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

Information source: Janssen Pharmaceutical K.K.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Pain; Osteoarthritis; Low Back Pain

Intervention: Fentanyl (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Janssen Pharmaceutical K.K.

Official(s) and/or principal investigator(s):
Janssen Pharmaceutical K.K., Japan Clinical Trial, Study Director, Affiliation: Janssen Pharmaceutical K.K.

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).

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Time From the Initial Day of Application in Double-Blind Period to Withdrawal Because of Insufficient Analgesic Efficacy

Secondary outcome:

Pain Visual Analog Scale (VAS) Score - Titration Period

Pain Visual Analog Scale (VAS) Score - Double-Blind Period

Number of Participants Evaluated as Per Participant's Overall Assessment - Titration Period

Number of Participants Evaluated as Per Participant's Overall Assessment - Double-Blind Period

Number of Doses of Rescue Treatment Per Day - Titration Period

Number of Doses of Rescue Treatment Per Day - Double-Blind Period

Brief Pain Inventory Short Form (BPI-sf) Score - Titration Period

Brief Pain Inventory Short Form (BPI-sf) Score - Double-Blind Period

Short-Form 36-Item Health Survey Version 2.0 (SF-36v2) - Titration Period

Short-Form 36-Item Health Survey Version 2.0 (SF-36v2) - Double-Blind Period:

Number of Participants Evaluated as Per Physician's Overall Assessment - Titration Period

Number of Participants Evaluated as Per Physician's Overall Assessment - Double-Blind Period

Detailed description: This is a multi-center (conducted in more than one center), double-blind (neither the participant nor the physician knows the assigned study drug), randomized (participants assigned study drug by chance), withdrawal study in opioid-naive participants with osteoarthritis or low back pain. The study will consist of titration period (10-29 days) and double-blind period (12 weeks) and the visits will include Day 5-7, 8, 15, 29 in titration period and Day 2-4, 8, 15, 22, 29, 43, 57, 71 and 85 in double-blind period. All the eligible participants will receive one-day adhesive transdermal patch (patch containing a drug that is put on the skin so the drug will enter the body through the skin) of either fentanyl at the dose ranging from 12. 5 to 50 microgram per hour (mcg/hr) or matching placebo. Efficacy will be evaluated primarily by time to withdrawal due to insufficient analgesic efficacy. Participants' safety will be monitored throughout the study.

Eligibility

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Participants whose pain because of osteoarthritis or low back pain is continuing for

at least 12 weeks prior to informed consent

- Participants who are continuously taking a non-opioid analgesic at the normal highest

dose or more for at least 14 consecutive days prior to informed consent, or participant at a certain dose (except the use on an as-needed base) on consecutive days

- Participants showing insufficient therapeutic efficacy of the non-opioid analgesic

currently being used, and requiring a continuous opioid analgesic as per the investigator or sub-investigator

- Participants with an average pain intensity of 50 millimeter or more on the Visual

Analog Scale (VAS) in 24-hour daily living prior to informed consent

- Participants who can be hospitalized to the 4th day after the initiation of titration

period Exclusion Criteria:

- In cases of low back pain, participants with severe pain of lower extremities due to

radiculopathy (a problem in which one or more nerves are affected) than that of low back pain, or participants with disc herniation (a medical condition affecting the spine due to trauma, lifting injuries, or idiopathic [unknown] causes) requiring an operation

- In cases of low back pain, participants with pain due to compression fracture

- Participants who had an operation that may affect the assessment within 30 days

before informed consent

- Participants whose main cause of the pain to be assessed is considered attributable

to psychogenic pain (physical pain that is caused, increased, or prolonged by mental, emotional, or behavioral factors)

- Participants with asthma, bradyarrhythmia (slow irregular heart beat) and severe

respiratory function disorders

Locations and Contacts

Aki, Japan

Ako, Japan

Amagasaki, Japan

Anan, Japan

Annaka, Japan

Chiba, Japan

Chiisagata, Japan

Fuchu, Japan

Fukuoka, Japan

Fukuyama, Japan

Hamamatsu, Japan

Hiki, Japan

Himeji, Japan

Hiratsuka, Japan

Hitachinaka, Japan

Ichikawa N/A, Japan

Ikeda N/A, Japan

Ikoma, Japan

Ito, Japan

Izumo, Japan

Kagoshima, Japan

Kanazawa, Japan

Kasama, Japan

Kitakyushu, Japan

Kochi, Japan

Koga, Japan

Komatsu, Japan

Kure, Japan

Kurume, Japan

Kyoto, Japan

Maebaru, Japan

Matsudo, Japan

Matsumoto, Japan

Miyazaki, Japan

Nagano, Japan

Nagoya, Japan

Niihama, Japan

Ohkawa, Japan

Ohmuta, Japan

Ohta-Ku, Japan

Ohtsu, Japan

Oita, Japan

Osaka, Japan

Otaru, Japan

Sagamihara, Japan

Saga, Japan

Sapporo, Japan

Sendai, Japan

Suginami-Ku, Japan

Takaoka, Japan

Takasaki, Japan

Takayama, Japan

Tatebayashi, Japan

Tokushima N/A, Japan

Tokyo, Japan

Toshima-Ku, Japan

Toyama, Japan

Ube, Japan

Yokohama, Japan

Additional Information

Starting date: January 2009
Last updated: November 29, 2013

Page last updated: August 23, 2015

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