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| ID | Type | Description | Link |
|---|---|---|---|
| TRAMAPPAI4035 | |||
| TRAMAP-CHN-MA-02 |
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The purpose of this study is to evaluate the efficacy and safety of tramadol hydrochloride-paracetamol tablets in treatment of moderate (medium level of seriousness) to severe (very serious) acute neck, shoulder and low back pain in orthopedics (pertaining to the bones) outpatient or emergency setting.
This is an open-label (all people know the identity of the intervention), non-randomized, multi-center (when more than one hospital or medical school team work on a medical research study) and prospective (study following participants forward in time) study of tramadol hydrochloride-paracetamol tablets. Participants will receive 1 to 2 tablets of tramadol hydrochloride-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325mg). Participants may be given the additional dose according to the clinical requirement. The total treatment duration will be 6 hours. The total study duration will be 4 months. Efficacy will be evaluated primarily by pain intensity and pain relief. Participants will evaluate the pain severity and pain relief at 0.5, 1, 2, 3, 4 and 6 hours respectively after the first dose; and the drug efficacy and overall satisfaction level at the end of 6 hours after the first dose. Participants' safety will be monitored throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tramadol Hydrochloride (HCl)-Paracetamol | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tramadol HCl-Paracetamol | Drug | Participants will receive 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325mg) for up to a total duration of 6 hours. Additional dose may be given based upon the clinical requirement. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 0.5 | 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. | Hour 0.5 |
| Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 1 | 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. | Hour 1 |
| Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 2 | 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. | Hour 2 |
| Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 3 | 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. | Hour 3 |
| Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 4 | 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. | Hour 4 |
| Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 6 | 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. | Hour 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Required Additional Dosage Administration | Number of participants who additionally required a second tablet within 2 hours after the first administration of the investigational drug was reported. | Baseline up to Hour 2 |
| Number of Participants With Analgesic Satisfaction Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xian-Janssen Pharmaceutical Ltd., China Clinical Trial | Xian-Janssen Pharmaceutical Ltd. | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Number of Participants With Pain Relief Score at Hour 0.5 | 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). | Hour 0.5 |
| Number of Participants With Pain Relief Score at Hour 1 | 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). | Hour 1 |
| Number of Participants With Pain Relief Score at Hour 2 | 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). | Hour 2 |
| Number of Participants With Pain Relief Score at Hour 3 | 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). | Hour 3 |
| Number of Participants With Pain Relief Score at Hour 4 | 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). | Hour 4 |
| Number of Participants With Pain Relief Score at Hour 6 | 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). | Hour 6 |
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. |
| Hour 6 |
| Number of Participants With Overall Analgesic Satisfaction Score | 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. | Hour 6 |
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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.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| Age Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 0.5 | 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. | Per protocol population included all participants who completed the clinical trial according to the trial protocol. | Posted | Mean | Standard Deviation | Units on a scale | Hour 0.5 |
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| Primary | Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 1 | 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. | Per protocol population included all participants who completed the clinical trial according to the trial protocol. | Posted | Mean | Standard Deviation | Units on a scale | Hour 1 |
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| Primary | Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 2 | 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. | Per protocol population included all participants who completed the clinical trial according to the trial protocol. | Posted | Mean | Standard Deviation | Units on a scale | Hour 2 |
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| Primary | Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 3 | 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. | Per protocol population included all participants who completed the clinical trial according to the trial protocol. | Posted | Mean | Standard Deviation | Units on a scale | Hour 3 |
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| Primary | Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 4 | 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. | Per protocol population included all participants who completed the clinical trial according to the trial protocol. | Posted | Mean | Standard Deviation | Units on a scale | Hour 4 |
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| Primary | Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 6 | 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. | Per protocol population included all participants who completed the clinical trial according to the trial protocol. | Posted | Mean | Standard Deviation | Units on a scale | Hour 6 |
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| Primary | Number of Participants With Pain Relief Score at Hour 0.5 | 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). | Per protocol population included all participants who completed the clinical trial according to the trial protocol. | Posted | Number | Participants | Hour 0.5 |
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| Primary | Number of Participants With Pain Relief Score at Hour 1 | 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). | Per protocol population included all participants who completed the clinical trial according to the trial protocol. | Posted | Number | Participants | Hour 1 |
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| Primary | Number of Participants With Pain Relief Score at Hour 2 | 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). | Per protocol population included all participants who completed the clinical trial according to the trial protocol. | Posted | Number | Participants | Hour 2 |
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| Primary | Number of Participants With Pain Relief Score at Hour 3 | 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). | Per protocol population included all participants who completed the clinical trial according to the trial protocol. | Posted | Number | Participants | Hour 3 |
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| Primary | Number of Participants With Pain Relief Score at Hour 4 | 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). | Per protocol population included all participants who completed the clinical trial according to the trial protocol. | Posted | Number | Participants | Hour 4 |
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| Primary | Number of Participants With Pain Relief Score at Hour 6 | 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). | Per protocol population included all participants who completed the clinical trial according to the trial protocol. | Posted | Number | Participants | Hour 6 |
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| Secondary | Number of Participants Who Required Additional Dosage Administration | Number of participants who additionally required a second tablet within 2 hours after the first administration of the investigational drug was reported. | Per protocol population included all participants who completed the clinical trial according to the trial protocol. | Posted | Number | Participants | Baseline up to Hour 2 |
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| Secondary | Number of Participants With Analgesic Satisfaction Score | 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. | Per protocol population included all participants who completed the clinical trial according to the trial protocol. | Posted | Number | Participants | Hour 6 |
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| Secondary | Number of Participants With Overall Analgesic Satisfaction Score | 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. | Per protocol population included all participants who completed the clinical trial according to the trial protocol. | Posted | Number | Participants | Hour 6 |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 1,059 | 86 | 1,059 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | General disorders | No coding applied | Non-systematic Assessment |
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| Vomiting | General disorders | No coding applied | Non-systematic Assessment |
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| Headache | General disorders | No coding applied | Non-systematic Assessment |
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| Dizziness | General disorders | No coding applied | Non-systematic Assessment |
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| Lethargy | General disorders | No coding applied | Non-systematic Assessment |
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| Weakness | General disorders | No coding applied | Non-systematic Assessment |
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| Skin itch | General disorders | No coding applied | Non-systematic Assessment |
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| Others | General disorders | No coding applied | Non-systematic Assessment |
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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.
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Physician | Janssen China, Beijing | +86-10-58218709 |
| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D020069 | Shoulder Pain |
| D019547 | Neck Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D018771 | Arthralgia |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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