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

NCT01008618 | Completed Phase 3 Results

• 2 other identifiers: CR015541JNS020QD-JPN-N01
• Study Type: interventional
• Target: 218
• Locations: 1 country
• Sites: 59

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).

Conditions

Chronic Pain; Osteoarthritis; Low Back Pain

Keywords

Chronic pain; Osteoarthritis; Low back pain; Fentanyl; JNS020QD; Patch, transdermal; Opioid analgesics

Outcome Measures

Primary Outcomes (1)

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

  Time from start of double-blind (researchers and participants were unaware of the treatment) period to withdrawal because of insufficient analgesic efficacy based on any of the pre-defined discontinuation criteria was noted.

  Day 1 up to Day 85 (double-blind period) and Day 92 (discontinuation of the study)

Secondary Outcomes (12)

• Pain Visual Analog Scale (VAS) Score - Titration Period

  Day 12-14 (Screening period) and Day 27-29 (Titration period)

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

  Day 27-29 (Titration period) and Day 83-85 (double-blind period)

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

  Day 1 and 29 or final evaluation (Titration period)

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

  Day 1 and 85 or final evaluation (double-blind period)

• Number of Doses of Rescue Treatment Per Day - Titration Period

  Day 1 and 29 or final evaluation (Titration period)

Study Arms (3)

Fentanyl (Titration period)

EXPERIMENTAL

One-day adhesive transdermal patch containing fentanyl (JNS020QD) applied to chest, abdomen, upper arm and thigh and replaced every day, starting at the dose of 12.5 microgram per hour (mcg/hr) for at least first 2 days, which will be increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and visual analog scale (VAS) score of the participants. The dose will be increased up to maximum of 50 mcg/hr. The treatment will be continued for 10-29 days and then the eligible participants from this group will be randomly assigned to either of the two groups in the double-blind period.

Drug: Fentanyl

Fentanyl (Double-blind period)

EXPERIMENTAL

Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, will be administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which will be same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment will be continued for 12 weeks.

Drug: Fentanyl

Placebo (Double-blind period)

PLACEBO COMPARATOR

Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, will be administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) will be gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo will be gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment will continue for 12 weeks.

Drug: Placebo

Interventions

Fentanyl DRUG

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.

Fentanyl (Double-blind period); Fentanyl (Titration period)

Placebo DRUG

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.

Placebo (Double-blind period)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Pharmaceutical K.K.: lead

Study Sites (59)

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Aki, Japan

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Akō, Japan

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Amagasaki, Japan

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Anan, Japan

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Annaka, Japan

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Chiba, Japan

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Chiisagata, Japan

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Fuchū, Japan

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Fukuoka, Japan

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Fukuyama, Japan

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Hamamatsu, Japan

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Hiki, Japan

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Himeji, Japan

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Hiratsuka, Japan

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Hitachi-Naka, Japan

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Ichikawa, Japan

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Ikeda, Japan

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Ikoma, Japan

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Itō, Japan

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Izumo, Japan

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Kagoshima, Japan

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Kanazawa, Japan

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Kasama, Japan

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Kitakyushu, Japan

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Kochi, Japan

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Koga, Japan

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Komatsu, Japan

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Kure, Japan

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Kurume, Japan

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Kyoto, Japan

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Maebaru, Japan

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Matsudo, Japan

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Matsumoto, Japan

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Miyazaki, Japan

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Nagano, Japan

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Nagoya, Japan

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Niihama, Japan

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Ohkawa, Japan

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Ohmuta, Japan

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Ohta-Ku, Japan

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Ohtsu, Japan

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Osaka, Japan

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Otaru, Japan

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Ōita, Japan

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Saga, Japan

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Sagamihara, Japan

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Sapporo, Japan

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Sendai, Japan

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Suginami-Ku, Japan

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Takaoka, Japan

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Takasaki, Japan

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Takayama, Japan

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Tatebayashi, Japan

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Tokushima, Japan

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Tokyo, Japan

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Toshima-Ku, Japan

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Toyama, Japan

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Ube, Japan

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Yokohama, Japan

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Related Publications (1)

• 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.

  PMID: 26359327 DERIVED

MeSH Terms

Conditions

Chronic Pain; Osteoarthritis; Low Back Pain

Interventions

Fentanyl

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Back Pain

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Director, Clinical Research
• Organization: Janssen Research & Development, L.L.C. USA

1 609 730-3387

Study Officials

• Janssen Pharmaceutical K.K., Japan Clinical Trial

  Janssen Pharmaceutical K.K.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2009
• First Posted: November 6, 2009
• Study Start: January 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: December 25, 2013
• Results First Posted: July 10, 2013

Record last verified: 2013-11

Locations

JP (59)