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

Chronic Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01819805
• Other study ID #: CR100722
• Secondary ID: TRAMAPPAI4047ULT
• Status: Completed
• Phase: Phase 4
• First received: February 7, 2013
• Last updated: December 31, 2014
• Start date: September 2011
• Est. completion date: July 2012

Study information

• Verified date: December 2014
• Source: Janssen Korea, Ltd., Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review BoardKorea: Food and Drug AdministrationRepublic of Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1065
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Pain

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Korea, Ltd., Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with more than 30 percentage reduction in percentage Pain Intensity Difference (PID) from baseline	Numerical Rating Scale (NRS) is an 11-point scale to measure the pain intensity and is used by patients to rate their pain from 0 (absence of pain) to 10 (extreme pain). Percentage PID =[(NRS score at baseline - NRS score at Week 12)/NRS score at baseline] X 100.	Baseline (Week 1) to Week 12	No
Secondary	Change in scores of Korean version of the EuroQol 5 Dimensional (KEQ-5D) Questionnaire from baseline	The KEQ-5D is a validated generic measure of quality of life which usually requires less than 1 minute to complete (eg, the questionnaire may have questions about mobility, self care, usual activities, pain/discomfort and anxiety/depression).	Baseline to Week 12	No
Secondary	The degree of night sleep disturbance due to pain	Sleep disturbance due to pain will be measured using a Numeric Rating Scale (NRS): 1 = None, 10 = Complete.	Baseline to Week 12	No
Secondary	The degree of Interference with activity of daily living due to Pain	The degree of interference with activity of daily living due to pain will be assessed on a 5-point scale: 1 = No interference, 5 = Great interference. Activity of daily living means household work performance, etc.	Baseline to Week 12	No
Secondary	The degree of Interference with social activities due to Pain	The degree of interference with social life performance due to pain will be measured on a 5-point scale; 1 = No interference, 5 = Great interference. Social activities means interpersonal relationship, going out, working life, etc.	Baseline to Week 12	No
Secondary	The investigator's global assessment of pain treatment	The investigator will assess on a 5-point scale (1= not effective, 5= greatly effective) how effective the study drug has been for a patient, in the judgment of the investigator.	Week 4 to Week 12	No
Secondary	The patient's global assessment of pain treatment	The patient will assess on a 5-point scale (1= not effective, 5= greatly effective) how effective the study drug has been in the judgment of the study patient.	Week 4 to Week 12	No
Secondary	The number of patients who experience adverse events as a measure of safety and tolerability		Week 4 to Week 12	Yes