An Efficacy and Safety Study of Transdermal Therapeutic System (TTS)-Fentanyl in Cancer Participants With Inadequately Controlled Pain by Non-Narcotic Analgesics

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier:
NCT01060124
First received: January 29, 2010
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Pain; Cancer
Drug: Fentanyl D-trans
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Use of Durogesic D-TRANS in Cancer Pain Patients With Inadequately Controlled Pain Relief From Weak Opioids

Resource links provided by NLM:


Further study details as provided by Janssen Korea, Ltd., Korea:

Primary Outcome Measures:
  • Percentage of Participants Satisfied With Pain Treatment [ Time Frame: Day 29 ] [ Designated as safety issue: No ]
    Participants were assessed for their satisfaction for pain treatment after the application of the Transdermal Therapeutic System (TTS)-fentanyl D-trans.


Secondary Outcome Measures:
  • Difference in Pain Intensity Before and After Administration of (TTS)-Fentanyl D-trans [ Time Frame: Day 1 and Day 29 ] [ Designated as safety issue: No ]
    Pain intensity difference was measured by Visual Analog Scale (VAS) score, which ranges from 0 to 10 centimeter (cm) where 0 cm=no pain and 10 cm= unimaginably severe pain.


Other Outcome Measures:
  • Number of Participants With Detailed Reason for Satisfaction With the Pain Treatment [ Time Frame: Day 29 ] [ Designated as safety issue: No ]
    Participants were assessed for satisfaction for pain treatment after the administration of the TTS-fentanyl D-trans in detail with satisfied reasons, which are excellent pain relieving effect, convenient administration, minor adverse event, generally satisfied and other.

  • Initial and End Point Dose of TTS-Fentanyl D-trans [ Time Frame: Day 1 and Day 29 ] [ Designated as safety issue: No ]
    Dose of TTS-fentanyl D-trans were monitored at start and end of the trial.

  • Number of Participants With Investigator's Overall Evaluation on the Pain Treatment [ Time Frame: Day 29 ] [ Designated as safety issue: No ]
    Investigator assessed the participants for satisfaction on pain treatment after the administration of the TTS-fentanyl D-trans as very satisfied, satisfied, average, dissatisfied or very dissatisfied.


Enrollment: 103
Study Start Date: April 2007
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Transdermal Therapeutic System (TTS)-Fentanyl D-trans Drug: Fentanyl D-trans
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.
Other Name: Durogesic D-Trans

Detailed Description:

This is an open-label (all people know the identity of the intervention), single-arm, multicenter (conducted in more than one hospital or medical school team work on a medical research study), prospective (study following participants forward in time) study conducted to assess the efficacy and safety of TTS-fentanyl D-trans in cancer participants of Korea with inadequately controlled pain by non-narcotic analgesics and for participant's satisfaction. The participants will receive the initial dose of TTS-fentanyl D-trans patch releasing 12 micrograms per hour (12 mcg/hr) of fentanyl and will be increased by 12 mcg/hr or 25 mcg/hr, every 3 days depending on the participant's pain control. Efficacy will primarily be evaluated by participant's satisfaction with pain treatment. Participant's safety will be monitored throughout the study.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01060124

Sponsors and Collaborators
Janssen Korea, Ltd., Korea
Investigators
Study Director: Janssen Korea, Ltd., Korea Clinical Trial Janssen Korea, Ltd., Korea
  More Information

No publications provided

Responsible Party: Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier: NCT01060124     History of Changes
Other Study ID Numbers: CR012256, FEN-KOR-13
Study First Received: January 29, 2010
Results First Received: March 14, 2013
Last Updated: April 10, 2014
Health Authority: Korea: Food and Drug Administration

Keywords provided by Janssen Korea, Ltd., Korea:
Pain; Cancer
TTS-Fentanyl D-trans
Durogesic D-trans

Additional relevant MeSH terms:
Fentanyl
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on September 18, 2014