Clinical trial NCT01819805: 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
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Keywords: Chronic pain
Chronic non-malignant pain
Non-malignant
Pain
Extended release tablet
Tramadol hydrochloride
Tramadol HCl
Acetaminophen
Ultracet ER
Lead sponsor: Janssen Korea, Ltd., Korea
Sponsor class: INDUSTRY
First posted: 2013-03-28
Enrollment: 1065
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic non-malignant pain taking tramadol hydrochloride and acetaminophen

Brief 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.

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 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)

Primary outcomes:
measure: Number of patients with more than 30 percentage reduction in percentage Pain Intensity Difference (PID) from baseline
timeFrame: Baseline (Week 1) to Week 12
Secondary outcomes:
measure: Change in scores of Korean version of the EuroQol 5 Dimensional (KEQ-5D) Questionnaire from baseline
timeFrame: Baseline to Week 12
measure: The degree of night sleep disturbance due to pain
timeFrame: Baseline to Week 12
measure: The degree of Interference with activity of daily living due to Pain
timeFrame: Baseline to Week 12
measure: The degree of Interference with social activities due to Pain
timeFrame: Baseline to Week 12
measure: The investigator's global assessment of pain treatment
timeFrame: Week 4 to Week 12
measure: The patient's global assessment of pain treatment
timeFrame: Week 4 to Week 12
measure: The number of patients who experience adverse events as a measure of safety and tolerability
timeFrame: Week 4 to Week 12
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
city: Cheonan
country: Korea, Republic of
city: Chungcheongbuk-Do
country: Korea, Republic of
city: Chungju-Si
country: Korea, Republic of
city: Daegu
country: Korea, Republic of
city: Daejeon
country: Korea, Republic of
city: Goyang
country: Korea, Republic of
city: Gyeonggi-Do
country: Korea, Republic of
city: Hwasun Gun
country: Korea, Republic of
city: Kwangiu
country: Korea, Republic of
city: Kwangjoo
country: Korea, Republic of
city: Kyungjoo
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Suwon
country: Korea, Republic of
Study officials:
affiliation: Janssen Korea, Ltd., Korea
name: Janssen Korea, Ltd., Korea Clinical trial
role: STUDY_DIRECTOR
References: