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

This study has been completed.

Study NCT00674115 Information provided by Schering-Plough

First Received on May 2, 2008. Last Updated on April 8, 2010 History of Changes

Results First Received: September 17, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Pharmacodynamics Study; Intervention Model: Crossover Assignment; Masking: Open Label
Conditions:	Gastric Acid Human Experimentation
Interventions:	Drug: Omeprazole/sodium bicarbonate Drug: omeprazole magnesium Drug: sodium bicarbonate

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
60 participants were randomized to either 1-Day or 7-Day Dosing in this crossover study (participants in both groups received 1 treatment [Zegerid or Prilosec], followed by washout period, followed by the other treatment [Prilosec or Zegerid]). Participants in the 1-day dosing group also received sodium bicarbonate after a washout period.

Reporting Groups

	Description
Zegerid, Prilosec, Sodium Bicarbonate	Participants received Zegerid Oral Suspension (omeprazole 20 mg and sodium bicarbonate 1680 mg) in the first intervention, Prilosec over-the-counter (OTC) Tablets (omeprazole 20 mg) in the second intervention (after washout period), and Sodium Bicarbonate Oral Suspension (sodium bicarbonate 1680 mg) in the third intervention (after washout period)
Prilosec, Zegerid, Sodium Bicarbonate	Participants received Prilosec OTC Tablets (omeprazole 20 mg) in the first intervention, Zegerid Oral Suspension (omeprazole 20 mg and sodium bicarbonate 1680 mg) in the second intervention (after washout period), and Sodium Bicarbonate Oral Suspension (sodium bicarbonate 1680 mg) in the third intervention (after washout period)
Zegerid, Prilosec	Participants received Zegerid Oral Suspension (omeprazole 20 mg and sodium bicarbonate 1680 mg) in the first intervention and Prilosec OTC Tablets (omeprazole 20 mg) in the second intervention (after washout period)
Prilosec, Zegerid	Participants received Prilosec OTC Tablets (omeprazole 20 mg) in the first intervention and Zegerid Oral Suspension (omeprazole 20 mg and sodium bicarbonate 1680 mg) in the second intervention (after washout period)

Participant Flow for 5 periods

Period 1: First Intervention

	Zegerid, Prilosec, Sodium Bicarbonate	Prilosec, Zegerid, Sodium Bicarbonate	Zegerid, Prilosec	Prilosec, Zegerid
STARTED	14	16	14	16
COMPLETED	14	16	14	16
NOT COMPLETED	0	0	0	0

Period 2: Washout Period of 2 Weeks

	Zegerid, Prilosec, Sodium Bicarbonate	Prilosec, Zegerid, Sodium Bicarbonate	Zegerid, Prilosec	Prilosec, Zegerid
STARTED	14	16	14	16
COMPLETED	14	16	14	16
NOT COMPLETED	0	0	0	0

Period 3: Second Intervention

	Zegerid, Prilosec, Sodium Bicarbonate	Prilosec, Zegerid, Sodium Bicarbonate	Zegerid, Prilosec	Prilosec, Zegerid
STARTED	14	16	14	16
COMPLETED	14	16	14	16
NOT COMPLETED	0	0	0	0

Period 4: Washout Period of 2 Weeks

	Zegerid, Prilosec, Sodium Bicarbonate	Prilosec, Zegerid, Sodium Bicarbonate
STARTED	14	16
COMPLETED	14	16
NOT COMPLETED	0	0

Period 5: Third Intervention

	Zegerid, Prilosec, Sodium Bicarbonate	Prilosec, Zegerid, Sodium Bicarbonate
STARTED	14	16
COMPLETED	14	16
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
Entire Study Population	No text entered.

Baseline Measures

	Entire Study Population
Number of Participants [units: participants]	60
Age [units: years] Mean ± Standard Deviation	25.3 ± 4.37
Gender [units: participants]
Female	22
Male	38

Outcome Measures

1. Primary:

Change From Baseline in Median 24-hour Intragastric pH on the 7th Day of Drug Administration [ Time Frame: Baseline and 7 days ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: No text entered.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Head, Clinical Trials Registry & Results Disclosure Group
Organization: Schering-Plough
e-mail: ClinicalTrialsDisclosure@spcorp.com

No publications provided

Responsible Party:	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier:	NCT00674115 History of Changes
Other Study ID Numbers:	CL2007-17
Study First Received:	May 2, 2008
Results First Received:	September 17, 2009
Last Updated:	April 8, 2010
Health Authority:	United States: Food and Drug Administration