An Efficacy and Safety Study of Transdermal Therapeutic System (TTS)-Fentanyl in Participants With Osteoarthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag Ltd.,Thailand
ClinicalTrials.gov Identifier:
NCT01774929
First received: January 21, 2013
Last updated: April 11, 2013
Last verified: April 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 participants with moderate (medium level of seriousness) to severe (very serious, life threatening) pain of osteoarthritis (disorder, which is seen mostly in older persons, in which the joints become painful and stiff).


Condition Intervention Phase
Osteoarthritis
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 of Efficacy and Safety of TTS-Fentanyl in Moderate to Severe Pain in Osteoarthritis Patients

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Pain Intensity Score at Day 15 [ Time Frame: Day 15 ] [ Designated as safety issue: No ]
    The pain intensity was assessed by using a 10 centimeter (cm) Visual Analog Scale (VAS) ranging from 0 cm=no pain to 10 cm=worse pain.

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


Secondary Outcome Measures:
  • Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) Score at Day 15 and Day 30 [ Time Frame: Baseline, Day 15 and Day 30 ] [ Designated as safety issue: No ]
    The WOMAC is a self-administered; participant reported health status questionnaire designed to capture elements of pain, stiffness and physical impairment in participants with osteoarthritis. It consists of 24 questions (5 questions about pain, 2 about stiffness and 17 about physical function) scored on a VAS of 0 to 10 cm (0 cm=no pain to 10 cm=worse pain). Individual question responses are assigned a score of between 0=extreme and 4=none. Maximum scores for each element differ and therefore, scores were normalized. Total normalized score ranges from 0=worst to 100=best.


Enrollment: 35
Study Start Date: October 2008
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Transdermal Therapeutic System (TTS)-fentanyl
TTS-fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches will be replaced every 3 days until 30 days.
Drug: TTS-fentanyl
TTS-fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches will be replaced every 3 days until 30 days.

Detailed Description:

This is an open-label (a medical research study in which participants and researchers are told which treatments the participants are receiving, "unblinded"), single-arm, prospective (study following participants forward in time), study of TTS-fentanyl in participants with moderate to severe pain of osteoarthritis. The study will consist of 2 phases: screening phase up to 7 days before starting the treatment and treatment phase of 30 days. The first patch will be applied by investigator then by participants until 30 days. The dose of TTS-fentanyl can be increased, if needed, by 12.5 microgram per hour until adequate (reasonably good) pain control is achieved and taking into account the daily dose of supplemental paracetamol required by the participant. Other concomitant (given at the same time) analgesics (drug used to control pain) will not be used during this phase. Efficacy with regard to pain control will be recorded principally by the participant through questionnaires in a daily diary. This record will be used to support more detailed assessments at study visits on Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire. Participants' safety will be monitored.

  Eligibility

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

Inclusion Criteria:

  • Chronic (lasting a long time) primary osteoarthritis pain for more than 3 months with Visual Analog Scale (VAS) greater than or equal to 5
  • Participants having moderate to severe pain (VAS greater than or equal to 5), which was not adequately controlled by weak opioids such as tramadol or codeine at optimal doses (at least 150 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

Exclusion Criteria:

  • Skin disease that prevents 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
  • Confusion, reduced level of consciousness, or concomitant (given at the same time) psychiatric disorder which, in the opinion of the investigator, could prevent participation in the trial
  • Pregnant or breast-feeding female; female participants of child bearing potential without adequate contraception
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01774929

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: NCT01774929     History of Changes
Other Study ID Numbers: CR014536, FENPAI 4053
Study First Received: January 21, 2013
Results First Received: February 13, 2013
Last Updated: April 11, 2013
Health Authority: Thailand: Food and Drug Administration, Ministry of Public Health

Keywords provided by Janssen-Cilag Ltd.,Thailand:
Osteoarthritis
Transdermal Therapeutic System (TTS)-fentanyl
Durogesic

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Fentanyl
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid

ClinicalTrials.gov processed this record on April 23, 2014