Completed

Efficacy, Safety and Quality of Life Outcome of Fentanyl Transdermal Patch (Durogesic-D-Trans) Among Filipino Patients With Osteoarthritis and Chronic Low Back Pain

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What is being tested

Fentanyl

Drug
Who is being recruted

Arthritis+8

+ Back Pain

+ Joint Diseases

From 18 to 65 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: January 2009
See protocol details

Summary

Principal SponsorJanssen Pharmaceutica
Last updated: July 15, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2009

Actual date on which the first participant was enrolled.

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.

NCT01795898
Principal SponsorJanssen Pharmaceutica
Last updated: July 15, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

237 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ArthritisBack PainJoint DiseasesMusculoskeletal DiseasesNeurologic ManifestationsPainRheumatic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsOsteoarthritisLow Back Pain

Criteria

4 inclusion criteria required to participate
3 months of persistent moderate to severe pain levels
Moderate to severe pain at Baseline (at least a score of 4 in the 11-point numerical pain scale)
More than 3 times a week frequency or daily moderate to severe pain
Participants diagnosed with osteoarthritis and chronic low back pain
5 exclusion criteria prevent from participating
Active skin disease preventing application of the transdermal system
Chronic pulmonary disease (lung disorder)
History of allergy to fentanyl transdermal patch or its components and history of illicit drug use for the past 3 months
Participants susceptible to intracranial (inside the skull) effects of carbon dioxide retention
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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).

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Quezon City, PhilippinesOpen in Google Maps
CompletedOne Study Center