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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Breakthrough Cancer Pain

Intervention / Treatment
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* Drug: Abstral Oral Disintegrating Tablet (ODT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Korean male and female adults at the age of 19 or older 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 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) Patient who has been on opioids for the treatment of background cancer pain Patient who did not administer Abstral ODT within 1 month prior to the baseline visit Patient who signs the data release consent to data use. Exclusion Criteria: Patient for whom Abstral ODT is contraindicated based on its summary of product characteristics Patient who is considered by the investigator to be ineligible for study participation for other reasons Patient who is participating or participated in an opioid related clinical trial within 30 days prior to the baseline visit Patient with neuropathic pain attacks

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Abstral Oral Disintegrating Tablet (ODT)<br>Abstral Oral Disintegrating Tablet (ODT) | Drug: Abstral Oral Disintegrating Tablet (ODT)<br>* Opioid(Fentanyl)<br>* Other names: Fentanyl;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects of successful dose titration | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |