NCT01688583

Brief Summary

The purpose of this study is to assess the effectiveness and tolerability of Fentanyl matrix in chronic non-cancer pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
410

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2011

Geographic Reach
1 country

11 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

December 1, 2011

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 20, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

November 21, 2013

Status Verified

November 1, 2013

Enrollment Period

1.2 years

First QC Date

September 17, 2012

Last Update Submit

November 20, 2013

Conditions

Chronic Pain

Keywords

Chronic painChronic non-cancer painFentanyl matrixTransdermal system

Outcome Measures

Primary Outcomes (1)

  • The percentage of patients with mean % Pain Intensity Difference (%PID) >= 50% from baseline to endpoint

    Pain intensity will be measured using a numeric rating scale (NRS), from 0 (no pain) to 10 (worst pain imaginable).

    12 weeks

Secondary Outcomes (7)

  • The change from baseline in mean pain intensity

    Baseline, Week 12

  • The difference between the patient's pain treatment goal set at baseline

    Baseline, Week 12

  • The degree of night sleep disturbance due to pain

    12 weeks

  • The degree of Interference with Daily Life Performance due to Pain

    12 weeks

  • The degree of Interference with Social Life Performance due to Pain

    12 weeks

  • +2 more secondary outcomes

Study Arms (1)

Fentanyl matrix

Drug: Fentanyl matrix

Interventions

Fentanyl matrixDRUG

Dose will be adjusted in accordance with patient's degree of pain and treatment response in the investigator's judgment.

Fentanyl matrix

Eligibility Criteria

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

Patients who complain of chronic pain and have pain inadequately controlled by previous treatment with narcotic analgesics (eg, tramadols, codeines, morphines, oxycodone), and are judged to require Fentanyl matrix administration will participate in this study.

You may qualify if:

  • Complain of chronic non-cancer pain that persists for \>= 3 months
  • Pain inadequately controlled by previous treatment with narcotic analgesics (opium or opium-like compounds with potent analgesic effects, eg, tramadol, codeine, morphine, oxycodone)
  • Women must be postmenopausal, surgically sterile, abstinent, or practicing an effective method of birth control if they have childbearing potential
  • Male patients who agree to use a method of birth control and not to donate sperm for 1 month after the last dose of the study drug
  • A written informed consent for study participation

You may not qualify if:

  • Experience of treatment with Fentanyl matrix within the past 4 weeks
  • No previous experience of use of narcotic analgesics
  • Past or current history of alcohol or drug abuse
  • Cannot use transdermal analgesics due to skin disorder
  • Have serious psychiatric disorder and cannot complete overall study procedures and questionnaire in the judgment of the investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Unknown Facility

Andong, South Korea

Location

Unknown Facility

Busan, South Korea

Location

Unknown Facility

Daegu, South Korea

Location

Unknown Facility

Daejeon, South Korea

Location

Unknown Facility

Goyang, South Korea

Location

Unknown Facility

Incheon, South Korea

Location

Unknown Facility

Jeonju, South Korea

Location

Unknown Facility

Kwangiu, South Korea

Location

Unknown Facility

Kwanju, South Korea

Location

Unknown Facility

Seoul, South Korea

Location

Unknown Facility

Wŏnju, South Korea

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic 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

September 17, 2012

First Posted

September 20, 2012

Study Start

December 1, 2011

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

November 21, 2013

Record last verified: 2013-11

Locations

KR(11)