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:
Janssen Korea, Ltd., Korea
Information provided by (Responsible Party):
Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier:
NCT01060124
First received: January 29, 2010
Last updated: March 14, 2013
Last verified: March 2013
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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 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: | March 14, 2013 |
| 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, Non-Narcotic Adjuvants, Anesthesia Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Narcotics Central Nervous System Depressants |
Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Anesthetics, Intravenous Anesthetics, General Anesthetics Analgesics, Opioid |
ClinicalTrials.gov processed this record on June 17, 2013