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A Confirmatory Study of Fentanyl in Participants With Osteoarthritis or Low Back Pain

NCT01008618 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 218

Last updated 2013-12-25

Study results available
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Summary

The purpose of this study is to evaluate efficacy and safety of fentanyl in opioid-naive participants with osteoarthritis (disorder, which is seen mostly in older persons, in which the joints become painful and stuff) or low back pain who cannot obtain a sufficient analgesic effect by the treatment of non-opioid analgesics (drug used to control pain).

Conditions

Interventions

DRUG

Fentanyl

One-day adhesive transdermal patch containing fentanyl 12.5 to 50 mcg/hr applied to chest, abdomen, upper arm or thigh and replaced every day.

DRUG

Placebo

Placebo patch indistinguishable from one-day adhesive transdermal patch containing fentanyl 12.5 to 50 mcg/hr applied to chest, abdomen, upper arm or thigh and replaced every day.

Sponsors & Collaborators

  • Janssen Pharmaceutical K.K.

    lead INDUSTRY

Principal Investigators

  • Janssen Pharmaceutical K.K., Japan Clinical Trial · Janssen Pharmaceutical K.K.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2010-02-28
Completion
2010-02-28

Countries

  • Japan

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01008618 on ClinicalTrials.gov