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

Janssen (J&J Innovative Medicine)

Status: Completed

Conditions: Chronic Pain

Treatments: Drug: No intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT01819805

CR100722

TRAMAPPAI4047 (Other Identifier)

ULTER-KOR-5005 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,065 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

1,065 participants in 1 patient group

Patients taking tramadol hydrochloride and acetaminophen

Treatment:

Drug: No intervention