Proportional Dose of Sublingual Fentanyl Tablet Based on Daily Opioid Requirement

Proportional Dose of Sublingual Fentanyl Tablet Based on Daily Opioid Requirement Versus Intravenous PCA for Breakthrough Cancer Pain: A Prospective, Randomized, Open Label, Non Inferiority Trial

Proportional dose of sublingual fentanyl tablet (Narco®) based on daily opioid requirement versus intravenous PCA for breakthrough cancer pain: A prospective, randomized, open-label, noninferiority trial.

Study Overview

• Status: Withdrawn
• Conditions: Breakthrough Pain; Cancer Pain
• Intervention / Treatment: Drug: Intravenous Infusion; Drug: Sublingual Tablet

Detailed Description

Based on the previous around-the-clock analgesic demand compared to IV PCA in cancer pain patients to prepare the basis for the administration of fentanyl sublingual tablets with an initial dose.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 19-80
• Cancer pain
• Admission for the control of cancer pain or consultation for the treatment of cancer pain
• Stable vital sign
• ECOG status ≤ 3 for more than 1 or 2 months
• Opioid-tolerant state
• No history of using sublingual fentanyl

Exclusion Criteria:

• Noncancer pain
• Opioid naive
• baseline NRS pain score> 4
• Current using sublingual fentanyl
• Difficult to assess cancer pain
• no evidence of disease(cancer)
• Planned surgical resection of cancer
• Allergy to fentanyl
• Severe renal and/or liver function
• Severe respiratory depression or uncontrolled COPD

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: IV PCA (proportional dosage); Breakthrough pain control by bolus based IV patient-controlled anagesia Fentanyl bolus = MME * 15%	Drug: Intravenous Infusion; IV PCA(fentanyl) Fentanyl bolus = MME * 15%; Other Names: PCA
Experimental: SL-FTN (equivalent dose for PCA bolus); Breakthrough pain control by sublingual fentanyl Fentanyl 100mcg/200mcg/300mcg according to the around-the-clock opioid requirement.	Drug: Sublingual Tablet; subligual fentanyl(Narco®) Fentanyl 100mcg/200mcg/300mcg according to the around-the-clock opioid requirement.; Other Names: sublingual

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 11-point scale NRS pain score	Change in pain score compared to baseline Score '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable"	30 minutes after administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 11-point scale NRS pain score	Change in pain score compared to baseline Score '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable"	15, 45, 60 minutes after administration
sum of pain intensity difference(SPID)	sum of pain intensity change compared to baseline difference	60 minutes after administration
number of additional doses	number of additional doses fentanyl bolus or subligual	immediately after the intervention
Pain interference	Pain interference using BPI-SF	immediately after the intervention
Insomnia	The severity of insomnia using ISI	immediately after the intervention
Depression	The severity of depression using Beck Depression Inventory(BDI) 1-10: These ups and downs are considered normal 11-16: Mild mood disturbance 17-20: Borderline clinical depression 21-30: Moderate depression 31-40: Severe depression over 40: Extreme depression	immediately after the intervention
Satisfaction scale	Satisfaction check using 5 Likert-scale (1) Very dissatisfied; (2) Not satisfied; (3) Neutral; (4) Satisfied; (5) Very satidfied	immediately after the intervention

Collaborators and Investigators

• Sponsor: Seoul National University
• Investigators: Study Chair: Jee Youn Moon, MD, PhD, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2022
• Primary Completion (Estimated): May 31, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: August 30, 2021
• First Submitted That Met QC Criteria: September 15, 2021
• First Posted (Actual): September 22, 2021

Study Record Updates

• Last Update Posted (Actual): August 7, 2023
• Last Update Submitted That Met QC Criteria: August 3, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Breakthrough Pain; Cancer Pain
• Other Study ID Numbers: 2012-144-1183

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No