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Study on the Safety and Effectiveness of Switching Between Two Forms of Tapentadol in Patients With Chronic Low Back Pain

This study has been completed.
Sponsor:
Collaborator:
Grünenthal GmbH
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00594516
First received: January 3, 2008
Last updated: September 23, 2010
Last verified: September 2010
Results First Received: April 28, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Low Back Pain
Interventions: Drug: tapentadol (CG5503) Immediate Release IR
Drug: tapentadol (CG5503) Extended Release (ER)
Drug: tapentadol (CG5503) Immediate Release (IR)

  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 first site opened on 30 November 2007. The recruitment period for this outpatient, multicenter study occurred between 10 December 2007 and 01 May 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study consisted of screening period (up to 21 days), washout period (from 3 to 7 days), open label (OL) treatment period (3 weeks), followed by a double blind (DB) active treatment period, with crossover design of 2 randomized sequences of tapentadol immediate release (IR) to tapentadol extended release (ER) and tapentadol ER to IR (4 weeks)

Reporting Groups
  Description
Tapentadol Subjects treated in the Tapentadol(CG5503) Immediate Release (IR) Open-Label period
Tapentadol IR to ER Tapentadol IR in first intervention period of double-blind phase and Tapentadol ER in second intervention period of double-blind phase
Tapentadol ER to IR Tapentadol ER in first intervention period of double-blind phase and Tapentadol IR in second intervention period of double-blind phase

Participant Flow for 2 periods

Period 1:   Open Label (OL): Tapentadol IR
    Tapentadol     Tapentadol IR to ER     Tapentadol ER to IR  
STARTED     116 [1]   0     0  
COMPLETED     87     0     0  
NOT COMPLETED     29     0     0  
Withdrawal by Subject                 4                 0                 0  
Lost to Follow-up                 2                 0                 0  
Adverse Event                 16                 0                 0  
Lack of Efficacy                 1                 0                 0  
Study Medication Non Compliant                 6                 0                 0  
[1] one patient was enrolled but lost to follow up at the start of open label therefore was not included

Period 2:   DB: Tapentadol IR to ER & ER to IR
    Tapentadol     Tapentadol IR to ER     Tapentadol ER to IR  
STARTED     0     44     43  
COMPLETED     0     37     35  
NOT COMPLETED     0     7     8  
Withdrawal by Subject                 0                 3                 3  
Study Medication Non compliant                 0                 3                 2  
Lack of Efficacy                 0                 1                 1  
Adverse Event                 0                 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
Tapentadol Subjects treated in the Tapentadol(CG5503) Immediate Release (IR) Open-Label period
Tapentadol IR to ER Tapentadol IR in first intervention period of double-blind phase and Tapentadol ER in second intervention period of double-blind phase
Tapentadol ER to IR Tapentadol ER in first intervention period of double-blind phase and Tapentadol IR in second intervention period of double-blind phase
Total Total of all reporting groups

Baseline Measures
    Tapentadol     Tapentadol IR to ER     Tapentadol ER to IR     Total  
Number of Participants  
[units: participants]
  116     0     0     116  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     86     0     0     86  
>=65 years     30     0     0     30  
Age  
[units: years]
Mean ± Standard Deviation
  53.6  ± 15.46             53.6  ± 15.46  
Gender  
[units: participants]
       
Female     65     0     0     65  
Male     51     0     0     51  
Race/Ethnicity, Customized [1]
[units: participants]
       
American Indian or Alaska Native     0     0     0     0  
Asian     0     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0     0  
Black or African American     14     0     0     14  
White     90     0     0     90  
Hispanic or Latino     12     0     0     12  
Other     0     0     0     0  
[1] Race/ethnicity



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   The Difference in the Mean Average Pain Intensity Score on an 11-point Numerical Rating Scale (NRS) During the Last 3 Days of Each Double-blind Treatment Period. (Difference Between Two DB Randomization Treatment Sequences)   [ Time Frame: 14 days for each cross-over period ]

2.  Secondary:   The Number of Patients Requiring Rescue Medication During the DB Tapentadol IR Treatment   [ Time Frame: 14 days for each cross-over period ]

3.  Secondary:   The Number of Patients Requiring Rescue Medication During the DB Tapentadol ER Treatment   [ Time Frame: 14 days for each cross-over period ]

4.  Secondary:   Total Daily Dose (TDD) of Tapentadol IR During the Double-blind Treatment Period   [ Time Frame: 14-day for each DB treatment period ]

5.  Secondary:   Total Daily Dose (TDD) of Tapentadol ER During the DB Treatment Period.   [ Time Frame: 14 days for each treatment period ]


  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: Mila Etropolski, MD Clinical Leader
Organization: Johnson & Johnson Pharmaceutical Research & Development
phone: 609-730-4537
e-mail: metropol@its.jnj.com


No publications provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Publications automatically indexed to this study:

Responsible Party: Director, Clinical Leader, Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00594516     History of Changes
Other Study ID Numbers: CR014242, R331333PAI3019
Study First Received: January 3, 2008
Results First Received: April 28, 2009
Last Updated: September 23, 2010
Health Authority: United States: Food and Drug Administration