Observational Study of Efficacy, Safety and Tolerability of Fentanyl in Korean Cancer Patients (OASIS)

April 29, 2022 updated by: A.Menarini Asia-Pacific Holdings Pte Ltd

An Observational Study to Assess the Efficacy, Safety, and Tolerability of Abstral Oral Disintegrating Tablet (ODT) for the Management of Breakthrough Cancer Pain in Korean Cancer Patients

The purpose of this observational study is:

To observe the efficacy, safety, and tolerability of Abstral ODT for the alleviation of breakthrough cancer pain in Korean patients with various cancers in real-world clinical settings and supplement and expand the previous cross-sectional survey results.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a multicenter, non-interventional, single-arm, non-randomized observational study designed to collect the efficacy, safety, and tolerability data of Abstral ODT for the treatment of breakthrough cancer pain in cancer patients in real-world outpatient and inpatient clinical settings.

As the purpose of this study is to investigate the efficacy and safety of Abstral ODT in routine clinical practice, drug prescription and treatment will be determined according to the medical judgment of the investigator, regardless of enrollment to this study. During the patient's visit to the institution, Abstral ODT will be prescribed according to the judgment of the investigator, and study participation will be suggested for this patient. Whether to participate in this study or not will not affect the patient's treatment (physician's prescription or diagnostic and therapeutic decision).

Due to the non-interventional observational nature of this study, there will be no visits or procedures to be performed mandatorily according to the protocol, and data will be collected at Week 1 (±3 days), Week 4 (±1 week), and Week 12 (±4 weeks) from the baseline visit according to the circumstances of clinical practice.

Status of successful dose titration for Abstral ODT will be determined according to the criteria in which dose titration is deemed successful when all of the following are met, and ineffective when one of the following is not met: no additional dose is administered within 2 h of administration of Abstral ODT during maintenance phase; Numeric Rating Scale scores at 30 and 60 min after administration is reduced by ≥2; adverse drug reactions are tolerable for the subject.The overall procedures of this study are as follows.

Study Type

Observational

Enrollment (Actual)

143

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients who have been regularly on treatment with opioids for cancer pain from before study initiation and have no prior treatment with Abstral ODT within 30 days prior to study initiation.

Description

Inclusion Criteria:

  1. Korean male and female adults at the age of 19 or older

  2. In patient with Breakthrough cancer pain in inpatient or outpatient settings,

    • Patient with minimally 1 attack per day for the last week
    • Uncontrolled Breakthrough cancer pain patient with previous treatment with other fentanyl based on Invenstigator's judgment or patient who had not satisfied with previous treatment with other fentanyl at patient's request
  3. Patient with opioid tolerance (treatment with at least 60 ㎎/day oral morphine, at least 25 mcg/hour transdermal fentanyl, at least 30 ㎎/day oxycodone, at least 8 ㎎/day oral hydromorphone, or other opioids at equivalent analgesic doses for 1 week or longer)
  4. Patient who has been on opioids for the treatment of background cancer pain
  5. Patient who did not administer Abstral ODT within 1 month prior to the baseline visit
  6. Patient who signs the data release consent to data use.

Exclusion Criteria:

  1. Patient for whom Abstral ODT is contraindicated based on its summary of product characteristics
  2. Patient who is considered by the investigator to be ineligible for study participation for other reasons
  3. Patient who is participating or participated in an opioid related clinical trial within 30 days prior to the baseline visit
  4. Patient with neuropathic pain attacks

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Abstral Oral Disintegrating Tablet (ODT)
Drug: Abstral Oral Disintegrating Tablet (ODT)
Opioid(Fentanyl)
Other Names:
  • Fentanyl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects of successful dose titration
Time Frame: week 1

Status of successful dose titration. Titration is considered successful when all of the following are met, and ineffective when one of the following is not met:

  • No additional dose is administered within 2 h of administration of Abstral ODT during maintenance phase;
  • Numeric Rating Scale scores at 30 mins after administration is reduced by ≥2; Numeric Rating Scale is to measure pain intensity in subject by verbally responding to a 10-point Numeric Rating Scale (0=no pain and 10=worst possible pain in total range)
  • Adverse drug reactions are tolerable for the subject.
week 1
Number of Subjects of successful dose titration
Time Frame: week 4

Status of successful dose titration. Titration is considered successful when all of the following are met, and ineffective when one of the following is not met:

  • No additional dose is administered within 2 h of administration of Abstral ODT during maintenance phase;
  • Numeric Rating Scale scores at 30 mins after administration is reduced by ≥2; Numeric Rating Scale is to measure pain intensity in subject by verbally responding to a 10-point Numeric Rating Scale (0=no pain and 10=worst possible pain in total range)
  • Adverse drug reactions are tolerable for the subject.
week 4
Number of Subjects of successful dose titration
Time Frame: week 12

Status of successful dose titration. Titration is considered successful when all of the following are met, and ineffective when one of the following is not met:

  • No additional dose is administered within 2 h of administration of Abstral ODT during maintenance phase;
  • Numeric Rating Scale scores at 30 mins after administration is reduced by ≥2; Numeric Rating Scale is to measure pain intensity in subject by verbally responding to a 10-point Numeric Rating Scale (0=no pain and 10=worst possible pain in total range)
  • Adverse drug reactions are tolerable for the subject.
week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Status of achievement of Numeric Rating Scale goal
Time Frame: week 1

Status of achievement of Numeric Rating Scale goal set by each subject

Numeric Rating Scale is to measure pain intensity in subject by verbally responding to a 10-point Numeric Rating Scale (0=no pain and 10=worst possible pain in total range)
week 1
Abstral ODT maintenance dose
Time Frame: week 1(dose titration)

Abstral ODT maintenance dose at Week 4 and 12 of treatment, and after dose titration

Data will be collected at Week 1 (±3 days), Week 4 (±1 week), and Week 12 (±4 weeks) from the baseline visit according to the circumstances of clinical practice.
week 1(dose titration)
Abstral ODT maintenance dose
Time Frame: week 4

Abstral ODT maintenance dose at Week 4 and 12 of treatment, and after dose titration

Data will be collected at Week 1 (±3 days), Week 4 (±1 week), and Week 12 (±4 weeks) from the baseline visit according to the circumstances of clinical practice.
week 4
Abstral ODT maintenance dose
Time Frame: week 12

Abstral ODT maintenance dose at Week 4 and 12 of treatment, and after dose titration

Data will be collected at Week 1 (±3 days), Week 4 (±1 week), and Week 12 (±4 weeks) from the baseline visit according to the circumstances of clinical practice.
week 12
Brief Pain Inventory-Korean and Pain Diary values and changes
Time Frame: week 1
Brief Pain Inventory-Korean and Pain Diary values (maximum pain intensity of all incidences of breakthrough pain, pain intensity difference at 30min, pain intensity difference at 60 mins, quality of sleep, etc.) and changes. Brief Pain Inventory-Korean is to measure pain intensity in subject by verbally responding to a 10-point scale(0=no pain and 10=worst possible pain in total range)
week 1
Brief Pain Inventory-Korean and Pain Diary values and changes
Time Frame: week 4
Brief Pain Inventory-Korean and Pain Diary values (maximum pain intensity of all incidences of breakthrough pain, pain intensity difference at 30min, pain intensity difference at 60 mins, quality of sleep, etc.) and changes. Brief Pain Inventory-Korean is to measure pain intensity in subject by verbally responding to a 10-point scale(0=no pain and 10=worst possible pain in total range)
week 4
Brief Pain Inventory-Korean and Pain Diary values and changes
Time Frame: week 12
Brief Pain Inventory-Korean and Pain Diary values (maximum pain intensity of all incidences of breakthrough pain, pain intensity difference at 30min, pain intensity difference at 60 mins, quality of sleep, etc.) and changes. Brief Pain Inventory-Korean is to measure pain intensity in subject by verbally responding to a 10-point scale(0=no pain and 10=worst possible pain in total range)
week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

A.Menarini Asia-Pacific Holdings Pte Ltd

Investigators

  • Principal Investigator: Jin-Seok Ahn, Samsung Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 4, 2017

Primary Completion (Actual)

June 28, 2019

Study Completion (Actual)

June 28, 2019

Study Registration Dates

First Submitted

November 15, 2018

First Submitted That Met QC Criteria

March 27, 2019

First Posted (Actual)

March 29, 2019

Study Record Updates

Last Update Posted (Actual)

May 5, 2022

Last Update Submitted That Met QC Criteria

April 29, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAKR/16/Abs-Can/001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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