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NCT05037539

Efficacy of Injectable Fentanyl in Sublingual Route Versus Oral Morphine Syrup for Breakthrough Pain

Completed Phase 1, PHASE2 Last updated 31 August 2022
What this trial tests

Phase 1, PHASE2 trial testing Fentanyl Citrate 50Mcg/Ml Inj_#1 in Pain, Breakthrough in 20 participants. Completed in 30 June 2022.

Timeline
15 June 2021
Primary endpoint
30 December 2021
30 June 2022

Quick facts

Lead sponsorDepartment of Medical Services Ministry of Public Health of Thailand
PhasePhase 1, PHASE2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designsingle group
Maskingtriple
Primary purposesupportive care
Enrollment20
Start date15 June 2021
Primary completion30 December 2021
Estimated completion30 June 2022
Sites1 location across Thailand

Drugs / interventions tested

Conditions studied

Sponsor

Department of Medical Services Ministry of Public Health of Thailand

Who can join

Eligibility, female only, with Pain, Breakthrough. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Randomized control trial that to comparison the efficacy of injectable fentanyl in sublingual route versus oral morphine syrup for breakthrough pain in gynecologic cancer patients with chronic cancer pain Primary outcome : to measure pain score after drug is given

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Efficacy of reconstituted intravenous fentanyl to sublingual solution versus oral morphine syrup for breakthrough pain among patients with chronic gynecologic cancer pain: A randomized, double-blind, placebo-controlled trial.
    Thantiprechapong T, Tilagul T, Vasikasin V. · · 2023 · cited 1× · PMID 37170709 · DOI 10.1111/jog.15674

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Other Department of Medical Services Ministry of Public Health of Thailand trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05037539.

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