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.
Study Type
OBSERVATIONAL
Enrollment
1,065
This is an observational study. Patients taking extended release tramadol hydrochloride 75 mg and acetaminophen 650 mg orally twice daily will be observed.
Unnamed facility
Busan, South Korea
Unnamed facility
Cheonan, South Korea
Unnamed facility
Chungcheongbuk-Do, South Korea
Unnamed facility
Chungju, South Korea
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.
Time frame: Baseline (Week 1) to Week 12
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).
Time frame: Baseline to Week 12
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to Week 12
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Unnamed facility
Daegu, South Korea
Unnamed facility
Daejeon, South Korea
Unnamed facility
Goyang, South Korea
Unnamed facility
Gyeonggi-do, South Korea
Unnamed facility
Hwasun Gun, South Korea
Unnamed facility
Kwangiu, South Korea
...and 4 more locations
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.
Time frame: 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.
Time frame: Week 4 to Week 12
The number of patients who experience adverse events as a measure of safety and tolerability
Time frame: Week 4 to Week 12