Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study to Evaluate the Effectiveness and Safety of Tapentadol (CG5503) in the Treatment of Acute Pain From Bunionectomy.

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: NCT00613938
Recruitment Status : Completed
First Posted : February 13, 2008
Results First Posted : April 23, 2010
Last Update Posted : May 9, 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
Conditions Arthralgia
Bunion
Hallux Valgus
Pain
Interventions Drug: Tapentadol (CG5503)
Drug: oxycodone
Drug: placebo
Enrollment 901
Recruitment Details The recruitment period for this inpatient, multicenter study occurred between January 28, 2008 and October 3, 2008.
Pre-assignment Details The study consisted of a screening period (duration up to 28 days), and a double blind active treatment period (4 days).
Arm/Group Title Placebo Tapentadol 50mg Fixed Dose Tapentadol 75mg Fixed Dose Oxycodone 10mg Fixed Dose
Hide Arm/Group Description Placebo capsule taken by mouth every 4 to 6 hours for 3 days. Tapentadol 50mg capsule taken by mouth every 4 to 6 hours for 3 days. Tapentadol 75mg capsule taken by mouth every 4 to 6 hours for 3 days. Oxycodone 10mg capsule taken by mouth every 4 to 6 hours for 3 days.
Period Title: Overall Study
Started 69 275 278 279 [1]
Completed 49 247 255 253
Not Completed 20 28 23 26
Reason Not Completed
Withdrawal by Subject             2             4             9             9
Adverse Event             1             4             8             5
Lack of Efficacy             16             18             5             9
Other             1             2             1             3
[1]
one patient did not have a valid baseline score therefore excluded from above
Arm/Group Title Placebo Tapentadol 50mg Fixed Dose Tapentadol 75mg Fixed Dose Oxycodone 10mg Fixed Dose Total
Hide Arm/Group Description Placebo capsule taken by mouth every 4 to 6 hours for 3 days. Tapentadol 50mg capsule taken by mouth every 4 to 6 hours for 3 days. Tapentadol 75mg capsule taken by mouth every 4 to 6 hours for 3 days. Oxycodone 10mg capsule taken by mouth every 4 to 6 hours for 3 days. Total of all reporting groups
Overall Number of Baseline Participants 69 275 278 279 901
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 69 participants 275 participants 278 participants 279 participants 901 participants
<=18 years 0 0 0 0 0
Between 18 and 65 years 68 265 268 265 866
>=65 years 1 10 10 13 34
[1]
Measure Description: One patient in the oxycodone 10mg group did not have a valid baseline score and was therefore excluded from the safety analysis set.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 69 participants 275 participants 278 participants 279 participants 901 participants
42.8  (13.65) 42.4  (13.23) 43.5  (12.57) 43.4  (13.25) 43.1  (13.05)
Gender   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 69 participants 275 participants 278 participants 279 participants 901 participants
Female 64 232 248 233 777
Male 5 43 30 45 123
[1]
Measure Description: One patient in the oxycodone 10mg group did not have a valid baseline score and was therefore excluded from the safety analysis set.
Region of Enrollment   [1] 
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 69 participants 275 participants 278 participants 279 participants 901 participants
69 275 278 278 900
[1]
Measure Description: One patient in the oxycodone 10mg group did not have a valid baseline score and was therefore excluded from the safety analysis set.
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. A positive difference between the mean SPID48 for an active study drug and placebo would indicate a numerically larger analgesic effect for subjects dosed with active study drug than in the placebo group. A higher value in SPID indicates greater pain relief.
Time Frame 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
The primary analysis set was the Intent to Treat (ITT) analysis set that included all subjects who were randomized, received at least one dose of study drug and had a non-missing baseline pain intensity score.
Arm/Group Title Placebo Tapentadol 50mg Fixed Dose Tapentadol 75mg Fixed Dose Oxycodone 10mg Fixed Dose
Hide Arm/Group Description:
Placebo capsule taken by mouth every 4 to 6 hours for 3 days.
Tapentadol 50mg capsule taken by mouth every 4 to 6 hours for 3 days.
Tapentadol 75mg capsule taken by mouth every 4 to 6 hours for 3 days.
Oxycodone 10mg capsule taken by mouth every 4 to 6 hours for 3 days.
Overall Number of Participants Analyzed 69 275 278 278
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
54.1  (105.74) 122.2  (98.66) 143.7  (96.52) 140.3  (99.52)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tapentadol 50mg Fixed Dose, Tapentadol 75mg Fixed Dose, Oxycodone 10mg Fixed Dose
Comments Null hypothesis: There are no differences in pain intensity measured by SPID-48 hours between any of tapentadol dose groups and placebo. ANCOVA model with factors of treatment, center and baseline pain intensity score was used for the primary analysis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Comparisons of tapentadol dose groups and placebo was performed with Hochberg procedure for adjustment for the multiple tests.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 62.4
Confidence Interval 95%
39.01 to 85.73
Parameter Dispersion
Type: Standard Error of the mean
Value: 11.9
Estimation Comments The results shown are the treatment group differences between Tapentadol IR 50mg group and placebo.
2.Secondary Outcome
Title Time to First Rescue Pain Medication Use.
Hide Description The effect of tapentadol (CG5503) IR on the time to the first use of rescue pain medication.
Time Frame 3 days
Hide Outcome Measure Data
Hide Analysis Population Description
The primary analysis set was the Intent to Treat (ITT) analysis set that included all subjects who were randomized, received at least one dose of study drug and had a non-missing baseline pain intensity score.
Arm/Group Title Placebo Tapentadol 50mg Fixed Dose Tapentadol 75mg Fixed Dose Oxycodone 10mg Fixed Dose
Hide Arm/Group Description:
Placebo capsule taken by mouth every 4 to 6 hours for 3 days.
Tapentadol 50mg capsule taken by mouth every 4 to 6 hours for 3 days.
Tapentadol 75mg capsule taken by mouth every 4 to 6 hours for 3 days.
Oxycodone 10mg capsule taken by mouth every 4 to 6 hours for 3 days.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title The SPID at 12 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. A positive difference between the mean SPID12 for an active study drug and placebo would indicate a numerically larger analgesic effect for subjects dosed with active study drug than in the placebo group. A higher value in SPID indicates greater pain relief.
Time Frame 12 hours
Hide Outcome Measure Data
Hide Analysis Population Description
The primary analysis set was the Intent to Treat (ITT) analysis set that included all subjects who were randomized, received at least one dose of study drug and had a non-missing baseline pain intensity score.
Arm/Group Title Placebo Tapentadol 50mg Fixed Dose Tapentadol 75mg Fixed Dose Oxycodone 10mg Fixed Dose
Hide Arm/Group Description:
Placebo capsule taken by mouth every 4 to 6 hours for 3 days.
Tapentadol 50mg capsule taken by mouth every 4 to 6 hours for 3 days.
Tapentadol 75mg capsule taken by mouth every 4 to 6 hours for 3 days.
Oxycodone 10mg capsule taken by mouth every 4 to 6 hours for 3 days.
Overall Number of Participants Analyzed 69 275 278 278
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
7.5  (20.7) 21.1  (21.89) 26.0  (23.11) 24.9  (22.8)
4.Secondary Outcome
Title SPID at 24 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. A positive difference between the mean SPID24 for an active study drug and placebo would indicate a numerically larger analgesic effect for subjects dosed with active study drug than in the placebo group. A higher value in SPID indicates greater pain relief.
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
The primary analysis set was the Intent to Treat (ITT) analysis set that included all subjects who were randomized, received at least one dose of study drug and had a non-missing baseline pain intensity score.
Arm/Group Title Placebo Tapentadol 50mg Fixed Dose Tapentadol 75mg Fixed Dose Oxycodone 10mg Fixed Dose
Hide Arm/Group Description:
Placebo capsule taken by mouth every 4 to 6 hours for 3 days.
Tapentadol 50mg capsule taken by mouth every 4 to 6 hours for 3 days.
Tapentadol 75mg capsule taken by mouth every 4 to 6 hours for 3 days.
Oxycodone 10mg capsule taken by mouth every 4 to 6 hours for 3 days.
Overall Number of Participants Analyzed 69 275 278 278
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
12.1  (43.64) 45.4  (45.73) 58.1  (45.89) 53.8  (46.69)
5.Secondary Outcome
Title Percentage of Patients Who Reported Very Much Improved or Much Improved From Baseline in Patient Global Impression of Change to Day 3
Hide Description Ordinal measure indicating change from the start of treatment (On a scale of 7 = Very much Worse to 1 = very much improved) to endpoint at Day 3
Time Frame Baseline and 3 days
Hide Outcome Measure Data
Hide Analysis Population Description
The primary analysis set was the Intent to Treat (ITT) analysis set that included all subjects who were randomized, received at least one dose of study drug and had a non-missing baseline pain intensity score.
Arm/Group Title Placebo Tapentadol 50mg Fixed Dose Tapentadol 75mg Fixed Dose Oxycodone 10mg Fixed Dose
Hide Arm/Group Description:
Placebo capsule taken by mouth every 4 to 6 hours for 3 days.
Tapentadol 50mg capsule taken by mouth every 4 to 6 hours for 3 days.
Tapentadol 75mg capsule taken by mouth every 4 to 6 hours for 3 days.
Oxycodone 10mg capsule taken by mouth every 4 to 6 hours for 3 days.
Overall Number of Participants Analyzed 69 275 278 278
Measure Type: Number
Unit of Measure: percentage of participants
65.2 83.2 87.8 86.0
6.Secondary Outcome
Title Total Pain Relief (TOTPAR)at 48 Hours
Hide Description Total Pain Relief (TOTPAR48) was defined as the weighted sum over all pain relief scores(PAR) from 0.5 hour to Hour 48, with the actual time elapsed from the previous PAR observation as the weight. A higher value in TOTPAR indicates greater pain relief.
Time Frame 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Placebo Tapentadol 50mg Fixed Dose Tapentadol 75mg Fixed Dose Oxycodone 10mg Fixed Dose
Hide Arm/Group Description:
Placebo capsule taken by mouth every 4 to 6 hours for 3 days.
Tapentadol 50mg capsule taken by mouth every 4 to 6 hours for 3 days.
Tapentadol 75mg capsule taken by mouth every 4 to 6 hours for 3 days.
Oxycodone 10mg capsule taken by mouth every 4 to 6 hours for 3 days.
Overall Number of Participants Analyzed 69 275 278 278
Mean (Standard Deviation)
Unit of Measure: scores on a scale
68.2  (39.48) 96.6  (37.39) 107.5  (35.74) 105.2  (37.4)
Time Frame All adverse events (AEs) were recorded from the time that the informed consent (ICF) was obtained until the last study procedure had been completed. For subjects who discontinued early, AEs were collected for 48 hours after the last intake of study drug.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Tapentadol 50mg Fixed Dose Tapentadol 75mg Fixed Dose Oxycodone 10mg Fixed Dose
Hide Arm/Group Description Placebo capsule taken by mouth every 4 to 6 hours for 3 days. Tapentadol 50mg capsule taken by mouth every 4 to 6 hours for 3 days. Tapentadol 75mg capsule taken by mouth every 4 to 6 hours for 3 days. Oxycodone 10mg capsule taken by mouth every 4 to 6 hours for 3 days.
All-Cause Mortality
Placebo Tapentadol 50mg Fixed Dose Tapentadol 75mg Fixed Dose Oxycodone 10mg Fixed Dose
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Tapentadol 50mg Fixed Dose Tapentadol 75mg Fixed Dose Oxycodone 10mg Fixed Dose
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/69 (0.00%)   0/275 (0.00%)   0/278 (0.00%)   1/279 (0.36%) 
Vascular disorders         
Deep vein thrombosis * 1  0/69 (0.00%)  0/275 (0.00%)  0/278 (0.00%)  1/279 (0.36%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (11.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Tapentadol 50mg Fixed Dose Tapentadol 75mg Fixed Dose Oxycodone 10mg Fixed Dose
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   25/69 (36.23%)   161/275 (58.55%)   192/278 (69.06%)   218/279 (78.14%) 
Gastrointestinal disorders         
Constipation * 1  1/69 (1.45%)  22/275 (8.00%)  15/278 (5.40%)  31/279 (11.11%) 
Nausea * 1  12/69 (17.39%)  93/275 (33.82%)  127/278 (45.68%)  160/279 (57.35%) 
Vomiting * 1  0/69 (0.00%)  34/275 (12.36%)  77/278 (27.70%)  72/279 (25.81%) 
Investigations         
Alanine aminotransferase increased * 1  1/69 (1.45%)  8/275 (2.91%)  7/278 (2.52%)  14/279 (5.02%) 
Nervous system disorders         
Dizziness * 1  7/69 (10.14%)  41/275 (14.91%)  69/278 (24.82%)  65/279 (23.30%) 
Headache * 1  11/69 (15.94%)  56/275 (20.36%)  52/278 (18.71%)  73/279 (26.16%) 
Somnolence * 1  2/69 (2.90%)  20/275 (7.27%)  37/278 (13.31%)  33/279 (11.83%) 
Skin and subcutaneous tissue disorders         
Pruritus * 1  2/69 (2.90%)  14/275 (5.09%)  23/278 (8.27%)  28/279 (10.04%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (11.0)
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.
Results Point of Contact
Name/Title: Senior Director, Clinical Leader
Organization: Johnson & Johnson Pharmaceutical Research & Development
Phone: 609-730-4537
Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00613938     History of Changes
Other Study ID Numbers: CR014116
KF5503/38
First Submitted: January 31, 2008
First Posted: February 13, 2008
Results First Submitted: October 2, 2009
Results First Posted: April 23, 2010
Last Update Posted: May 9, 2014