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Safety Study of HZT-501 in Patients Who Require Long-Term Daily Non-steroidal Anti-inflammatory Drug Treatment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Horizon Pharma Ireland, Ltd., Dublin Ireland
ClinicalTrials.gov Identifier:
NCT00984815
First received: September 23, 2009
Last updated: June 19, 2013
Last verified: June 2013
Results First Received: March 18, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Osteoarthritis
Rheumatoid Arthritis
Chronic Low Back Pain
Chronic Regional Pain Syndrome
Chronic Soft Tissue Pain
Intervention: Drug: HZT-501

  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
Up to 100 eligible participants were to be enrolled at 4 U.S. study centers (3 private practice rheumatology centers and 1 academic center) between September, 2009 and June, 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Eligible participants, 40-80 years of age inclusive, expected to require daily administration of a non-steroidal anti-inflammatory drug (NSAID) for at least the coming 12 months were enrolled. Of the approximately 100 participants enrolled, it was expected that at least 30 would complete the 54-week treatment period.

Reporting Groups
  Description
HZT-501 Open-label treatment with HZT-501(ibuprofen 800 mg/famotidine 26.6 mg) tablets. All doses of study drug will be self-administered orally 3 times daily (TID), for up to 54 weeks.

Participant Flow:   Overall Study
    HZT-501  
STARTED     86  
COMPLETED     56  
NOT COMPLETED     30  



  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 Open-label treatment with HZT-501 (ibuprofen 800 mg/famotidine 26.6 mg) tablets self-administered orally three times daily (TID) for up to 54 weeks.

Baseline Measures
    HZT-501  
Number of Participants  
[units: participants]
  86  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     69  
>=65 years     17  
Age  
[units: years]
Mean ± Standard Deviation
  56.3  ± 9.39  
Gender  
[units: participants]
 
Female     62  
Male     24  
Region of Enrollment  
[units: participants]
 
United States     86  



  Outcome Measures
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1.  Primary:   Number of Participants With Treatment Emergent Adverse Events   [ Time Frame: 54 weeks ]

2.  Secondary:   Change From Baseline in the Pain Intensity Scale of the Severity of Dyspepsia Assessment (SODA) Questionnaire at 54 Weeks   [ Time Frame: Baseline and 54 Weeks ]

3.  Secondary:   Change From Baseline in the Non-pain Symptoms Scale of the Severity of Dyspepsia Assessment (SODA) Questionnaire at 54 Weeks   [ Time Frame: Baseline and 54 Weeks ]

4.  Secondary:   Change From Baseline in the Satisfaction With Dyspepsia-Related Health Scale of the Severity of Dyspepsia Assessment (SODA) Questionnaire at 54 Weeks   [ Time Frame: Baseline and 54 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 Y. Grahn, MS
Organization: Horizon Pharma
phone: 224-383-3012
e-mail: agrahn@horizonpharma.com


No publications provided


Responsible Party: Horizon Pharma Ireland, Ltd., Dublin Ireland
ClinicalTrials.gov Identifier: NCT00984815     History of Changes
Other Study ID Numbers: HZ-CA-401
Study First Received: September 23, 2009
Results First Received: March 18, 2013
Last Updated: June 19, 2013
Health Authority: United States: Food and Drug Administration