Efficacy and Safety Study of HZT-501 in Subjects Requiring Nonsteroidal Anti-Inflammatory Drug (NSAID) Treatment

This study has been completed.

Study NCT00450216 Information provided by Horizon Therapeutics, Inc.

First Received on March 19, 2007. Last Updated on May 17, 2011 History of Changes

Results First Received: May 17, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Prevention
Condition:	Ulcer
Interventions:	Drug: Ibuprofen/famotidine Drug: Ibuprofen

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
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Reporting Groups

	Description
HZT-501	HZT-501: Ibuprofen 800mg/famotidine 26.6mg
Ibuprofen	Ibuprofen 800mg

Participant Flow: Overall Study

	HZT-501	Ibuprofen
STARTED	607	299
COMPLETED	433	170
NOT COMPLETED	174	129
Adverse Event	38	23
Withdrawal by Subject	48	26
Lost to Follow-up	16	9
UGI ulcer	51	51
misc	21	20

Baseline Characteristics

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Reporting Groups

	Description
HZT-501	HZT-501: Ibuprofen 800mg/famotidine 26.6mg
Ibuprofen	Ibuprofen 800mg

Baseline Measures

	HZT-501	Ibuprofen	Total
Number of Participants [units: participants]	607	299	906
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	500	240	740
>=65 years	107	59	166
Age [units: years] Mean ± Standard Deviation	55.5 ± 9.2	55.9 ± 9.3	55.6 ± 9.2
Gender [units: participants]
Female	416	208	624
Male	191	91	282
Region of Enrollment [units: participants]
United States	607	299	906

Outcome Measures

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1. Primary:

Proportion of Subjects Who Develop Endoscopically-diagnosed Gastric Ulcers [ Time Frame: 24 weeks ]

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2. Secondary:

The Proportion of Subjects Who Develop Endoscopically-diagnosed Upper Gastrointestinal (UGI) Ulcers During the 24-week Treatment Period. [ Time Frame: 24 weeks ]

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3. Secondary:

The Proportion of Subjects Who Develop Endoscopically-diagnosed Duodenal Ulcers During the 24-week Treatment Period. [ Time Frame: 24 weeks ]

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4. Secondary:

The Number of Subjects Developing NSAID-associated Serious Gastrointestinal Complications (Perforation of Ulcers, Gastric Outlet Obstruction Due to Ulcers, Gastrointestinal Bleeding) [ Time Frame: 24 weeks ]

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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 reserves the right to publish or otherwise make public the Study results provided that such communication occurs only after (i) the results of the multicenter Study in its entirety have been publicly disclosed by, or with consent of the sponsor or (ii) 18 months after conclusion of the Study at all sites, whichever comes first. Following this, PI can publish, present or use any non-confidential study results following Sponsor review. PI will not make public raw data or Case Reports.

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: Amy Grahn, MS Senior Vice President, Clinical Development and Operations
Organization: Horizon Pharma, Inc.
phone: 224-383-3012
e-mail: agrahn@horizonpharma.com

No publications provided

Responsible Party:	George Tidmarsh, MD PhD, Horizon Therapeutics, Inc.
ClinicalTrials.gov Identifier:	NCT00450216 History of Changes
Other Study ID Numbers:	HZ-CA-303
Study First Received:	March 19, 2007
Results First Received:	May 17, 2011
Last Updated:	May 17, 2011
Health Authority:	United States: Food and Drug Administration