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Completed

NCT Number: NCT01795898

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

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.

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Key information

Conditions

Osteoarthritis Arthritis Back Pain Joint Diseases Low Back Pain Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Quezon City, Philippines

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fentanyl

Drug

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 names: DUROGESIC-D-TRANS

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Janssen Pharmaceutica

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Feb 21, 2013
Registry last updated
Jul 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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