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A Study to Evaluate the Effectiveness and Safety of Tapentadol(CG5503) in the Treatment of Acute Pain After Hip Replacement Surgery Compared With Oxycodone and Placebo Followed by a Voluntary Open-Label Extension For Safety

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: NCT00364533
Recruitment Status : Terminated (Slow enrollment)
First Posted : August 15, 2006
Results First Posted : July 8, 2009
Last Update Posted : April 21, 2014
Sponsor:
Collaborator:
Grünenthal GmbH
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Arthroplasty
Interventions Drug: Tapentadol IR (CG5503)
Drug: Placebo
Drug: Oxycodone HCL IR
Enrollment 367
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tapentadol IR Fixed Dose 50 mg Tapentadol IR Fixed Dose 75 mg Tapentadol IR Fixed Dose 100 mg Oxycodone HCL IR Fixed Dose 10 mg Placebo Fixed Dose
Hide Arm/Group Description Tapentadol taken by mouth every 4-6 hours for 3 days Tapentadol taken by mouth every 4-6 hours for 3 days Tapentadol taken by mouth every 4-6 hours for 3 days oxycodone 10mg taken by mouth every 4-6 hours for 3 days Matching placebo taken by mouth every 4-6 hours for 3 days
Period Title: Overall Study
Started 77 71 75 67 75
Completed 35 31 30 36 24
Not Completed 42 40 45 31 51
Reason Not Completed
Adverse Event             8             7             15             5             2
Withdrawal by Subject             4             8             6             6             6
Lack of Efficacy             22             22             21             17             42
Subject discharged from hospital             4             1             2             3             1
Variations in drug compliance             2             1             1             0             0
Non-compliance             1             0             0             0             0
Protocol Violation             1             1             0             0             0
Arm/Group Title Tapentadol IR Fixed Dose 50 mg Tapentadol IR Fixed Dose 75 mg Tapentadol IR Fixed Dose 100 mg Oxycodone HCL IR Fixed Dose 10 mg Placebo Fixed Dose Total
Hide Arm/Group Description Tapentadol taken by mouth every 4-6 hours for 3 days Tapentadol taken by mouth every 4-6 hours for 3 days Tapentadol taken by mouth every 4-6 hours for 3 days oxycodone 10mg taken by mouth every 4-6 hours for 3 days Matching placebo taken by mouth every 4-6 hours for 3 days Total of all reporting groups
Overall Number of Baseline Participants 77 71 75 67 75 365
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 77 participants 71 participants 75 participants 67 participants 75 participants 365 participants
62.2  (12.20) 62.8  (9.24) 63.3  (10.3) 61.3  (12.39) 64.0  (11.23) 62.7  (11.11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 77 participants 71 participants 75 participants 67 participants 75 participants 365 participants
Female
39
  50.6%
32
  45.1%
41
  54.7%
41
  61.2%
44
  58.7%
197
  54.0%
Male
38
  49.4%
39
  54.9%
34
  45.3%
26
  38.8%
31
  41.3%
168
  46.0%
1.Primary Outcome
Title Sum of Pain Intensity Difference Over 48 Hours (SPID48)
Hide Description The SPID score incorporates the cumulative analgesic effects of tapentadol IR on pain intensity over an extended period (48 hours) allowing for an evaluation of multiple doses of drug, even when dosing frequency may vary. Scoring is derived from the Numerical Rating Scale (NRS) from 0 = No pain to 11 = Pain as bad as you can imagine.
Time Frame 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Because the Sponsor terminated the study, the planned sample size was not reached in any treatment group, therefore, only a brief summary of an exploratory analysis of the primary efficacy variable (SPID48) is presented.
Arm/Group Title Tapentadol IR Fixed Dose 50 mg Tapentadol IR Fixed Dose 75 mg Tapentadol IR Fixed Dose 100 mg Oxycodone HCL IR Fixed Dose 10 mg Placebo Fixed Dose
Hide Arm/Group Description:
Tapentadol taken by mouth every 4-6 hours for 3 days
Tapentadol taken by mouth every 4-6 hours for 3 days
Tapentadol taken by mouth every 4-6 hours for 3 days
oxycodone 10mg taken by mouth every 4-6 hours for 3 days
Matching placebo taken by mouth every 4-6 hours for 3 days
Overall Number of Participants Analyzed 35 31 30 36 24
Mean (Standard Deviation)
Unit of Measure: score on a scale
73.9  (123.89) 54.4  (128.22) 49.3  (136.92) 57.6  (125.73) -18.6  (130.74)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tapentadol IR Fixed Dose 50 mg, Placebo Fixed Dose
Comments The study was terminated and did not reach the planned sample size.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference of SPID48
Estimated Value 91.4
Confidence Interval 95%
49.77 to 133.07
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tapentadol IR Fixed Dose 75 mg, Placebo Fixed Dose
Comments The study was terminated and did not reach the planned sample size.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference of SPID48
Estimated Value 81.5
Confidence Interval 95%
38.66 to 124.29
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tapentadol IR Fixed Dose 100 mg, Placebo Fixed Dose
Comments The study was terminated and did not reach the planned sample size.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference of SPID48
Estimated Value 81.5
Confidence Interval 95%
39.21 to 123.80
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Oxycodone HCL IR Fixed Dose 10 mg, Placebo Fixed Dose
Comments The study was terminated and did not reach the planned sample size.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference of SPID48
Estimated Value 82.4
Confidence Interval 95%
38.96 to 125.88
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Time to First Rescue Pain Medication.
Hide Description [Not Specified]
Time Frame 3 days
Hide Outcome Measure Data
Hide Analysis Population Description
Due to termination of trial, results were not analyzed.
Arm/Group Title Tapentadol IR Fixed Dose 50 mg Tapentadol IR Fixed Dose 75 mg Tapentadol IR Fixed Dose 100 mg Oxycodone HCL IR Fixed Dose 10 mg Placebo Fixed Dose
Hide Arm/Group Description:
Tapentadol taken by mouth every 4-6 hours for 3 days
Tapentadol taken by mouth every 4-6 hours for 3 days
Tapentadol taken by mouth every 4-6 hours for 3 days
oxycodone 10mg taken by mouth every 4-6 hours for 3 days
Matching placebo taken by mouth every 4-6 hours for 3 days
Overall Number of Participants Analyzed 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title The SPID at 12, 24, and 72 Hours Relative to First Dose.
Hide Description The SPID score incorporates the cumulative analgesic effects of tapentadol IR on pain intensity over an extended period (12 to 72 hours) allowing for an evaluation of multiple doses of drug, even when dosing frequency may vary. Scoring is derived from the Numerical Rating Scale (NRS) from 0 = No pain to 11 = Pain as bad as you can imagine.
Time Frame 3 days
Hide Outcome Measure Data
Hide Analysis Population Description
Due to termination of trial, results were not analyzed.
Arm/Group Title Tapentadol IR Fixed Dose 50 mg Tapentadol IR Fixed Dose 75 mg Tapentadol IR Fixed Dose 100 mg Oxycodone HCL IR Fixed Dose 10 mg Placebo Fixed Dose
Hide Arm/Group Description:
Tapentadol taken by mouth every 4-6 hours for 3 days
Tapentadol taken by mouth every 4-6 hours for 3 days
Tapentadol taken by mouth every 4-6 hours for 3 days
oxycodone 10mg taken by mouth every 4-6 hours for 3 days
Matching placebo taken by mouth every 4-6 hours for 3 days
Overall Number of Participants Analyzed 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tapentadol IR Fixed Dose 50 mg Tapentadol IR Fixed Dose 75 mg Tapentadol IR Fixed Dose 100 mg Oxycodone HCL IR Fixed Dose 10 mg Placebo Fixed Dose
Hide Arm/Group Description Tapentadol taken by mouth every 4-6 hours for 3 days Tapentadol taken by mouth every 4-6 hours for 3 days Tapentadol taken by mouth every 4-6 hours for 3 days oxycodone 10mg taken by mouth every 4-6 hours for 3 days Matching placebo taken by mouth every 4-6 hours for 3 days
All-Cause Mortality
Tapentadol IR Fixed Dose 50 mg Tapentadol IR Fixed Dose 75 mg Tapentadol IR Fixed Dose 100 mg Oxycodone HCL IR Fixed Dose 10 mg Placebo Fixed Dose
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Tapentadol IR Fixed Dose 50 mg Tapentadol IR Fixed Dose 75 mg Tapentadol IR Fixed Dose 100 mg Oxycodone HCL IR Fixed Dose 10 mg Placebo Fixed Dose
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/77 (1.30%)   1/71 (1.41%)   3/75 (4.00%)   1/67 (1.49%)   0/75 (0.00%) 
Cardiac disorders           
Atrial Fibrillation * 1  0/77 (0.00%)  0/71 (0.00%)  1/75 (1.33%)  0/67 (0.00%)  0/75 (0.00%) 
Supraventricular Tachycardia * 1  1/77 (1.30%)  0/71 (0.00%)  0/75 (0.00%)  0/67 (0.00%)  0/75 (0.00%) 
Gastrointestinal disorders           
Ileus * 1  0/77 (0.00%)  1/71 (1.41%)  0/75 (0.00%)  0/67 (0.00%)  0/75 (0.00%) 
Nervous system disorders           
Lethargy * 1  0/77 (0.00%)  0/71 (0.00%)  1/75 (1.33%)  0/67 (0.00%)  0/75 (0.00%) 
Psychiatric disorders           
Confusional State * 1  0/77 (0.00%)  0/71 (0.00%)  0/75 (0.00%)  1/67 (1.49%)  0/75 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Chronic Obstructive Pulmonary Disease * 1  0/77 (0.00%)  0/71 (0.00%)  1/75 (1.33%)  0/67 (0.00%)  0/75 (0.00%) 
Pulmonary Embolism * 1  1/77 (1.30%)  0/71 (0.00%)  0/75 (0.00%)  0/67 (0.00%)  0/75 (0.00%) 
Vascular disorders           
Deep Vein Thrombosis * 1  1/77 (1.30%)  0/71 (0.00%)  0/75 (0.00%)  0/67 (0.00%)  0/75 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 10.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Tapentadol IR Fixed Dose 50 mg Tapentadol IR Fixed Dose 75 mg Tapentadol IR Fixed Dose 100 mg Oxycodone HCL IR Fixed Dose 10 mg Placebo Fixed Dose
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   52/77 (67.53%)   38/71 (53.52%)   53/75 (70.67%)   43/67 (64.18%)   44/75 (58.67%) 
Blood and lymphatic system disorders           
Anaemia * 1  6/77 (7.79%)  3/71 (4.23%)  8/75 (10.67%)  11/67 (16.42%)  7/75 (9.33%) 
Gastrointestinal disorders           
Constipation * 1  11/77 (14.29%)  6/71 (8.45%)  10/75 (13.33%)  12/67 (17.91%)  7/75 (9.33%) 
Dry Mouth * 1  1/77 (1.30%)  7/71 (9.86%)  3/75 (4.00%)  3/67 (4.48%)  0/75 (0.00%) 
Nausea * 1  19/77 (24.68%)  5/71 (7.04%)  12/75 (16.00%)  12/67 (17.91%)  11/75 (14.67%) 
Vomiting * 1  5/77 (6.49%)  6/71 (8.45%)  4/75 (5.33%)  10/67 (14.93%)  12/75 (16.00%) 
General disorders           
Pyrexia * 1  15/77 (19.48%)  8/71 (11.27%)  13/75 (17.33%)  14/67 (20.90%)  7/75 (9.33%) 
Investigations           
Body Temperature Increased * 1  8/77 (10.39%)  7/71 (9.86%)  4/75 (5.33%)  5/67 (7.46%)  7/75 (9.33%) 
Musculoskeletal and connective tissue disorders           
Muscle Spasms * 1  2/77 (2.60%)  4/71 (5.63%)  0/75 (0.00%)  1/67 (1.49%)  1/75 (1.33%) 
Nervous system disorders           
Dizziness * 1  7/77 (9.09%)  8/71 (11.27%)  16/75 (21.33%)  14/67 (20.90%)  4/75 (5.33%) 
Headache * 1  5/77 (6.49%)  5/71 (7.04%)  2/75 (2.67%)  9/67 (13.43%)  13/75 (17.33%) 
Somnolence * 1  11/77 (14.29%)  10/71 (14.08%)  17/75 (22.67%)  6/67 (8.96%)  1/75 (1.33%) 
Psychiatric disorders           
Confusional State * 1  6/77 (7.79%)  4/71 (5.63%)  11/75 (14.67%)  1/67 (1.49%)  0/75 (0.00%) 
Hallucination, Visual * 1  2/77 (2.60%)  5/71 (7.04%)  8/75 (10.67%)  2/67 (2.99%)  2/75 (2.67%) 
Insomnia * 1  1/77 (1.30%)  3/71 (4.23%)  1/75 (1.33%)  3/67 (4.48%)  4/75 (5.33%) 
Skin and subcutaneous tissue disorders           
Pruritus * 1  3/77 (3.90%)  2/71 (2.82%)  4/75 (5.33%)  4/67 (5.97%)  0/75 (0.00%) 
Vascular disorders           
Hypotension * 1  4/77 (5.19%)  1/71 (1.41%)  5/75 (6.67%)  1/67 (1.49%)  2/75 (2.67%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 10.1
Sponsor terminated study, sample size not reached. The protocol section describes 4 study arms defining the treatment groups in the study design. The participant flow module describes the 5 treatment groups analyzed for the primary endpoint
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.
A provision provides for 60 day prior review by sponsor extendable by 60 days to file a patent application and prior written consent of sponsor for disclosure of confidential information, if any.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Director, Clinical Leader
Organization: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Phone: 609-730-6780
Layout table for additonal information
Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00364533     History of Changes
Other Study ID Numbers: CR011221
R331333PAI3001 ( Other Identifier: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. )
KF5503/31 ( Other Identifier: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. )
First Submitted: August 11, 2006
First Posted: August 15, 2006
Results First Submitted: December 19, 2008
Results First Posted: July 8, 2009
Last Update Posted: April 21, 2014