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

NCT01005719 | Completed Phase 3 Results

• 3 other identifiers: 18135CL2008-18P07815
• Study Type: interventional
• Target: 63
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Human Experimentation

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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

  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

  Treatment dose to 4 hours Post-dose on Day 7

• Median 24-hr Intragastric pH on Day 7

  Treatment dose to 24-hour post-dose on Day 7

Study Arms (3)

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.

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.

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.

Interventions

Zegerid DRUG

Zegerid (20 mg omeprazole/ 1100 mg sodium bicarbonate) taken with approximately 2 oz of water once daily for 7 days.

Also known as: omeprazole/sodium bicarbonate, SCH 900934

Zegerid

Prevacid® DRUG

Prevacid (15 mg lansoprazole) taken with approximately 2 oz of water once daily for 7 days.

Also known as: lansoprazole

Prevacid®

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead

MeSH Terms

Interventions

omeprazole, sodium bicarbonate drug combination; Omeprazole; Sodium Bicarbonate; Lansoprazole

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2009
• First Posted: November 2, 2009
• Study Start: September 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: March 11, 2015
• Results First Posted: January 28, 2011

Record last verified: 2015-02