Trial Outcomes & Findings for An Efficacy and Safety Study of Fentanyl Transdermal Patch in Filipino Participants With Osteoarthritis and Chronic Low Back Pain (NCT NCT01795898)

Last Updated: 2013-07-15

Results Overview

BPI is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions. BPI- severity consists of 4 questions (items) that assess pain intensity (worst, least, average, right now). Each question (item) is answered on a scale ranging from 0 to 10; '0=No pain and 10=Pain as bad as you can imagine'. Measure can be scored by item, with lower scores being indicative of less pain or pain interference. Change: Score at Day 30 minus score at Baseline.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

237 participants

Primary outcome timeframe

Baseline and Day 30

Results posted on

2013-07-15

Participant Flow

Participant milestones

Participant milestones
Measure	Fentanyl Fentanyl transdermal (through the skin) patches releasing 12.5 microgram (mcg) of fentanyl were applied for 3 days. The patches were replaced every 3 days (Day 3, 7 and 10) with an increase in dose by 12.5 mcg to a maximum of 50 mcg.
Overall Study STARTED	237
Overall Study COMPLETED	177
Overall Study NOT COMPLETED	60

Reasons for withdrawal

Reasons for withdrawal
Measure	Fentanyl Fentanyl transdermal (through the skin) patches releasing 12.5 microgram (mcg) of fentanyl were applied for 3 days. The patches were replaced every 3 days (Day 3, 7 and 10) with an increase in dose by 12.5 mcg to a maximum of 50 mcg.
Overall Study Adverse Event	27
Overall Study Lost to Follow-up	20
Overall Study Withdrawal of consent	6
Overall Study Diagnosed with metastasis	1
Overall Study No pain	1
Overall Study Death	1
Overall Study Withdrew consent & had adverse events	3
Overall Study Physician Decision	1

Baseline Characteristics

An Efficacy and Safety Study of Fentanyl Transdermal Patch in Filipino Participants With Osteoarthritis and Chronic Low Back Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fentanyl n=237 Participants Fentanyl transdermal patches releasing 12.5 mcg of fentanyl were applied for 3 days. The patches were replaced every 3 days (Day 3, 7 and 10) with an increase in dose by 12.5 mcg to a maximum of 50 mcg.
Age Continuous	48.202 Years STANDARD_DEVIATION 11.137 • n=5 Participants
Sex: Female, Male Female	174 Participants n=5 Participants
Sex: Female, Male Male	63 Participants n=5 Participants
Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score: Clinician Not evaluated	46 Participants n=5 Participants
Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score: Clinician No change	21 Participants n=5 Participants
Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score: Clinician Minimally improved	38 Participants n=5 Participants
Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score: Clinician Much improved	93 Participants n=5 Participants
Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score: Clinician Very Much improved	5 Participants n=5 Participants
Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score: Participant Not evaluated	46 Participant n=5 Participants
Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score: Participant No change	21 Participant n=5 Participants
Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score: Participant Minimally improved	40 Participant n=5 Participants
Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score: Participant Much improved	88 Participant n=5 Participants
Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score: Participant Very Much improved	8 Participant n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Day 30

Population: The intent-to-treat (ITT) population was defined as all the participants who received at least 1 dose of study medication and had at least 1 follow-up visit with assessment.

Outcome measures

Outcome measures
Measure	Fentanyl n=203 Participants Fentanyl transdermal patches releasing 12.5 mcg of fentanyl were applied for 3 days. The patches were replaced every 3 days (Day 3, 7 and 10) with an increase in dose by 12.5 mcg to a maximum of 50 mcg.
Change From Baseline in Brief Pain Inventory (BPI) Severity Score at Day 30 Baseline: Worst	7.20 Units on a scale Standard Deviation 1.922
Change From Baseline in Brief Pain Inventory (BPI) Severity Score at Day 30 Baseline: Least	3.83 Units on a scale Standard Deviation 1.904
Change From Baseline in Brief Pain Inventory (BPI) Severity Score at Day 30 Baseline: Average	5.59 Units on a scale Standard Deviation 1.682
Change From Baseline in Brief Pain Inventory (BPI) Severity Score at Day 30 Baseline: Right now	5.49 Units on a scale Standard Deviation 2.121
Change From Baseline in Brief Pain Inventory (BPI) Severity Score at Day 30 Change at Day 30: Worst	-5.000 Units on a scale Standard Deviation 2.661
Change From Baseline in Brief Pain Inventory (BPI) Severity Score at Day 30 Change at Day 30: Least	-3.049 Units on a scale Standard Deviation 2.124
Change From Baseline in Brief Pain Inventory (BPI) Severity Score at Day 30 Change at Day 30: Average	-4.246 Units on a scale Standard Deviation 2.096
Change From Baseline in Brief Pain Inventory (BPI) Severity Score at Day 30 Change at Day 30: Right now	-4.404 Units on a scale Standard Deviation 2.464

PRIMARY outcome

Timeframe: Baseline and Day 30

Population: The ITT population was defined as all the participants who received at least 1 dose of study medication and had at least 1 follow-up visit with assessment.

BPI is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions. BPI-interference consists of 7 questions (items) that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each question (item) is answered on a scale ranging from 0 to 10; '0=No pain and 10=Pain as bad as you can imagine'. Measure can be scored by item, with lower scores being indicative of less pain or pain interference. Change: Score at Day 30 minus score at Baseline.

Outcome measures

Outcome measures
Measure	Fentanyl n=203 Participants Fentanyl transdermal patches releasing 12.5 mcg of fentanyl were applied for 3 days. The patches were replaced every 3 days (Day 3, 7 and 10) with an increase in dose by 12.5 mcg to a maximum of 50 mcg.
Change From Baseline in Brief Pain Inventory (BPI) Interference Score at Day 30 Baseline: General activity	5.73 Units on a scale Standard Deviation 2.020
Change From Baseline in Brief Pain Inventory (BPI) Interference Score at Day 30 Baseline: Mood	4.94 Units on a scale Standard Deviation 2.288
Change From Baseline in Brief Pain Inventory (BPI) Interference Score at Day 30 Baseline: Walking ability	5.25 Units on a scale Standard Deviation 2.417
Change From Baseline in Brief Pain Inventory (BPI) Interference Score at Day 30 Baseline: Normal work	5.34 Units on a scale Standard Deviation 2.242
Change From Baseline in Brief Pain Inventory (BPI) Interference Score at Day 30 Baseline: Relationship w/others	4.33 Units on a scale Standard Deviation 2.345
Change From Baseline in Brief Pain Inventory (BPI) Interference Score at Day 30 Baseline: Sleep	5.05 Units on a scale Standard Deviation 2.430
Change From Baseline in Brief Pain Inventory (BPI) Interference Score at Day 30 Baseline: Enjoyment of life	4.71 Units on a scale Standard Deviation 2.513
Change From Baseline in Brief Pain Inventory (BPI) Interference Score at Day 30 Change at Day 30: General activity	-4.502 Units on a scale Standard Deviation 2.470
Change From Baseline in Brief Pain Inventory (BPI) Interference Score at Day 30 Change at Day 30: Mood	-4.118 Units on a scale Standard Deviation 2.487
Change From Baseline in Brief Pain Inventory (BPI) Interference Score at Day 30 Change at Day 30: Walking ability	-4.182 Units on a scale Standard Deviation 2.618
Change From Baseline in Brief Pain Inventory (BPI) Interference Score at Day 30 Change at Day 30: Normal work	-4.251 Units on a scale Standard Deviation 2.504
Change From Baseline in Brief Pain Inventory (BPI) Interference Score at Day 30 Change at Day 30: Relationship w/others	-3.700 Units on a scale Standard Deviation 2.486
Change From Baseline in Brief Pain Inventory (BPI) Interference Score at Day 30 Change at Day 30: Sleep	-4.355 Units on a scale Standard Deviation 2.639
Change From Baseline in Brief Pain Inventory (BPI) Interference Score at Day 30 Change at Day 30: Enjoyment of life	-3.966 Units on a scale Standard Deviation 2.611

PRIMARY outcome

Timeframe: Day 30

Population: All participants suffering from osteoarthritis (disorder, which is seen mostly in older persons, in which the joints become painful and stuff) and chronic (lasting a long time) low back pain and who took at least 1 dose of study medication and had at least 1 follow-up visit during the study.

Rescue medications are periodic supplemental doses of analgesic which might be required to control pain. Tramadol 50mg tablet at a maximum of 6 tablets per day was used as standard rescue medication.

Outcome measures

Outcome measures
Measure	Fentanyl n=237 Participants Fentanyl transdermal patches releasing 12.5 mcg of fentanyl were applied for 3 days. The patches were replaced every 3 days (Day 3, 7 and 10) with an increase in dose by 12.5 mcg to a maximum of 50 mcg.
Number of Participants Requiring Rescue Medication	41 Participants

PRIMARY outcome

Timeframe: Day 30

Population: The ITT population was defined as all the participants who received at least 1 dose of study medication and had at least 1 follow-up visit with assessment.

CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.

Outcome measures

Outcome measures
Measure	Fentanyl n=203 Participants Fentanyl transdermal patches releasing 12.5 mcg of fentanyl were applied for 3 days. The patches were replaced every 3 days (Day 3, 7 and 10) with an increase in dose by 12.5 mcg to a maximum of 50 mcg.
Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score: Clinician Very much worse	1 Participants
Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score: Clinician No change	5 Participants
Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score: Clinician Minimally improved	16 Participants
Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score: Clinician Much improved	30 Participants
Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score: Clinician Very Much improved	151 Participants

PRIMARY outcome

Timeframe: Day 30

Population: The ITT population was defined as all the participants who received at least 1 dose of study medication and had at least 1 follow-up visit with assessment.

CGI-I is a 7-point scale that requires the Participant to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.

Outcome measures

Outcome measures
Measure	Fentanyl n=203 Participants Fentanyl transdermal patches releasing 12.5 mcg of fentanyl were applied for 3 days. The patches were replaced every 3 days (Day 3, 7 and 10) with an increase in dose by 12.5 mcg to a maximum of 50 mcg.
Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score: Participant No change	5 Participants
Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score: Participant Very much worse	1 Participants
Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score: Participant Minimally worse	1 Participants
Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score: Participant Minimally improved	14 Participants
Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score: Participant Much improved	33 Participants
Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score: Participant Very Much improved	149 Participants

Adverse Events

Fentanyl

Serious events: 5 serious events

Other events: 156 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Fentanyl n=237 participants at risk Fentanyl transdermal patches releasing 12.5 mcg of fentanyl were applied for 3 days. The patches were replaced every 3 days (Day 3, 7 and 10) with an increase in dose by 12.5 mcg to a maximum of 50 mcg.
Gastrointestinal disorders Nausea	0.84% 2/237 • Baseline up to Day 30
Vascular disorders Aneurysm ruptured	100.0% 1/1 • Baseline up to Day 30
Gastrointestinal disorders Vomiting	0.84% 2/237 • Baseline up to Day 30
Cardiac disorders Bradycardia	0.42% 1/237 • Baseline up to Day 30
Skin and subcutaneous tissue disorders Erythema nodosum	0.42% 1/237 • Baseline up to Day 30
Vascular disorders Hypertension	0.42% 1/237 • Baseline up to Day 30
Nervous system disorders Hypoaesthesia	0.42% 1/237 • Baseline up to Day 30
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.42% 1/237 • Baseline up to Day 30
Cardiac disorders Palpitations	0.42% 1/237 • Baseline up to Day 30
Nervous system disorders Dizziness	0.42% 1/237 • Baseline up to Day 30

Other adverse events

Other adverse events
Measure	Fentanyl n=237 participants at risk Fentanyl transdermal patches releasing 12.5 mcg of fentanyl were applied for 3 days. The patches were replaced every 3 days (Day 3, 7 and 10) with an increase in dose by 12.5 mcg to a maximum of 50 mcg.
General disorders Dizziness	54.0% 128/237 • Baseline up to Day 30
General disorders Nausea	38.8% 92/237 • Baseline up to Day 30
General disorders Vomiting	25.7% 61/237 • Baseline up to Day 30
General disorders Somnolence	16.5% 39/237 • Baseline up to Day 30
General disorders Pruritus	5.5% 13/237 • Baseline up to Day 30
General disorders Insomnia	2.1% 5/237 • Baseline up to Day 30
General disorders Headache	1.7% 4/237 • Baseline up to Day 30
General disorders Palpitation	1.3% 3/237 • Baseline up to Day 30
General disorders Rashes	1.3% 3/237 • Baseline up to Day 30
General disorders Weakness	1.3% 3/237 • Baseline up to Day 30
General disorders Chest pain	0.84% 2/237 • Baseline up to Day 30
General disorders Cold clammy perspiration	0.84% 2/237 • Baseline up to Day 30
General disorders Flushing	0.84% 2/237 • Baseline up to Day 30
General disorders Muscle trembling	0.84% 2/237 • Baseline up to Day 30
General disorders Arm heaviness	0.42% 1/237 • Baseline up to Day 30
General disorders Blurring of vision	0.42% 1/237 • Baseline up to Day 30
General disorders Chills	0.42% 1/237 • Baseline up to Day 30
General disorders Constipation	1.3% 3/237 • Baseline up to Day 30
General disorders Dryness of mouth	0.42% 1/237 • Baseline up to Day 30
General disorders Dyspepsia	0.42% 1/237 • Baseline up to Day 30
General disorders Hematoma	0.42% 1/237 • Baseline up to Day 30
General disorders Hypertension	0.42% 1/237 • Baseline up to Day 30
General disorders Swelling of both ankles	0.42% 1/237 • Baseline up to Day 30

Additional Information

Medical Affairs Manager

Janssen Philippines

Phone: +632-8247901

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place