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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 Description
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Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of fentanyl among Filipino participants with osteoarthritis (disorder which is seen mostly in older persons in which the joints become painful and stiff) and chronic (lasting a long time) low back pain.

Condition or disease Intervention/treatment Phase
Osteoarthritis Low Back Pain Drug: Fentanyl Phase 4

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 and prospective study (study following participants forward in time) of fentanyl in participants with osteoarthritis and Chronic low back pain with moderate (medium level of seriousness) and severe (very serious, life threatening) pain levels. Participants will be treated with fentanyl transdermal patch (patch containing a drug that is put on the skin so the drug will enter the body through the skin) starting with 12.5 microgram (mcg) dose of fentanyl. The dose will be increased on Day 3, if needed, by 12.5 mcg. Dose adjustments will be done every 3 days. Maximum of 50 mcg dose of fentanyl will be allowed. Participants will be evaluated for pain levels and quality of life using Brief pain inventory (BPI) score and Clinical global impression-severity (CGI-S) score. Tramadol 50 milligram tablet at a maximum of 6 tablets per day will be used as supplemental doses of analgesic (drug used to control pain). Participants' safety will be monitored through out the study.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 237 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy, Safety and Quality of Life Outcome of Fentanyl Transdermal Patch (Durogesic-D-Trans) Among Filipino Patients With Osteoarthritis and Chronic Low Back Pain
Study Start Date : January 2009
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Fentanyl transdermal patch
Fentanyl transdermal patches releasing 12.5 microgram of fentanyl will be applied for 3 days. The patches will be replaced every 3 days (Day 3, 7 and 10).
 Drug: Fentanyl
Fentanyl transdermal patches releasing 12.5 microgram of fentanyl will be applied for 3 days. The patches will be replaced every 3 days (Day 3, 7 and 10).
Other Name: DUROGESIC-D-TRANS


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline in Brief Pain Inventory (BPI) Severity Score at Day 30 [ Time Frame: Baseline and Day 30 ]
    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.

  2. Change From Baseline in Brief Pain Inventory (BPI) Interference Score at Day 30 [ Time Frame: Baseline and Day 30 ]
    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.

  3. Number of Participants Requiring Rescue Medication [ Time Frame: Day 30 ]
    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.

  4. Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score: Clinician [ Time Frame: Day 30 ]
    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.

  5. Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score: Participant [ Time Frame: Day 30 ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants diagnosed with osteoarthritis and chronic low back pain
  • 3 months of persistent moderate to severe pain levels
  • More than 3 times a week frequency or daily moderate to severe pain
  • Moderate to severe pain at Baseline (at least a score of 4 in the 11-point numerical pain scale) Exclusion Criteria
  • History of allergy to fentanyl transdermal patch or its components and history of illicit drug use for the past 3 months
  • Active skin disease preventing application of the transdermal system
  • Chronic pulmonary disease (lung disorder)
  • Participants susceptible to intracranial (inside the skull) effects of carbon dioxide retention
  • Pregnant and breastfeeding mothers
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01795898


Locations
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Philippines
Quezon City, Philippines
Sponsors and Collaborators
Janssen Pharmaceutica
Investigators
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Study Director: Janssen Pharmaceutica Clinical trial Janssen Pharmaceutica
More Information
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Responsible Party: Janssen Pharmaceutica
ClinicalTrials.gov Identifier: NCT01795898    
Other Study ID Numbers: CR015268
FENPAI4074
First Posted: February 21, 2013    Key Record Dates
Results First Posted: July 15, 2013
Last Update Posted: July 15, 2013
Last Verified: June 2013
Keywords provided by Janssen Pharmaceutica:
Osteoarthritis
Low back pain
Fentanyl transdermal patch
Durogesic-D-Trans
Additional relevant MeSH terms:
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Osteoarthritis
Back Pain
Low Back Pain
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Pain
Neurologic Manifestations
Fentanyl
Analgesics, Opioid
 Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics