Clinical trial NCT00788372: An Efficacy and Safety Study of Fentanyl in Participants With Chronic Pain
Official title: A Long-Term Study of JNS020QD in Patients With Chronic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Pain
Keywords: Chronic pain
Fentanyl Patch
Lead sponsor: Janssen Pharmaceutical K.K.
Sponsor class: INDUSTRY
First posted: 2008-11-10
Enrollment: 142
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of fentanyl one-day transdermal patch (JNS020QD, patch containing a drug that is put on the skin so the drug will enter the body through the skin) in participants with chronic (lasting a long time) pain.

Detailed description: This is an open-label (all people know the identity of the intervention), multi-center (conducted in more than one center) and non-comparative study of fentanyl one-day transdermal patch. The study consists of 4 periods: Screening period (3-14 days), Treatment period 1 (4 weeks), Treatment period 2 (48 weeks), Tapering period (0-6 weeks) and Follow-up period (1 week). Treatment will be initiated at 12.5 microgram per hour (mcg/hr). In both Treatment period 1 and 2, the dose will be increased as per the Investigator's discretion, ranging from 12.5 mcg/hr to 100 mcg/hr and the maximum application dose will be 300 mcg/hr. However, in Treatment period 2, the dose will be increased on 7th day before the day of medical examination (only if the participant used rescue treatment for minimum of 3 times per day for minimum of 4 days). The patch will be applied on areas including the chest, abdomen, upper arm and femoral region and replaced daily. Efficacy will primarily be evaluated by visual analog scale (VAS) score. The total duration of the study treatment will be 52 weeks. Participants' safety will be monitored throughout the study.

Eligibility criteria: Inclusion Criteria:

* Participants whose medication for chronic pain meets one of the criteria among a to e (2 or more types of opioid analgesics must not be used): a) Participants who are taking non-opioid analgesic at the normal highest dose or more for at least 14 consecutive days during 12 weeks before the informed consent, but were not continuously taking the non-opioid analgesic during 14 days before the informed consent for medical reasons such as safety b) Participants who are continuously taking an additional analgesic with a certain dosage and administration for at least 14 consecutive days before the informed consent c)Participants who are continuously taking codeine phosphate or dihydrocodeine phosphate less than 270 milligram (mg) daily (except for rescue treatment) for at least 14 consecutive days before the informed consent d) Participants who are continuously taking codeine morphine hydrochloride of oral morphine equivalent dose of less than 45 mg daily (except for rescue treatment) for at least 14 consecutive days before the informed consent (less than 30 mg daily for suppositories and less than 15 mg daily for injections) e) Participants who are continuously taking fentanyl citrate injection of less than 0.3 mg daily (except for rescue treatment) for at least 14 consecutive days before the informed consent
* Participants with chronic pain continuing for at least 12 weeks before informed consent
* Participants with an average pain intensity of greater than or equal to 50 millimeter (mm) on the Visual Analog Scale in 24-hour daily living before informed consent
* Participants who can be hospitalized to the 4th day after the initiation of patch application
* Participants who were given a sufficient explanation about the investigational product and the study and gave their own consent to participate in the study

Exclusion Criteria:

* Participants whose main cause of the pain to be assessed is considered attributable to psychogenic pain
* Participants with severe respiratory function disorders
* Participants with asthma (breathing disorder in which there is wheezing and difficulty breathing) and bradyarrhythmia (slow, irregular heartbeats)
* Participants with hepatic dysfunction function such as fulminant hepatitis (inflammation of the liver) and liver cirrhosis (serious liver disorder in which connective tissue replaces normal liver tissue, and liver failure often occurs), or renal impairment such as nephritic syndrome, acute renal failure, and chronic renal failure
* Participants with organic disorder in the brain such as brain tumor who have any of these symptoms: intracranial pressure increased, consciousness disturbance or coma and respiratory disorder

Primary outcomes:
measure: Questionnaire of Opioid Withdrawal Symptoms
timeFrame: Week 52 or endpoint (1 week after last treatment or early discontinuation)
measure: Dependence Questionnaire (DQ)
timeFrame: Week 52 or end point (early discontinuation)
measure: Pain Visual Analogue Scale Score
timeFrame: Week 52 or end point (early discontinuation)
measure: Number of Participants With Pain Assessed by Categorical Scale for Pain
timeFrame: Week 52 or final evaluation (early discontinuation)
measure: Number of Participants With Total Painful Time Per Day
timeFrame: Week 52 or final evaluation (early discontinuation)
measure: Number of Participants With Quality of Sleep
timeFrame: Week 52 or final evaluation (early discontinuation)
measure: Number of Rescue Treatments
timeFrame: Week 52 or final evaluation (early discontinuation)
measure: Short-Form 36-Item Health Survey (SF-36) Scores
timeFrame: Week 52 or final evaluation (early discontinuation)
measure: Physician's Global Assessment Scale
timeFrame: Week 52 or final evaluation (early discontinuation)
measure: Participants Overall Assessment
timeFrame: Week 52 or final evaluation (early discontinuation)
measure: Brief Pain Inventory-Short Form (BPI-SF) Total Score
timeFrame: Week 52 or final evaluation (early discontinuation)
Secondary outcomes:
Other outcomes:
Locations:
city: Amagasaki
country: Japan
city: Chuo
country: Japan
city: Fukuoka
country: Japan
city: Hiroshima
country: Japan
city: Izumo
country: Japan
city: Kanazawa
country: Japan
city: Kawasaki N/A
country: Japan
city: Kitakyushu
country: Japan
city: Kobe
country: Japan
city: Kochi
country: Japan
city: Koga
country: Japan
city: Maebashi
country: Japan
city: Matsumoto
country: Japan
city: Minato
country: Japan
city: Nishinomiya
country: Japan
city: Ohmura
country: Japan
city: Ohta-Ku
country: Japan
city: Okayama
country: Japan
city: Saga
country: Japan
city: Sapporo
country: Japan
city: Shimotsuga
country: Japan
city: Suita
country: Japan
city: Ube
country: Japan
Study officials:
affiliation: Janssen Pharmaceutical K.K.
name: Janssen Pharmaceutical K.K.,Japan Clinical Trial
role: STUDY_DIRECTOR
References: