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An Efficacy and Safety Study of Transdermal Therapeutic System (TTS)-Fentanyl in Severe Chronic Low Back Pain

Information source: Janssen-Cilag Ltd.,Thailand
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Low Back Pain

Intervention: TTS-fentanyl (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Janssen-Cilag Ltd.,Thailand

Official(s) and/or principal investigator(s):
Janssen-Cilag Ltd.,Thailand Clinical trial, Study Director, Affiliation: Janssen-Cilag Ltd.,Thailand

Summary

The purpose of this study is to evaluate the efficacy and safety of Transdermal Therapeutic System (TTS)-fentanyl patch (transdermal patch containing a drug that is put on the skin so the drug will enter the body through the skin) in severe (very serious, life threatening) chronic (lasting a long time) low back pain in Thai participants.

Clinical Details

Official title: Evaluation Study of Efficacy and Safety of TTS-Fentanyl in Severe Chronic Low Back Pain

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

Primary outcome:

Pain Intensity at Day 15

Pain Intensity at Day 30

Secondary outcome:

Number of Participants With Investigator Global Assessment

Number of Participants With Participant Global Assessment

Detailed description: This is an open label (all people know the identity of the intervention), single arm, prospective (study following participants forward in time) study conducted to assess the efficacy and safety of TTS-fentanyl in Thai participants with chronic low back pain. All participants start treatment with 12. 5 micrograms (µg) per hour patch. The patches will be replaced every 3 days. On Day 3, and every 3 days thereafter, the TTS-fentanyl dose increases will be considered based on rescue medication consumption and pain assessment. No increase in TTS-fentanyl dose will be performed within the 72-hour dosing interval. The duration of the treatment will be 30 days. Primary efficacy assessment will be pain control rated by participants. Assessment time points will be at Day 0 (baseline), on Day 15 and Day 30 (trial end). At the end of study, global preference on efficacy, side effects and overall satisfaction will also be rated by investigator and participants. Participants' safety will be monitored throughout the study.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: - Chronic low back pain with moderate to severe pain at least 3 months

- Participants needed to be treated with strong opioid and haven't been treated with strong

opioid in the past - Participants who still had moderate to severe pain (Visual Analog

Scale [VAS] >= 4), which was not adequately controlled by weak opioids such as tramadol or codeine at optimal doses (at least 120 milligram [mg] per day for tramadol or 200 mg per day for codeine) for at least 7 consecutive days

- Participants who failed from other treatments such as operation or lack of efficacy of

current treatment - Participant who has signed the informed consent form Exclusion

Criteria: - Skin disease that prevent the use of the transdermal system or which could

affect the absorption of fentanyl or local tolerability - History or suspicion of alcohol

or drug abuse within the past 5 years - History of cardiac, nervous system or respiratory

disease which in the investigator's judgment precludes participation in the study because

of the potential for respiratory depression - Concomitant use of Non Steroidal

Anti-Inflammatory Drugs (NSAIDs), Cyclooxygenase - 2 (COX-2), muscle relaxant, topical

analgesic during the previous week (unless on stable drug dose for at least 1 month before

study entry) - Pregnancy or breast-feeding female; female participants of childbearing

potential without adequate contraception

Locations and Contacts

Bangkok, Thailand
Additional Information

Starting date: August 2008
Last updated: February 18, 2013

Page last updated: August 23, 2015

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