NCT01816243View on ClinicalTrials.gov

An Efficacy and Safety Study of Transdermal Therapeutic System (TTS)-Fentanyl in Thai Participants With Chronic Non-Malignant Pain

PHASE4CompletedINTERVENTIONAL
Enrollment

39

Participants

Timeline

Start Date

April 30, 2004

Primary Completion Date

March 31, 2008

Study Completion Date

March 31, 2008

Conditions
Chronic Pain
Interventions
DRUG

TTS-Fentanyl

Transdermal Therapeutic System (TTS)-fentanyl patches releasing fentanyl in the range of 12.5 to 100 microgram per hour (mcg/hr) rate. The initial dose of fentanyl TTS will be calculated based on each participant's opioid requirement. Patches will be usually replaced every 72 hours. Doses will be escalated in steps of 25 mcg/hr, if pain cannot be controlled. The study duration will be 30 days after first patch application.

DRUG

Morphine

Participants will be allowed the use of oral morphine syrup for the duration of TTS-fentanyl treatment to enable appropriate dose titration. It is expected that most of the participants will be titrated to an appropriate dose of TTS-fentanyl within 1 week.

Trial Locations (2)

Unknown

Department of Anesthesia, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok

Bangkok

All Listed Sponsors
lead

Janssen-Cilag Ltd.,Thailand

INDUSTRY

NCT01816243 - An Efficacy and Safety Study of Transdermal Therapeutic System (TTS)-Fentanyl in Thai Participants With Chronic Non-Malignant Pain | Biotech Hunter | Biotech Hunter