A Study to Assess the Improvement of Pain and Health-Related Quality of Life in Patients With Chronic Non-Malignant Pain Taking Tramadol Hydrochloride and Acetaminophen
Information source: Janssen Korea, Ltd., Korea
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Pain
Intervention: No intervention (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Janssen Korea, Ltd., Korea Official(s) and/or principal investigator(s): Janssen Korea, Ltd., Korea Clinical trial, Study Director, Affiliation: Janssen Korea, Ltd., Korea
Summary
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.
Clinical Details
Official title: Evaluation of the Improvement of Pain and Health-Related Quality of Life in Patients With Chronic Non-Malignant Pain Taking Tramadol HCl (75mg)/Acetaminophen (650mg) Extended Release Tablet: Multicenter, Open Label, Prospective, Observational Study
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Number of patients with more than 30 percentage reduction in percentage Pain Intensity Difference (PID) from baseline
Secondary outcome: Change in scores of Korean version of the EuroQol 5 Dimensional (KEQ-5D) Questionnaire from baselineThe degree of night sleep disturbance due to pain The degree of Interference with activity of daily living due to Pain The degree of Interference with social activities due to Pain The investigator's global assessment of pain treatment The patient's global assessment of pain treatment The number of patients who experience adverse events as a measure of safety and tolerability
Detailed description:
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.
Eligibility
Minimum age: 20 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients with the prescription of ULTRACET ER for the treatment of moderate to severe
pain
- Complaining of chronic pain for more than 3 months
Exclusion Criteria:
- Patient who had been treated with extended release tramadol hydrochloride (75mg) and
acetaminophen (650mg) or strong opioids (eg, morphine, fentanyl, oxycodone,
hydromorphone) within the past 4 weeks
- Patient with a severe mental disease and with a medical history of hypersensitivity
to opioid analgesics
- Pregnant females or the females likely to become pregnant during the study period
- Patient who had been believed likely to complain of more pain than the real pain he
or she is experiencing because of industrial disaster, car insurance, and others
- Patients who are contraindicated according to the warnings, precautions and
prohibitions regarding extended release tramadol hydrochloride (75mg) and
acetaminophen (650mg)
Locations and Contacts
Busan, Korea, Republic of
Cheonan, Korea, Republic of
Chungcheongbuk-Do, Korea, Republic of
Chungju-Si, Korea, Republic of
Daegu, Korea, Republic of
Daejeon, Korea, Republic of
Goyang, Korea, Republic of
Gyeonggi-Do, Korea, Republic of
Hwasun Gun, Korea, Republic of
Kwangiu, Korea, Republic of
Kwangjoo, Korea, Republic of
Kyungjoo, Korea, Republic of
Seoul, Korea, Republic of
Suwon, Korea, Republic of
Additional Information
Starting date: September 2011
Last updated: December 31, 2014
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