Proportional Dose of Sublingual Fentanyl Tablet Based on Daily Opioid Requirement

NCT05053308 | Withdrawn

• 1 other identifier: 2012-144-1183
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Cancer Pain; Breakthrough Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change in 11-point scale NRS pain score

  15, 45, 60 minutes after administration

• sum of pain intensity difference(SPID)

  60 minutes after administration

• number of additional doses

  immediately after the intervention

• Pain interference

  immediately after the intervention

• Insomnia

  immediately after the intervention

Study Arms (2)

IV PCA (proportional dosage)

ACTIVE COMPARATOR

Breakthrough pain control by bolus based IV patient-controlled anagesia Fentanyl bolus = MME \* 15%

Drug: Intravenous Infusion

SL-FTN (equivalent dose for PCA bolus)

EXPERIMENTAL

Breakthrough pain control by sublingual fentanyl Fentanyl 100mcg/200mcg/300mcg according to the around-the-clock opioid requirement.

Drug: Sublingual Tablet

Interventions

Intravenous Infusion DRUG

IV PCA(fentanyl) Fentanyl bolus = MME \* 15%

Also known as: PCA

IV PCA (proportional dosage)

Sublingual Tablet DRUG

subligual fentanyl(Narco®) Fentanyl 100mcg/200mcg/300mcg according to the around-the-clock opioid requirement.

Also known as: sublingual

SL-FTN (equivalent dose for PCA bolus)

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University: lead

MeSH Terms

Conditions

Cancer Pain; Breakthrough Pain

Interventions

Infusions, Intravenous; Passive Cutaneous Anaphylaxis; Administration, Sublingual

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Administration, Intravenous; Drug Administration Routes; Drug Therapy; Therapeutics; Infusions, Parenteral; Skin Tests; Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques; Antigen-Antibody Reactions; Immune System Phenomena; Administration, Oral

Study Officials

• Jee Youn Moon, MD, PhD

  Seoul National University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 30, 2021
• First Posted: September 22, 2021
• Study Start: December 1, 2022
• Primary Completion: May 31, 2023
• Study Completion: December 31, 2023
• Last Updated: August 7, 2023

Record last verified: 2023-08