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Phase 3 Study of Hydrocodone Bitartrate Controlled-release Capsules in Subjects With Chronic Low Back Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Zogenix, Inc.
ClinicalTrials.gov Identifier:
NCT01081912
First received: March 4, 2010
Last updated: March 25, 2014
Last verified: March 2014
Results First Received: February 4, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Back Pain Lower Back Chronic
Interventions: Drug: Placebo
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 510 subjects treated with Hydrocodone Bitartrate Extended Release (HC-ER) capsules in the Conversion/Titration Phase, 208 subjects discontinued early and 151 subjects were randomized into each of the two treatment groups (Maintenance HC-ER Treatment and Placebo Treatment).

Reporting Groups
  Description
Conversion/Titration Phase - Open-Label Conversion/Titration Phase: Hydrocodone Bitartrate Extended Release capsules twice daily for up to 6 weeks (Open-Label Period)
Double-Blind Treatment Phase

Treatment Phase: Hydrocodone Bitartrate Controlled-Release Capsules twice daily up to 12 weeks (Double-Blind Period)

Hydrocodone bitartrate: dosage form: capsule

Strengths 10mg, 20mg, 30mg, 40mg, 50mg

Double-Blind Treatment Phase: Placebo Comparator

Placebo: Capsules, no active substance, shells identical to active comparator capsules.

Placebo capsules twice daily for up to 12 weeks (Double-Blind Period)


Participant Flow for 2 periods

Period 1:   Conversion/Titration
    Conversion/Titration Phase - Open-Label     Double-Blind Treatment Phase     Double-Blind Treatment Phase: Placebo Comparator  
STARTED     510     0     0  
COMPLETED     302     0     0  
NOT COMPLETED     208     0     0  
Adverse Event                 47                 0                 0  
Lack of Efficacy                 17                 0                 0  
Lost to Follow-up                 5                 0                 0  
Physician Decision                 2                 0                 0  
Protocol Violation                 67                 0                 0  
Withdrawal by Subject                 23                 0                 0  
Non-Compliance                 47                 0                 0  

Period 2:   Maintenance Treatment
    Conversion/Titration Phase - Open-Label     Double-Blind Treatment Phase     Double-Blind Treatment Phase: Placebo Comparator  
STARTED     0     151     151  
COMPLETED     0     124     59  
NOT COMPLETED     0     27     92  
Adverse Event                 0                 2                 12  
Lack of Efficacy                 0                 14                 64  
Lost to Follow-up                 0                 1                 0  
Physician Decision                 0                 0                 1  
Protocol Violation                 0                 1                 2  
Withdrawal by Subject                 0                 5                 5  
Non-Compliance                 0                 4                 7  
Withdrawal by Medical Monitor                 0                 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.
Out of 510 subjects treated with Hydrocodone Bitartrate Extended Release (HC-ER) capsules in the Conversion/Titration Phase, 208 subjects discontinued early and 151 subjects were randomized into each of the two treatment groups (Maintenance HC-ER Treatment and Placebo Treatment).

Reporting Groups
  Description
Open-label Conversion/Titration Phase Hydrocodone Bitartrate Extended Release capsules twice daily for up to 6 weeks (Open-Label)

Baseline Measures
    Open-label Conversion/Titration Phase  
Number of Participants  
[units: participants]
  510  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     462  
>=65 years     48  
Gender  
[units: participants]
 
Female     273  
Male     237  
Region of Enrollment  
[units: participants]
 
United States     510  



  Outcome Measures

1.  Primary:   Mean Change in 24-hour Pain Intensity Ratings Scale (NRS).   [ Time Frame: Baseline to Day 85 (Treatment Phase) ]

2.  Secondary:   Mean Change of the Clinic NRS Pain Intensity   [ Time Frame: Baseline to Day 85 visit ]
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: NCT01081912     History of Changes
Other Study ID Numbers: ZX002-0801
Study First Received: March 4, 2010
Results First Received: February 4, 2014
Last Updated: March 25, 2014
Health Authority: United States: Food and Drug Administration