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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag Ltd.,Thailand
ClinicalTrials.gov Identifier:
NCT01774903
First received: January 21, 2013
Last updated: February 18, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Low Back Pain
Drug: TTS-fentanyl
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation Study of Efficacy and Safety of TTS-Fentanyl in Severe Chronic Low Back Pain

Resource links provided by NLM:


Further study details as provided by Janssen-Cilag Ltd.,Thailand:

Primary Outcome Measures:
  • Pain Intensity at Day 15 [ Time Frame: Day 15 ] [ Designated as safety issue: No ]
    Pain control was assessed by using a 10 centimeter (cm) visual analog scale (VAS) ranging from 0 to 10, where 0 cm=no pain and 10 cm=worse pain.

  • Pain Intensity at Day 30 [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
    Pain control was assessed by using a 10 cm VAS ranging from 0 to 10, where 0 cm=no pain and 10 cm=worse pain.


Secondary Outcome Measures:
  • Number of Participants With Investigator Global Assessment [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
    Investigator completed a global assessment of the participants treatment with respect to pain control using a 9-point scale (-4 to 4; where, -4=100 percent worse, 0=unchanged and 4=100 percent improvement), safety using 5-point scale (1 to 5; where, 1=no, 2=mild, 3=moderate, 4=severe and 5=most severe side effects) and 5-point overall satisfaction scale (1-5; where, 1=no, 2=mild, 3=moderate, 4=good, 5=excellent).

  • Number of Participants With Participant Global Assessment [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
    Participants completed a global assessment with respect to pain control using a 9-point scale (-4 to 4; where, -4=100 percent worse, 0=unchanged and 4=100 percent improvement), safety using 5-point scale (1 to 5; where, 1=no, 2=Mild, 3=Moderate, 4=Severe and 5=most severe side effects) and 5-point overall satisfaction scale (1-5; where, 1=no, 2=mild, 3=moderate, 4=good, 5=excellent).


Enrollment: 45
Study Start Date: August 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TTS-fentanyl Drug: TTS-fentanyl
TTS-fentanyl patches releasing drug at the rate of 12.5 microgram (µg) per hour for 3 days. The patches will be replaced every 3 days until 30 days.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01774903

Locations
Thailand
Bangkok, Thailand
Sponsors and Collaborators
Janssen-Cilag Ltd.,Thailand
Investigators
Study Director: Janssen-Cilag Ltd.,Thailand Clinical trial Janssen-Cilag Ltd.,Thailand
  More Information

No publications provided

Responsible Party: Janssen-Cilag Ltd.,Thailand
ClinicalTrials.gov Identifier: NCT01774903     History of Changes
Other Study ID Numbers: CR014533, FENPAI4051
Study First Received: January 21, 2013
Results First Received: February 18, 2013
Last Updated: February 18, 2013
Health Authority: Thailand: Food and Drug Administration, Ministry of Public Health

Keywords provided by Janssen-Cilag Ltd.,Thailand:
Low Back Pain
TTS-fentanyl
Durogesic

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Fentanyl
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on September 18, 2014