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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,065 (actual)
• Sponsor: Janssen Korea, Ltd., Korea · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2011-09-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2013-03-28
• Last updated: 2015-01-01

Locations

14 sites across 1 country: South Korea