamic Study Comparing the Effects of Two Proton Pump Inhibitors
ClinicalTrials.gov ID: NCT01005719
Acronym / sponsor ID: 18135
Conditions: Human Experimentation
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 63 participants (actual)
Lead sponsor: BayerIndustry (pharma, biotech, devices)
Study start: Sep 2009
Primary completion: Jan 2010 (actual)
Study completion: Jan 2010 (actual)
First posted: 2 Nov 2009 (estimated)
Results: Posted 28 Jan 2011

Clinical summary

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

This study will determine differences between Proton Pump Inhibitors (PPI) formulations relative to their effects on gastric acidity.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Zegerid	Experimental	Drug: ZegeridParticipants receiving Zegerid (omeprazole/sodium bicarbonate) in Periods 1, 2 or 3. All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order. All participants also took approximately 2 oz of water with their medication.
Prevacid®	Active comparator	Drug: Prevacid®Participants receiving Prevacid® (lansoprazole) in Periods 1, 2 or 3. All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order. All participants also took approximately 2 oz of water with their medication.
No treatment	No intervention	–Participants receiving No treatment in Periods 1, 2 or 3. All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order. All participants took approximately 2 oz of water once daily for 7 days.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Healthy non-Asian, male or non-lactating, non-pregnant female participants who are 18-65 years of age.
Clinical laboratory test must be within normal limits or clinically acceptable to the Investigator/Sponsor.
Participants must have normal or clinically acceptable physical exam and ECG.
Participants must be free of any clinically significant disease that requires a physician's care and/or would interfere with study evaluations, procedures, or participation.
Able to understand and comply with study procedures required and able and willing to provide written informed consent prior to any study procedures being performed.

Key exclusion criteria (12 listed)

History of hypersensitivity, allergy or intolerance to omeprazole, or other proton pump inhibitors
History of peptic ulcer disease or other acid related gastrointestinal symptoms or heartburn with a frequency of more than one/month.
Positive H. pylori breath test at screening.
Participation in any study of an investigational treatment in the 30 days before Screening or participation in another study at any time during the period of this study
Any significant medical illness that would contraindicate participation in the study

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
ZegeridAlso: omeprazole/sodium bicarbonate, SCH 900934Zegerid (20 mg omeprazole/ 1100 mg sodium bicarbonate) taken with approximately 2 oz of water once daily for 7 days.	Drug	Zegerid
Prevacid®Also: lansoprazolePrevacid (15 mg lansoprazole) taken with approximately 2 oz of water once daily for 7 days.	Drug	Prevacid®

Primary outcome

Achievement of Sustained Difference in Inhibition of Intragastric Acidity Based on Median pH Values Between the Two Active Study Treatments at Steady-state on Day 7
Time frame: Treatment dose to 4-hr post-dose on Day 7
Median intragastric pH scores were collected at 5 minute intervals after treatment dose. The achievement of sustained difference was the earliest time for which a statistically significant difference was observed in the median intragastric pH scores for 3 consecutive 5-minute intervals. The earliest 3 time points for which a statistically significant difference was observed between the median intragastric pH values for the two active treatments for three consecutive 5-minute intervals are shown here.

17 secondary outcomes

Achievement of Sustained Difference in Inhibition of Intragastric Acidity Based on Median pH Values Between the Two Active Study Treatments at Steady-state on Day 1
Time frame: Treatment dose to 4-hr post-dose on Day 1
The Difference in the Onset of Action Based on Median pH Values Between the Two Active Treatments Compared to No Treatment on Day 1 and Day 7
Time frame: Treatment dose to 4-hr post-dose on Day 1 and Day 7
Median Time to Achieve Intragastric pH > = 3.5 for a 10-Minute Period
Time frame: Treatment dose to 4-hr post-dose on Day 1 and Day 7
Percentage Time Intragastric pH >4 During the First 4 Hours After Dosing on Day 7
Time frame: Treatment dose to 4 hours Post-dose on Day 7
Median 24-hr Intragastric pH on Day 7
Time frame: Treatment dose to 24-hour post-dose on Day 7
Percentage of Time Intragastric is pH >4 Over 24-hour Period on Day 7
Time frame: Treatment dose to 24-hour post-dose on Day 7
Percentage of Time Intragastric pH >3.5 Over 24-hour Period on Day 7
Time frame: Treatment dose to 24-hours post-dose on Day 7
Number of Participants With Intragastric pH >4 for More Than 50% of the Time on Day 7
Time frame: Treatment dose to 24-hour post-dose on Day 7
Number of Participants With Intragastric pH >3.5 for More Than 50% of the Time on Day 7
Time frame: Treatment dose to 24-hour post-dose on Day 7
Percentage of Time Intragastric pH >4 Over the Nocturnal Period on Day 7
Time frame: Treatment dose to 24-hour post-dose on Day 7
Time to Achieve Sustained Intragastric pH > 3.5 at Steady-state on Day 7
Time frame: Treatment dose to 2-hours post-dose on Day 7
Time to Onset of Inhibition of Acid Secretion on Day 1
Time frame: Treatment dose to onset of event on Day 1
Number of Participants Maintaining Intragastric pH > 4 for at Least 12 Hours on Day 1
Time frame: Treatment dose to 24-hr post-dose on Day 1
Number of Participants Maintaining Intragastric pH > 3.5 for at Least 12 Hours on Day 1
Time frame: Treatment dose to 24-hr post-dose on Day 1
Percentage of Time Intragastric pH >4 Over the Nocturnal Period on Day 1
Time frame: Treatment dose to 24-hour post-dose on Day 1
Percentage of Time Intragastric pH >4 During the First 4 Hours on Day 1
Time frame: Treatment dose to 4-hours post-dose on Day 1
Time to Achieve Sustained Advantage Over No Treatment During the First 4 Hours After Dosing
Time frame: Treatment dose to event on Day 1 and Day 7

Results and safety

Results posted to the registry on 28 Jan 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Zegerid-Prevacid®-No Treatment	10	10
Zegerid-No Treatment-Prevacid®	10	10
Prevacid®-Zegerid-No Treatment	10	10
Prevacid®-No Treatment-Zegerid	11	10
No Treatment-Zegerid-Prevacid®	11	11
No Treatment-Prevacid®-Zegerid	11	10

Primary outcome: Achievement of Sustained Difference in Inhibition of Intragastric Acidity Based on Median pH Values Between the Two Active Study Treatments at Steady-state on Day 7

Time frame: Treatment dose to 4-hr post-dose on Day 7. Median (Full Range). Unit: pH

Measure	Zegerid n = 59	Prevacid® n = 59
10-15 Minutes Post-dose on Day 7	2.600 (0.52 to 7.94)	1.820 (0.64 to 6.38)
15-20 Minutes Post-dose on Day 7	3.230 (0.45 to 8.16)	1.760 (0.59 to 6.78)
20-25 Minutes Post-dose on Day 7	4.920 (0.34 to 8.25)	1.950 (0.45 to 7.04)

Zegerid vs Prevacid®: p = 0.0242, Wilcoxon (Mann-Whitney)
Zegerid vs Prevacid®: p = 0.0270, Wilcoxon (Mann-Whitney)
Zegerid vs Prevacid®: p = 0.0067, Wilcoxon (Mann-Whitney)

Population analysed: Participants who received at least one dose of study treatment, and did not have missing values.

17 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Zegerid	1 of 60 (1.7%)	4 of 60 (6.7%)	Not reported
Prevacid®	0 of 61 (0%)	8 of 61 (13.1%)	Not reported
No Treatment	0 of 62 (0%)	5 of 62 (8.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Zegerid and Prevacid® in people with Human Experimentation, run by Bayer.

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 5 inclusion and 12 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 11 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 Jan 2011). 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?

Achievement of Sustained Difference in Inhibition of Intragastric Acidity Based on Median pH Values Between the Two Active Study Treatments at Steady-state on Day 7 (time frame: Treatment dose to 4-hr post-dose on Day 7). 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 NCT01005719.

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 11 Mar 2015.