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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01060124
Recruitment Status : Completed
First Posted : February 2, 2010
Results First Posted : April 26, 2013
Last Update Posted : April 29, 2014
Information provided by (Responsible Party):
Janssen Korea, Ltd., Korea

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.

Condition or disease Intervention/treatment Phase
Pain; Cancer Drug: Fentanyl D-trans Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of Durogesic D-TRANS in Cancer Pain Patients With Inadequately Controlled Pain Relief From Weak Opioids
Study Start Date : April 2007
Primary Completion Date : February 2009
Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Percentage of Participants Satisfied With Pain Treatment [ Time Frame: Day 29 ]
    Participants were assessed for their satisfaction for pain treatment after the application of the Transdermal Therapeutic System (TTS)-fentanyl D-trans.

Secondary Outcome Measures :
  1. Difference in Pain Intensity Before and After Administration of (TTS)-Fentanyl D-trans [ Time Frame: Day 1 and Day 29 ]
    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:
  1. Number of Participants With Detailed Reason for Satisfaction With the Pain Treatment [ Time Frame: Day 29 ]
    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.

  2. Initial and End Point Dose of TTS-Fentanyl D-trans [ Time Frame: Day 1 and Day 29 ]
    Dose of TTS-fentanyl D-trans were monitored at start and end of the trial.

  3. Number of Participants With Investigator's Overall Evaluation on the Pain Treatment [ Time Frame: Day 29 ]
    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.

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01060124

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

Responsible Party: Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier: NCT01060124     History of Changes
Other Study ID Numbers: CR012256
First Posted: February 2, 2010    Key Record Dates
Results First Posted: April 26, 2013
Last Update Posted: April 29, 2014
Last Verified: April 2014

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

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