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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00450216
First Posted: March 22, 2007
Last Update Posted: April 29, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Horizon Pharma Ireland, Ltd., Dublin Ireland
Results First Submitted: May 17, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, 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
No text entered.

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 tablets t.i.d.
Ibuprofen Ibuprofen 800mg tablets t.i.d.

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 
upper gastrointestinal (UGI) ulcer                51                51 
misc                21                20 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
HZT-501 HZT-501: Ibuprofen 800mg/famotidine 26.6mg
Ibuprofen Ibuprofen 800mg
Total Total of all reporting groups

Baseline Measures
   HZT-501   Ibuprofen   Total 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

1.  Primary:   Number of Participants Who Develop Endoscopically-diagnosed Gastric Ulcers   [ Time Frame: 24 weeks ]

2.  Secondary:   Number of Participants Who Develop Endoscopically-diagnosed Upper Gastrointestinal (UGI) Ulcers During the 24-week Treatment Period.   [ Time Frame: 24 weeks ]

3.  Secondary:   Number of Participants Who Develop Endoscopically-diagnosed Duodenal Ulcers During the 24-week Treatment Period.   [ Time Frame: 24 weeks ]

4.  Secondary:   The Number of Participants Developing Non-steroidal Anti-inflammatory (NSAID)Associated Serious Gastrointestinal Complications (Perforation of Ulcers, Gastric Outlet Obstruction Due to Ulcers, Gastrointestinal Bleeding)   [ Time Frame: 24 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  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:
unchecked 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.
unchecked 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.


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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Horizon Pharma Ireland, Ltd., Dublin Ireland
ClinicalTrials.gov Identifier: NCT00450216     History of Changes
Other Study ID Numbers: HZ-CA-303
First Submitted: March 19, 2007
First Posted: March 22, 2007
Results First Submitted: May 17, 2011
Results First Posted: June 21, 2011
Last Update Posted: April 29, 2013