Phase 3
N=63
Study to Compare Gastric Inhibition of Two Proton Pump Inhibitors (CL2008-18)(P07815)(COMPLETED)
Human Experimentation
Bottom Line
View on ClinicalTrials.gov: NCT01005719 ↗Enrolled (actual)
63
Serious AEs
0.5%
Results posted
Jan 2011
Primary outcome: Primary: 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 — 2.600; 1.820; 3.230; 1.760 pH — p=0.0242
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Zegerid (Drug); Prevacid® (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bayer
- Primary completion
- Jan 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
2.600; 1.820; 3.230; 1.760; 4.920; 1.950 | 0.0242 sig |
| SECONDARY 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 |
1.330; 1.070; 1.420; 1.080; 1.590; 0.990 | 0.0465 sig |
| SECONDARY 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 |
1.050; 1.180; 0.92; 1.840; 1.950; 0.82 | <0.05 sig |
| SECONDARY Median Time to Achieve Intragastric pH > = 3.5 for a 10-Minute Period |
64.867; 108.867; 240.00; 22.667; 66.667; 240.00 | — |
| SECONDARY Percentage Time Intragastric pH >4 During the First 4 Hours After Dosing on Day 7 |
64.639; 44.194; 6.056 | — |
| SECONDARY Median 24-hr Intragastric pH on Day 7 |
3.600; 3.100; 0.800 | — |
| SECONDARY Percentage of Time Intragastric is pH >4 Over 24-hour Period on Day 7 |
40.538; 36.917; 4.852 | — |
| SECONDARY Percentage of Time Intragastric pH >3.5 Over 24-hour Period on Day 7 |
51.321; 43.990; 7.927 | — |
| SECONDARY Number of Participants With Intragastric pH >4 for More Than 50% of the Time on Day 7 |
26; 18; 0 | — |
| SECONDARY Number of Participants With Intragastric pH >3.5 for More Than 50% of the Time on Day 7 |
30; 23; 0 | — |
| SECONDARY Percentage of Time Intragastric pH >4 Over the Nocturnal Period on Day 7 |
9.236; 9.685; 0.028 | — |
| SECONDARY Time to Achieve Sustained Intragastric pH > 3.5 at Steady-state on Day 7 |
25.000; 65.000; 100.000 | — |
| SECONDARY Time to Onset of Inhibition of Acid Secretion on Day 1 |
240.00; 240.00; 240.00 | — |
| SECONDARY Number of Participants Maintaining Intragastric pH > 4 for at Least 12 Hours on Day 1 |
8; 5; 0 | — |
| SECONDARY Number of Participants Maintaining Intragastric pH > 3.5 for at Least 12 Hours on Day 1 |
11; 11; 0 | — |
| SECONDARY Percentage of Time Intragastric pH >4 Over the Nocturnal Period on Day 1 |
0.681; 1.987; 0.111 | — |
| SECONDARY Percentage of Time Intragastric pH >4 During the First 4 Hours on Day 1 |
21.500; 9.525; 3.667 | — |
| SECONDARY Time to Achieve Sustained Advantage Over No Treatment During the First 4 Hours After Dosing |
35.000; 85.000; 10.000; 5.000 | — |
Summary
This study will determine differences between Proton Pump Inhibitors (PPI) formulations relative to their effects on gastric acidity.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
- 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.
Data sourced from ClinicalTrials.gov (NCT01005719). 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.