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Efficacy and Safety Study of Buprenorphine HCl Buccal Film in Subjects With Low Back Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Endo Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01256450
First received: December 7, 2010
Last updated: September 14, 2016
Last verified: August 2016
Results First Received: November 4, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Pain
Low Back Pain
Interventions: Drug: Buprenorphine
Drug: Placebo

  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
Of 334 subjects who were enrolled in the open-label (OL) titration phase; a total of 235 completed the open-label titration phase and were randomized in the double-blind (DB) treatment phase.

Reporting Groups
  Description
OL Buprenorphine HCl Buccal Film Buprenorphine hydrochloride (HCl) buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for up to 4 weeks in the open-label titration period
DB Buprenorphine HCl Buccal Film Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
DB Placebo Film Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period

Participant Flow for 2 periods

Period 1:   Open-label Titration
    OL Buprenorphine HCl Buccal Film   DB Buprenorphine HCl Buccal Film   DB Placebo Film
STARTED   334   0   0 
COMPLETED   235   0   0 
NOT COMPLETED   99   0   0 
Adverse Event                39                0                0 
Lost to Follow-up                7                0                0 
Lack of analgesic effect                30                0                0 
Non-compliance                9                0                0 
Screen failure                1                0                0 
Not specified                13                0                0 

Period 2:   Double-blind Treatment
    OL Buprenorphine HCl Buccal Film   DB Buprenorphine HCl Buccal Film   DB Placebo Film
STARTED   0 [1]   117 [2]   118 [2] 
COMPLETED   0   89   81 
NOT COMPLETED   0   28   37 
Adverse Event                0                8                6 
Lost to Follow-up                0                1                7 
Withdrawal by Subject                0                0                1 
Lack of analgesic effect                0                5                6 
Non-compliance                0                5                4 
Opioid withdrawal symptoms                0                0                1 
Not specified                0                9                12 
[1] All subjects completing OL titration in the previous period were randomized to a DB treatment.
[2] Subjects were randomized to DB treatment after completing OL titration in the previous period.



  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.
Analysis based on Randomized population; all subjects who were randomized into the double-blind period, even if study drug was not taken in the period

Reporting Groups
  Description
DB Buprenorphine HCl Buccal Film Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
DB Placebo Film Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
Total Total of all reporting groups

Baseline Measures
   DB Buprenorphine HCl Buccal Film   DB Placebo Film   Total 
Overall Participants Analyzed 
[Units: Participants]
 117   118   235 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   100   100   200 
>=65 years   17   18   35 
Age 
[Units: Years]
Median (Full Range)
 52.0 
 (21 to 89) 
 51.5 
 (20 to 77) 
 52.0 
 (20 to 89) 
Gender 
[Units: Participants]
     
Female   62   66   128 
Male   55   52   107 
Region of Enrollment 
[Units: Participants]
     
United States   117   118   235 


  Outcome Measures
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1.  Primary:   Change in Pain Intensity From Baseline to Week 12   [ Time Frame: Baseline, Week 12 ]

2.  Secondary:   Change From Baseline in Pain Intensity Over Time Using NRS Scale   [ Time Frame: Baseline; Day 14, Day 28, Day 42, Day 56, Day 70, and Day 84 ]

3.  Secondary:   Number of Participants With Response to Treatment as Assessed by an NRS Scale   [ Time Frame: Week 12 ]

4.  Secondary:   Percentage of Participants With Treatment Failure in the Double-blind Treatment Phase (up to 12 Weeks)   [ Time Frame: Baseline to treatment failure or end of double-blind treatment phase (up to 12 weeks) ]

5.  Secondary:   Subject Impression of Change in Pain Intensity From Baseline to Week 12 Using PGIC Scale   [ Time Frame: Baseline, Week 12 ]

6.  Secondary:   Change From Baseline to Week 12 in Treatment Satisfaction Using TSQM   [ Time Frame: Baseline, Week 12 ]

7.  Secondary:   Change From Baseline to Week 12 in Roland Morris Disability Questionnaire   [ Time Frame: Baseline, Week 12 ]

8.  Secondary:   Change From Baseline to Week 12 in Subject’s Overall Satisfaction With Study Drug   [ Time Frame: Baseline, Week 12 ]

9.  Secondary:   Change From Baseline to Week 12 in Investigator’s Overall Satisfaction With Study Drug   [ Time Frame: Baseline, Week 12 ]

10.  Secondary:   Use of Rescue Medication   [ Time Frame: Day 7, 14, 28, 42, 56, 70, 84, and 91 within double-blind treatment phase ]


  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 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: Clinical Trial Coordinator
Organization: Endo Pharmaceuticals Inc.
e-mail: clinicalsite.inquiries@endo.com



Responsible Party: Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01256450     History of Changes
Other Study ID Numbers: BUP-301
Study First Received: December 7, 2010
Results First Received: November 4, 2015
Last Updated: September 14, 2016
Health Authority: United States: Food and Drug Administration