Fentanyl Matrix Application for Cancer Pain: Multicenter, Prospective, Observational Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

636 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-12-31

Study Completion Date

2009-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to show the clinical usefulness of fentanyl matrix by measuring satisfaction with pain treatment after administering fentanyl matrix in patients whose pain was not controlled sufficiently with the previous analgesic use in real practice at the investigator's discretion.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Effectiveness and Tolerability of Fentanyl Matrix in Chronic Non-cancer Pain; Assessment of Patient's Pain Treatment Goal Achievement

NCT01688583

Chronic Pain

COMPLETED

A Study to Evaluate the Safety and Effectiveness of Fentanyl-TTS Compared to Weak Opioids in Patients With Moderate to Severe Chronic Cancer Pain Previously Treated With NSAIDS (Non-steroidal Anti-inflammatory Drugs).

NCT00576017

Pain

COMPLETED PHASE4

Phase II Clinical Trial of Fentanyl Transdermal Matrix Patch, in the Management of Cancer Pain- Assessment of Effectiveness, Safety and Pharmacokinetics -

NCT00216658

Pain, Intractable

COMPLETED PHASE2

Study on Impact of Fentanyl Matrix on Improvement of Pain and Functioning in Spinal Disorder-related Pain

NCT00797017

Low Back Pain

COMPLETED

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

NCT01060124

Pain; Cancer

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a multi-center, open-label (all people know the identity of the intervention), prospective (the patients are identified and then followed forward in time for the outcome of the study) observational study. The study population comprises patients who are admitted to a study center during the study period and are receiving a strong oral long-acting opioid analgesic but deemed to control pain insufficiently. Since this study is an observational study conducted in real practice, a dose of fentanyl matrix should be adjusted depending on an individual patient's response at the investigator's discretion. However, for the patients whose pain is not sufficiently controlled despite administration of strong long-acting opioid analgesics, the minimum initial dose will be fentanyl matrix 75 micrograms/h and the investigator can adjust dosage according to the degree of the patients' pain control during the 9 days of the study period.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Fentanyl matrix

No intervention

Intervention Type DRUG

This is an observational study. The minimum initial dose will be fentanyl matrix 75 micrograms/h and the investigator can adjust the dosage according to the degree of the patients' pain control during the 9 days of the study period. Fentanyl matrix is a transdermal patch that is applied on the patient's skin.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

No intervention

This is an observational study. The minimum initial dose will be fentanyl matrix 75 micrograms/h and the investigator can adjust the dosage according to the degree of the patients' pain control during the 9 days of the study period. Fentanyl matrix is a transdermal patch that is applied on the patient's skin.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients complaining of cancer pain which requires administration of long-acting opioid analgesics
* Patients whose pain is not sufficiently controlled despite administration of strong long-acting opioid analgesics
* Patients who are deemed to need an initial minimum dose of fentanyl matrix 75 micrograms/h
* Patients who signed the informed consent form

Exclusion Criteria

* Patients with a history of or current drug or alcohol abuse
* Childbearing women who are pregnant or likely to be pregnant during the study period and men who are neither infertile nor willing to refrain from sexual relations but whose partner does not conduct an effective contraception
* Patients who are unable to use a transdermal system due to skin disease
* Patients with history of hypersensitivity to opioid analgesics
* Patients who are not eligible for the study participation based on warnings, precautions and contraindications in the package insert of the study drug at the investigator's discretion

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No