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Long-Term Study of Hydrocodone Bitartrate Controlled-release Capsules in Subjects With Chronic Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Zogenix, Inc.
ClinicalTrials.gov Identifier:
NCT01115569
First received: April 30, 2010
Last updated: March 25, 2014
Last verified: March 2014
Results First Received: February 4, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Chronic Pain
Intervention: Drug: Hydrocodone Bitartrate

  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
Out of 638 subjects treated with Hydrocodone Bitartate Extended Release (HC-ER) capsules in the Conversion/Titration Phase, 214 subjects discontinued early and 424 continued in the Maintenance HC-ER Treatment Phase; 285 subjects completed.

Reporting Groups
  Description
Open-label Hydrocodone Bitartrate Extended Release (HC-ER) Conversion/Titration Phase: HC-ER capsules daily for up to 6 weeks
Open-label Hydrocodone Bitartrate Extended Release Capsules

Maintenance HC-ER Treatment Phase: Open-label, all patients fulfilling the protocol Inclusion/Exclusion criteria will receive HC-ER in a flexible dosing regimen.

Hydrocodone Bitartrate: Open-Label, Capsule Strengths 10 mg, 20 mg, 30 mg, 40 mg, 50 mg; by mouth (PO) twice a day (BID) for up to 48 weeks


Participant Flow for 2 periods

Period 1:   Conversion/Titration Phase
    Open-label Hydrocodone Bitartrate Extended Release (HC-ER)     Open-label Hydrocodone Bitartrate Extended Release Capsules  
STARTED     638     0  
COMPLETED     424     0  
NOT COMPLETED     214     0  
Adverse Event                 59                 0  
Lost to Follow-up                 3                 0  
Physician Decision                 5                 0  
Protocol Violation                 68                 0  
Withdrawal by Subject                 26                 0  
Non-Compliance with Study Drug                 53                 0  

Period 2:   Maintenance Phase
    Open-label Hydrocodone Bitartrate Extended Release (HC-ER)     Open-label Hydrocodone Bitartrate Extended Release Capsules  
STARTED     0     424  
COMPLETED     0     285  
NOT COMPLETED     0     139  
Adverse Event                 0                 43  
Lost to Follow-up                 0                 8  
Physician Decision                 0                 3  
Protocol Violation                 0                 9  
Withdrawal by Subject                 0                 27  
Non-Compliance with Study Drug                 0                 48  
Administrative                 0                 1  



  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
Open-label Hydrocodone Bitartate Extended Release (HC-ER) Conversion/Titration Phase: HC-ER capsules daily for up to 6 weeks

Baseline Measures
    Open-label Hydrocodone Bitartate Extended Release (HC-ER)  
Number of Participants  
[units: participants]
  638  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     572  
>=65 years     66  
Gender  
[units: participants]
 
Female     360  
Male     278  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     3  
Asian     1  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     107  
White     518  
More than one race     9  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
United States     638  



  Outcome Measures

1.  Primary:   Mean Change in Average Daily Pain   [ Time Frame: 1 year ]

2.  Secondary:   Maintenance of Efficacy   [ Time Frame: 1 year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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
No text entered.


  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 Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Kevin Romanko
Organization: Zogenix
phone: (510) 550-8323
e-mail: kromanko@zogenix.com


No publications provided


Responsible Party: Zogenix, Inc.
ClinicalTrials.gov Identifier: NCT01115569     History of Changes
Other Study ID Numbers: ZX002-0802
Study First Received: April 30, 2010
Results First Received: February 4, 2014
Last Updated: March 25, 2014
Health Authority: United States: Food and Drug Administration