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| ID | Type | Description | Link |
|---|---|---|---|
| TRAMAPPAI4047 | Other Identifier | Janssen Korea, Ltd., Korea | |
| ULTER-KOR-5005 | Other Identifier | Janssen Korea, Ltd., Korea |
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The purpose of this study is to evaluate the impact of extended release tramadol hydrochloride (75 mg) and acetaminophen (650 mg) tablets on improvement of pain.
This is a multi-center (study conducted at multiple sites), open label (all people know the identity of the intervention), prospective (in which the participants are first identified and then followed forward as time passes), observational study to assess the improvement of pain and health-related quality of life in patients with moderate to severe chronic non-malignant pain. The study will enroll patients who had already filled a prescription for extended release tramadol hydrochloride 75 mg and acetaminophen 650 mg (ULTRACET ER). The study medication will be administered according to local label insert. The study medication will be taken twice daily, 1 to 2 tablets each time, for a maximum of 4 tablets. Safety evaluations for adverse events will be performed throughout the study. The total duration of the study will be approximately of 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients taking tramadol hydrochloride and acetaminophen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Drug | This is an observational study. Patients taking extended release tramadol hydrochloride 75 mg and acetaminophen 650 mg orally twice daily will be observed. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with more than 30 percentage reduction in percentage Pain Intensity Difference (PID) from baseline | Numerical Rating Scale (NRS) is an 11-point scale to measure the pain intensity and is used by patients to rate their pain from 0 (absence of pain) to 10 (extreme pain). Percentage PID =[(NRS score at baseline - NRS score at Week 12)/NRS score at baseline] X 100. | Baseline (Week 1) to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in scores of Korean version of the EuroQol 5 Dimensional (KEQ-5D) Questionnaire from baseline | The KEQ-5D is a validated generic measure of quality of life which usually requires less than 1 minute to complete (eg, the questionnaire may have questions about mobility, self care, usual activities, pain/discomfort and anxiety/depression). | Baseline to Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with chronic non-malignant pain taking tramadol hydrochloride and acetaminophen
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Korea, Ltd., Korea Clinical trial | Janssen Korea, Ltd., Korea | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Busan | South Korea | |||||
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|
| The degree of night sleep disturbance due to pain | Sleep disturbance due to pain will be measured using a Numeric Rating Scale (NRS): 1 = None, 10 = Complete. | Baseline to Week 12 |
| The degree of Interference with activity of daily living due to Pain | The degree of interference with activity of daily living due to pain will be assessed on a 5-point scale: 1 = No interference, 5 = Great interference. Activity of daily living means household work performance, etc. | Baseline to Week 12 |
| The degree of Interference with social activities due to Pain | The degree of interference with social life performance due to pain will be measured on a 5-point scale; 1 = No interference, 5 = Great interference. Social activities means interpersonal relationship, going out, working life, etc. | Baseline to Week 12 |
| The investigator's global assessment of pain treatment | The investigator will assess on a 5-point scale (1= not effective, 5= greatly effective) how effective the study drug has been for a patient, in the judgment of the investigator. | Week 4 to Week 12 |
| The patient's global assessment of pain treatment | The patient will assess on a 5-point scale (1= not effective, 5= greatly effective) how effective the study drug has been in the judgment of the study patient. | Week 4 to Week 12 |
| The number of patients who experience adverse events as a measure of safety and tolerability | Week 4 to Week 12 |
| Cheonan |
| South Korea |
| Chungcheongbuk-Do | South Korea |
| Chungju | South Korea |
| Daegu | South Korea |
| Daejeon | South Korea |
| Goyang | South Korea |
| Gyeonggi-do | South Korea |
| Hwasun Gun | South Korea |
| Kwangiu | South Korea |
| Kwangjoo | South Korea |
| Kyungjoo | South Korea |
| Seoul | South Korea |
| Suwon | South Korea |
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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