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NCT Number: NCT01060124

An Efficacy and Safety Study of Transdermal Therapeutic System (TTS)-Fentanyl in Cancer Participants With Inadequately Controlled Pain by Non-Narcotic Analgesics

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.

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Key information

Conditions

Pain; Cancer Cancer Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fentanyl D-trans

Drug

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 names: Durogesic D-Trans

Primary outcomes

  1. Percentage of Participants Satisfied With Pain Treatment

    Time frame: Day 29

    Participants were assessed for their satisfaction for pain treatment after the application of the Transdermal Therapeutic System (TTS)-fentanyl D-trans.

Secondary outcomes

  1. Difference in Pain Intensity Before and After Administration of (TTS)-Fentanyl D-trans

    Time frame: Day 1 and Day 29

    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 outcomes

  1. Number of Participants With Detailed Reason for Satisfaction With the Pain Treatment

    Time frame: Day 29

    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.

  2. Initial and End Point Dose of TTS-Fentanyl D-trans

    Time frame: Day 1 and Day 29

    Dose of TTS-fentanyl D-trans were monitored at start and end of the trial.

  3. Number of Participants With Investigator's Overall Evaluation on the Pain Treatment

    Time frame: Day 29

    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.

Sponsors and collaborators

Lead sponsor

Janssen Korea, Ltd., Korea

Industry

Registry information

Official study title

Use of Durogesic D-TRANS in Cancer Pain Patients With Inadequately Controlled Pain Relief From Weak Opioids

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Feb 2, 2010
Registry last updated
Apr 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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