Trial Outcomes & Findings for Efficacy and Safety Study of Transdermal Therapeutic System (TTS) Fentanyl in Participants With Osteoarthritis Knee Pain (NCT NCT01742897)

Last Updated: 2013-07-03

Results Overview

The WOMAC is a self administered, participant health related questionnaire consisting of three subscales (pain, stiffness and physical function). Pain subscale score ranges from 0-100 mm (0 mm=no pain to 100 mm=extreme pain); stiffness subscale score ranges from 0-100 mm (0 mm=no stiffness to 100 mm=extreme stiffness) and physical function subscale ranges from 0-100 mm (0 mm=no difficulty to 100 mm=extreme difficulty). The overall WOMAC score is the sum of the 3 subscale scores which ranges from 0-300 mm (0 mm=none to 300 mm=extreme/worst).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

35 participants

Primary outcome timeframe

Baseline, Day 30

Results posted on

2013-07-03

Participant Flow

Participant milestones

Participant milestones
Measure	TTS-Fentanyl Transdermal therapeutic system (TTS) fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches were replaced every 3 days until 30 days.
Overall Study STARTED	35
Overall Study Treated	33
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	TTS-Fentanyl Transdermal therapeutic system (TTS) fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches were replaced every 3 days until 30 days.
Overall Study Adverse Event	3
Overall Study Withdrawal by Subject	1
Overall Study Other	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TTS-Fentanyl n=35 Participants Transdermal therapeutic system (TTS) fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches were replaced every 3 days until 30 days.
Age Continuous	66.34 Years STANDARD_DEVIATION 6.11 • n=5 Participants
Sex: Female, Male Female	34 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) Scores Pain	43.9 Millimeter (mm) STANDARD_DEVIATION 1.51 • n=5 Participants
Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) Scores Stiffness	41.6 Millimeter (mm) STANDARD_DEVIATION 1.92 • n=5 Participants
Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) Scores Physical function	47.6 Millimeter (mm) STANDARD_DEVIATION 1.12 • n=5 Participants
Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) Scores Overall	133.1 Millimeter (mm) STANDARD_DEVIATION 4.04 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Day 30

Population: Intent-to-treat (ITT) analysis population included all participants regardless of their compliance with the protocol.

Outcome measures

Outcome measures
Measure	TTS-Fentanyl n=35 Participants Transdermal therapeutic system (TTS) fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches were replaced every 3 days until 30 days.
Change From Baseline in Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) Score at Day 30 Pain	-22.2 Millimeter (mm) Interval -28.42 to -15.97
Change From Baseline in Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) Score at Day 30 Stiffness	-21.5 Millimeter (mm) Interval -28.66 to -14.26
Change From Baseline in Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) Score at Day 30 Physical function	-29.5 Millimeter (mm) Interval -34.06 to -24.93
Change From Baseline in Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) Score at Day 30 Overall	-73.2 Millimeter (mm) Interval -88.63 to -57.67

Adverse Events

TTS-Fentanyl

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	TTS-Fentanyl n=33 participants at risk Transdermal therapeutic system (TTS) fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches were replaced every 3 days until 30 days.
General disorders Nausea	21.2% 7/33
General disorders Vomiting	21.2% 7/33
General disorders Dizziness	6.1% 2/33

Additional Information

Medical Affairs Director

Medical Affairs, Janssen-Cilag (Thailand)

Phone: 662-739-7200

Results disclosure agreements

Principal investigator is a sponsor employee Company shall have right to publish data or information generated in trial without approval of Principal Investigator (PI). PI shall have right to publish results and information provided by Company if necessary. Prior to submission, PI will provide company 60 days for review. No paper with confidential Information will be submitted without company consent. If requested, PI will withhold it for 60 days to allow patent application filing. PI warrants compliance of all personnel involved in Study.
Publication restrictions are in place

Restriction type: OTHER