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Study to Evaluate the Long-Term Safety of Hydrocodone Bitartrate Extended-Release Tablets (CEP-33237) in Patients Who Require Opioid Treatment for an Extended Period of Time

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01223365
First Posted: October 19, 2010
Last Update Posted: June 5, 2017
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):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
Results First Submitted: February 19, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Chronic Pain
Intervention: Drug: Hydrocodone ER

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
365 patients with chronic pain were screened for enrollment into this study: 25 patients were excluded on the basis of exclusion criteria, 6 withdrew consent, 2 were lost to follow up before the baseline visit, 1 patient did not meet an inclusion criteria, and 1 patient had an opioid violation because of self increasing analgesic medication.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
330 enrolled patients came from 61 centers in the US: 166 rolled-over from study 3079, 52 were new opioid-naïve participants and 112 were new opioid-experienced participants. One enrolled patient was withdrawn before taking any study drug.

Reporting Groups
  Description
Hydrocodone ER Participants were titrated (or re-titrated for roll-over participants) at escalating dosages of hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours until deemed successful for managing their pain during the open-label titration period. Once a successful dose was identified, participants entered the 52 week open-label treatment period in which hydrocodone ER was administered at the successful dose (15, 30, 45, 60, or 90 mg) every 12 hours.

Participant Flow for 2 periods

Period 1:   Open-label Titration Period
    Hydrocodone ER
STARTED   330 
Safety Analysis Set   329 
Achieved Stable Pain Relief   294 
COMPLETED   291 
NOT COMPLETED   39 
Enrolled but not treated                1 
Adverse Event                23 
Lack of Efficacy                3 
Withdrawal by Subject                5 
Protocol Violation                1 
Lost to Follow-up                2 
Noncompliance with study drug admin                1 
Noncompliance with study procedures                2 
Starting physical therapy                1 

Period 2:   Open-label Treatment Period
    Hydrocodone ER
STARTED   291 
COMPLETED   189 
NOT COMPLETED   102 
Adverse Event                39 
Lack of Efficacy                2 
Withdrawal by Subject                19 
Protocol Violation                15 
Lost to Follow-up                7 
Noncompliance with study drug admin                7 
Noncompliance with study procedures                6 
Moved out of area                2 
Negative urine drug screen when on treat                1 
"Out of window"                1 
Starting physical therapy                1 
Physician Decision                2 



  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.
Enrolled patients

Reporting Groups
  Description
Hydrocodone ER Participants were titrated (or re-titrated for roll-over participants) at escalating dosages of hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours until deemed successful for managing their pain during the open-label titration period. Once a successful dose was identified, participants entered the 52 week open-label treatment period in which hydrocodone ER was administered at th3 successful dose (15, 30, 45, 60, or 90 mg) every 12 hours.

Baseline Measures
   Hydrocodone ER 
Overall Participants Analyzed 
[Units: Participants]
 330 
Age 
[Units: Years]
Mean (Standard Deviation)
 
Participants Analyzed 
[Units: Participants]
 330 
   54.4  (11.51) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Participants Analyzed 
[Units: Participants]
 330 
Female      197  59.7% 
Male      133  40.3% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
 
White   
Participants Analyzed 
[Units: Participants]
 330 
White   260 
Black   
Participants Analyzed 
[Units: Participants]
 330 
Black   66 
Asian   
Participants Analyzed 
[Units: Participants]
 330 
Asian   2 
Pacific Islander   
Participants Analyzed 
[Units: Participants]
 330 
Pacific Islander   1 
Other   
Participants Analyzed 
[Units: Participants]
 330 
Other   1 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
 
Hispanic or Latino   
Participants Analyzed 
[Units: Participants]
 330 
Hispanic or Latino   10 
Non-Hispanic and non-Latino   
Participants Analyzed 
[Units: Participants]
 330 
Non-Hispanic and non-Latino   319 
Unknown   
Participants Analyzed 
[Units: Participants]
 330 
Unknown   1 
Weight [1] 
[Units: Kg]
Mean (Standard Deviation)
 
Participants Analyzed 
[Units: Participants]
 329 
   95.6  (23.97) 
[1] one participant data was missing the value
Height [1] 
[Units: Cm]
Mean (Standard Deviation)
 
Participants Analyzed 
[Units: Participants]
 329 
   169.7  (10.57) 
[1] one participant data was missing the value
Body Mass Index [1] 
[Units: Kg/m^2]
Mean (Standard Deviation)
 
Participants Analyzed 
[Units: Participants]
 329 
   33.1  (7.38) 
[1] one participant data was missing the value
Type of Pain 
[Units: Participants]
Count of Participants
 
Low back pain   
Participants Analyzed 
[Units: Participants]
 330 
Low back pain   113 
Back pain   
Participants Analyzed 
[Units: Participants]
 330 
Back pain   103 
Osteoarthritis   
Participants Analyzed 
[Units: Participants]
 330 
Osteoarthritis   82 
Diabetic peripheral neuropathy   
Participants Analyzed 
[Units: Participants]
 330 
Diabetic peripheral neuropathy   12 
Postherpetic neuralgia   
Participants Analyzed 
[Units: Participants]
 330 
Postherpetic neuralgia   0 
Traumatic injury   
Participants Analyzed 
[Units: Participants]
 330 
Traumatic injury   3 
Neck pain   
Participants Analyzed 
[Units: Participants]
 330 
Neck pain   10 
Complex regional pain syndrome   
Participants Analyzed 
[Units: Participants]
 330 
Complex regional pain syndrome   3 
Rheumatoid arthritis   
Participants Analyzed 
[Units: Participants]
 330 
Rheumatoid arthritis   2 
Other   
Participants Analyzed 
[Units: Participants]
 330 
Other   2 
Duration Since Diagnosis 
[Units: Years]
Mean (Standard Deviation)
 
Participants Analyzed 
[Units: Participants]
 330 
   12.3  (9.54) 
Duration on Opioid Therapy 
[Units: Years]
Mean (Standard Deviation)
 
Participants Analyzed 
[Units: Participants]
 330 
   4.4  (5.27) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Participants With Adverse Experiences   [ Time Frame: Day 1 of open-label titration period - Week 52 of the open-label treatment period ]

2.  Primary:   Participants With Potentially Clinically Significant (PCS) Abnormal Laboratory Values During the Open-Label Treatment Period by Participant Status   [ Time Frame: Day 1 - Week 52 of the open-label treatment period ]

3.  Primary:   Participants With Potentially Clinically Significant Abnormal Vital Signs Values by Participant Status   [ Time Frame: Day 1 of open-label titration period - Week 52 of the open-label treatment period ]

4.  Primary:   Shifts in Electrocardiogram (ECG) Findings From Baseline to Overall Study by Participant Status   [ Time Frame: Baseline for new participants was between Day -7 and -14 (the study 3080 screening visit); baseline for rollover participants was the last ECG in study 3079. During study ECGs were performed on weeks 24 and 52 of the open-label treatment period ]

5.  Primary:   Participants With Clinically Significant (CS) Hearing Changes From Baseline in Pure Tone Audiometry Test Results by Patient Status   [ Time Frame: Baseline for new participants was between Day -7 and -14 (study 3080 screening visit); baseline for rollover participants was the baseline test in study 3079. During study covers both open-label titration and 52-week treatment periods ]

6.  Secondary:   Participant Global Assessment (PGA) of the Method of Pain Control by Participant Status   [ Time Frame: Baseline for new participants was Day 1, i.e. the first day of open-label titration. Baseline for rollover participants was the baseline in study 3079. Week 4 (end of titration, start of open-label treatment), Week 52, last visit up to Week 52 ]

7.  Secondary:   Participants by Risk Category for Aberrant Drug Misuse Based on the Total Score in the Screener and Opioid Assessment for Patients With Pain – Revised (SOAPP-R)   [ Time Frame: End of Open-label Titration Period. Weeks 4 and 24 of the Open-label Treatment Period ]

8.  Secondary:   Addiction Behavior Checklist (ABC) Total Scores During Both the Open-Label Titration and Open-Label Treatment Periods by Participant Status   [ Time Frame: Baseline for new participants was Day 1 of open-label titration; rollover participants baseline was in study 3079. End of Open-label Titration: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36 40, 44, 48, 52 and last visit up to week 52 ]

9.  Secondary:   Current Opioid Misuse Measure (COMM) Scores During Both the Open-Label Titration and Open-Label Treatment Periods by Participant Status   [ Time Frame: Baseline for new participants was Day 1 of open-label titration; rollover participants baseline was in study 3079. End of Open-label Titration Period. Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36 40, 44, 48, 52 and last visit up to week 52 ]


  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: Director, Clinical Research
Organization: Teva Branded Pharmaceutical Products, R&D Inc.
phone: 215-591-3000
e-mail: ustevatrials@tevapharm.com



Responsible Party: Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
ClinicalTrials.gov Identifier: NCT01223365     History of Changes
Other Study ID Numbers: C33237/3080
First Submitted: October 15, 2010
First Posted: October 19, 2010
Results First Submitted: February 19, 2017
Results First Posted: April 5, 2017
Last Update Posted: June 5, 2017