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

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ClinicalTrials.gov Identifier: NCT01795898
Recruitment Status : Completed
First Posted : February 21, 2013
Results First Posted : July 15, 2013
Last Update Posted : July 15, 2013
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutica

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Osteoarthritis
Low Back Pain
Intervention Drug: Fentanyl
Enrollment 237
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Fentanyl
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 237
Completed 177
Not Completed 60
Reason Not Completed
Adverse Event             27
Lost to Follow-up             20
Withdrawal of consent             6
Diagnosed with metastasis             1
No pain             1
Death             1
Withdrew consent & had adverse events             3
Physician Decision             1
Arm/Group Title Fentanyl
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 237
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 237 participants
48.202  (11.137)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 237 participants
Female
174
  73.4%
Male
63
  26.6%
Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score: Clinician   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 237 participants
Not evaluated 46
No change 21
Minimally improved 38
Much improved 93
Very Much improved 5
[1]
Measure Description: 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. Here, 'N' signifies the participants analyzed for this study specific Baseline characteristic and is Intent-to-treat population defined as all the participants who received at least 1 dose of study medication and had at least 1 follow-up visit with assessment=203.
Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score: Participant   [1] 
Measure Type: Number
Unit of measure:  Participant
Number Analyzed 237 participants
Not evaluated 46
No change 21
Minimally improved 40
Much improved 88
Very Much improved 8
[1]
Measure Description: 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. Number of participants analysed for this study specific Baseline characteristic=203.
1.Primary Outcome
Title Change From Baseline in Brief Pain Inventory (BPI) Severity Score at Day 30
Hide Description 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.
Time Frame Baseline and Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Fentanyl
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 203
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline: Worst 7.20  (1.922)
Baseline: Least 3.83  (1.904)
Baseline: Average 5.59  (1.682)
Baseline: Right now 5.49  (2.121)
Change at Day 30: Worst -5.000  (2.661)
Change at Day 30: Least -3.049  (2.124)
Change at Day 30: Average -4.246  (2.096)
Change at Day 30: Right now -4.404  (2.464)
2.Primary Outcome
Title Change From Baseline in Brief Pain Inventory (BPI) Interference Score at Day 30
Hide Description 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.
Time Frame Baseline and Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Fentanyl
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 203
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline: General activity 5.73  (2.020)
Baseline: Mood 4.94  (2.288)
Baseline: Walking ability 5.25  (2.417)
Baseline: Normal work 5.34  (2.242)
Baseline: Relationship w/others 4.33  (2.345)
Baseline: Sleep 5.05  (2.430)
Baseline: Enjoyment of life 4.71  (2.513)
Change at Day 30: General activity -4.502  (2.470)
Change at Day 30: Mood -4.118  (2.487)
Change at Day 30: Walking ability -4.182  (2.618)
Change at Day 30: Normal work -4.251  (2.504)
Change at Day 30: Relationship w/others -3.700  (2.486)
Change at Day 30: Sleep -4.355  (2.639)
Change at Day 30: Enjoyment of life -3.966  (2.611)
3.Primary Outcome
Title Number of Participants Requiring Rescue Medication
Hide Description 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.
Time Frame Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Fentanyl
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 237
Measure Type: Number
Unit of Measure: Participants
41
4.Primary Outcome
Title Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score: Clinician
Hide Description 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.
Time Frame Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Fentanyl
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 203
Measure Type: Number
Unit of Measure: Participants
Very much worse 1
No change 5
Minimally improved 16
Much improved 30
Very Much improved 151
5.Primary Outcome
Title Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score: Participant
Hide Description 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.
Time Frame Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Fentanyl
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 203
Measure Type: Number
Unit of Measure: Participants
Very much worse 1
Minimally worse 1
No change 5
Minimally improved 14
Much improved 33
Very Much improved 149
Time Frame Baseline up to Day 30
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fentanyl
Hide Arm/Group Description 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.
All-Cause Mortality
Fentanyl
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Fentanyl
Affected / at Risk (%)
Total   5/237 (2.11%) 
Cardiac disorders   
Bradycardia *  1/237 (0.42%) 
Palpitations *  1/237 (0.42%) 
Gastrointestinal disorders   
Nausea *  2/237 (0.84%) 
Vomiting *  2/237 (0.84%) 
Musculoskeletal and connective tissue disorders   
Musculoskeletal pain *  1/237 (0.42%) 
Nervous system disorders   
Hypoaesthesia *  1/237 (0.42%) 
Dizziness *  1/237 (0.42%) 
Skin and subcutaneous tissue disorders   
Erythema nodosum *  1/237 (0.42%) 
Vascular disorders   
Aneurysm ruptured *  1/1 (100.00%) 
Hypertension *  1/237 (0.42%) 
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Fentanyl
Affected / at Risk (%)
Total   156/237 (65.82%) 
General disorders   
Dizziness *  128/237 (54.01%) 
Nausea *  92/237 (38.82%) 
Vomiting *  61/237 (25.74%) 
Somnolence *  39/237 (16.46%) 
Pruritus *  13/237 (5.49%) 
Insomnia *  5/237 (2.11%) 
Headache *  4/237 (1.69%) 
Palpitation *  3/237 (1.27%) 
Rashes *  3/237 (1.27%) 
Weakness *  3/237 (1.27%) 
Chest pain *  2/237 (0.84%) 
Cold clammy perspiration *  2/237 (0.84%) 
Flushing *  2/237 (0.84%) 
Muscle trembling *  2/237 (0.84%) 
Arm heaviness *  1/237 (0.42%) 
Blurring of vision *  1/237 (0.42%) 
Chills *  1/237 (0.42%) 
Constipation *  3/237 (1.27%) 
Dryness of mouth *  1/237 (0.42%) 
Dyspepsia *  1/237 (0.42%) 
Hematoma *  1/237 (0.42%) 
Hypertension *  1/237 (0.42%) 
Swelling of both ankles *  1/237 (0.42%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Medical Affairs Manager
Organization: Janssen Philippines
Phone: +632-8247901
Responsible Party: Janssen Pharmaceutica
ClinicalTrials.gov Identifier: NCT01795898     History of Changes
Other Study ID Numbers: CR015268
FENPAI4074
First Submitted: February 19, 2013
First Posted: February 21, 2013
Results First Submitted: March 18, 2013
Results First Posted: July 15, 2013
Last Update Posted: July 15, 2013