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A Dose-finding and Double Blinded Study of JNS020 QD(Fentanyl) in Patients With Cancerous Pain Previously Untreated With Opioid Analgesics
This study has been completed.
First Received: March 24, 2008   Last Updated: July 10, 2009   History of Changes
Sponsor: Janssen Pharmaceutical K.K.
Information provided by: Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier: NCT00644787
  Purpose

The purpose of this study is to evaluate the effectiveness and safety of JNS020 QD(fentanyl) at an initial dose of 12.5 mcg/h in cancer pain patients who require the use of opioid analgesics because of inadequate response to non-opioid analgesics (e.g., non-steroidal anti-inflammatory drugs) and to assess the noninferiority of JNS020 QD(fentanyl) to JNS005 in effectiveness in patients whose pain is controlled with JNS020 QD(fentanyl).


Condition Intervention Phase
Cancer
Pain
 Drug: JNS005; JNS020QD(Placebo)
Drug: JNS020QD: JNS005(Placebo)
Drug: JNS020QD
 Phase II
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title: A Phase 2/3 Dose-finding and Double Blinded Study of JNS020 QD(Fentanyl) in Comparison With JNS005 in Patients With Cancerous Pains Previously Untreated With Opipoid Analgesics

Resource links provided by NLM:

MedlinePlus related topics: Cancer
Drug Information available for: Fentanyl
U.S. FDA Resources

Further study details as provided by Janssen Pharmaceutical K.K.:

Primary Outcome Measures:
  • Period 1: Dose titration success rate Period 2: The mean VAS score for the last 3 days before the completion (or discontinuation) of Period 2 [ Time Frame: The primary outcome measure of Period I is from the first system application (Period 1-Day 1) until the dose is fixed (Up to Period 1-Day14). The primary outcome measure of Period II is from the end of Period I to Period 2- Day 10. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient's global assessment, pain intensity (VAS), pain control achievement rate, pain intensity (categorical scale), total duration of pain per day, rescue dose, physician's global assessment [ Time Frame: The secondary outcome measure of Period I is from the first system application (Period 1-Day 1) until the dose is fixed (Up to Period 1-Day14). The primary outcome measure of Period II is from the end of Period I to Period 2- Day 10. ] [ Designated as safety issue: Yes ]

Enrollment: 163
Study Start Date: December 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
003: Active Comparator Drug: JNS005; JNS020QD(Placebo)
continuous application of JNS005 patch plus JNS020QD patch (Placebo) for 10 days
002: Experimental Drug: JNS020QD: JNS005(Placebo)
continuous application of JNS020QD patch plus JNS005(Placebo) patch for 10 days
001: Experimental Drug: JNS020QD
continuous application of JNS020QD patch (12.5-100 ug/h) for 5-14 days

Detailed Description:

Fentanyl patch system for 3-day application is widely used for management of cancer related pain. Patch for 1-day application is useful and it can allow daily dose adjustment, an optimal clinical dose can be selected for patients previously untreated with opioid analgesics. This is a multicenter study to evaluate the effectiveness and safety of JNS020 QD(fentanyl), consisting of two periods. Period 1 is non-blind, uncontrolled, Period 2 is double-blinded, positive control, randomized. JNS005, a fentanyl patch for 3-day application, is used as control drug. Patients receive initially 12.5 mcg/h JNS020 QD(fentanyl), subsequently the dose of JNS020 QD(fentanyl) can be increased up to 100 mcg/h in Period 1. Patients are randomly allocated to either the JNS020 QD(fentanyl) group or the JNS005 group in Period 2. Patients receive JNS020 QD(fentanyl) at the same dose as used at period 1 in the JNS020 QD(fentanyl) group. Patients receive JNS005 at the same daily dose as used at period 1 in the JNS005 group. The duration of period 2 is 10 days. The VAS score changes of each group in period 2 are compared to assess the noninferiority of JNS020 QD(fentanyl) to JNS005. Patients receive initially 12.5 mcg/h JNS020 QD(fentanyl), subsequently the dose of JNS020 QD(fentanyl) can be increased up to 100 mcg/h in Period 1. The duration of Period 1 is 5 to 14 days. In Period 2, the assigned patch is applied for 10 days at the same dose as used at the end of Period 1.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cancer pain patients previously untreated with opioid analgesics for the pain
  • Patients treated with non-opioid analgesics (e.g., non-steroidal anti-inflammatory drugs)
  • Patients with a pain score of >= 35 mm on a 100-mm visual analog scale (VAS)
  • Patients who are considered to have "insufficient response" to non-opioid analgesics and to require the treatment with opioid analgesics by the physician
  • Patients who have an established diagnosis of cancer and are notified of the disease

Exclusion Criteria:

  • Patients with impaired respiratory function due to chronic lung disease or others
  • Patients with asthma
  • Patients with bradyarrhythmia
  • Patients who are found to have any of the following measurements indicative of hepatic or renal impairment with laboratory tests during the pre-treatment observation period: AST (GOT) > 5 times the upper limit of reference range, ALT (GPT) > 5 times the upper limit of reference range, serum creatinine > 3 times the upper limit of reference range
  • Patients with any organic cerebral damage, such as brain tumor, accompanied by increased intracranial pressure, disturbance of consciousness, coma, or respiratory disturbance
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00644787

Sponsors and Collaborators
Janssen Pharmaceutical K.K.
Investigators
Study Director: Janssen Pharmaceutical K.K. Clinical Trial Janssen Pharmaceutical K.K.
  More Information

No publications provided

Responsible Party: ( Director of Clinical R&D Dept.3 )
Study ID Numbers: CR014899, FENPAI2003, JNS020QD-JPN-C02
Study First Received: March 24, 2008
Last Updated: July 10, 2009
ClinicalTrials.gov Identifier: NCT00644787     History of Changes
Health Authority: Japan: Japan Pharmaceuticals And Medical Devices Evaluation Center

Keywords provided by Janssen Pharmaceutical K.K.:
cancer
pain
control
non opioid analgesics
patch

Additional relevant MeSH terms:
Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Depressants
Peripheral Nervous System Agents
 Analgesics
Central Nervous System Agents
Pharmacologic Actions
Analgesics, Opioid

ClinicalTrials.gov processed this record on November 09, 2009



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