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

NCT ID: NCT01819805

Last Updated: 2015-01-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1065 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2012-07-31

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.

Conditions

Chronic Pain

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients taking tramadol hydrochloride and acetaminophen

No intervention

Intervention Type: DRUG

This is an observational study. Patients taking extended release tramadol hydrochloride 75 mg and acetaminophen 650 mg orally twice daily will be observed.

Interventions

No intervention

This is an observational study. Patients taking extended release tramadol hydrochloride 75 mg and acetaminophen 650 mg orally twice daily will be observed.

Intervention Type: DRUG

Other Intervention Names

ULTRACET ER

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)

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Korea, Ltd., Korea

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Korea, Ltd., Korea Clinical trial

Role: STUDY_DIRECTOR

Janssen Korea, Ltd., Korea

Locations

Busan, , South Korea

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

Countries

South Korea

Other Identifiers

TRAMAPPAI4047

Identifier Type: OTHER

Identifier Source: secondary_id

ULTER-KOR-5005

Identifier Type: OTHER

Identifier Source: secondary_id

CR100722

Identifier Type: -

Identifier Source: org_study_id