NCT01309386

Brief Summary

The purpose of this study is to evaluate the conversion rate based on the number of participants achieving pain control and safety within 1 week after switching the opioid (morphine-like medications) analgesics (drug used to control pain), when tapentadol extended-release (ER) (JNS024ER) is orally administered to participants treated with around-the-clock opioid analgesics, for their 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Aug 2010

Geographic Reach
1 country

22 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2011

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 7, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

March 13, 2013

Completed
Last Updated

March 13, 2013

Status Verified

February 1, 2013

Enrollment Period

1.4 years

First QC Date

February 17, 2011

Results QC Date

February 8, 2013

Last Update Submit

February 8, 2013

Conditions

Neoplasms

Keywords

TapentadolTumor related painOpioidCancer related painMorphine

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants Who Achieved Pain Control

    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.

    Week 1

Secondary Outcomes (6)

  • Change From Baseline in Numerical Rating Scale (NRS) at Week 1, 2, 3, 4, 5, 6, 7 and 8

    Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8

  • Number of Participants Who Discontinued Study Treatment Due to Lack of Efficacy

    Baseline up to Week 8

  • Number of Participants With Patient Global Impression of Change (PGIC)

    Week 1, 4 and 8

  • Total Number of Days of Rescue Medication Over Time

    Baseline up to Week 8

  • Number of Doses of Rescue Medication Over Time

    Baseline up to Week 8

  • +1 more secondary outcomes

Study Arms (2)

Tapentadol ER

EXPERIMENTAL

Tapentadol extended-release (ER) (JNS024ER) oral tablets 100 to 400 milligram (mg) daily for 8 weeks (maximum dose could be up to 500 mg daily), as per Investigator's discretion.

Drug: Tapentadol ER

Morphine SR

ACTIVE COMPARATOR

Morphine sustained-release (SR) oral tablets 30 to 120 mg daily for 8 weeks (maximum dose could be up to 140 mg daily), as per Investigator's discretion.

Drug: Morphine SR

Interventions

Tapentadol ERDRUG

Tapentadol ER 100 to 400 milligram (mg) orally daily for 8 weeks (maximum up to 500 mg daily), as per Investigator's discretion.

Tapentadol ER
Morphine SRDRUG

Morphine SR 30 to 120 mg orally daily for 8 weeks (maximum up to 140 mg daily), as per Investigator's discretion.

Morphine SR

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

Unknown Facility

Chiba, Japan

Location

Unknown Facility

Hamamatsu, Japan

Location

Unknown Facility

Ibaraki, Japan

Location

Unknown Facility

Kanagawa, Japan

Location

Unknown Facility

Katsushika-ku, Japan

Location

Unknown Facility

Kobe, Japan

Location

Unknown Facility

Kumamoto, Japan

Location

Unknown Facility

Matsumoto, Japan

Location

Unknown Facility

Matsuyama, Japan

Location

Unknown Facility

Nagasaki, Japan

Location

Unknown Facility

Nagoya, Japan

Location

Unknown Facility

Nishinomiya, Japan

Location

Unknown Facility

Ohmura, Japan

Location

Unknown Facility

Ohta, Japan

Location

Unknown Facility

Osaka, Japan

Location

Unknown Facility

Saga, Japan

Location

Unknown Facility

Sapporo, Japan

Location

Unknown Facility

Tokyo, Japan

Location

Unknown Facility

Toyama, Japan

Location

Unknown Facility

Toyohashi, Japan

Location

Unknown Facility

Utsunomiya, Japan

Location

Unknown Facility

Yokohama, Japan

Location

Related Publications (1)

  • Imanaka K, Tominaga Y, Etropolski M, Ohashi H, Hirose K, Matsumura T. Ready conversion of patients with well-controlled, moderate to severe, chronic malignant tumor-related pain on other opioids to tapentadol extended release. Clin Drug Investig. 2014 Jul;34(7):501-11. doi: 10.1007/s40261-014-0204-3.

    PMID: 24906437DERIVED

MeSH Terms

Conditions

NeoplasmsCancer Pain

Interventions

Morphine

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Results Point of Contact

Title
Manager
Organization
Neuroscience department, Clinical science department, R&D in Janssen, Chiyodaku, Tokyo 101-0065, Japan
+81-3-4411-5509

Study Officials

  • Janssen Pharmaceutical K.K. 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 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2011

First Posted

March 7, 2011

Study Start

August 1, 2010

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

March 13, 2013

Results First Posted

March 13, 2013

Record last verified: 2013-02

Locations

JP(22)