Pain; Cancer Clinical Trial
Official title:
Use of Durogesic D-TRANS in Cancer Pain Patients With Inadequately Controlled Pain Relief From Weak Opioids
| Verified date | April 2014 |
| Source | Janssen Korea, Ltd., Korea |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Korea: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 103 |
| Est. completion date | February 2009 |
| Est. primary completion date | February 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 20 Years and older |
| Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Janssen Korea, Ltd., Korea |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Number of Participants With Detailed Reason for Satisfaction With the Pain Treatment | 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. | Day 29 | No |
| Other | Initial and End Point Dose of TTS-Fentanyl D-trans | Dose of TTS-fentanyl D-trans were monitored at start and end of the trial. | Day 1 and Day 29 | No |
| Other | Number of Participants With Investigator's Overall Evaluation on the Pain Treatment | 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. | Day 29 | No |
| Primary | 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 | No |
| Secondary | Difference in Pain Intensity Before and After Administration of (TTS)-Fentanyl D-trans | 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. | Day 1 and Day 29 | No |