Clinical trial · Observational
Observational Study of Efficacy, Safety and Tolerability of Fentanyl in Korean Cancer Patients
An Observational Study to Assess the Efficacy, Safety, and Tolerability of Abstral Oral Disintegrating Tablet (ODT) for the Management of Breakthrough Cancer Pain in Korean Cancer Patients
NCT03895762CI-TRIAL-00058266OASIScompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this observational study is: To observe the efficacy, safety, and tolerability of Abstral ODT for the alleviation of breakthrough cancer pain in Korean patients with various cancers in real-world clinical settings and supplement and expand the previous cross-sectional survey results.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breakthrough Cancer Pain | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abstral Oral Disintegrating Tablet (ODT) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Abstral Oral Disintegrating Tablet (ODT)
- description
- Abstral Oral Disintegrating Tablet (ODT)
- interventionNames
- Drug: Abstral Oral Disintegrating Tablet (ODT)
Primary outcomes (3)
- measure
- Number of Subjects of successful dose titration
- timeFrame
- week 1
- description
- Status of successful dose titration. Titration is considered successful when all of the following are met, and ineffective when one of the following is not met: * No additional dose is administered within 2 h of administration of Abstral ODT during maintenance phase; * Numeric Rating Scale scores at 30 mins after administration is reduced by ≥2; Numeric Rating Scale is to measure pain intensity in subject by verbally responding to a 10-point Numeric Rating Scale (0=no pain and 10=worst possible pain in total range) * Adverse drug reactions are tolerable for the subject.
- measure
- Number of Subjects of successful dose titration
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: 1. Korean male and female adults at the age of 19 or older 2. In patient with Breakthrough cancer pain in inpatient or outpatient settings, * Patient with minimally 1 attack per day for the last week * Uncontrolled Breakthrough cancer pain patient with previous treatment with other fentanyl based on Invenstigator's judgment or patient who had not satisfied with previous treatment with other fentanyl at patient's request 3. Patient with opioid tolerance (treatment with at least 60 ㎎/day oral morphine, at least 25 mcg/hour transdermal fentanyl, at least 30 ㎎/day oxycodone, at least 8 ㎎/day oral hydromorphone, or other opioids at equivalent analgesic doses for 1 week or longer) 4. Patient who has been on opioids for the treatment of background cancer pain 5. Patient who did not administer Abstral ODT within 1 month prior to the baseline visit 6. Patient who signs the data release consent to data use. Exclusion Criteria: 1. Patient for whom Abstral ODT is contraindicated based on its summary of product characteristics 2. Patient who is considered by the investigator to be ineligible for study participation for other reasons 3. Patient who is participating or participated in an opioid related clinical trial within 30 days prior to the baseline visit 4. Patient with neuropathic pain attacks
References
Publications (18)
- BACKGROUNDHaugen DF, Hjermstad MJ, Hagen N, Caraceni A, Kaasa S; European Palliative Care Research Collaborative (EPCRC). Assessment and classification of cancer breakthrough pain: a systematic literature review. Pain. 2010 Jun;149(3):476-482. doi: 10.1016/j.pain.2010.02.035. Epub 2010 Mar 16. PMID 20236762
- BACKGROUNDDavies AN, Dickman A, Reid C, Stevens AM, Zeppetella G; Science Committee of the Association for Palliative Medicine of Great Britain and Ireland. The management of cancer-related breakthrough pain: recommendations of a task group of the Science Committee of the Association for Palliative Medicine of Great Britain and Ireland. Eur J Pain. 2009 Apr;13(4):331-8. doi: 10.1016/j.ejpain.2008.06.014. Epub 2008 Aug 15. PMID 18707904
- BACKGROUNDCorli O, Floriani I, Roberto A, Montanari M, Galli F, Greco MT, Caraceni A, Kaasa S, Dragani TA, Azzarello G, Luzzani M, Cavanna L, Bandieri E, Gamucci T, Lipari G, Di Gregorio R, Valenti D, Reale C, Pavesi L, Iorno V, Crispino C, Pacchioni M, Apolone G; CERP STUDY OF PAIN GROUP (List of collaborators). Are strong opioids equally effective and safe in the treatment of chronic cancer pain? A multicenter randomized phase IV 'real life' trial on the variability of response to opioids. Ann Oncol. 2016 Jun;27(6):1107-1115. doi: 10.1093/annonc/mdw097. Epub 2016 Mar 2. PMID 26940689
- BACKGROUNDDeandrea S, Corli O, Consonni D, Villani W, Greco MT, Apolone G. Prevalence of breakthrough cancer pain: a systematic review and a pooled analysis of published literature. J Pain Symptom Manage. 2014 Jan;47(1):57-76. doi: 10.1016/j.jpainsymman.2013.02.015. Epub 2013 Jun 21. PMID 23796584
- BACKGROUNDPortenoy RK, Hagen NA. Breakthrough pain: definition, prevalence and characteristics. Pain. 1990 Jun;41(3):273-281. doi: 10.1016/0304-3959(90)90004-W. PMID 1697056
- BACKGROUNDPortenoy RK, Payne D, Jacobsen P. Breakthrough pain: characteristics and impact in patients with cancer pain. Pain. 1999 May;81(1-2):129-34. doi: 10.1016/s0304-3959(99)00006-8.