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An Open-label Extension Study With Flexible Dosing of Extended-release (ER) Tapentadol (CG5503) to Treat Patients With Moderate to Severe Chronic Pain

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.
ClinicalTrials.gov Identifier: NCT00487435
Recruitment Status : Completed
First Posted : June 18, 2007
Results First Posted : July 23, 2010
Last Update Posted : May 9, 2014
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Pain
Low Back Pain
Intervention: Drug: Tapentadol (CG5503) Extended Release (ER)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The recruitment period for this out-patient, multicenter study occurred between 4 June 2007 and 29 June 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
Tapentadol (CG5503) Extended Release (ER) Tapentadol (CG5503) extended release (ER) 100 to 250mg oral tablet twice daily (BID) for up to one year

Participant Flow:   Overall Study
    Tapentadol (CG5503) Extended Release (ER)
STARTED   1154 [1] 
Adverse Event                146 
Death                2 
Lack of Efficacy                33 
Lost to Follow-up                54 
Pregnancy                2 
Withdrawal by Subject                132 
Resolution Of Pain                1 
Study Medication Non-Compliant                32 
Other                83 
[1] Patients who received at least one dose of Tapentadol (CG5503) Extended Release (ER)

  Baseline Characteristics

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
Tapentadol (CG5503) Extended Release (ER) Tapentadol (CG5503) extended release (ER) 100 to 250mg oral tablet twice daily (BID) for up to one year

Baseline Measures
   Tapentadol (CG5503) Extended Release (ER) 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   954 
>=65 years   200 
[Units: Years]
Mean (Standard Deviation)
 54.3  (11.43) 
[Units: Participants]
Female   668 
Male   486 
Region Enroll 
[Units: Participants]
Australia   15 
Canada   178 
New Zealand   10 
United States of America   951 

  Outcome Measures

1.  Primary:   Number of Subjects With Treatment-emergent Adverse Events (TEAE)   [ Time Frame: 52 weeks ]

2.  Secondary:   Change From Baseline in Average Pain Intensity Scores at Week 52 Using the Numerical Rating Scale (NRS)   [ Time Frame: Baseline, 52 weeks ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

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

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 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.
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: Senior Director, Clinical Leader
Organization: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
phone: 609-730-4537

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00487435     History of Changes
Other Study ID Numbers: CR013567
First Submitted: June 14, 2007
First Posted: June 18, 2007
Results First Submitted: June 24, 2010
Results First Posted: July 23, 2010
Last Update Posted: May 9, 2014