NCT01819805

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,065

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2011

Shorter than P25 for all trials

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 28, 2013

Completed
Last Updated

January 1, 2015

Status Verified

December 1, 2014

Enrollment Period

10 months

First QC Date

February 7, 2013

Last Update Submit

December 31, 2014

Conditions

Chronic Pain

Keywords

Chronic painChronic non-malignant painNon-malignantPainExtended release tabletTramadol hydrochlorideTramadol HClAcetaminophenUltracet ER

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (7)

  • Change in scores of Korean version of the EuroQol 5 Dimensional (KEQ-5D) Questionnaire from baseline

    Baseline to Week 12

  • The degree of night sleep disturbance due to pain

    Baseline to Week 12

  • The degree of Interference with activity of daily living due to Pain

    Baseline to Week 12

  • The degree of Interference with social activities due to Pain

    Baseline to Week 12

  • The investigator's global assessment of pain treatment

    Week 4 to Week 12

  • +2 more secondary outcomes

Study Arms (1)

Patients taking tramadol hydrochloride and acetaminophen

Drug: No intervention

Interventions

No interventionDRUG

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

Also known as: ULTRACET ER
Patients taking tramadol hydrochloride and acetaminophen

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with chronic non-malignant pain taking tramadol hydrochloride and acetaminophen

You may qualify if:

  • Patients with the prescription of ULTRACET ER for the treatment of moderate to severe pain
  • Complaining of chronic pain for more than 3 months

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Unknown Facility

Busan, South Korea

Location

Unknown Facility

Cheonan, South Korea

Location

Unknown Facility

Chungcheongbuk-Do, South Korea

Location

Unknown Facility

Chungju, South Korea

Location

Unknown Facility

Daegu, South Korea

Location

Unknown Facility

Daejeon, South Korea

Location

Unknown Facility

Goyang, South Korea

Location

Unknown Facility

Gyeonggi-do, South Korea

Location

Unknown Facility

Hwasun Gun, South Korea

Location

Unknown Facility

Kwangiu, South Korea

Location

Unknown Facility

Kwangjoo, South Korea

Location

Unknown Facility

Kyungjoo, South Korea

Location

Unknown Facility

Seoul, South Korea

Location

Unknown Facility

Suwon, South Korea

Location

MeSH Terms

Conditions

Chronic PainPain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Janssen Korea, Ltd., Korea Clinical trial

    Janssen Korea, Ltd., Korea

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2013

First Posted

March 28, 2013

Study Start

September 1, 2011

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

January 1, 2015

Record last verified: 2014-12

Locations

KR(14)