A Dose-Finding Study of Fentanyl (JNS020 QD) 1-Day Transdermal Patch in Participants With Cancer Pain

NCT00644787 | Completed Phase 2 Results

• 2 other identifiers: CR014899JNS020QD-JPN-C02
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 43

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of fentanyl 1-day application (JNS020QD) transdermal patch (patch containing a drug that is put on the skin so the drug can enter the body through the skin) and to assess the non-inferiority of fentanyl 1-day application transdermal patch to fentanyl 3-day application (JNS005) transdermal patch in participants with cancer pain.

Conditions

Pain; Cancer

Keywords

Pain; Cancer; Fentanyl; JNS020QD; JNS005

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants Achieving Dose Titration Success

  Participants achieving dose titration success included all participants who had a mean Visual Analog Scale (VAS) score of less than or equal to 34 millimeter (mm) and received not more than 2 rescue doses during the last 3 days before the completion or discontinuation of dose titration phase. Pain Intensity VAS measured severity of pain on a 100 mm scale ranging from 0 mm (no pain) to 100 mm (severest pain conceivable) and rescue dose was defined as dose of a fast-acting oral morphine hydrochloride solution or morphine in water solution used in the case of breakthrough pain.

  Day 14 or early discontinuation (ED)

• Change From Dose Titration Phase in the Mean Visual Analog Scale (VAS) Score at Double Blind Phase

  The mean VAS score for the last 3 days before the completion or discontinuation of Double Blind Phase was compared with that for the last 3 days before the completion or discontinuation of Dose Titration Phase and the change from Dose Titration Phase in the mean VAS Score at Double Blind Phase was reported. Pain Intensity VAS measured severity of pain on a 100 mm scale ranging from 0 mm (no pain) to 100 mm (severest pain conceivable).

  Dose Titration Phase (Day 12 to Day 14) and Double Blind Phase (Day 8 to Day 10)

Secondary Outcomes (13)

• Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase

  Day 1 pre-application (PA), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12, Day 13 and Day 14 or ED

• Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase

  Day 14-End of Titration Phase (ETP), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9 and Day 10 or ED

• Pain Intensity Visual Analog Scale (VAS) Score in Titration Phase

  Day 1 PA, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12, Day 13 and Day 14 or ED

• Pain Intensity Visual Analog Scale (VAS) Score in Double Blind Phase

  Day 14-End of Titration Phase (ETP), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9 and Day 10 or ED

• Percentage of Participants Achieving Pain Control in Double Blind Phase

  Day 10 or ED

Study Arms (3)

Fentanyl 1-day transdermal patch (Titration Phase)

EXPERIMENTAL

Fentanyl 1-day application transdermal patch releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) applied once daily, and maintained for 2 days. Dose escalation or reduction is done as per Investigator's discretion (maximum applied dose is 100 mcg/hr) up to Day 11 and then dose is fixed up to end of treatment period, that is Day 14. Participants who met the predefined criteria at the end of Titration Phase enter the Double Blind Phase.

Drug: Fentanyl 1-day transdermal patch (Titration Phase)

Fentanyl 1-day transdermal patch (Double Blind Phase)

EXPERIMENTAL

Participants who meet the predefined criteria at the end of Titration Phase and enter the Double Blind Phase receive fentanyl 1-day application transdermal patch and placebo matched to fentanyl 3-day application (JNS005) transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.

Drug: Fentanyl 1-day transdermal patch (Double Blind Phase); Drug: Placebo

Fentanyl 3-day transdermal patch (Double Blind Phase)

ACTIVE COMPARATOR

Participants who meet the predefined criteria at the end of Titration Phase and enter the Double Blind Phase receive fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.

Drug: Fentanyl 3-day transdermal patch (Double Blind Phase); Drug: Placebo

Interventions

Fentanyl 1-day transdermal patch (Titration Phase) DRUG

Fentanyl 1-day application transdermal patch releasing the drug at the rate of 12.5 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction is done as per Investigator's discretion (maximum applied dose is 100 mcg/hr) up to Day 11 and then dose is fixed up to end of treatment period, that is Day 14.

Also known as: JNS020QD

Fentanyl 1-day transdermal patch (Titration Phase)

Fentanyl 1-day transdermal patch (Double Blind Phase) DRUG

Fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.

Also known as: JNS020QD

Fentanyl 1-day transdermal patch (Double Blind Phase)

Fentanyl 3-day transdermal patch (Double Blind Phase) DRUG

Fentanyl 3-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.

Also known as: JNS005

Fentanyl 3-day transdermal patch (Double Blind Phase)

Placebo DRUG

Placebo matching to fentanyl 3-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase for 10 days.

Fentanyl 1-day transdermal patch (Double Blind Phase)

Eligibility Criteria

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

You may qualify if:

• Participants with cancer pain who were previously not treated with opioid analgesics (drug used to control pain)
• Participants with a pain score of greater than or equal to 35 millimeter (mm) on a 100-mm visual analog scale (VAS)
• Participants who are considered to have "insufficient response" to non-opioid analgesics and require treatment with opioid analgesics by the physician
• Participants who have an established diagnosis of cancer and are notified of the disease
• Participants who can be hospitalized during Period 1 (dose-titration period)

You may not qualify if:

• Participants with impaired respiratory function due to chronic lung disease or others
• Participants with asthma (breathing disorder in which there is wheezing and difficulty in breathing)
• Participants with bradyarrhythmia (slow, irregular heartbeats)
• Participants with following measurements indicative of hepatic or renal impairment during the pre-treatment observation period: Aspartate transaminase (AST) greater than 5 times the upper limit of reference range, Alanine transaminase (ALT) greater than 5 times the upper limit of reference range, serum creatinine greater than 3 times the upper limit of reference range
• Participants with any cerebral damage, such as brain tumor, accompanied by increased intracranial pressure, disturbance of consciousness, coma, or respiratory disturbance

Sponsors & Collaborators

• Janssen Pharmaceutical K.K.: lead

Study Sites (43)

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Asahi, Japan

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Asahikawa, Japan

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Bunkyō City, Japan

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Chiba, Japan

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Chikushino-shi, Japan

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Fukuoka, Japan

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Fushimi, Japan

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Higashi-Ibaraki, Japan

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Himeji, Japan

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Hirosaki, Japan

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Hiroshima, Japan

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Hitachi, Japan

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Hohfu, Japan

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Ichinomiya, Japan

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Ikeda, Japan

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Iwakuni, Japan

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Kawachi-Nagano, Japan

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Kawasaki, Japan

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Kitakyushu, Japan

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Kiyose, Japan

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Kobe, Japan

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Kochi, Japan

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Matsue, Japan

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Matsuyama, Japan

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Nishinomiya, Japan

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Okayama, Japan

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Osaka, Japan

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Ōita, Japan

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Ōtake, Japan

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Sakai, Japan

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Sendai, Japan

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Shigenobu N/A, Japan

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Sonogishukugō, Japan

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Sunto, Japan

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Tamaho N/A, Japan

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Tokushima, Japan

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Tokyo, Japan

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Toyohashi, Japan

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Tsukuba, Japan

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Utsunomiya, Japan

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Wako, Japan

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Yamaguchi, Japan

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Yonago, Japan

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MeSH Terms

Conditions

Pain; Neoplasms

Interventions

Fentanyl; Transdermal Patch

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Equipment and Supplies

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 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2008
• First Posted: March 27, 2008
• Study Start: December 1, 2007
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: June 13, 2013
• Results First Posted: May 21, 2013

Record last verified: 2013-06

Locations

JP (43)