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

April 11, 2013 updated by: Janssen-Cilag Ltd.,Thailand

Evaluation of Efficacy and Safety of TTS-Fentanyl in Moderate to Severe Pain in Osteoarthritis Patients

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Intensity Score at Day 15
Time Frame: Day 15
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.
Day 15
Pain Intensity Score at Day 30
Time Frame: Day 30
The pain intensity was assessed by using a 10 cm VAS ranging from 0 cm=no pain to 10 cm=worse pain.
Day 30

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) Score at Day 15 and Day 30
Time Frame: Baseline, Day 15 and Day 30
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.
Baseline, Day 15 and Day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen-Cilag Ltd.,Thailand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

January 21, 2013

First Submitted That Met QC Criteria

January 23, 2013

First Posted (Estimate)

January 24, 2013

Study Record Updates

Last Update Posted (Estimate)

May 22, 2013

Last Update Submitted That Met QC Criteria

April 11, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR014536
  • FENPAI 4053

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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