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An Efficacy and Safety Study of Tramadol Hydrochloride-Paracetamol in Treatment of Moderate to Severe Acute Neck-Shoulder Pain and Low Back Pain

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ClinicalTrials.gov Identifier: NCT01843660
Recruitment Status : Completed
First Posted : April 30, 2013
Results First Posted : August 26, 2013
Last Update Posted : August 26, 2013
Sponsor:
Information provided by (Responsible Party):
Xian-Janssen Pharmaceutical Ltd.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Low Back Pain
Shoulder Pain
Neck Pain
Intervention Drug: Tramadol HCl-Paracetamol
Enrollment 1059
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tramadol Hydrochloride (HCl)-Paracetamol
Hide Arm/Group Description Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
Period Title: Overall Study
Started 1059
Completed 1029
Not Completed 30
Reason Not Completed
Other             30
Arm/Group Title Tramadol Hydrochloride (HCl)-Paracetamol
Hide Arm/Group Description Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
Overall Number of Baseline Participants 1035
Hide Baseline Analysis Population Description
Out of a total of 1059 participants, baseline characteristic (age and gender) was available for only 1035 participants who were included in the full analysis set.
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1035 participants
42.43  (12.34)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1035 participants
Female
493
  47.6%
Male
542
  52.4%
1.Primary Outcome
Title Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 0.5
Hide Description Pain intensity was measured using NRS (0=painless and 10=most severe pain). Score of 1-3 means mild pain; 4-6 means moderate pain and 7-10 means severe pain.
Time Frame Hour 0.5
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population included all participants who completed the clinical trial according to the trial protocol.
Arm/Group Title Tramadol Hydrochloride (HCl)-Paracetamol
Hide Arm/Group Description:
Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
Overall Number of Participants Analyzed 1029
Mean (Standard Deviation)
Unit of Measure: Units on a scale
5.29  (2.07)
2.Primary Outcome
Title Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 1
Hide Description Pain intensity was measured using NRS (0=painless and 10=most severe pain). Score of 1-3 means mild pain; 4-6 means moderate pain and 7-10 means severe pain.
Time Frame Hour 1
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population included all participants who completed the clinical trial according to the trial protocol.
Arm/Group Title Tramadol Hydrochloride (HCl)-Paracetamol
Hide Arm/Group Description:
Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
Overall Number of Participants Analyzed 1029
Mean (Standard Deviation)
Unit of Measure: Units on a scale
4.32  (2.20)
3.Primary Outcome
Title Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 2
Hide Description Pain intensity was measured using NRS (0=painless and 10=most severe pain). Score of 1-3 means mild pain; 4-6 means moderate pain and 7-10 means severe pain.
Time Frame Hour 2
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population included all participants who completed the clinical trial according to the trial protocol.
Arm/Group Title Tramadol Hydrochloride (HCl)-Paracetamol
Hide Arm/Group Description:
Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
Overall Number of Participants Analyzed 1029
Mean (Standard Deviation)
Unit of Measure: Units on a scale
3.52  (2.14)
4.Primary Outcome
Title Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 3
Hide Description Pain intensity was measured using NRS (0=painless and 10=most severe pain). Score of 1-3 means mild pain; 4-6 means moderate pain and 7-10 means severe pain.
Time Frame Hour 3
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population included all participants who completed the clinical trial according to the trial protocol.
Arm/Group Title Tramadol Hydrochloride (HCl)-Paracetamol
Hide Arm/Group Description:
Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
Overall Number of Participants Analyzed 1029
Mean (Standard Deviation)
Unit of Measure: Units on a scale
2.93  (2.00)
5.Primary Outcome
Title Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 4
Hide Description Pain intensity was measured using NRS (0=painless and 10=most severe pain). Score of 1-3 means mild pain; 4-6 means moderate pain and 7-10 means severe pain.
Time Frame Hour 4
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population included all participants who completed the clinical trial according to the trial protocol.
Arm/Group Title Tramadol Hydrochloride (HCl)-Paracetamol
Hide Arm/Group Description:
Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
Overall Number of Participants Analyzed 1029
Mean (Standard Deviation)
Unit of Measure: Units on a scale
2.56  (1.92)
6.Primary Outcome
Title Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 6
Hide Description Pain intensity was measured using NRS (0=painless and 10=most severe pain). Score of 1-3 means mild pain; 4-6 means moderate pain and 7-10 means severe pain.
Time Frame Hour 6
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population included all participants who completed the clinical trial according to the trial protocol.
Arm/Group Title Tramadol Hydrochloride (HCl)-Paracetamol
Hide Arm/Group Description:
Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
Overall Number of Participants Analyzed 1029
Mean (Standard Deviation)
Unit of Measure: Units on a scale
2.39  (1.97)
7.Primary Outcome
Title Number of Participants With Pain Relief Score at Hour 0.5
Hide Description Pain relief was measured using 6-point Likert Scale (4=complete, 3=significant/comparatively large, 2=moderate, 1=mild/slight, 0=none, -1=exacerbated/heavier).
Time Frame Hour 0.5
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population included all participants who completed the clinical trial according to the trial protocol.
Arm/Group Title Tramadol Hydrochloride (HCl)-Paracetamol
Hide Arm/Group Description:
Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
Overall Number of Participants Analyzed 1029
Measure Type: Number
Unit of Measure: Participants
Complete 7
Significant 92
Moderate 209
Mild 326
None 394
Exacerbated 1
8.Primary Outcome
Title Number of Participants With Pain Relief Score at Hour 1
Hide Description Pain relief was measured using 6-point Likert Scale (4=complete, 3=significant/comparatively large, 2=moderate, 1=mild/slight, 0=none, -1=exacerbated/heavier).
Time Frame Hour 1
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population included all participants who completed the clinical trial according to the trial protocol.
Arm/Group Title Tramadol Hydrochloride (HCl)-Paracetamol
Hide Arm/Group Description:
Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
Overall Number of Participants Analyzed 1029
Measure Type: Number
Unit of Measure: Participants
Complete 46
Significant 226
Moderate 271
Mild 332
None 154
Exacerbated 0
9.Primary Outcome
Title Number of Participants With Pain Relief Score at Hour 2
Hide Description Pain relief was measured using 6-point Likert Scale (4=complete, 3=significant/comparatively large, 2=moderate, 1=mild/slight, 0=none, -1=exacerbated/heavier).
Time Frame Hour 2
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population included all participants who completed the clinical trial according to the trial protocol.
Arm/Group Title Tramadol Hydrochloride (HCl)-Paracetamol
Hide Arm/Group Description:
Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
Overall Number of Participants Analyzed 1029
Measure Type: Number
Unit of Measure: Participants
Complete 104
Significant 351
Moderate 270
Mild 230
None 74
Exacerbated 0
10.Primary Outcome
Title Number of Participants With Pain Relief Score at Hour 3
Hide Description Pain relief was measured using 6-point Likert Scale (4=complete, 3=significant/comparatively large, 2=moderate, 1=mild/slight, 0=none, -1=exacerbated/heavier).
Time Frame Hour 3
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population included all participants who completed the clinical trial according to the trial protocol.
Arm/Group Title Tramadol Hydrochloride (HCl)-Paracetamol
Hide Arm/Group Description:
Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
Overall Number of Participants Analyzed 1029
Measure Type: Number
Unit of Measure: Participants
Complete 179
Significant 392
Moderate 307
Mild 99
None 52
Exacerbated 0
11.Primary Outcome
Title Number of Participants With Pain Relief Score at Hour 4
Hide Description Pain relief was measured using 6-point Likert Scale (4=complete, 3=significant/comparatively large, 2=moderate, 1=mild/slight, 0=none, -1=exacerbated/heavier).
Time Frame Hour 4
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population included all participants who completed the clinical trial according to the trial protocol.
Arm/Group Title Tramadol Hydrochloride (HCl)-Paracetamol
Hide Arm/Group Description:
Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
Overall Number of Participants Analyzed 1029
Measure Type: Number
Unit of Measure: Participants
Complete 222
Significant 484
Moderate 194
Mild 86
None 43
Exacerbated 0
12.Primary Outcome
Title Number of Participants With Pain Relief Score at Hour 6
Hide Description Pain relief was measured using 6-point Likert Scale (4=complete, 3=significant/comparatively large, 2=moderate, 1=mild/slight, 0=none, -1=exacerbated/heavier).
Time Frame Hour 6
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population included all participants who completed the clinical trial according to the trial protocol.
Arm/Group Title Tramadol Hydrochloride (HCl)-Paracetamol
Hide Arm/Group Description:
Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
Overall Number of Participants Analyzed 1029
Measure Type: Number
Unit of Measure: Participants
Complete 304
Significant 377
Moderate 218
Mild 78
None 51
Exacerbated 1
13.Secondary Outcome
Title Number of Participants Who Required Additional Dosage Administration
Hide Description Number of participants who additionally required a second tablet within 2 hours after the first administration of the investigational drug was reported.
Time Frame Baseline up to Hour 2
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population included all participants who completed the clinical trial according to the trial protocol.
Arm/Group Title Tramadol Hydrochloride (HCl)-Paracetamol
Hide Arm/Group Description:
Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
Overall Number of Participants Analyzed 1029
Measure Type: Number
Unit of Measure: Participants
97
14.Secondary Outcome
Title Number of Participants With Analgesic Satisfaction Score
Hide Description Participants evaluated their satisfaction with the analgesic effect of the study drug using a 4-point scale (4=very good, 3=good, 2=average, 1=poor). Number of participants in each category was reported.
Time Frame Hour 6
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population included all participants who completed the clinical trial according to the trial protocol.
Arm/Group Title Tramadol Hydrochloride (HCl)-Paracetamol
Hide Arm/Group Description:
Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
Overall Number of Participants Analyzed 1029
Measure Type: Number
Unit of Measure: Participants
Very good 128
Good 659
Average 212
Poor 29
Missing 1
15.Secondary Outcome
Title Number of Participants With Overall Analgesic Satisfaction Score
Hide Description Participants and physicians separately evaluated their satisfaction with the analgesic effect of the study drug using a 5-point scale (1=very unsatisfied, 2 =unsatisfied, 3=average, 4= satisfied and 5=very satisfied). Number of participants in each category was reported.
Time Frame Hour 6
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population included all participants who completed the clinical trial according to the trial protocol.
Arm/Group Title Tramadol Hydrochloride (HCl)-Paracetamol
Hide Arm/Group Description:
Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
Overall Number of Participants Analyzed 1029
Measure Type: Number
Unit of Measure: Participants
Participants' evaluation: Very unsatisfied 3
Participants' evaluation: Unsatisfied 39
Participants' evaluation: Average 207
Participants' evaluation: Satisfied 669
Participants' evaluation: Very satisfied 111
Physicians' evaluation: Very unsatisfied 1
Physicians' evaluation: Unsatisfied 33
Physicians' evaluation: Average 159
Physicians' evaluation: Satisfied 710
Physicians' evaluation: Very satisfied 126
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tramadol Hydrochloride (HCl)-Paracetamol
Hide Arm/Group Description Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
All-Cause Mortality
Tramadol Hydrochloride (HCl)-Paracetamol
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Tramadol Hydrochloride (HCl)-Paracetamol
Affected / at Risk (%)
Total   0/1059 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Tramadol Hydrochloride (HCl)-Paracetamol
Affected / at Risk (%)
Total   86/1059 (8.12%) 
General disorders   
Nausea * 1  35/1059 (3.31%) 
Vomiting * 1  9/1059 (0.85%) 
Headache * 1  5/1059 (0.47%) 
Dizziness * 1  31/1059 (2.93%) 
Lethargy * 1  14/1059 (1.32%) 
Weakness * 1  2/1059 (0.19%) 
Skin itch * 1  1/1059 (0.09%) 
Others * 1  19/1059 (1.79%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, No coding applied
Results are reported for 'number of participants who required additional dosage administration' instead of 'time to achieve analgesic effect' due to change in planned analysis.
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.
Disclosure restriction on the PI is that the PI should submit manuscript to the Sponsor for review no less than 60 days prior to public release. Only with written approval of the Sponsor, the results communications could be public released.
Results Point of Contact
Name/Title: Therapeutic Area Physician
Organization: Janssen China, Beijing
Phone: +86-10-58218709
Responsible Party: Xian-Janssen Pharmaceutical Ltd.
ClinicalTrials.gov Identifier: NCT01843660     History of Changes
Other Study ID Numbers: CR016117
TRAMAPPAI4035
TRAMAP-CHN-MA-02
First Submitted: April 26, 2013
First Posted: April 30, 2013
Results First Submitted: June 18, 2013
Results First Posted: August 26, 2013
Last Update Posted: August 26, 2013