Evaluating PN 400 (VIMOVO) in Reducing Gastric Ulcers Compared to Non-steroidal Antiinflammatory Drug (NSAID) Naproxen

This study has been completed.

Study NCT00527787 Information provided by POZEN

First Received on September 10, 2007. Last Updated on November 29, 2010 History of Changes

Results First Received: May 27, 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: Naproxen

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
A multi-center US study in which 59 sites recruited subjects between September 2007 and September 2008

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)	Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg
Naproxen	Naproxen 500 mg

Participant Flow: Overall Study

	PN400 (VIMOVO)	Naproxen
STARTED	218	216 ^[1]
COMPLETED	180	153
NOT COMPLETED	38	63
Adverse Event	14	24
Withdrawal by Subject	13	25
Lost to Follow-up	5	2
Duodenal Ulcer	1	10
misc	5	2

[1]	Safety and Intent-to-treat population (>=1 dose drug + no baseline ulcer) N=216

Baseline Characteristics

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Reporting Groups

	Description
PN400 (VIMOVO)	Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg
Naproxen	Naproxen 500 mg

Baseline Measures

	PN400 (VIMOVO)	Naproxen	Total
Number of Participants [units: participants]	218	216	434
Age [units: years] Mean ± Standard Deviation	60.8 ± 8.8	61.9 ± 8.5	61.3 ± 8.6
Gender [units: subjects]
Female	150	149	299
Male	68	67	135

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:

The Number of Participants With Pre-Specified NSAID-Associated Upper GI Adverse Events or Duodenal Ulcers [ Time Frame: 6 months ]

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3. Secondary:

The Number of Participants Discontinuing From the Study Due to NSAID-Associated Upper GI Adverse Events or to Duodenal Ulcer [ Time Frame: 6 Months ]

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4. Secondary:

The Number of Participants Developing Duodenal Ulcers Throughout 6 Months of Treatment [ Time Frame: 6 months ]

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5. Secondary:

Heartburn Symptom Resolution, ie no Heartburn Symptoms During the Last 7 Days Prior to the Visit [ Time Frame: 6 months ]

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6. Secondary:

Improvement From Baseline in Upper Abdominal Pain and Discomfort Scores at 6 Months, Based on the Overall Treatment Evaluation for Dyspepsia Questionnaire [ Time Frame: change from baseline at 6 Months ]

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7. Secondary:

Mean Change From Baseline on Pain Intensity of the Severity of Dyspepsia Assessment (SODA) Subscales [ Time Frame: baseline to 6 Months ]

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8. Secondary:

Mean Change From Baseline on Non-Pain Symptoms of the Severity of Dyspepsia Assessment (SODA) Subscales [ Time Frame: baseline to 6 Months ]

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9. Secondary:

Mean Change From Baseline on Satisfaction of the Severity of Dyspepsia Assessment (SODA) Subscales [ Time Frame: baseline to 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. Restriction Description: PI agrees that the first publication will be a multi-center publication of the study results. Following this multi-center publication, PI can publish, present or use any non-confidential results following Sponsor review and comment.

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

No publications provided

Responsible Party:	Senior Vice President, Clinical Research, Pozen Inc.
ClinicalTrials.gov Identifier:	NCT00527787 History of Changes
Other Study ID Numbers:	PN400-301
Study First Received:	September 10, 2007
Results First Received:	May 27, 2010
Last Updated:	November 29, 2010
Health Authority:	United States: Food and Drug Administration