Proportional Dose of Sublingual Fentanyl Tablet Based on Daily Opioid Requirement

Cancer Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05053308
• Other study ID #: 2012-144-1183
• Status: Withdrawn
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: August 2023
• Source: Seoul National University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Breakthrough Pain
• Cancer Pain

Intervention

Drug:
• Intravenous Infusion
IV PCA(fentanyl) Fentanyl bolus = MME * 15%
• Sublingual Tablet
subligual fentanyl(Narco®) Fentanyl 100mcg/200mcg/300mcg according to the around-the-clock opioid requirement.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	sum of pain intensity difference(SPID)	sum of pain intensity change compared to baseline difference	60 minutes after administration
Secondary	number of additional doses	number of additional doses fentanyl bolus or subligual	immediately after the intervention
Secondary	Pain interference	Pain interference using BPI-SF	immediately after the intervention
Secondary	Insomnia	The severity of insomnia using ISI	immediately after the intervention
Secondary	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
Secondary	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