Phase 2 Study of Tapentadol Prolonged Release in Cancer Pain Participants

NCT00805142 | Completed Phase 2 Results

• 2 other identifiers: CR015532JNS024PR-JPN-C01
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 21

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.

Conditions

Pain; Cancer

Keywords

Pain; Cancer; Tapentadol

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Sustained Pain Control for 5 Day Fixed Dose Phase

  Percentage of participants with sustained pain control for 5 day fixed dose phase were the participants who completed 5 day maintenance period, whose mean Numerical Rating Scale (NRS) score during the fixed dose phase and which was assessed immediately before giving each dose was less than 4 and the number of rescue doses per day for fixed dose phase was 2 or less. Pain intensity scores were recorded 0 to 30 minutes before dose on 11 point NRS where 0 = no pain and 10 = severest pain imaginable.

  Day 15 up to Day 19

Secondary Outcomes (9)

• Percentage of Participants Who Achieve Dose Adjustment

  Day 3 up to Day 14

• Pain Assessment Using 24-hour Numerical Rating Scores (NRS) Scale

  Baseline (Average of Day -1 and Day 0 morning scores), Day 20

• Pain Assessment Using Visual Analog Scale (VAS) Score

  Baseline and Day 19

• Rescue Doses

  Day 12, 13, 14, 15, 16, 17, 18 and 19

• Number of Participants Who Discontinued Study Treatment Because of Any Adverse Event (AE) or Lack of Efficacy

  Baseline up to 7 days after last dose of study treatment

Study Arms (2)

Opioid-Naive Participants (Tapentadol PR)

EXPERIMENTAL

Opioid-naive participants are defined as those who had moderate to severe cancer pain that is not controlled sufficiently with non-opioid medications. Treatment period comprises of Titration and Maintenance period. Titration period (3-14 days) is duration between start of treatment to day before initial dose in the maintenance period. Treatment will be initiated with tapentadol prolonged release (JNS024PR, PR) 25 milligram (mg) oral tablet twice daily. Dose will be increased or decreased as per Investigator's discretion up to Day 14. Maximum dose limit will be 500 mg per day. Participants will then be assigned to the treatment in the maintenance period (15-19 days). The maintenance period is duration between the first dose and the final assessment in the maintenance period. Participants will receive tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period.

Drug: Tapentadol PR

Opioid-Switch Participants (Tapentadol PR)

EXPERIMENTAL

Opioid-switching participants are defined as those who had moderate to severe cancer pain that is controlled sufficiently with opioid therapy. Treatment period comprises of Titration and Maintenance period. Titration period (3-14 days) is duration between start of treatment to day before initial dose in maintenance period. Initial dose of tapentadol PR is selected according to daily dose of opioid (morphine sustained release \[SR\] preparation, oxycodone hydrochloride \[HCl\] SR tablet or fentanyl patch). Equivalent dose of tapentadol PR oral tablet twice daily is given depending on daily dose of opioid at completion of Screening period. Maximum dose limit is 500 mg per day. Participants will then be assigned to treatment in maintenance period (15-19 days). Maintenance period is defined as duration between first dose and final assessment in maintenance period. Participants will receive tapentadol PR oral tablet twice daily for 5 days at same dose used on last day of titration period.

Drug: Tapentadol PR

Interventions

Tapentadol PR DRUG

Tapentadol PR tablets will be administered orally twice daily initiated at dose of 25 mg. Dose will be adjusted as per Investigator's discretion. Maximum dose limit is 500 mg per day. Total duration of treatment is 19 days.

Also known as: Tapentadol hydrochloride, JNS024

Opioid-Naive Participants (Tapentadol PR); Opioid-Switch Participants (Tapentadol PR)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Pharmaceutical K.K.: lead
• Grünenthal GmbH: collaborator

Study Sites (21)

Unknown Facility

Chiba, Japan

Location

Unknown Facility

Chikushino-shi, Japan

Location

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Fukuoka, Japan

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Himeji, Japan

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Hirosaki, Japan

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Ichinomiya, Japan

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Ikeda, Japan

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Iwakuni, Japan

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Kobe, Japan

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Kochi, Japan

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Kyoto, Japan

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Nishinomiya, Japan

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Ohta, Japan

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Osaka, Japan

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Sapporo, Japan

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Sasebo, Japan

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Shizuoka, Japan

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Sonogishukugō, Japan

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Tokyo, Japan

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Unknown Facility

Toyonaka, Japan

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Unknown Facility

Utsunomiya, Japan

Location

MeSH Terms

Conditions

Pain; Neoplasms

Interventions

Tapentadol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Senior Director, Clinical Leader
• Organization: Janssen R&D, 1125 Trenton-Harbourton Road, Titusville, PA 18902, USA

609-730-6777

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: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2008
• First Posted: December 9, 2008
• Study Start: November 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: July 29, 2013
• Results First Posted: July 29, 2013

Record last verified: 2013-06

Locations

JP (21)