An interventional study of Intravenous Infusion and Sublingual Tablet in Cancer Pain and Breakthrough Pain, sponsored by Seoul National University. Withdrawn. Open to participants aged 19 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-08-07.
Sponsored by Seoul National University · Not applicable, Interventional, and Treatment
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.
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.
310 studies on the registry are indexed under Cancer Pain; 73 are open to participants now.
Browse Cancer Pain studies →Seoul National University is the lead sponsor of 32 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Breakthrough pain control by bolus based IV patient-controlled anagesia Fentanyl bolus = MME \* 15%
Drug: Intravenous Infusion
Breakthrough pain control by sublingual fentanyl Fentanyl 100mcg/200mcg/300mcg according to the around-the-clock opioid requirement.
Drug: Sublingual Tablet
IV PCA(fentanyl) Fentanyl bolus = MME \* 15%
Also known as: PCA
subligual fentanyl(Narco®) Fentanyl 100mcg/200mcg/300mcg according to the around-the-clock opioid requirement.
Also known as: sublingual
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"
Time frame: 30 minutes after administration
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"
Time frame: 15, 45, 60 minutes after administration
sum of pain intensity difference(SPID)
sum of pain intensity change compared to baseline difference
Time frame: 60 minutes after administration
number of additional doses
number of additional doses fentanyl bolus or subligual
Time frame: immediately after the intervention
Pain interference
Pain interference using BPI-SF
Time frame: immediately after the intervention
Insomnia
The severity of insomnia using ISI
Time frame: immediately after the intervention
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
Time frame: immediately after the intervention
Satisfaction scale
Satisfaction check using 5 Likert-scale (1) Very dissatisfied; (2) Not satisfied; (3) Neutral; (4) Satisfied; (5) Very satidfied
Time frame: immediately after the intervention
No study locations are listed for this record.
Start is estimated for Dec 2022; primary completion for May 2023, 5 months later.
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This study is withdrawn, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Seoul National University