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Flurbiprofen Tape for Treatment of Chronic Low Back Pain (LBP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teikoku Pharma USA
ClinicalTrials.gov Identifier:
NCT00759330
First received: September 24, 2008
Last updated: August 12, 2016
Last verified: June 2016
Results First Received: May 13, 2016  
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: Chronic Low Back Pain
Interventions: Drug: Placebo Tape (Arm 1)
Drug: Flurbiprofen Tape (Arm 2)
Drug: Placebo Tape (Arm 3)
Drug: Flurbiprofen Tape (Arm 4)

  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
The study was conducted at 10 clinical sites in the US from September 2007 to July 2008. Patients with chronic LBP below the 12th thoracic vertebra of greater than 3 months duration and with an average daily pain score of 4 or greater on an 11-point categorical pain scale for the last 3 days of the baseline phase were eligible to participate.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Prior to randomization into the Tape Treatment Phase, participants began a 14-day washout period of previously used pain medications. Participants were then randomized to 1 of 4 treatments. After 7 days of treatment, patients returned to the clinic for a study exit visit. Participants were provided with rescue medication throughout the study.

Reporting Groups
  Description
Placebo Tape, Daily for 12 Hours Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day.
Flurbiprofen Tape, Daily for 12 Hours Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
Placebo Tape, Daily for 24 Hours Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day.
Flurbiprofen Tape, Daily for 24 Hours Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day. Each tape included 31.5 mg flurbiprofen for a total daily dose of 63 mg.

Participant Flow:   Overall Study
    Placebo Tape, Daily for 12 Hours   Flurbiprofen Tape, Daily for 12 Hours   Placebo Tape, Daily for 24 Hours   Flurbiprofen Tape, Daily for 24 Hours
STARTED   20   42   22   43 
COMPLETED   19   41   22   41 
NOT COMPLETED   1   1   0   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.
No text entered.

Reporting Groups
  Description
Placebo Tape, Daily for 12 Hours Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day.
Flurbiprofen Tape, Daily for 12 Hours Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
Placebo Tape, Daily for 24 Hours Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day.
Flurbiprofen Tape, Daily for 24 Hours Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
Total Total of all reporting groups

Baseline Measures
   Placebo Tape, Daily for 12 Hours   Flurbiprofen Tape, Daily for 12 Hours   Placebo Tape, Daily for 24 Hours   Flurbiprofen Tape, Daily for 24 Hours   Total 
Overall Participants Analyzed 
[Units: Participants]
 20   42   22   43   127 
Age 
[Units: Years]
Mean (Standard Deviation)
 51.8  (14.47)   50.1  (13.02)   53.6  (13.46)   53.0  (11.98)   52.1  (13.2) 
Gender 
[Units: Participants]
         
Female   9   23   9   28   69 
Male   11   19   13   15   58 


  Outcome Measures
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1.  Primary:   Cumulative Summed Pain Intensity Difference (SPID+)   [ Time Frame: Days 4 and 7 of tape treatment phase ]

2.  Secondary:   Pain Intensity Difference (PID+)   [ Time Frame: Days 1 through 7 of tape treatment phase ]

3.  Secondary:   Average Daily Categorical Pain Scale Scores   [ Time Frame: Days 1 through 7 of tape treatment phase ]

4.  Secondary:   Percent Change From Baseline in Total Functional Rating Index (FRI)   [ Time Frame: baseline to Day 7 of tape treatment phase ]

5.  Secondary:   Change From Baseline in Total Tender Point Examination Score   [ Time Frame: Baseline to Day 7 of tape treatment phase ]

6.  Secondary:   Patient Global Impression of Change (PGIC)   [ Time Frame: Day 7 ]

7.  Secondary:   Acetaminophen Used During the Tape Treatment Phase   [ Time Frame: Day 1 through Day 7 of the tape treatment phase ]

8.  Secondary:   Acetaminophen Used During the Tape Treatment Phase   [ Time Frame: Day 1 through Day 7 of the tape treatment phase ]

9.  Secondary:   Percentage of Patients Who Discontinued   [ Time Frame: Days 1 through Day 7 of tape treatment phase ]

10.  Secondary:   Patient Assessment of Wearability of Therapy   [ Time Frame: Day 7 ]


  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 of Clinical Trials
Organization: Teikoku Pharma USA, Inc.
phone: 408-501-1821



Responsible Party: Teikoku Pharma USA
ClinicalTrials.gov Identifier: NCT00759330     History of Changes
Other Study ID Numbers: TPU FT-US06-01
Study First Received: September 24, 2008
Results First Received: May 13, 2016
Last Updated: August 12, 2016
Health Authority: United States: Food and Drug Administration