Clinical trial NCT00805142: Phase 2 Study of Tapentadol Prolonged Release in Cancer Pain Participants
Official title: Phase II Study of JNS024PR in Cancer Pain Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain
Cancer
Keywords: Pain
Cancer
Tapentadol
Lead sponsor: Janssen Pharmaceutical K.K.
Sponsor class: INDUSTRY
Collaborators: name: Grünenthal GmbH
First posted: 2008-12-09
Enrollment: 78
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics (how the drug is absorbed in the body, distributed within the body, and how it is removed from the body over time; explores what the body does to the drug) of tapentadol prolonged release (JNS024PR, PR) in participants with moderate to severe cancer (abnormal tissue that grows and spreads in the body until it kills) pain.

Detailed description: This is a Phase 2 open-label (all people know the identity of the intervention), multi-centric (conducted in more than one center), non-comparative, optional dose-titration study of tapentadol PR in Japanese participants with cancer pain. This study will consist of Screening period (3 to 7 days), Dose adjustment period (3 to 14 days), Fixed dose period (5 days) and Follow-up period (7 days). Tapentadol PR will be administered orally (taken by mouth; to be swallowed) twice daily before meal. For participants previously using opioids, the initial dose of tapentadol PR will be selected depending on the daily dose of opioid at the completion of Screening period. For opioid-naive (moderate to severe cancer pain that is not controlled adequately with non-opioid medications) participants, the initial dose of tapentadol PR will be 25 milligram (mg) twice daily. Participants will receive the same dose of tapentadol PR for the first 2 days of the dose adjustment period and from Day 3, the dose can be titrated as per the Investigator's discretion up to Day 14. After that participants will receive fixed dose regimen for 5 days at the same dose as that used at the end of the dose adjustment period. Efficacy will primarily be evaluated by sustained pain control for the 5 day fixed dose phase. Participants' safety will be monitored throughout the study.

Eligibility criteria: Inclusion Criteria:

* Opioid switching participants should meet the following criteria from a to c: a) Participants with cancer pain b) previously were on opioid medications (morphine sustained release preparations \[120 milligram per day {mg/day} or less\], oxycodone hydrochloride sustained release tablets \[80 mg/day or less\], fentanyl transdermal \[through the skin\] application system \[4.2 mg or less\]) c) had achieved adequate pain control with opioid therapy
* Opioid naive participants should meet the following criteria from a to b: a) Participants with cancer pain b) should not have received any pain control therapy with opioids (excluding narcotic antagonist analgesics \[drug used to control pain\])
* Definite diagnosis of any type of cancer, which has been notified to the participant
* Participants who can be hospitalized during the treatment period
* Participant who can record 11 point Numerical Rating Scale (NRS) and 100 millimeter (mm) Visual Analog Scale (VAS) scores appropriately throughout the study

Exclusion Criteria:

* Participants with bradyarrhythmia (slow, irregular heartbeats)
* History of mild or moderate traumatic (causing damage, like a toll used to crush tissue) encephalopathy, cerebral (having to do with the cerebrum) infarction (death of tissue because of lack of blood supply) or transient ischemic (decreased oxygen in a tissue \[usually because of decreased blood flow\]) attack within 1 year before informed consent
* Previous or concurrent epilepsy (seizure disorder) or convulsive diseases accompanied by disturbance of consciousness
* Previous or concurrent alcohol dependence or narcotic abuse
* History of active hepatitis (inflammation of the liver) B or C within 3 months before informed consent

Primary outcomes:
measure: Percentage of Participants With Sustained Pain Control for 5 Day Fixed Dose Phase
timeFrame: Day 15 up to Day 19
Secondary outcomes:
measure: Percentage of Participants Who Achieve Dose Adjustment
timeFrame: Day 3 up to Day 14
measure: Pain Assessment Using 24-hour Numerical Rating Scores (NRS) Scale
timeFrame: Baseline (Average of Day -1 and Day 0 morning scores), Day 20
measure: Pain Assessment Using Visual Analog Scale (VAS) Score
timeFrame: Baseline and Day 19
measure: Rescue Doses
timeFrame: Day 12, 13, 14, 15, 16, 17, 18 and 19
measure: Number of Participants Who Discontinued Study Treatment Because of Any Adverse Event (AE) or Lack of Efficacy
timeFrame: Baseline up to 7 days after last dose of study treatment
measure: Sleep Questionnaire Regarding Time to Sleep and Total Time Slept
timeFrame: Pre-dose (Day 1) and Day 20
measure: Sleep Questionnaire Regarding Number of Awakenings
timeFrame: Pre-dose (Day 1) and Day 20
measure: Sleep Questionnaire Regarding the Quality of Sleep
timeFrame: Pre-dose (Day 1) and Day 20
measure: Patient's Global Impression of Change (PGI-C)
timeFrame: Day 19
Other outcomes:
Locations:
city: Chiba
country: Japan
city: Chikushino
country: Japan
city: Fukuoka N/A
country: Japan
city: Fukuoka
country: Japan
city: Higashi-Sonogi
country: Japan
city: Himeji
country: Japan
city: Hirosaki
country: Japan
city: Ichinomiya
country: Japan
city: Ikeda
country: Japan
city: Iwakuni
country: Japan
city: Kobe
country: Japan
city: Kochi
country: Japan
city: Kyoto
country: Japan
city: Nishinomiya
country: Japan
city: Ohta
country: Japan
city: Osaka
country: Japan
city: Sapporo
country: Japan
city: Sasebo
country: Japan
city: Shizuoka
country: Japan
city: Tokyo
country: Japan
city: Toyonaka
country: Japan
city: Utsunomiya
country: Japan
Study officials:
affiliation: Janssen Pharmaceutical K.K.
name: Janssen Pharmaceutical K.K., Japan Clinical Trial
role: STUDY_DIRECTOR
References: