Clinical trial

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

Name

2012-144-1183

Description

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.

Trial arms

Trial start

2022-12-01

Estimated PCD

2023-05-31

Trial end

2023-12-31

Status

Withdrawn

Treatment

Intravenous Infusion

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

Arms:

IV PCA (proportional dosage)

Other names:

PCA

Sublingual Tablet

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

Arms:

SL-FTN (equivalent dose for PCA bolus)

Other names:

sublingual

Primary endpoint

Change in 11-point scale NRS pain score

30 minutes after administration

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 0, 'type': 'ACTUAL'}}

Updated at

2023-08-07

1 organization

2 products

2 indications

Organization

Seoul National University

Product

Indication

Indication

Product