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Assessment of the Utility of Fentanyl Matrix in Cancer Patients With Inadequately Controlled Pain by Non-opioids

2014-08-27 03:16:15 | BioPortfolio

Summary

The purpose of this study is to find out patient satisfaction with the treatment with fentanyl matrix and utility of fentanyl matrix in patients with pain inadequately controlled by non-opioids. Many researches have published findings about treating pain with transdermal fentanyl in patients who had been using strong opioids, but there is no domestic research to assess the treatment with fentanyl matrix for the purpose of controlling inadequately controlled pain by non-opioids.

Description

This study is open-label, single-arm, multicenter, prospective study to find out subject satisfaction with treatment with fentanyl matrix and the utility of fentanyl matrix in aspects of pain control in cancer patients with pain inadequately controlled pain by non-opioids. Patient satisfaction with pain treatment is the primary endpoint of this study and secondary endpoints are followings: Difference in pain intensity pre- and post-administration of study drug for 28 days; detailed reasons for patient satisfaction; dose of fentanyl matrix, times daily and dose of rescue analgesic, Investigator's overall evaluation on the pain treatment, change in Korean Cancer Pain Assessment Tool (KCPAT) pre- and post-administration of fentanyl matrix. Accurate assessment of pain is the most important factor in treating cancer pain. However, cancer pain assessment is so difficult because the assessment is very subjective itself, is complicated and has a strong psychological side. The interest in cancer pain treatment is on an increasing trend in Korea. In 2003, Korean Cancer Pain Assessment Tool (K-CPAT) was developed as a reflection of such interest and since then, its reliability, validity and utility were tested. starting with 12mcg/h of fentanyl matrix, the dose will be adjusted every 3 days depending on the patient's pain control (single-arm)

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Pain

Intervention

fentanyl matrix

Status

Completed

Source

Janssen Korea, Ltd., Korea

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:15-0400

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