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An Efficacy and Safety Study of Extended Release (ER) Tramadol Hydrochloride (HCl)/Acetaminophen in Participants With Chronic Low-Back Pain

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ClinicalTrials.gov Identifier: NCT01112267
Recruitment Status : Completed
First Posted : April 28, 2010
Results First Posted : July 24, 2013
Last Update Posted : July 24, 2013
Sponsor:
Information provided by (Responsible Party):
Janssen Korea, Ltd., Korea

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Low Back Pain
Interventions Drug: Tramadol HCl/acetaminophen Extended Release
Drug: Placebo
Enrollment 248
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tramadol HCl/Acetaminophen Placebo
Hide Arm/Group Description Participants received 1 tablet containing fixed dose of combination of tramadol hydrochloride (HCl) 75 milligram (mg) /acetaminophen Extended Release (ER) 650 mg orally once daily on Days 1 to 3, 1 tablet twice daily (tramadol HCl 150 mg/acetaminophen 1300 mg) on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28. Participants received 1 tablet of matching placebo once daily orally on Days 1 to 3, 1 tablet twice daily on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
Period Title: Overall Study
Started 126 122
Treated 125 120
Completed 92 104
Not Completed 34 18
Reason Not Completed
Adverse Event             24             6
Withdrawal by Subject             3             5
Protocol Violation             5             3
Participants not compliant             1             2
Participants not receive any study drug             1             2
Arm/Group Title Tramadol HCl/Acetaminophen Placebo Total
Hide Arm/Group Description Participants received 1 tablet containing fixed dose of combination of tramadol hydrochloride (HCl) 75 milligram (mg) /acetaminophen Extended Release (ER) 650 mg orally once daily on Days 1 to 3, 1 tablet twice daily (tramadol HCl 150 mg/acetaminophen 1300 mg) on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28. Participants received 1 tablet of matching placebo once daily orally on Days 1 to 3, 1 tablet twice daily on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28. Total of all reporting groups
Overall Number of Baseline Participants 125 120 245
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 125 participants 120 participants 245 participants
59.93  (10.72) 60.39  (9.87) 60.16  (10.29)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 125 participants 120 participants 245 participants
Female
94
  75.2%
89
  74.2%
183
  74.7%
Male
31
  24.8%
31
  25.8%
62
  25.3%
1.Primary Outcome
Title Percentage of Participants With Reduction in Pain Intensity
Hide Description The percentage of participants with extent of reduction in pain intensity greater than or equal to 30 percent was reported. Pain intensity change rate was calculated by Visual Analog Scale (VAS) score at baseline minus VAS score at Day 29 divided by VAS score at Baseline. VAS is a 10 centimeter (cm) scale. Intensity of pain range: 0 cm=no pain to 10 cm=worst possible pain.
Time Frame Baseline up to Day 29
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) population included all participants who had received investigational product and had at least 1 data of measurement of primary efficacy endpoint.
Arm/Group Title Tramadol HCl/Acetaminophen Placebo
Hide Arm/Group Description:
Participants received 1 tablet containing fixed dose of combination of tramadol hydrochloride (HCl) 75 milligram (mg) /acetaminophen Extended Release (ER) 650 mg orally once daily on Days 1 to 3, 1 tablet twice daily (tramadol HCl 150 mg/acetaminophen 1300 mg) on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
Participants received 1 tablet of matching placebo once daily orally on Days 1 to 3, 1 tablet twice daily on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
Overall Number of Participants Analyzed 85 90
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
57.65
(47.14 to 68.15)
41.11
(30.95 to 51.28)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tramadol HCl/Acetaminophen, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0367
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments p-value for percentage of participants with reduction in pain intensity was calculated for tramadol HCl/acetaminophen and placebo groups
2.Primary Outcome
Title Change From Baseline in Pain Intensity at Day 29
Hide Description Change in pain intensity experienced by participants over the last 48 hours was measured on Day 29 against Baseline with VAS. VAS is a 10 cm scale. Intensity of pain range: 0 cm=no pain to 10 cm=worst possible pain.
Time Frame Baseline and Day 29
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The FAS population included all the participants who had received investigational product and had at least 1 data of measurement of primary efficacy endpoint.
Arm/Group Title Tramadol HCl/Acetaminophen Placebo
Hide Arm/Group Description:
Participants received 1 tablet containing fixed dose of combination of tramadol hydrochloride (HCl) 75 milligram (mg) /acetaminophen Extended Release (ER) 650 mg orally once daily on Days 1 to 3, 1 tablet twice daily (tramadol HCl 150 mg/acetaminophen 1300 mg) on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
Participants received 1 tablet of matching placebo once daily orally on Days 1 to 3, 1 tablet twice daily on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
Overall Number of Participants Analyzed 85 90
Mean (Standard Deviation)
Unit of Measure: Unit on a scale
Baseline 6.334  (1.383) 6.000  (1.331)
Change at Day 29 2.299  (1.764) 1.549  (1.578)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tramadol HCl/Acetaminophen, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0095
Comments p-value for change in reduction in pain intensity at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups
Method Mann-Whitney U test
Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants With Pain Relief
Hide Description Pain relief was measured in 6 stages to assess the participant's pain relief. Extent of pain relief was measured on a scale ranging from 4 to -1, where 4=complete disappearance, 3=fair relief, 2=moderate relief, 1=slight relief, 0=no change and -1=pain worsening. Relief more than 'slight relief (1)' was considered as pain relief success.
Time Frame Day 8, Day 15 and Day 29
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
the FAS population included all the participants who had received investigational product and had at least 1 data of measurement of primary efficacy endpoint.
Arm/Group Title Tramadol HCl/Acetaminophen Placebo
Hide Arm/Group Description:
Participants received 1 tablet containing fixed dose of combination of tramadol hydrochloride (HCl) 75 milligram (mg) /acetaminophen Extended Release (ER) 650 mg orally once daily on Days 1 to 3, 1 tablet twice daily (tramadol HCl 150 mg/acetaminophen 1300 mg) on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
Participants received 1 tablet of matching placebo once daily orally on Days 1 to 3, 1 tablet twice daily on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
Overall Number of Participants Analyzed 85 90
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Day 8: Slight relief (n=82,88)
70.73
(60.88 to 80.58)
53.41
(42.99 to 63.83)
Day 15: Slight relief (n=85,89)
82.35
(74.25 to 90.46)
65.17
(55.27 to 75.07)
Day 29, Slight relief (85,89)
81.18
(72.87 to 89.49)
77.53
(68.86 to 86.20)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tramadol HCl/Acetaminophen, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0202
Comments p-value for percentage of participants with pain relief at Day 8 was calculated for tramadol HCl/acetaminophen and placebo groups
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tramadol HCl/Acetaminophen, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0102
Comments p-value for percentage of participants with pain relief at Day 15 was calculated for tramadol HCl/acetaminophen and placebo groups
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tramadol HCl/Acetaminophen, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4652
Comments p-value for percentage of participants with pain relief at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups
Method Chi-squared
Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in Short Form (SF)-36 Score at Day 29
Hide Description The quality of life of participants was evaluated by SF-36 Korean version questionnaire. It is composed of 8 domains: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. Participants answered to the questionnaire of 36 questions; and physical, social, and psychological health status were assessed. It ranges 0 to 100, and higher score indicates better quality of life, But in "Reported (Rptd.) Health Transition" domain higher score indicates worse quality of life.
Time Frame Baseline and Day 29
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The FAS population included all the participants who had received investigational product and had at least 1 data of measurement of primary efficacy endpoint.
Arm/Group Title Tramadol HCl/Acetaminophen Placebo
Hide Arm/Group Description:
Participants received 1 tablet containing fixed dose of combination of tramadol hydrochloride (HCl) 75 milligram (mg) /acetaminophen Extended Release (ER) 650 mg orally once daily on Days 1 to 3, 1 tablet twice daily (tramadol HCl 150 mg/acetaminophen 1300 mg) on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
Participants received 1 tablet of matching placebo once daily orally on Days 1 to 3, 1 tablet twice daily on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
Overall Number of Participants Analyzed 85 90
Mean (Standard Deviation)
Unit of Measure: Unit on a scale
Baseline: Physical functioning 46.71  (20.71) 47.94  (20.80)
Change at Day 29: Physical functioning (n=83,87) 9.82  (18.35) 6.67  (15.99)
Baseline: Role physical 44.93  (24.18) 49.51  (26.17)
Change at Day 29: Role Physical (n=83,87) 16.04  (23.89) 8.69  (22.62)
Baseline: Bodily pain 34.66  (14.46) 35.99  (13.89)
Change at Day 29: Bodily pain (n=83,87) 19.39  (18.99) 17.69  (14.84)
Baseline: General health 43.56  (17.92) 48.11  (17.05)
Change at Day 29: General health (n=83,87) 7.36  (14.41) 2.77  (12.58)
Baseline: Vitality 38.82  (19.93) 42.71  (17.83)
Change at Day 29: Vitality (n=83,87) 11.14  (20.55) 5.82  (18.94)
Baseline: Social functioning 64.26  (22.59) 64.58  (26.98)
Change at Day 29: Social functioning (n=83,87) 11.75  (25.70) 6.61  (20.60)
Baseline: Role emotional 61.76  (27.41) 61.57  (29.34)
Change at Day 29: Role emotional (n=83,87) 8.13  (28.93) 7.47  (28.25)
Baseline: Mental Health 61.06  (19.03) 60.56  (19.34)
Change at Day 29: Mental Health (n=83,87) 20.48  (23.20) 18.39  (24.61)
Baseline: Rptd. health transition 65.00  (24.76) 63.61  (20.92)
Change at Day 29: Rptd. health transition(n=83,87) -18.07  (25.99) -6.90  (30.19)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tramadol HCl/Acetaminophen, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3524
Comments p-value for change from Baseline in physical conditioning at Day 29 was calculated using for tramadol HCl/acetaminophen and placebo groups
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tramadol HCl/Acetaminophen, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0224
Comments p-value for change from Baseline in role physical at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tramadol HCl/Acetaminophen, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5712
Comments p-value for change from Baseline in bodily pain at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tramadol HCl/Acetaminophen, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0395
Comments p-value for change from Baseline in general health at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Tramadol HCl/Acetaminophen, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0524
Comments p-value for change from Baseline in vitality at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Tramadol HCl/Acetaminophen, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.115
Comments p-value for change from Baseline in social functioning at Day 29 was calculated using for tramadol HCl/acetaminophen and placebo groups.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Tramadol HCl/Acetaminophen, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7788
Comments p-value for change from Baseline in role emotional at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Tramadol HCl/Acetaminophen, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7776
Comments p-value for change from Baseline in mental health at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Tramadol HCl/Acetaminophen, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0047
Comments p-value for change from Baseline in Reptd. health transition at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in Oswestry Disability Index (ODI) Korean Version Score at Day 29
Hide Description The ODI Korean version was used to assess the participant's functionality. The ODI is a low back pain-specific, validated instrument that consists of questions related to limitations in performing specific activities of daily living and 1 question related to pain intensity. The ODI is a self-administered questionnaire consists of 10 sections. Each section consists of 6 statements ranked from 0 to 5 (0=good to 5=worse). Total score is the sum of score obtained in each section and ranges from 0 to 50. A higher score represents greater disability.
Time Frame Baseline and Day 29
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS population included all participants who had received investigational product and had at least 1 data of measurement of primary efficacy endpoint.
Arm/Group Title Tramadol HCl/Acetaminophen Placebo
Hide Arm/Group Description:
Participants received 1 tablet containing fixed dose of combination of tramadol hydrochloride (HCl) 75 milligram (mg) /acetaminophen Extended Release (ER) 650 mg orally once daily on Days 1 to 3, 1 tablet twice daily (tramadol HCl 150 mg/acetaminophen 1300 mg) on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
Participants received 1 tablet of matching placebo once daily orally on Days 1 to 3, 1 tablet twice daily on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
Overall Number of Participants Analyzed 85 90
Mean (Standard Deviation)
Unit of Measure: Unit on a scale
Baseline 39.626  (12.239) 38.126  (13.518)
Change at Day 29 (n=87,83) 11.216  (11.856) 7.178  (13.879)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tramadol HCl/Acetaminophen, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0527
Comments p-value for change from Baseline in ODI- Korean version at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Participants With Investigator's Global Assessment on Investigational Product
Hide Description Global assessment on investigational product was done by investigator on how well the investigational product controlled chronic (lasting a long time) low back pain. Assessment was done by categories 'Very bad (-2)' 'Bad (-1)' 'Not changed (0) 'Good (1)' and 'Very good (2)'. Assessment better than "Good" was considered as pain improvement success. Percentage of participants with pain improvement success is reported here.
Time Frame Day 29
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The FAS population included all the participants who had received investigational product and had at least 1 data of measurement of primary efficacy endpoint. Here ‘N’ signifies those participants who were evaluated for this outcome measure.
Arm/Group Title Tramadol HCl/Acetaminophen Placebo
Hide Arm/Group Description:
Participants received 1 tablet containing fixed dose of combination of tramadol hydrochloride (HCl) 75 milligram (mg) /acetaminophen Extended Release (ER) 650 mg orally once daily on Days 1 to 3, 1 tablet twice daily (tramadol HCl 150 mg/acetaminophen 1300 mg) on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
Participants received 1 tablet of matching placebo once daily orally on Days 1 to 3, 1 tablet twice daily on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
Overall Number of Participants Analyzed 80 83
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
81.25
(72.70 to 89.80)
69.88
(60.01 to 79.75)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tramadol HCl/Acetaminophen, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0917
Comments p-value for investigator's global assessment on investigational product at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups.
Method Chi-squared
Comments [Not Specified]
7.Secondary Outcome
Title Percentage of Participants With Participants' Global Assessment on Investigational Product
Hide Description Global assessment on investigational product was done by participants on how well the investigational product controlled chronic (lasting a long time) low back pain. Assessment was done by categories 'Very bad (-2)' 'Bad (-1)' 'Not changed (0) 'Good (1)' and 'Very good (2)'. Assessment better than "Good" was considered as pain improvement success. Percentage of participants with pain improvement success is reported here.
Time Frame Day 29
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The FAS population included all the participants who had received investigational product and had at least 1 data of measurement of primary efficacy endpoint. Here ‘N’ signifies those participants who were evaluated for this outcome measure.
Arm/Group Title Tramadol HCl/Acetaminophen Placebo
Hide Arm/Group Description:
Participants received 1 tablet containing fixed dose of combination of tramadol hydrochloride (HCl) 75 milligram (mg) /acetaminophen Extended Release (ER) 650 mg orally once daily on Days 1 to 3, 1 tablet twice daily (tramadol HCl 150 mg/acetaminophen 1300 mg) on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
Participants received 1 tablet of matching placebo once daily orally on Days 1 to 3, 1 tablet twice daily on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
Overall Number of Participants Analyzed 80 83
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
76.25
(66.92 to 85.58)
72.29
(62.66 to 81.92)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tramadol HCl/Acetaminophen, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5632
Comments p-value for participant's global assessment on investigational product at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups.
Method Chi-squared
Comments [Not Specified]
Time Frame Baseline up to Day 29
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tramadol HCl/Acetaminophen Placebo
Hide Arm/Group Description Participants received 1 tablet containing fixed dose of combination of tramadol hydrochloride (HCl) 75 milligram (mg) /acetaminophen Extended Release (ER) 650 mg orally once daily on Days 1 to 3, 1 tablet twice daily (tramadol HCl 150 mg/acetaminophen 1300 mg) on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28. Participants received 1 tablet of matching placebo once daily orally on Days 1 to 3, 1 tablet twice daily on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
All-Cause Mortality
Tramadol HCl/Acetaminophen Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Tramadol HCl/Acetaminophen Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   1/125 (0.80%)   0/120 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast cancer * 1  1/125 (0.80%)  0/120 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Tramadol HCl/Acetaminophen Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   102/125 (81.60%)   52/120 (43.33%) 
Gastrointestinal disorders     
Dry mouth * 1  5/125 (4.00%)  0/120 (0.00%) 
Nausea * 1  45/125 (36.00%)  12/120 (10.00%) 
Constipation * 1  23/125 (18.40%)  4/120 (3.33%) 
Abdominal pain * 1  3/125 (2.40%)  0/120 (0.00%) 
Dyspepsia * 1  13/125 (10.40%)  12/120 (10.00%) 
Vomiting * 1  21/125 (16.80%)  5/120 (4.17%) 
Abdominal discomfort * 1  0/125 (0.00%)  4/120 (3.33%) 
General disorders     
Thirst * 1  3/125 (2.40%)  0/120 (0.00%) 
Face oedema * 1  3/125 (2.40%)  0/120 (0.00%) 
Infections and infestations     
Nasopharyngitis * 1  0/125 (0.00%)  3/120 (2.50%) 
Metabolism and nutrition disorders     
Decreased appetite * 1  6/125 (4.80%)  4/120 (3.33%) 
Musculoskeletal and connective tissue disorders     
Myalgia * 1  0/125 (0.00%)  3/120 (2.50%) 
Nervous system disorders     
Headache * 1  11/125 (8.80%)  6/120 (5.00%) 
Dizziness * 1  34/125 (27.20%)  10/120 (8.33%) 
Somnolence * 1  18/125 (14.40%)  4/120 (3.33%) 
Psychiatric disorders     
Insomnia * 1  6/125 (4.80%)  0/120 (0.00%) 
Renal and urinary disorders     
Dysuria * 1  4/125 (3.20%)  0/120 (0.00%) 
Skin and subcutaneous tissue disorders     
Pruritus * 1  18/125 (14.40%)  4/120 (3.33%) 
Hyperhidrosis * 1  4/125 (3.20%)  0/120 (0.00%) 
Urticaria * 1  3/125 (2.40%)  0/120 (0.00%) 
Rash * 1  3/125 (2.40%)  0/120 (0.00%) 
Cold sweating * 1  3/125 (2.40%)  0/120 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
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.
PI cannot provide the any trial related information to external parties’ without mutual agreement with the sponsor. This is valid even after the contract is canceled.
Results Point of Contact
Name/Title: Therapeutic area Scientist
Organization: Janssen Korea/ Seoul
Phone: +82-2-2094-4802
Responsible Party: Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier: NCT01112267     History of Changes
Other Study ID Numbers: CR016222
ULTER-KOR-3003
TRAMAPPAI3004
First Submitted: April 1, 2010
First Posted: April 28, 2010
Results First Submitted: April 1, 2013
Results First Posted: July 24, 2013
Last Update Posted: July 24, 2013