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

NCT ID: NCT01795898

Last Updated: 2013-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 237 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2009-09-30

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.

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.

Conditions

Osteoarthritis; Low Back Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Fentanyl

Intervention Type: 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).

Interventions

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).

Intervention Type: DRUG

Other Intervention Names

DUROGESIC-D-TRANS

Eligibility 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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Pharmaceutica

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Pharmaceutica Clinical trial

Role: STUDY_DIRECTOR

Janssen Pharmaceutica

Locations

Quezon City, , Philippines

Countries

Philippines

Other Identifiers

FENPAI4074

Identifier Type: -

Identifier Source: secondary_id

CR015268

Identifier Type: -

Identifier Source: org_study_id