A Study to Compare the Frequency of Constipation Symptoms With Tapentadol Immediate Release (IR) Treatment Versus Oxycodone IR Treatment in Patients With End-stage Joint Disease

This study has been completed.
Sponsor:
Collaborator:
Grünenthal GmbH
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00784277
First received: October 31, 2008
Last updated: January 9, 2012
Last verified: January 2012
Results First Received: July 22, 2010  
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: Joint Diseases
Arthritis
Osteoarthritis
Interventions: Drug: oxycodone CR
Drug: oxycodone IR
Drug: Tapentadol ER (CG5503)
Drug: Tapentadol IR (CG5503)
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
A total of 1000 participants were screened, 598 were randomized, 596 participants received medication in the first part of the double-blind treatment period (IR treatment phase). A total of 463 participants received medication in the second part of the double-blind treatment period (ER treatment phase).

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

Reporting Groups
  Description
Placebo IR Treatment : 1 capsule for 14 days
Tapentadol 50 mg IR Treatment : 50mg for 14 days
Tapentadol 75 mg IR Treatment : 75mg for 14 days
Oxycodone IR Treatment : 10mg for 14 days
Placebo ER ER Treatment : Tablets and capsules 2 x a day for 28 days
Tapentadol ER ER Treatment : flexible dose tablets and capsules 2 x a day for 28 days (100-500mg/day)
Oxycodone CR ER Treatment : flexible dose tablets and capsules 2 x a day for 28 days (20-60mg/day)

Participant Flow for 2 periods

Period 1:   IR Treatment
    Placebo     Tapentadol 50 mg     Tapentadol 75 mg     Oxycodone     Placebo ER     Tapentadol ER     Oxycodone CR  
STARTED     148     151     154     143     0 [1]   0 [1]   0 [1]
COMPLETED     132     134     126     100     0     0     0  
NOT COMPLETED     16     17     28     43     0     0     0  
Adverse Event                 4                 8                 19                 35                 0                 0                 0  
Lack of Efficacy                 4                 4                 1                 0                 0                 0                 0  
Lost to Follow-up                 1                 0                 1                 0                 0                 0                 0  
Withdrawal by Subject                 5                 1                 4                 6                 0                 0                 0  
Resolution Of Pain                 0                 1                 0                 0                 0                 0                 0  
Other                 2                 3                 3                 2                 0                 0                 0  
[1] "0" in ER column indicates this reporting group is not relevant to IR phase.

Period 2:   ER Treatment
    Placebo     Tapentadol 50 mg     Tapentadol 75 mg     Oxycodone     Placebo ER     Tapentadol ER     Oxycodone CR  
STARTED     0 [1]   0 [1]   0 [1]   0 [1]   122 [2]   250 [2]   91 [3]
COMPLETED     0     0     0     0     113     226     76  
NOT COMPLETED     0     0     0     0     9     24     15  
Adverse Event                 0                 0                 0                 0                 1                 7                 7  
Lack of Efficacy                 0                 0                 0                 0                 3                 4                 0  
Lost to Follow-up                 0                 0                 0                 0                 0                 2                 0  
Withdrawal by Subject                 0                 0                 0                 0                 2                 5                 3  
Study Medication Non-Compliant                 0                 0                 0                 0                 2                 3                 3  
Other                 0                 0                 0                 0                 1                 3                 2  
[1] "0" in IR column indicates this reporting group is not relevant to ER phase.
[2] 10 participants who had completed IR treatment have not taken any ER treatment.
[3] 9 participants who had completed IR treatment have not taken any ER treatment.



  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 IR Treatment : 1 capsule for 14 days
Tapentadol 50 mg IR Treatment : 50mg capsule for 14 days
Tapentadol 75 mg IR Treatment : 75mg capsule for 14 days
Oxycodone IR Treatment : 10mg capsule for 14 days
Total Total of all reporting groups

Baseline Measures
    Placebo     Tapentadol 50 mg     Tapentadol 75 mg     Oxycodone     Total  
Number of Participants  
[units: participants]
  148     151     154     143     596  
Age  
[units: participants]
         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     110     113     114     109     446  
>=65 years     38     38     40     34     150  
Age  
[units: years]
Mean ± Standard Deviation
  58.8  ± 9.57     58  ± 9.47     58.4  ± 7.66     59.4  ± 7.94     58.7  ± 8.70  
Gender  
[units: Participants]
         
Female     100     93     75     81     349  
Male     48     58     79     62     247  
Region Enroll  
[units: Participants]
         
Canada     32     36     37     34     139  
USA     116     115     117     109     457  



  Outcome Measures
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1.  Primary:   5-Day Sum of Pain Intensity Difference (SPID5)   [ Time Frame: Day 1 to Day 5 ]

2.  Primary:   Spontaneous Bowel Movements Per Week (SBMs/Week)   [ Time Frame: Week 1 to Week 2 ]


  Serious Adverse Events


  Other Adverse Events


  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 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.


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.  


Results Point of Contact:  
Name/Title: Senior Director, Clinical Leader
Organization: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
phone: 609-730-4537


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

Publications automatically indexed to this study:

Responsible Party: Senior Director, Clinical Leader, Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00784277     History of Changes
Other Study ID Numbers: CR014326, KF5503/41
Study First Received: October 31, 2008
Results First Received: July 22, 2010
Last Updated: January 9, 2012
Health Authority: United States: Food and Drug Administration