A Safety and Efficacy Study of Oral Tapentadol Extended-Release in Japanese Participants

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01309386
• Other study ID #: CR017326
• Secondary ID: JNS024ER-JPN-C03
• Status: Completed
• Phase: Phase 3
• First received: February 17, 2011
• Last updated: February 8, 2013
• Start date: August 2010
• Est. completion date: January 2012

Study information

• Verified date: February 2013
• Source: Janssen Pharmaceutical K.K.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Neoplasms

Intervention

Drug:
• Tapentadol ER
Tapentadol ER 100 to 400 milligram (mg) orally daily for 8 weeks (maximum up to 500 mg daily), as per Investigator's discretion.
• Morphine SR
Morphine SR 30 to 120 mg orally daily for 8 weeks (maximum up to 140 mg daily), as per Investigator's discretion.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Pharmaceutical K.K.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change From Baseline in Numerical Rating Scale (NRS) at Week 1, 2, 3, 4, 5, 6, 7 and 8	Average pain intensity was assessed using an 11-point NRS to measure the pain level for the past 24-hours where 0=no pain to 10=pain as bad as you can imagine.	Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8	No
Secondary	Number of Participants Who Discontinued Study Treatment Due to Lack of Efficacy	Number of participants who discontinued the treatment due to lack of efficacy were assessed throughout the study.	Baseline up to Week 8	No
Secondary	Number of Participants With Patient Global Impression of Change (PGIC)	The PGIC is a single-item questionnaire designed to provide an overall assessment of treatment from the participant's perspective since the start of the study. It is measured on a 7-point scale, where 1=very much improved and 7=very much worse. A participant is considered a responder if they have a response of "very much improved" or "much improved".	Week 1, 4 and 8	No
Secondary	Total Number of Days of Rescue Medication Over Time	Total number of days of rescue medication over time were assessed. Rescue medications are medicines that are 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. Supplemental analgesics (drug used to control pain) were used as rescue medication.	Baseline up to Week 8	No
Secondary	Number of Doses of Rescue Medication Over Time	Number of doses of rescue medication over time were assessed. Rescue medications are medicines that are 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. Supplemental analgesics (drug used to control pain) were used as rescue medication.	Baseline up to Week 8	No
Secondary	Average Change From Baseline in Amount of Rescue Medication Over Time	Rescue medications are medicines that are 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. Supplemental analgesics (drug used to control pain) were used as rescue medication. Average amount was the averages of all doses recorded during the baseline period or during each week (Week 1, 2, 3, 4, 5, 6, 7 and 8).	Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8	No