Clinical trial NCT01060124: An Efficacy and Safety Study of Transdermal Therapeutic System (TTS)-Fentanyl in Cancer Participants With Inadequately Controlled Pain by Non-Narcotic Analgesics
Official title: Use of Durogesic D-TRANS in Cancer Pain Patients With Inadequately Controlled Pain Relief From Weak Opioids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain; Cancer
Keywords: Pain; Cancer
TTS-Fentanyl D-trans
Durogesic D-trans
Lead sponsor: Janssen Korea, Ltd., Korea
Sponsor class: INDUSTRY
First posted: 2010-02-02
Enrollment: 103
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Percentage of Participants Satisfied With Pain Treatment
timeFrame: Day 29
Secondary outcomes:
measure: Difference in Pain Intensity Before and After Administration of (TTS)-Fentanyl D-trans
timeFrame: Day 1 and Day 29
Other outcomes:
measure: Number of Participants With Detailed Reason for Satisfaction With the Pain Treatment
timeFrame: Day 29
measure: Initial and End Point Dose of TTS-Fentanyl D-trans
timeFrame: Day 1 and Day 29
measure: Number of Participants With Investigator's Overall Evaluation on the Pain Treatment
timeFrame: Day 29
Locations:
Study officials:
affiliation: Janssen Korea, Ltd., Korea
name: Janssen Korea, Ltd., Korea Clinical Trial
role: STUDY_DIRECTOR
References: