Clinical trial NCT01008618: A Confirmatory Study of Fentanyl in Participants With Osteoarthritis or Low Back Pain
Official title: A Verification Study of JNS020QD in Patients With Osteoarthritis or Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Pain
Osteoarthritis
Low Back Pain
Keywords: Chronic pain
Osteoarthritis
Low back pain
Fentanyl
JNS020QD
Patch, transdermal
Opioid analgesics
Lead sponsor: Janssen Pharmaceutical K.K.
Sponsor class: INDUSTRY
First posted: 2009-11-06
Enrollment: 218
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

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 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

Primary outcomes:
measure: Time From the Initial Day of Application in Double-Blind Period to Withdrawal Because of Insufficient Analgesic Efficacy
timeFrame: Day 1 up to Day 85 (double-blind period) and Day 92 (discontinuation of the study)
Secondary outcomes:
measure: Pain Visual Analog Scale (VAS) Score - Titration Period
timeFrame: Day 12-14 (Screening period) and Day 27-29 (Titration period)
measure: Pain Visual Analog Scale (VAS) Score - Double-Blind Period
timeFrame: Day 27-29 (Titration period) and Day 83-85 (double-blind period)
measure: Number of Participants Evaluated as Per Participant's Overall Assessment - Titration Period
timeFrame: Day 1 and 29 or final evaluation (Titration period)
measure: Number of Participants Evaluated as Per Participant's Overall Assessment - Double-Blind Period
timeFrame: Day 1 and 85 or final evaluation (double-blind period)
measure: Number of Doses of Rescue Treatment Per Day - Titration Period
timeFrame: Day 1 and 29 or final evaluation (Titration period)
measure: Number of Doses of Rescue Treatment Per Day - Double-Blind Period
timeFrame: Day 1 and 85 or final evaluation (double-blind period)
measure: Brief Pain Inventory Short Form (BPI-sf) Score - Titration Period
timeFrame: Day 1 and 29 or final evaluation (Titration period)
measure: Brief Pain Inventory Short Form (BPI-sf) Score - Double-Blind Period
timeFrame: Day 1 and 85 or final evaluation (double-blind period)
measure: Short-Form 36-Item Health Survey Version 2.0 (SF-36v2) - Titration Period
timeFrame: Day 1 and 29 or final evaluation (Titration period)
measure: Short-Form 36-Item Health Survey Version 2.0 (SF-36v2) - Double-Blind Period:
timeFrame: Day 1 and 85 or final evaluation (double-blind period)
measure: Number of Participants Evaluated as Per Physician's Overall Assessment - Titration Period
timeFrame: Day 29 or final evaluation (Titration period)
measure: Number of Participants Evaluated as Per Physician's Overall Assessment - Double-Blind Period
timeFrame: Day 1 and 85 or final evaluation (double-blind period)
Other outcomes:
Locations:
city: Aki
country: Japan
city: Ako
country: Japan
city: Amagasaki
country: Japan
city: Anan
country: Japan
city: Annaka
country: Japan
city: Chiba
country: Japan
city: Chiisagata
country: Japan
city: Fuchu
country: Japan
city: Fukuoka
country: Japan
city: Fukuyama
country: Japan
city: Hamamatsu
country: Japan
city: Hiki
country: Japan
city: Himeji
country: Japan
city: Hiratsuka
country: Japan
city: Hitachinaka
country: Japan
city: Ichikawa N/A
country: Japan
city: Ikeda N/A
country: Japan
city: Ikoma
country: Japan
city: Ito
country: Japan
city: Izumo
country: Japan
city: Kagoshima
country: Japan
city: Kanazawa
country: Japan
city: Kasama
country: Japan
city: Kitakyushu
country: Japan
city: Kochi
country: Japan
city: Koga
country: Japan
city: Komatsu
country: Japan
city: Kure
country: Japan
city: Kurume
country: Japan
city: Kyoto
country: Japan
city: Maebaru
country: Japan
city: Matsudo
country: Japan
city: Matsumoto
country: Japan
city: Miyazaki
country: Japan
city: Nagano
country: Japan
city: Nagoya
country: Japan
city: Niihama
country: Japan
city: Ohkawa
country: Japan
city: Ohmuta
country: Japan
city: Ohta-Ku
country: Japan
city: Ohtsu
country: Japan
city: Oita
country: Japan
city: Osaka
country: Japan
city: Otaru
country: Japan
city: Sagamihara
country: Japan
city: Saga
country: Japan
city: Sapporo
country: Japan
city: Sendai
country: Japan
city: Suginami-Ku
country: Japan
city: Takaoka
country: Japan
city: Takasaki
country: Japan
city: Takayama
country: Japan
city: Tatebayashi
country: Japan
city: Tokushima N/A
country: Japan
city: Tokyo
country: Japan
city: Toshima-Ku
country: Japan
city: Toyama
country: Japan
city: Ube
country: Japan
city: Yokohama
country: Japan
Study officials:
affiliation: Janssen Pharmaceutical K.K.
name: Janssen Pharmaceutical K.K., Japan Clinical Trial
role: STUDY_DIRECTOR
References:
citation: Arai T, Kashimoto Y, Ukyo Y, Tominaga Y, Imanaka K. Two placebo-controlled, randomized withdrawal studies to evaluate the fentanyl 1 day patch in opioid-naive patients with chronic pain. Curr Med Res Opin. 2015 Dec;31(12):2207-18. doi: 10.1185/03007995.2015.1092127. Epub 2015 Oct 19.