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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 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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


  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 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: 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