NCT01774929

Brief 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 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2008

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

January 21, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 24, 2013

Completed
4 months until next milestone

Results Posted

Study results publicly available

May 22, 2013

Completed
Last Updated

May 22, 2013

Status Verified

April 1, 2013

Enrollment Period

6 months

First QC Date

January 21, 2013

Results QC Date

February 13, 2013

Last Update Submit

April 11, 2013

Conditions

Osteoarthritis

Keywords

OsteoarthritisTransdermal Therapeutic System (TTS)-fentanylDurogesic

Outcome Measures

Primary Outcomes (2)

  • Pain Intensity Score at 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

    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 Outcomes (1)

  • Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) Score at Day 15 and Day 30

    Baseline, Day 15 and Day 30

Study Arms (1)

Transdermal Therapeutic System (TTS)-fentanyl

EXPERIMENTAL

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

Interventions

TTS-fentanylDRUG

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.

Transdermal Therapeutic System (TTS)-fentanyl

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Bangkok, Thailand

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Results Point of Contact

Title
Medical Affairs Director
Organization
Medical Affairs, Janssen-Cilag (Thailand)
662-792-7200

Study Officials

  • Janssen-Cilag Ltd.,Thailand Clinical Trial

    Janssen-Cilag Ltd.,Thailand

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2013

First Posted

January 24, 2013

Study Start

October 1, 2008

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

May 22, 2013

Results First Posted

May 22, 2013

Record last verified: 2013-04

Locations

TH(1)