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A Study to Evaluate Long-Term Safety of Multiple Doses of Tapentadol (CG5503) Prolonged-Release (PR) and Oxycodone Controlled-Release (CR) in Patients With Chronic Pain
This study has been completed.
Study NCT00361504   Information provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
First Received: August 4, 2006   Last Updated: September 14, 2009   History of Changes
Study Type: Interventional
Study Design: Randomized, Open Label, Parallel Assignment
Conditions: Osteoarthritis, Hip
Osteoarthritis, Knee
Lower Back Pain
Pain
Interventions: Drug: tapentadol (CG5503) PR
Drug: oxycodone CR

  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 recruitment period for this out-patient, multicenter study occurred between 14 November 2006 and 25 July 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study consisted of a screening period (duration up to 14 days), a washout period (duration 3 to 7 days), and an open label active treatment phase with titration and maintenance (total duration of 52 weeks).

Reporting Groups
  Description
Tapentadol (CG5503) Tapentadol (CG5503) extended release (ER) 100 to 250mg twice daily (BID) for up to one year
Oxycodone oxycodone controlled release (CR) 20 to 50mg twice daily (BID) for up to one year.

Participant Flow:   Overall Study
  Tapentadol (CG5503) Oxycodone
STARTED   894     223  
COMPLETED   413     78  
NOT COMPLETED   481     145  
      Withdrawal by Subject               94                 31  
      Lost to Follow-up               40                 7  
      Adverse Event               203                 82  
      Lack of Efficacy               72                 7  
      Resolution of Pain               2                 0  
      Study medication non compliant               42                 15  
      All other               28                 3  



  Baseline Characteristics
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Reporting Groups
  Description
Tapentadol (CG5503) Tapentadol (CG5503) extended release (ER) 100 to 250mg twice daily (BID) for up to one year
Oxycodone oxycodone controlled release (CR) 20 to 50mg twice daily (BID) for up to one year.

Baseline Measures
  Tapentadol (CG5503) Oxycodone Total
Number of Participants  
[units: participants]
 		894 223 1117
Age  
[units: participants]
 		     
<=18 years 0 0 0
Between 18 and 65 years 649 156 805
>=65 years 245 67 312
Age  
[units: years]
Mean ± Standard Deviation 		56.8 ± 12.51 58.1 ± 11.83 57.0 ± 12.38
Gender  
[units: participants]
 		     
Female 515 125 640
Male 379 98 477
Region of Enrollment  
[units: participants]
 		     
North America 684 170 854
Europe 210 53 263



  Outcome Measures
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1.  Primary:   Number of Subjects With Treatment-emergent Adverse Events (TEAE)   [ 52 weeks ]
  Show Outcome Measure 1

2.  Secondary:   Change From Baseline in Average Pain Intensity Scores at Week 52 Using the Numerical Rating Scale (NRS)   [ 52 Weeks ]
  Show Outcome Measure 2


  Serious Adverse Events
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Time Frame No text entered.
Additional Description No text entered.

Reporting Groups
  Description
Tapentadol (CG5503) Tapentadol (CG5503) extended release (ER) 100 to 250mg twice daily (BID) for up to one year
Oxycodone oxycodone controlled release (CR) 20 to 50mg twice daily (BID) for up to one year.

Serious Adverse Events
  Tapentadol (CG5503) Oxycodone
Total, serious adverse events    
# participants affected 49   9  
Cardiac disorders    
Atrial Fibrillation   *
      # participants affected / at risk
3/894 (0.34%)  
0/223 (0.00%)  
Acute myocardial infarction   *
      # participants affected / at risk
1/894 (0.11%)  
0/223 (0.00%)  
Angina Pectoris   *
      # participants affected / at risk
1/894 (0.11%)  
0/223 (0.00%)  
Cardiac Failure Congestive   *
      # participants affected / at risk
1/894 (0.11%)  
0/223 (0.00%)  
Coronary Artery Disease   *
      # participants affected / at risk
1/894 (0.11%)  
0/223 (0.00%)  
Myocardial Infarction   *
      # participants affected / at risk
1/894 (0.11%)  
0/223 (0.00%)  
Ventricular Fibrillation   *
      # participants affected / at risk
1/894 (0.11%)  
0/223 (0.00%)  
Congenital, familial and genetic disorders    
Hydrocele   *
      # participants affected / at risk
1/894 (0.11%)  
0/223 (0.00%)  
Ear and labyrinth disorders    
Vertigo   *
      # participants affected / at risk
1/894 (0.11%)  
0/223 (0.00%)  
Eye disorders    
Visual Disturbance   *
      # participants affected / at risk
1/894 (0.11%)  
0/223 (0.00%)  
Gastrointestinal disorders    
Abdominal Pain   *
      # participants affected / at risk
2/894 (0.22%)  
0/223 (0.00%)  
Intestinal Obstruction   *
      # participants affected / at risk
2/894 (0.22%)  
0/223 (0.00%)  
Colonic Polyp   *
      # participants affected / at risk
1/894 (0.11%)  
0/223 (0.00%)  
Constipation   *
      # participants affected / at risk
1/894 (0.11%)  
0/223 (0.00%)  
Diabetic Gastroparesis   *
      # participants affected / at risk
1/894 (0.11%)  
0/223 (0.00%)  
Dysphagia   *
      # participants affected / at risk
1/894 (0.11%)  
0/223 (0.00%)  
Gastritis   *
      # participants affected / at risk
1/894 (0.11%)  
0/223 (0.00%)  
Impaired Gastric Emptying   *
      # participants affected / at risk
1/894 (0.11%)  
0/223 (0.00%)  
Nausea   *
      # participants affected / at risk
1/894 (0.11%)  
0/223 (0.00%)  
Volvulus   *
      # participants affected / at risk
1/894 (0.11%)  
0/223 (0.00%)  
Colitis   *
      # participants affected / at risk
0/894 (0.00%)  
1/223 (0.45%)  
Ileitis   *
      # participants affected / at risk
0/894 (0.00%)  
1/223 (0.45%)  
Small Intestinal Obstruction   *
      # participants affected / at risk
0/894 (0.00%)  
1/223 (0.45%)  
General disorders    
Asthenia   *
      # participants affected / at risk
1/894 (0.11%)  
0/223 (0.00%)  
Chest Pain   *
      # participants affected / at risk
1/894 (0.11%)  
0/223 (0.00%)  
Drug Withdrawal Syndrome   *
      # participants affected / at risk
1/894 (0.11%)  
0/223 (0.00%)  
Hernia Obstructive   *
      # participants affected / at risk
1/894 (0.11%)  
0/223 (0.00%)  
Oedema Peripheral   *
      # participants affected / at risk
1/894 (0.11%)  
0/223 (0.00%)  
Treatment Failure   *
      # participants affected / at risk
1/894 (0.11%)  
0/223 (0.00%)  
Hepatobiliary disorders    
Cholecystitis   *
      # participants affected / at risk
1/894 (0.11%)  
0/223 (0.00%)  
Infections and infestations    
Appendicitis   *
      # participants affected / at risk
1/894 (0.11%)  
1/223 (0.45%)  
Cellulitis   *
      # participants affected / at risk
1/894 (0.11%)  
0/223 (0.00%)  
Diverticulitis   *
      # participants affected / at risk
1/894 (0.11%)  
0/223 (0.00%)  
Gastroenteritis   *
      # participants affected / at risk
1/894 (0.11%)  
0/223 (0.00%)  
Pneumonia   *
      # participants affected / at risk
1/894 (0.11%)  
1/223 (0.45%)  
Pyelonephritis   *
      # participants affected / at risk
1/894 (0.11%)  
0/223 (0.00%)  
Septic Shock   *
      # participants affected / at risk
1/894 (0.11%)  
0/223 (0.00%)  
Urinary Tract Infection   *
      # participants affected / at risk
1/894 (0.11%)  
0/223 (0.00%)  
Injury, poisoning and procedural complications    
Ankle Fracture   *
      # participants affected / at risk
1/894 (0.11%)  
0/223 (0.00%)  
Femoral Neck Fracture   *
      # participants affected / at risk
1/894 (0.11%)  
0/223 (0.00%)  
Fibula Fracture   *
      # participants affected / at risk
1/894 (0.11%)  
0/223 (0.00%)  
Foot Fracture   *
      # participants affected / at risk
1/894 (0.11%)  
0/223 (0.00%)  
Hip Fracture   *
      # participants affected / at risk
1/894 (0.11%)  
0/223 (0.00%)  
Lower Limb Fracture   *
      # participants affected / at risk
1/894 (0.11%)  
0/223 (0.00%)  
Overdose   *
      # participants affected / at risk
1/894 (0.11%)  
0/223 (0.00%)  
Subdural Haematoma   *
      # participants affected / at risk
1/894 (0.11%)  
0/223 (0.00%)  
Thermal Burn   *
      # participants affected / at risk
1/894 (0.11%)  
0/223 (0.00%)  
Ligament Sprain   *
      # participants affected / at risk
0/894 (0.00%)  
1/223 (0.45%)  
Metabolism and nutrition disorders    
Dehydration   *
      # participants affected / at risk
2/894 (0.22%)  
0/223 (0.00%)  
Anorexia   *
      # participants affected / at risk
1/894 (0.11%)  
0/223 (0.00%)  
Hypoglycemia   *
      # participants affected / at risk
1/894 (0.11%)  
0/223 (0.00%)  
Hypokalemia   *
      # participants affected / at risk
0/894 (0.00%)  
1/223 (0.45%)  
Musculoskeletal and connective tissue disorders    
Osteoarthritis   *
      # participants affected / at risk
2/894 (0.22%)  
0/223 (0.00%)  
Arthralgia   *
      # participants affected / at risk
1/894 (0.11%)  
2/223 (0.90%)  
Arthritis   *
      # participants affected / at risk
1/894 (0.11%)  
0/223 (0.00%)  
Joint Swelling   *
      # participants affected / at risk
1/894 (0.11%)  
0/223 (0.00%)  
Pain in Extremity   *
      # participants affected / at risk
1/894 (0.11%)  
0/223 (0.00%)  
Lumbar Spinal Stenosis   *
      # participants affected / at risk
0/894 (0.00%)  
1/223 (0.45%)  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)    
Breast cancer   *
      # participants affected / at risk
1/894 (0.11%)  
0/223 (0.00%)  
Thymoma   *
      # participants affected / at risk
1/894 (0.11%)  
0/223 (0.00%)  
Thyoid Neoplasm   *
      # participants affected / at risk
1/894 (0.11%)  
0/223 (0.00%)  
Benign Gastrointestinal Neoplasm   *
      # participants affected / at risk
0/894 (0.00%)  
1/223 (0.45%)  
Nervous system disorders    
Syncope   *
      # participants affected / at risk
2/894 (0.22%)  
0/223 (0.00%)  
Dizziness   *
      # participants affected / at risk
1/894 (0.11%)  
0/223 (0.00%)  
Nerve Compression   *
      # participants affected / at risk
1/894 (0.11%)  
0/223 (0.00%)  
Somnolence   *
      # participants affected / at risk
1/894 (0.11%)  
0/223 (0.00%)  
Psychiatric disorders    
Bipolar Disorder   *
      # participants affected / at risk
1/894 (0.11%)  
0/223 (0.00%)  
Depression   *
      # participants affected / at risk
1/894 (0.11%)  
0/223 (0.00%)  
Euphoric Mood   *
      # participants affected / at risk
1/894 (0.11%)  
0/223 (0.00%)  
Substance Abuse   *
      # participants affected / at risk
1/894 (0.11%)  
0/223 (0.00%)  
Suicidal Ideation   *
      # participants affected / at risk
1/894 (0.11%)  
0/223 (0.00%)  
Reproductive system and breast disorders    
Breast Mass   *
      # participants affected / at risk
1/894 (0.11%)  
0/223 (0.00%)  
Menstrual Disorder   *
      # participants affected / at risk
0/894 (0.00%)  
1/223 (0.45%)  
Respiratory, thoracic and mediastinal disorders    
Chronic Obstructive Pulmonary Disease   *
      # participants affected / at risk
2/894 (0.22%)  
0/223 (0.00%)  
Acute Respiratory Distress Syndrome   *
      # participants affected / at risk
1/894 (0.11%)  
0/223 (0.00%)  
Asthma   *
      # participants affected / at risk
1/894 (0.11%)  
0/223 (0.00%)  
Dysphonia   *
      # participants affected / at risk
1/894 (0.11%)  
0/223 (0.00%)  
Skin and subcutaneous tissue disorders    
Erythema   *
      # participants affected / at risk
1/894 (0.11%)  
0/223 (0.00%)  
Vascular disorders    
Deep Vein Thrombosis   *
      # participants affected / at risk
1/894 (0.11%)  
0/223 (0.00%)  
* Indicates events were collected by non-systematic assessment.


  Other Adverse Events
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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 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


Responsible Party: Johnson & Johnson Pharmaceutical Research and Development, L.L.C. ( Senior Director, Clinical Leader )
Study ID Numbers: CR011074
Study First Received: August 4, 2006
Results First Received: July 24, 2009
Last Updated: September 14, 2009
ClinicalTrials.gov Identifier: NCT00361504     History of Changes
Health Authority: United States: Food and Drug Administration





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