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A Randomized, Open-Label, Parallel-Arm, Optimal Dose-Titration, Multicenter Study to Evaluate the Safety and Efficacy of Oral JNS024 Extended-Release (ER) in Japanese Subjects Treated With Around-the-Clock Opioid Analgesics for Their Moderate to Severe Chronic Malignant Tumor- Related Cancer Pain


Phase 3
20 Years
N/A
Not Enrolling
Both
Neoplasms

Thank you

Trial Information

A Randomized, Open-Label, Parallel-Arm, Optimal Dose-Titration, Multicenter Study to Evaluate the Safety and Efficacy of Oral JNS024 Extended-Release (ER) in Japanese Subjects Treated With Around-the-Clock Opioid Analgesics for Their Moderate to Severe Chronic Malignant Tumor- Related Cancer Pain


This is a randomized (study drug assigned by chance), open-label (a medical research study
in which participants and researchers are told which treatments the participants are
receiving, "unblinded"), parallel-arm (participants receive 1 of 2 possible interventions
during the same time frame throughout the study), optimal dose-titration, multicenter (when
more than one hospital or medical school team work on a medical research study) study
evaluating the conversion rate based on the number of participants achieving pain control
and safety within 1 week after switching from an ongoing around-the-clock opioid analgesic
(morphine sustained-release [SR], oxycodone controlled-release, or fentanyl transdermal) to
tapentadol ER or morphine SR, for their moderate to severe chronic, malignant tumor-related
cancer pain. The study consists of 2 periods: 1 to 2 week screening period, followed by
8-week open-label treatment period. During the study period, participants will be
hospitalized or outpatient. However, it is preferable to be hospitalized 1 week before and 1
week after to evaluate efficacy before and after switching opioids for securing
participants' safety. At Day 1, participants will receive either tapentadol ER or morphine
SR twice daily. During the treatment period, the dose of the study drug will be titrated to
the participant's optimal dose. The participants will receive either tapentadol ER or
morphine SR twice daily for 8 weeks. The maximum dose allowed for tapentadol ER will be 500
milligram (mg) daily or morphine SR 140 mg daily throughout the study. Efficacy is primarily
evaluated using pain intensity score on an 11 point Numerical Rating Scale (an 11-point NRS
is used to measure the pain level where 0=no pain to 10=pain as bad as you can imagine).
Participants' safety will also be monitored.


Inclusion Criteria:



- Participants with documented clinical diagnosis (determination of the cause of a
medical problem) of any type of cancer (abnormal tissue that grows and spreads in
the body)

- Participants with mean 24-hour Numerical Rating Scale (NRS) score (11-point NRS used
to measure the pain level for the past 24-hours where 0=no pain to 10=pain as bad as
you can imagine) during 3 days (Day -4 to Day -2) before randomization (study drug
assigned by chance) less than 4.0

- Women must be post-menopausal, surgically sterile, or before entry and throughout the
study practicing an effective method of birth control

- Participants using immediate-release (IR) morphine hydrochloride (HCl) or oxycodone
HCl hydrate as rescue medication (rescue medications are medicines that may be
administered to the participants when the efficacy of the study drug is not
satisfactory, or the effect of the study drug is too great and is likely to cause a
hazard to the participant, or to manage an emergency situation) for breakthrough pain

- Participants treated with around-the-clock opioid (morphine-like medications) therapy
for moderate to severe (very serious, life threatening) chronic (lasting a long
time), malignant (cancerous) tumor-related (a mass in a specific area) cancer
(abnormal tissue that grows and spreads in the body) pain using one of the following
opioid analgesics (drug used to control pain) before randomization: morphine SR
tablet less than or equal to 120 milligram (mg) per day, oxycodone hydrochloride
controlled release (CR) tablet: 15 mg to 80 mg per day, durotep MT (fentanyl
transdermal [through the skin] matrix) patch less than or equal to 8.4 mg per patch,
fentos tape less than or equal to 4 mg per tape, or oneduro patch less than or equal
to 3.4 mg per patch

Exclusion Criteria:

- Participants with complicated uncontrolled/clinically significant arrhythmia (uneven
heart beat)

- Participants who had received rescue doses 3 times or more daily within 3 days (Day
-4 to Day -2) before the randomization

- History of surgery intended for the cure of the primary disease or for the treatment
of cancer pain within 28 days before screening

- Participants who had application of radiotherapy (treatment of cancer using x-rays),
nerve block, or stimulation analgesia within 7 days before screening

- Participants with known allergies (over sensitivity to a substance),
hypersensitivity, or intolerance to opioid analgesics or its excipients

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Percentage of Participants Who Achieved Pain Control

Outcome Description:

Pain control was considered to be achieved for participants who met both of the following criteria for any consecutive 3 days during the first week of treatment period: a) Change from baseline of mean 24 hour numerical rating scale (NRS) (an 11-point NRS is used to measure the pain level where 0=no pain to 10=pain as bad as you can imagine) score less than +1.5, and b) when the frequency of rescue medication was twice or less per day.

Outcome Time Frame:

Week 1

Safety Issue:

No

Principal Investigator

Janssen Pharmaceutical K.K. Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Janssen Pharmaceutical K.K.

Authority:

Japan: Pharmaceuticals and Medical Devices Agency

Study ID:

CR017326

NCT ID:

NCT01309386

Start Date:

August 2010

Completion Date:

January 2012

Related Keywords:

  • Neoplasms
  • Tapentadol
  • Tumor related pain
  • Opioid
  • Cancer related pain
  • Morphine
  • Neoplasms

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