Efficacy and Safety Study of HZT-501 in Reducing the Risk of Ibuprofen-associated Ulcers

This study has been completed.

Study NCT00450658 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:	Peptic 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
A multi-center US study in which 80 sites recruited subjects between March 2007 and February 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
HZT-501	HZT-501: Ibuprofen 800mg/Famotidine 26.6mg
Ibuprofen	Ibuprofen 800mg

Participant Flow: Overall Study

	HZT-501	Ibuprofen
STARTED	415	212
COMPLETED	272	122
NOT COMPLETED	143	90
Adverse Event	24	15
Withdrawal by Subject	43	26
Lost to Follow-up	22	5
UGI ulcer	33	34
misc	21	10

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]	415	212	627
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	342	173	515
>=65 years	73	39	112
Age [units: years] Mean ± Standard Deviation	55.3 ± 9.0	55.7 ± 9.5	55.4 ± 9.1
Gender [units: participants]
Female	272	152	424
Male	143	60	203
Region of Enrollment [units: participants]
United States	415	212	627

Outcome Measures

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1. Primary:

Proportion of Subjects Who Develop Endoscopically-diagnosed Upper Gastrointestinal Ulcers Confirmed by Endoscopy. [ Time Frame: 24 weeks ]

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2. Secondary:

The Proportion of Subjects Who Develop Endoscopically-diagnosed Gastric 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 Incidence Rate of NSAID-associated Serious Gastrointestinal Complications. [ 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:	NCT00450658 History of Changes
Other Study ID Numbers:	HZ-CA-301
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