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A Confirmatory Study of Fentanyl in Participants With Post-herpetic Neuralgia, Complex Regional Pain Syndrome or Postoperative Pain Syndrome

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: Postherpetic Neuralgia; Complex Regional Pain Syndromes (CRPS); Postoperative 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 the efficacy and safety of fentanyl in opioid-naive participants with post-herpetic neuralgia, complex regional pain syndrome or post-operative pain syndrome 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 Post-herpetic Neuralgia, Complex Regional Pain Syndrome (CRPS) or Postoperative Pain Syndrome

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) Score - Titration Period

Short-Form 36-Item Health Survey Version 2.0 (SF-36v2) Score - 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 post-herpetic neuralgia (intense, typically intermittent pain along the course of a nerve caused by the varicella zoster virus), complex regional pain syndrome or post-operative pain syndrome. 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, 22, 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/hour 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 post-herpetic neuralgia, Complex Regional Pain

Syndrome (CRPS) or post-operative pain syndrome 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 at a certain dose (except the use on an as-needed base) on consecutive days or participants who are continuously taking an analgesic adjuvant with a certain dosage and administration (except the use on an as-needed base) for at least 14 consecutive days prior to informed consent

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

currently being used, and to 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 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:

- 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

- Participants complicated with hepatic dysfunction 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 a history of hypersensitivity to fentanyl and other opioid

analgesics

Locations and Contacts

Aichi, Japan

Amagasaki, Japan

Asahikawa N/A, Japan

Asahikawa, Japan

Bunkyo, Japan

Chigasaki, Japan

Chuo, Japan

Ebetsu, Japan

Fujieda, Japan

Fujisawa, Japan

Fukuoka N/A, Japan

Fukuoka, Japan

Hakodate, Japan

Hamamatsu, Japan

Hatsukaichi, Japan

Higashi-Kitami, Japan

Hiratsuka, Japan

Hirosaki, Japan

Hiroshima N/A, Japan

Hiroshima, Japan

Ichikawa N/A, Japan

Ikeda, Japan

Isesaki, Japan

Itabashi-Ku, Japan

Izumo N/A, Japan

Izumo, Japan

Kakegawa, Japan

Kanazawa, Japan

Kasama, Japan

Kasuga, Japan

Kawasaki N/A, Japan

Kita-Gun, Japan

Kitakyushu, Japan

Kitamoto, Japan

Kobe, Japan

Kochi, Japan

Koga, Japan

Komatsu, Japan

Koshigaya, Japan

Kyoto, Japan

Maebashi N/A, Japan

Maebashi, Japan

Matsumoto, Japan

Meguro, Japan

Miki N/A, Japan

Miki, Japan

Minato, Japan

Miyazaki, Japan

Moriguchi, Japan

Morioka, Japan

Nagasaki, Japan

Nagoya N/A, Japan

Nagoya, Japan

Niihama, Japan

Nishinomiya, Japan

Obihiro, Japan

Ohmura, Japan

Ohta-Ku, Japan

Ohtsu N/A, Japan

Ohtsu, Japan

Okayama, Japan

Onomichi, Japan

Osaka, Japan

Saga, Japan

Sakai, Japan

Sapporo, Japan

Sendai, Japan

Setagaya, Japan

Shigenobu N/A, Japan

Shimotsuga, Japan

Shinagawa, Japan

Suita N/A, Japan

Suita, Japan

Suzaka, Japan

Tamaho N/A, Japan

Tokushima N/A, Japan

Tokyo N/A, Japan

Tokyo, Japan

Ube N/A, Japan

Ube, Japan

Urayasu N/A, Japan

Ureshino, Japan

Wakayama, Japan

Yachiyo, Japan

Yamaguchi, Japan

Yamanashi, Japan

Yokohama N/A, Japan

Yokohama, Japan

Yonago N/A, Japan

Yubari, Japan

Additional Information

Starting date: December 2008
Last updated: June 19, 2013

Page last updated: August 23, 2015

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