NCT01060124

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of Transdermal Therapeutic System (TTS)-fentanyl D-Trans (transdermal patch containing a drug that is put on the skin so the drug will enter the body through the skin) treatment in cancer participants of Korea with inadequately controlled pain by non-narcotic analgesics (drug used to control pain) and participant's satisfaction.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
103

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2007

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

April 1, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 2, 2010

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

April 26, 2013

Completed
Last Updated

April 29, 2014

Status Verified

April 1, 2014

Enrollment Period

1.8 years

First QC Date

January 29, 2010

Results QC Date

March 14, 2013

Last Update Submit

April 10, 2014

Conditions

Pain; Cancer

Keywords

Pain; CancerTTS-Fentanyl D-transDurogesic D-trans

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants Satisfied With Pain Treatment

    Participants were assessed for their satisfaction for pain treatment after the application of the Transdermal Therapeutic System (TTS)-fentanyl D-trans.

    Day 29

Secondary Outcomes (1)

  • Difference in Pain Intensity Before and After Administration of (TTS)-Fentanyl D-trans

    Day 1 and Day 29

Other Outcomes (3)

  • Number of Participants With Detailed Reason for Satisfaction With the Pain Treatment

    Day 29

  • Initial and End Point Dose of TTS-Fentanyl D-trans

    Day 1 and Day 29

  • Number of Participants With Investigator's Overall Evaluation on the Pain Treatment

    Day 29

Study Arms (1)

Transdermal Therapeutic System (TTS)-Fentanyl D-trans

EXPERIMENTAL
Drug: Fentanyl D-trans

Interventions

Fentanyl D-transDRUG

Fentanyl D-trans will be applied as transdermal patch releasing drug at the rate of 12.5 microgram per hour (mcg/hr) for 3 days with a dose ranging from 12 mcg/hr to 50 mcg/hr.

Also known as: Durogesic D-Trans
Transdermal Therapeutic System (TTS)-Fentanyl D-trans

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants who complains of cancer pain
  • Participants who have taken non-opioid analgesics for the past one month for cancer pain relief purpose, but still have average 4 or higher pain level on the Visual Analogue Scale (VAS) for the last 24 hours
  • Participants with an estimated life expectancy of at least 2 months
  • Participants who are able to communicate with the investigator
  • Participants who can avoid getting pregnant appropriately if there is a possibility of pregnancy during this study period

You may not qualify if:

  • Participants participating in another clinical trial
  • Participants with a history of oversensitive reaction to a narcotic analgesic or with an existing history of drug abuse
  • Participants who have active skin disease, avoiding application of the transdermal system
  • Participants with a history of CO2 (carbon di-oxide) retention (i.e. chronic obstructive pulmonary disease)
  • Participants undergoing chemotherapy/radiotherapy right now or is going to get chemotherapy/radiotherapy within the study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cancer Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
CRA
Organization
Medical affairs, Janssen Korea, Ltd.
82220944835

Study Officials

  • Janssen Korea, Ltd., Korea Clinical Trial

    Janssen Korea, Ltd., Korea

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2010

First Posted

February 2, 2010

Study Start

April 1, 2007

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

April 29, 2014

Results First Posted

April 26, 2013

Record last verified: 2014-04