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Study on the Safety and Effectiveness of Switching Between Two Forms of Tapentadol in Patients With Chronic Low Back Pain

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ClinicalTrials.gov Identifier: NCT00594516
Recruitment Status : Completed
First Posted : January 15, 2008
Results First Posted : July 26, 2010
Last Update Posted : April 15, 2015
Sponsor:
Collaborator:
Grünenthal GmbH
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Low Back Pain
Interventions Drug: tapentadol (CG5503) Immediate Release IR
Drug: tapentadol (CG5503) Extended Release (ER)
Drug: tapentadol (CG5503) Immediate Release (IR)
Enrollment 117

Recruitment Details The first site opened on 30 November 2007. The recruitment period for this outpatient, multicenter study occurred between 10 December 2007 and 01 May 2008.
Pre-assignment Details The study consisted of screening period (up to 21 days), washout period (from 3 to 7 days), open label (OL) treatment period (3 weeks), followed by a double blind (DB) active treatment period, with crossover design of 2 randomized sequences of tapentadol immediate release (IR) to tapentadol extended release (ER) and tapentadol ER to IR (4 weeks)
Arm/Group Title Tapentadol Tapentadol IR to ER Tapentadol ER to IR
Hide Arm/Group Description Subjects treated in the Tapentadol(CG5503) Immediate Release (IR) Open-Label period Tapentadol IR in first intervention period of double-blind phase and Tapentadol ER in second intervention period of double-blind phase Tapentadol ER in first intervention period of double-blind phase and Tapentadol IR in second intervention period of double-blind phase
Period Title: Open Label (OL): Tapentadol IR
Started 116 [1] 0 0
Completed 87 0 0
Not Completed 29 0 0
Reason Not Completed
Withdrawal by Subject             4             0             0
Lost to Follow-up             2             0             0
Adverse Event             16             0             0
Lack of Efficacy             1             0             0
Study Medication Non Compliant             6             0             0
[1]
one patient was enrolled but lost to follow up at the start of open label therefore was not included
Period Title: DB: Tapentadol IR to ER & ER to IR
Started 0 44 43
Completed 0 37 35
Not Completed 0 7 8
Reason Not Completed
Withdrawal by Subject             0             3             3
Study Medication Non compliant             0             3             2
Lack of Efficacy             0             1             1
Adverse Event             0             0             2
Arm/Group Title Tapentadol
Hide Arm/Group Description Subjects treated in the Tapentadol(CG5503) Immediate Release (IR) Open-Label period
Overall Number of Baseline Participants 116
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 116 participants
<=18 years
0
   0.0%
Between 18 and 65 years
86
  74.1%
>=65 years
30
  25.9%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 116 participants
53.6  (15.46)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 116 participants
Female
65
  56.0%
Male
51
  44.0%
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 116 participants
American Indian or Alaska Native 0
Asian 0
Native Hawaiian or Other Pacific Islander 0
Black or African American 14
White 90
Hispanic or Latino 12
Other 0
[1]
Measure Description: Race/ethnicity
1.Primary Outcome
Title The Difference in the Mean Average Pain Intensity Score on an 11-point Numerical Rating Scale (NRS) During the Last 3 Days of Each Double-blind Treatment Period. (Difference Between Two DB Randomization Treatment Sequences)
Hide Description For this twice daily pain assessment, the subjects were to indicate the level of average pain experienced over the previous 12 hours on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine".
Time Frame 14 days for each cross-over period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per-protocol set defined as the number of randomized subjects who took at least one dose of study drug during the DB treatment period, and who met additional criteria which were identified prior to unblinding.
Arm/Group Title Tapentadol
Hide Arm/Group Description:
Subjects treated in the Tapentadol Immediate Release (IR) Open-Label period (followed by randomization to double-blind crossover maintenance period in which all subjects receive both IR and ER formulations)
Overall Number of Participants Analyzed 60
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
0.1
(-0.09 to 0.28)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tapentadol
Comments Comparison of Tapentadol IR to ER analysis of variance model with factors for treatment, double blind cross-over period and subject.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority margin of (-2, 2). A prespecified equivalence margin of (-2,2) was used for equivalence analysis.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.1
Confidence Interval 95%
-0.09 to 0.28
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.09
Estimation Comments [Not Specified]
2.Secondary Outcome
Title The Number of Patients Requiring Rescue Medication During the DB Tapentadol IR Treatment
Hide Description [Not Specified]
Time Frame 14 days for each cross-over period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
DB safety set defined as randomized subjects who took at least one dose of study drug during the DB treatment period.
Arm/Group Title Tapentadol
Hide Arm/Group Description:
Subjects treated in the Tapentadol Immediate Release (IR) Open-Label period (followed by randomization to double-blind crossover maintenance period in which all subjects receive both IR and ER formulations)
Overall Number of Participants Analyzed 81
Measure Type: Number
Unit of Measure: participants
24
3.Secondary Outcome
Title The Number of Patients Requiring Rescue Medication During the DB Tapentadol ER Treatment
Hide Description [Not Specified]
Time Frame 14 days for each cross-over period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
DB safety set defined as randomized subjects who took at least one dose of study drug during the DB treatment period.
Arm/Group Title Tapentadol
Hide Arm/Group Description:
Subjects treated in the Tapentadol Immediate Release (IR) Open-Label period (followed by randomization to double-blind crossover maintenance period in which all subjects receive both IR and ER formulations)
Overall Number of Participants Analyzed 84
Measure Type: Number
Unit of Measure: participants
29
4.Secondary Outcome
Title Total Daily Dose (TDD) of Tapentadol IR During the Double-blind Treatment Period
Hide Description Average total daily dose (TDD) of tapentadol IR during the double blind treatment period
Time Frame 14-day for each DB treatment period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
DB safety set defined as randomized subjects who took at least one dose of study drug during the DB treatment period.
Arm/Group Title Tapentadol
Hide Arm/Group Description:
Subjects treated in the Tapentadol Immediate Release (IR) Open-Label period (followed by randomization to double-blind crossover maintenance period in which all subjects receive both IR and ER formulations)
Overall Number of Participants Analyzed 81
Mean (Standard Deviation)
Unit of Measure: mg
331.0  (116.17)
5.Secondary Outcome
Title Total Daily Dose (TDD) of Tapentadol ER During the DB Treatment Period.
Hide Description Average total daily dose (TDD) of tapentadol ER during the double-blind treatment period.
Time Frame 14 days for each treatment period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
DB safety set defined as randomized subjects who took at least one dose of study drug during the DB treatment period.
Arm/Group Title Tapentadol
Hide Arm/Group Description:
Subjects treated in the Tapentadol Immediate Release (IR) Open-Label period (followed by randomization to double-blind crossover maintenance period in which all subjects receive both IR and ER formulations)
Overall Number of Participants Analyzed 84
Mean (Standard Deviation)
Unit of Measure: mg
330.4  (123.73)
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 (up to 63 days post dose). 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
Hide Arm/Group Description Subjects treated in the Tapentadol Immediate Release (IR) open-label and the double-blind crossover period.
All-Cause Mortality
Tapentadol
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Tapentadol
Affected / at Risk (%) # Events
Total   2/116 (1.72%)    
Injury, poisoning and procedural complications   
Hip Fracture * 1  1/116 (0.86%)  1
Musculoskeletal and connective tissue disorders   
Back Pain * 1  1/116 (0.86%)  1
*
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%
Tapentadol
Affected / at Risk (%) # Events
Total   98/116 (84.48%)    
Gastrointestinal disorders   
Nausea * 1  16/116 (13.79%) 
Vomiting * 1  9/116 (7.76%) 
Constipation * 1  8/116 (6.90%) 
Dry Mouth * 1  6/116 (5.17%) 
General disorders   
Fatigue * 1  10/116 (8.62%) 
Pyrexia * 1  7/116 (6.03%) 
Infections and infestations   
Upper Respiratory Tract Infection * 1  9/116 (7.76%) 
Nervous system disorders   
Dizziness * 1  28/116 (24.14%) 
Headache * 1  19/116 (16.38%) 
Somnolence * 1  19/116 (16.38%) 
Psychiatric disorders   
Anxiety * 1  6/116 (5.17%) 
Skin and subcutaneous tissue disorders   
Pruritus * 1  9/116 (7.76%) 
*
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: Mila Etropolski, MD Clinical Leader
Organization: Johnson & Johnson Pharmaceutical Research & Development
Phone: 609-730-4537
Responsible Party: Director, Clinical Leader, Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00594516     History of Changes
Other Study ID Numbers: CR014242
R331333PAI3019
First Submitted: January 3, 2008
First Posted: January 15, 2008
Results First Submitted: April 28, 2009
Results First Posted: July 26, 2010
Last Update Posted: April 15, 2015