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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 baseline

The 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

Page last updated: August 23, 2015

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