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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01005719
First received: October 30, 2009
Last updated: January 28, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention Phase
Human Experimentation
Drug: Zegerid
Drug: Prevacid®
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized, Crossover, Pharmacodynamic Study Comparing the Effects of Two Proton Pump Inhibitors

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
  • Median 24-hr Intragastric pH on Day 7 [ Time Frame: Treatment dose to 24-hour post-dose on Day 7 ] [ Designated as safety issue: No ]
    The median intragastric pH values were recorded over a 24-hr period.

  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

    Number of participants maintaining intragastric pH > 4 for at least 12 hrs at

    steady-state 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 ] [ Designated as safety issue: No ]

    Number of participants maintaining intragastric pH > 3.5 for at least 12 hrs at

    steady-state 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    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.

  • Time to Onset of Inhibition of Acid Secretion on Day 1 [ Time Frame: Treatment dose to onset of event on Day 1 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

    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.)



Enrollment: 63
Study Start Date: September 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Zegerid
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.
Drug: Zegerid
Zegerid (20 mg omeprazole/ 1100 mg sodium bicarbonate) taken with approximately 2 oz of water once daily for 7 days.
Other Name: omeprazole/sodium bicarbonate, SCH 900934
Active Comparator: 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.
Drug: Prevacid®
Prevacid (15 mg lansoprazole) taken with approximately 2 oz of water once daily for 7 days.
Other Name: lansoprazole
No Intervention: No treatment
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01005719     History of Changes
Other Study ID Numbers: P07815, CL2008-18
Study First Received: October 30, 2009
Results First Received: January 4, 2011
Last Updated: January 28, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Omeprazole
Lansoprazole
Dexlansoprazole
Omeprazole, sodium bicarbonate drug combination
Proton Pump Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014