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

NCT01816503 | Completed

• 3 other identifiers: CR015778FENPAI4084FEN-KOR-5027
• Study Type: observational
• Target: 636
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Pain

Keywords

Pain; Cancer pain; Fentanyl; Fentanyl matrix; Opioid analgesic

Outcome Measures

Primary Outcomes (1)

• The percentage of patients who are very satisfied or satisfied with the pain treatment after the study drug administration

  The overall satisfaction is measured by a 5-point scale. Patients' answers are rated as: "very satisfied", "satisfied", "fair", "dissatisfied", or "very dissatisfied".

  Day 10

Secondary Outcomes (8)

• The change from baseline in pain intensity

  Baseline, up to Day 10

• The change from baseline in Karnofsky Performance Status Scale

  Baseline, Day 10

• Sleep disturbance caused by the number of awakening caused by pain the patient experienced over the last night

  10 days

• Sleep disturbance caused by pain the patient experienced over the last 24 hours

  10 days

• The change from baseline in Clinical Global Impression - Improvement (CGI-I)

  Baseline, Day 10

Study Arms (1)

Fentanyl matrix

Drug: No intervention

Interventions

No intervention 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.

Fentanyl matrix

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Korea, Ltd., Korea: lead

MeSH Terms

Conditions

Pain; Cancer Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Janssen Korea, Ltd., Korea Clinical Trial

  Janssen Korea, Ltd., Korea

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2013
• First Posted: March 22, 2013
• Study Start: December 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: March 22, 2013

Record last verified: 2013-03