Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being collected

Drug Data

Collected from today forward - Prospective
Drug
Who is being recruted

Neurologic Manifestations+2

+ Signs and Symptoms

+ Pathological Conditions, Signs and Symptoms

Over 20 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: September 2011
See protocol details

Summary

Principal SponsorJanssen Korea, Ltd., Korea
Last updated: January 1, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2011

Actual date on which the first participant was enrolled.

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.

NCT01819805
Principal SponsorJanssen Korea, Ltd., Korea
Last updated: January 1, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

1065 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 20 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPainChronic Pain

Criteria

2 inclusion criteria required to participate
Complaining of chronic pain for more than 3 months
Patients with the prescription of ULTRACET ER for the treatment of moderate to severe pain
5 exclusion criteria prevent from participating
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
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
Patients who are contraindicated according to the warnings, precautions and prohibitions regarding extended release tramadol hydrochloride (75mg) and acetaminophen (650mg)
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 14 locations

Busan, South KoreaOpen in Google Maps

Cheonan, South Korea

Chungcheongbuk-Do, South Korea

Chungju, South Korea
Completed14 Study Centers