Phase 4
Completed N=103
An Efficacy and Safety Study of Transdermal Therapeutic System (TTS)-Fentanyl in Cancer Participants With Inadequately Controlled Pain by Non-Narcotic Analgesics
Pain; Cancer
Source: ClinicalTrials.gov NCT01060124 ↗
Enrolled (actual)
103
Serious AEs
17.5%
Results posted
Apr 2013
Primary outcomePrimary: Percentage of Participants Satisfied With Pain Treatment — 82.81 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Satisfied With Pain Treatment |
82.81 | — |
| SECONDARY Difference in Pain Intensity Before and After Administration of (TTS)-Fentanyl D-trans |
6.61; 3.66 | — |
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
Data sourced from ClinicalTrials.gov (NCT01060124). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.