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A Pharmacodynamic Study Comparing Zegerid® and Prilosec OTC® (CL2007-17 )(P07813)(COMPLETED)

This study has been completed.
Sponsor:
Collaborator:
Salix Pharmaceuticals
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00674115
First received: May 2, 2008
Last updated: May 30, 2014
Last verified: May 2014

May 2, 2008
May 30, 2014
April 2008
June 2008   (final data collection date for primary outcome measure)
Change From Baseline in Median 24-hour Intragastric pH on the 7th Day of Drug Administration [ Time Frame: Baseline and 7 days ] [ Designated as safety issue: No ]
The change from Baseline in median pH was calculated as: median pH on Day 7 minus median pH at Baseline. PH measures how acidic or basic a substance is. The pH scale ranges from 0 to 14. A pH of 7 is neutral. A pH less than 7 is acidic. A pH greater than 7 is basic.
The primary outcome measure is the change from baseline in median 24-hr intragastric pH for Zegerid and Prilosec OTC on the 7th day of drug administration. [ Time Frame: For single dose group- the 24 hours after dosing. ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00674115 on ClinicalTrials.gov Archive Site
Not Provided
  • Changes from baseline in median 24-hr intragastric pH on the 1st day of drug administration. [ Time Frame: For single dose group- 24 hours after dosing. ] [ Designated as safety issue: No ]
  • Changes from baseline of mean gastric acid concentration over 24-hrs on the 1st and 7th days of treatment. [ Time Frame: For single dose group- 24 hours after dosing. ] [ Designated as safety issue: No ]
  • Time to onset of inhibition of acid secretion on the first day of treatment. [ Time Frame: For single dose group- 24 hours after dosing. ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Pharmacodynamic Study Comparing Zegerid® and Prilosec OTC® (CL2007-17 )(P07813)(COMPLETED)
Randomized, Crossover Pharmacodynamic Study Comparing the Effects of Zegerid® (20 mg Omeprazole/Sodium Bicarbonate) and Prilosec OTC® (20 Mg-equivalent Omeprazole)

Open-label randomized crossover design studies. 60 participants will be evaluated on Day 1 to compare effects on stomach acid; 30 participants will continue treatment for 7 days and will have repeat evaluations at Day 7. The other 30 participants will receive a single administration of sodium bicarbonate.

Enrolled participants were divided into 2 groups, with 30 participants in each group.

Group 1: This group was randomized into a 2-way crossover design with an added third period. These participants received single administrations (day 1 dosing only) of Zegerid Powder for Oral Suspension, and Prilosec OTC (both at a 20 mg omeprazole dose), in a 2-way randomized order, with a minimum of a 2-week washout period between treatment legs. Following completion of the 2-way crossover study, and a subsequent washout period (minimum of 2 weeks), all participants then received a single administration of sodium bicarbonate (at same dose as contained in Zegerid Powder for Oral Suspension) in Period 3. This group underwent a 24-hour intragastric pH study on each of the 3 dosing occasions.

Group 2: This group was randomized into a 2-way crossover design in which they received 7 days administration of Zegerid Powder for Oral Suspension and Prilosec OTC tablets, respectively. As with the prior group, there was a minimum of a 2-week washout period between treatment legs. Participants assigned to this treatment group also underwent 24-hour intragastric pH recordings on the days on which they received their 1st and last (7th) dose of the two treatment drugs.

In addition to the above detailed procedures, all participants (both groups) underwent a 24-hour baseline intragastric pH study prior to starting their randomized treatments. This study design enabled all 60 participants to be evaluated for effects of the first dose of Prilosec OTC and Zegerid Powder for Oral Suspension on change in intragastric pH during the subsequent 24-hour period following the first dose.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
  • Gastric Acid
  • Human Experimentation
  • Drug: Omeprazole/sodium bicarbonate
    Omeprazole/sodium bicarbonate. Single dose per day for either 1 or 7 days.
    Other Name: Zegerid
  • Drug: omeprazole magnesium
    Omeprazole 20 mg tablet. Single dose per day for either 1 or 7 days.
    Other Name: Prilosec OTC Tablet
  • Drug: sodium bicarbonate
    Sodium bicarbonate. Single dose.
  • Experimental: Single Dose Zegerid for 1 or 7 days
    Omeprazole 20 mg/Sodium Bicarbonate 1680 mg Powder for Oral Suspension
    Intervention: Drug: Omeprazole/sodium bicarbonate
  • Active Comparator: Single Dose Prilosec 1 or 7 days
    Omeprazole magnesium 20 mg over-the-counter (OTC) Tablet
    Intervention: Drug: omeprazole magnesium
  • Active Comparator: Sodium Bicarbonate
    Sodium Bicarbonate 1680 mg Oral Suspension
    Intervention: Drug: sodium bicarbonate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
June 2008
June 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Normal subjects who are 18-65 years of age.
  • Non-childbearing potential females or those using birth control.

Exclusion Criteria:

  • History of hypersensitivity, allergy or intolerance to omeprazole or other proton pump inhibitors
  • History of significant gastrointestinal disease
  • Any significant medical illness
  • Gastrointestinal disorder or surgery leading to impaired drug absorption
  • Currently using gastrointestinal medications
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00674115
P07813, CL2007-17
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Salix Pharmaceuticals
Not Provided
Merck Sharp & Dohme Corp.
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP