Evaluating PN 400 (VIMOVO) in Reducing Gastric Ulcers in High Risk Subjects Compared to Arthrotec

This study has been terminated.

( POZEN agreed with FDA to stop study due to low and inadequate enrollment )

Study NCT00594854 Information provided by POZEN

First Received on December 19, 2007. Last Updated on August 27, 2010 History of Changes

Results First Received: May 28, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Gastric Ulcer
Interventions:	Drug: PN400 (VIMOVO) Drug: Diclofenac/Misoprostol

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
Multi-center US study, 16 sites recruited subjects between November 2007 and June 2008. On May 2, 2008 POZEN reached agreement with the FDA to terminate the study based on difficulty in recruiting subjects.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Screening for eligibility and wash-out of restricted medications.

Reporting Groups

	Description
PN400 (VIMOVO)	PN 400 (esomeprazole/naproxen) dosed twice daily (bid)
Arthrotec	diclofenac/misoprostol dosed twice daily (bid)

Participant Flow: Overall Study

	PN400 (VIMOVO)	Arthrotec
STARTED	9	11
COMPLETED	2 ^[1]	1 ^[1]
NOT COMPLETED	7	10
Study terminated	7	10

[1]	POZEN reached an agreement with the FDA to terminate the study due to low and inadequate enrollment.

Baseline Characteristics

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Reporting Groups

	Description
PN400 (VIMOVO)	PN 400 (esomeprazole/naproxen) dosed twice daily (bid)
Arthrotec	diclofenac/misoprostol dosed twice daily (bid)

Baseline Measures

	PN400 (VIMOVO)	Arthrotec	Total
Number of Participants [units: participants]	9	11	20
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	6	8	14
>=65 years	3	3	6
Age [units: years] Mean ± Standard Deviation	63.2 ± 9.5	54.4 ± 17.2	58.4 ± 14.6
Gender [units: participants]
Female	5	6	11
Male	4	5	9
Region of Enrollment [units: participants]
United States	9	11	20

Outcome Measures

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1. Primary:

Number of Participants With Gastric Ulcer Confirmed by Endoscopy [ Time Frame: 6 months ]

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2. Secondary:

Number of Participants With Duodenal Ulcers Confirmed by Endoscopy [ Time Frame: 6 months ]

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3. Secondary:

Number of Participants With Upper Gastro-intestinal Injury Grade 4 as Measured by Lanza (1991) Score [ Time Frame: 6 months ]

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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.

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
Early termination due to small number of subjects.

Results Point of Contact:

Name/Title: Senior Vice President, Clinical Research
Organization: Pozen Inc.
phone: 919-913-1030
e-mail: eorlemans@pozen.com

No publications provided

Responsible Party:	Everardus Orlemans, PhD, VP, Clinical Research, POZEN Inc
ClinicalTrials.gov Identifier:	NCT00594854 History of Changes
Other Study ID Numbers:	PN400-303
Study First Received:	December 19, 2007
Results First Received:	May 28, 2010
Last Updated:	August 27, 2010
Health Authority:	United States: Food and Drug Administration