WithdrawnNot Applicable

Proportional Dose of Sublingual Fentanyl Tablet Based on Daily Opioid Requirement

Stopped: The supply of IP is disrupted

0Started 2022-12-01

Plain-language 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.

Who can participate

Age range19 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change in 11-point scale NRS pain score

Timeframe: 30 minutes after administration

Trial details

NCT IDNCT05053308

SponsorSeoul National University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-05-31

View on ClinicalTrials.gov More Cancer Pain trials