CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 218 enrolled
Drug / intervention
Fentanyl +1 moredrug
Likely dose
Fentanyl 50 mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01008618
NCT01008618Phase 3Completed
CompareCT.gov

A Verification Study of JNS020QD in Patients With Osteoarthritis or Low Back Pain

Janssen Pharmaceutical K.K.·interventional·Posted Nov 6, 2009·Updated Dec 25, 2013

In Brief

A Phase 3 clinical trial evaluating Fentanyl and Placebo for Chronic Pain and 2 related conditions. Completed, enrolled 218 participants across 59 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Pain, Osteoarthritis, Low Back Pain
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 6, 2009
Enrollment StartJan 1, 2009
Primary CompletionFeb 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 16.7 years ago

Interventions

Fentanyldrug

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.

Placebodrug

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.