Trial Outcomes & Findings for An Efficacy and Safety Study of Tramadol Hydrochloride-Paracetamol in Treatment of Moderate to Severe Acute Neck-Shoulder Pain and Low Back Pain (NCT NCT01843660)
NCT ID: NCT01843660
Last Updated: 2013-08-26
Results Overview
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.
COMPLETED
PHASE4
1059 participants
Hour 0.5
2013-08-26
Participant Flow
Participant milestones
| Measure |
Tramadol Hydrochloride (HCl)-Paracetamol
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.
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|---|---|
|
Overall Study
STARTED
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1059
|
|
Overall Study
COMPLETED
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1029
|
|
Overall Study
NOT COMPLETED
|
30
|
Reasons for withdrawal
| Measure |
Tramadol Hydrochloride (HCl)-Paracetamol
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.
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|---|---|
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Overall Study
Other
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30
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Baseline Characteristics
An Efficacy and Safety Study of Tramadol Hydrochloride-Paracetamol in Treatment of Moderate to Severe Acute Neck-Shoulder Pain and Low Back Pain
Baseline characteristics by cohort
| Measure |
Tramadol Hydrochloride (HCl)-Paracetamol
n=1035 Participants
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.
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|---|---|
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Age Continuous
|
42.43 Years
STANDARD_DEVIATION 12.34 • n=5 Participants
|
|
Sex: Female, Male
Female
|
493 Participants
n=5 Participants
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Sex: Female, Male
Male
|
542 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Hour 0.5Population: Per protocol population included all participants who completed the clinical trial according to the trial protocol.
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.
Outcome measures
| Measure |
Tramadol Hydrochloride (HCl)-Paracetamol
n=1029 Participants
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.
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|---|---|
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Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 0.5
|
5.29 Units on a scale
Standard Deviation 2.07
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PRIMARY outcome
Timeframe: Hour 1Population: Per protocol population included all participants who completed the clinical trial according to the trial protocol.
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.
Outcome measures
| Measure |
Tramadol Hydrochloride (HCl)-Paracetamol
n=1029 Participants
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.
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|---|---|
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Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 1
|
4.32 Units on a scale
Standard Deviation 2.20
|
PRIMARY outcome
Timeframe: Hour 2Population: Per protocol population included all participants who completed the clinical trial according to the trial protocol.
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.
Outcome measures
| Measure |
Tramadol Hydrochloride (HCl)-Paracetamol
n=1029 Participants
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.
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|---|---|
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Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 2
|
3.52 Units on a scale
Standard Deviation 2.14
|
PRIMARY outcome
Timeframe: Hour 3Population: Per protocol population included all participants who completed the clinical trial according to the trial protocol.
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.
Outcome measures
| Measure |
Tramadol Hydrochloride (HCl)-Paracetamol
n=1029 Participants
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.
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|---|---|
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Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 3
|
2.93 Units on a scale
Standard Deviation 2.00
|
PRIMARY outcome
Timeframe: Hour 4Population: Per protocol population included all participants who completed the clinical trial according to the trial protocol.
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.
Outcome measures
| Measure |
Tramadol Hydrochloride (HCl)-Paracetamol
n=1029 Participants
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.
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|---|---|
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Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 4
|
2.56 Units on a scale
Standard Deviation 1.92
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PRIMARY outcome
Timeframe: Hour 6Population: Per protocol population included all participants who completed the clinical trial according to the trial protocol.
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.
Outcome measures
| Measure |
Tramadol Hydrochloride (HCl)-Paracetamol
n=1029 Participants
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.
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|---|---|
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Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 6
|
2.39 Units on a scale
Standard Deviation 1.97
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PRIMARY outcome
Timeframe: Hour 0.5Population: Per protocol population included all participants who completed the clinical trial according to the trial protocol.
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).
Outcome measures
| Measure |
Tramadol Hydrochloride (HCl)-Paracetamol
n=1029 Participants
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.
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|---|---|
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Number of Participants With Pain Relief Score at Hour 0.5
Complete
|
7 Participants
|
|
Number of Participants With Pain Relief Score at Hour 0.5
Significant
|
92 Participants
|
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Number of Participants With Pain Relief Score at Hour 0.5
Moderate
|
209 Participants
|
|
Number of Participants With Pain Relief Score at Hour 0.5
Mild
|
326 Participants
|
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Number of Participants With Pain Relief Score at Hour 0.5
None
|
394 Participants
|
|
Number of Participants With Pain Relief Score at Hour 0.5
Exacerbated
|
1 Participants
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PRIMARY outcome
Timeframe: Hour 1Population: Per protocol population included all participants who completed the clinical trial according to the trial protocol.
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).
Outcome measures
| Measure |
Tramadol Hydrochloride (HCl)-Paracetamol
n=1029 Participants
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.
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|---|---|
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Number of Participants With Pain Relief Score at Hour 1
Complete
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46 Participants
|
|
Number of Participants With Pain Relief Score at Hour 1
Significant
|
226 Participants
|
|
Number of Participants With Pain Relief Score at Hour 1
Moderate
|
271 Participants
|
|
Number of Participants With Pain Relief Score at Hour 1
Mild
|
332 Participants
|
|
Number of Participants With Pain Relief Score at Hour 1
None
|
154 Participants
|
|
Number of Participants With Pain Relief Score at Hour 1
Exacerbated
|
0 Participants
|
PRIMARY outcome
Timeframe: Hour 2Population: Per protocol population included all participants who completed the clinical trial according to the trial protocol.
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).
Outcome measures
| Measure |
Tramadol Hydrochloride (HCl)-Paracetamol
n=1029 Participants
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.
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|---|---|
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Number of Participants With Pain Relief Score at Hour 2
Complete
|
104 Participants
|
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Number of Participants With Pain Relief Score at Hour 2
Significant
|
351 Participants
|
|
Number of Participants With Pain Relief Score at Hour 2
Moderate
|
270 Participants
|
|
Number of Participants With Pain Relief Score at Hour 2
Mild
|
230 Participants
|
|
Number of Participants With Pain Relief Score at Hour 2
None
|
74 Participants
|
|
Number of Participants With Pain Relief Score at Hour 2
Exacerbated
|
0 Participants
|
PRIMARY outcome
Timeframe: Hour 3Population: Per protocol population included all participants who completed the clinical trial according to the trial protocol.
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).
Outcome measures
| Measure |
Tramadol Hydrochloride (HCl)-Paracetamol
n=1029 Participants
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.
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|---|---|
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Number of Participants With Pain Relief Score at Hour 3
Complete
|
179 Participants
|
|
Number of Participants With Pain Relief Score at Hour 3
Significant
|
392 Participants
|
|
Number of Participants With Pain Relief Score at Hour 3
Moderate
|
307 Participants
|
|
Number of Participants With Pain Relief Score at Hour 3
Mild
|
99 Participants
|
|
Number of Participants With Pain Relief Score at Hour 3
None
|
52 Participants
|
|
Number of Participants With Pain Relief Score at Hour 3
Exacerbated
|
0 Participants
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PRIMARY outcome
Timeframe: Hour 4Population: Per protocol population included all participants who completed the clinical trial according to the trial protocol.
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).
Outcome measures
| Measure |
Tramadol Hydrochloride (HCl)-Paracetamol
n=1029 Participants
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.
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|---|---|
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Number of Participants With Pain Relief Score at Hour 4
Complete
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222 Participants
|
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Number of Participants With Pain Relief Score at Hour 4
Significant
|
484 Participants
|
|
Number of Participants With Pain Relief Score at Hour 4
Moderate
|
194 Participants
|
|
Number of Participants With Pain Relief Score at Hour 4
Mild
|
86 Participants
|
|
Number of Participants With Pain Relief Score at Hour 4
None
|
43 Participants
|
|
Number of Participants With Pain Relief Score at Hour 4
Exacerbated
|
0 Participants
|
PRIMARY outcome
Timeframe: Hour 6Population: Per protocol population included all participants who completed the clinical trial according to the trial protocol.
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).
Outcome measures
| Measure |
Tramadol Hydrochloride (HCl)-Paracetamol
n=1029 Participants
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.
|
|---|---|
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Number of Participants With Pain Relief Score at Hour 6
Complete
|
304 Participants
|
|
Number of Participants With Pain Relief Score at Hour 6
Significant
|
377 Participants
|
|
Number of Participants With Pain Relief Score at Hour 6
Moderate
|
218 Participants
|
|
Number of Participants With Pain Relief Score at Hour 6
Mild
|
78 Participants
|
|
Number of Participants With Pain Relief Score at Hour 6
None
|
51 Participants
|
|
Number of Participants With Pain Relief Score at Hour 6
Exacerbated
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Hour 2Population: Per protocol population included all participants who completed the clinical trial according to the trial protocol.
Number of participants who additionally required a second tablet within 2 hours after the first administration of the investigational drug was reported.
Outcome measures
| Measure |
Tramadol Hydrochloride (HCl)-Paracetamol
n=1029 Participants
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.
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|---|---|
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Number of Participants Who Required Additional Dosage Administration
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97 Participants
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SECONDARY outcome
Timeframe: Hour 6Population: Per protocol population included all participants who completed the clinical trial according to the trial protocol.
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.
Outcome measures
| Measure |
Tramadol Hydrochloride (HCl)-Paracetamol
n=1029 Participants
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.
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|---|---|
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Number of Participants With Analgesic Satisfaction Score
Very good
|
128 Participants
|
|
Number of Participants With Analgesic Satisfaction Score
Good
|
659 Participants
|
|
Number of Participants With Analgesic Satisfaction Score
Average
|
212 Participants
|
|
Number of Participants With Analgesic Satisfaction Score
Poor
|
29 Participants
|
|
Number of Participants With Analgesic Satisfaction Score
Missing
|
1 Participants
|
SECONDARY outcome
Timeframe: Hour 6Population: Per protocol population included all participants who completed the clinical trial according to the trial protocol.
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.
Outcome measures
| Measure |
Tramadol Hydrochloride (HCl)-Paracetamol
n=1029 Participants
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.
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|---|---|
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Number of Participants With Overall Analgesic Satisfaction Score
Physicians' evaluation: Very satisfied
|
126 Participants
|
|
Number of Participants With Overall Analgesic Satisfaction Score
Participants' evaluation: Very unsatisfied
|
3 Participants
|
|
Number of Participants With Overall Analgesic Satisfaction Score
Participants' evaluation: Unsatisfied
|
39 Participants
|
|
Number of Participants With Overall Analgesic Satisfaction Score
Participants' evaluation: Average
|
207 Participants
|
|
Number of Participants With Overall Analgesic Satisfaction Score
Participants' evaluation: Satisfied
|
669 Participants
|
|
Number of Participants With Overall Analgesic Satisfaction Score
Participants' evaluation: Very satisfied
|
111 Participants
|
|
Number of Participants With Overall Analgesic Satisfaction Score
Physicians' evaluation: Very unsatisfied
|
1 Participants
|
|
Number of Participants With Overall Analgesic Satisfaction Score
Physicians' evaluation: Unsatisfied
|
33 Participants
|
|
Number of Participants With Overall Analgesic Satisfaction Score
Physicians' evaluation: Average
|
159 Participants
|
|
Number of Participants With Overall Analgesic Satisfaction Score
Physicians' evaluation: Satisfied
|
710 Participants
|
Adverse Events
Tramadol Hydrochloride (HCl)-Paracetamol
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Tramadol Hydrochloride (HCl)-Paracetamol
n=1059 participants at risk
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.
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|---|---|
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General disorders
Nausea
|
3.3%
35/1059
|
|
General disorders
Vomiting
|
0.85%
9/1059
|
|
General disorders
Headache
|
0.47%
5/1059
|
|
General disorders
Dizziness
|
2.9%
31/1059
|
|
General disorders
Lethargy
|
1.3%
14/1059
|
|
General disorders
Weakness
|
0.19%
2/1059
|
|
General disorders
Skin itch
|
0.09%
1/1059
|
|
General disorders
Others
|
1.8%
19/1059
|
Additional Information
Therapeutic Area Physician
Janssen China, Beijing
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER