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Breakthrough Cancer PainOASISNCT03895762

Observational Study of Efficacy, Safety and Tolerability of Fentanyl in Korean Cancer Patients

An observational study of Breakthrough Cancer Pain, run by A.Menarini Asia-Pacific Holdings Pte Ltd at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Breakthrough Cancer Pain
What is being tested?
Abstral Oral Disintegrating Tablet (ODT)
Type of treatment
Pill or oral medicine
How many people
143 participants
Where
1 siteSouth Korea
Study dates
4 Jul 2017to 28 Jun 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients who have been regularly on treatment with opioids for cancer pain from before study initiation and have no prior treatment with Abstral ODT within 30 days prior to study initiation.

Who may be able to join

  • Korean male and female adults at the age of 19 or older
  • 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
  • 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)
  • Patient who has been on opioids for the treatment of background cancer pain
  • Patient who did not administer Abstral ODT within 1 month prior to the baseline visit
  • Patient who signs the data release consent to data use.

Who cannot join

  • Patient for whom Abstral ODT is contraindicated based on its summary of product characteristics
  • Patient who is considered by the investigator to be ineligible for study participation for other reasons
  • Patient who is participating or participated in an opioid related clinical trial within 30 days prior to the baseline visit
  • Patient with neuropathic pain attacks

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Samsung Medical Center

    Seoul, 06351

Other trials in South Korea

About this study

Official title: 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

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.

Read the detailed description

This is a multicenter, non-interventional, single-arm, non-randomized observational study designed to collect the efficacy, safety, and tolerability data of Abstral ODT for the treatment of breakthrough cancer pain in cancer patients in real-world outpatient and inpatient clinical settings.

As the purpose of this study is to investigate the efficacy and safety of Abstral ODT in routine clinical practice, drug prescription and treatment will be determined according to the medical judgment of the investigator, regardless of enrollment to this study. During the patient's visit to the institution, Abstral ODT will be prescribed according to the judgment of the investigator, and study participation will be suggested for this patient. Whether to participate in this study or not will not affect the patient's treatment (physician's prescription or diagnostic and therapeutic decision).

Due to the non-interventional observational nature of this study, there will be no visits or procedures to be performed mandatorily according to the protocol, and data will be collected at Week 1 (±3 days), Week 4 (±1 week), and Week 12 (±4 weeks) from the baseline visit according to the circumstances of clinical practice.

Status of successful dose titration for Abstral ODT will be determined according to the criteria in which dose titration is deemed 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 and 60 min after administration is reduced by ≥2; adverse drug reactions are tolerable for the subject.The overall procedures of this study are as follows.

Being tested
Abstral Oral Disintegrating Tablet (ODT)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Abstral Oral Disintegrating Tablet (ODT)Drug

    Also called Fentanyl

    Opioid(Fentanyl)

Study groups in NCT03895762
Study groupRoleWhat they receive
Abstral Oral Disintegrating Tablet (ODT)Abstral Oral Disintegrating Tablet (ODT)
Receives: Drug: Abstral Oral Disintegrating Tablet (ODT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Subjects of successful dose titration

    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.

    Measured: week 1

  2. Number of Subjects of successful dose titration

    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.

    Measured: week 4

  3. Number of Subjects of successful dose titration

    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.

    Measured: week 12

Secondary outcomes (7)

  1. Status of achievement of Numeric Rating Scale goal

    Status of achievement of Numeric Rating Scale goal set by each subject

    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)

    Measured: week 1

  2. Abstral ODT maintenance dose

    Abstral ODT maintenance dose at Week 4 and 12 of treatment, and after dose titration

    Data will be collected at Week 1 (±3 days), Week 4 (±1 week), and Week 12 (±4 weeks) from the baseline visit according to the circumstances of clinical practice.

    Measured: week 1(dose titration)

  3. Abstral ODT maintenance dose

    Abstral ODT maintenance dose at Week 4 and 12 of treatment, and after dose titration

    Data will be collected at Week 1 (±3 days), Week 4 (±1 week), and Week 12 (±4 weeks) from the baseline visit according to the circumstances of clinical practice.

    Measured: week 4

  4. Abstral ODT maintenance dose

    Abstral ODT maintenance dose at Week 4 and 12 of treatment, and after dose titration

    Data will be collected at Week 1 (±3 days), Week 4 (±1 week), and Week 12 (±4 weeks) from the baseline visit according to the circumstances of clinical practice.

    Measured: week 12

  5. Brief Pain Inventory-Korean and Pain Diary values and changes

    Brief Pain Inventory-Korean and Pain Diary values (maximum pain intensity of all incidences of breakthrough pain, pain intensity difference at 30min, pain intensity difference at 60 mins, quality of sleep, etc.) and changes. Brief Pain Inventory-Korean is to measure pain intensity in subject by verbally responding to a 10-point scale(0=no pain and 10=worst possible pain in total range)

    Measured: week 1

  6. Brief Pain Inventory-Korean and Pain Diary values and changes

    Brief Pain Inventory-Korean and Pain Diary values (maximum pain intensity of all incidences of breakthrough pain, pain intensity difference at 30min, pain intensity difference at 60 mins, quality of sleep, etc.) and changes. Brief Pain Inventory-Korean is to measure pain intensity in subject by verbally responding to a 10-point scale(0=no pain and 10=worst possible pain in total range)

    Measured: week 4

  7. Brief Pain Inventory-Korean and Pain Diary values and changes

    Brief Pain Inventory-Korean and Pain Diary values (maximum pain intensity of all incidences of breakthrough pain, pain intensity difference at 30min, pain intensity difference at 60 mins, quality of sleep, etc.) and changes. Brief Pain Inventory-Korean is to measure pain intensity in subject by verbally responding to a 10-point scale(0=no pain and 10=worst possible pain in total range)

    Measured: week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2019
  2. Study start4 Jul 2017
  3. Primary completion28 Jun 2019
  4. Study completion28 Jun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
143 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03895762
Sponsor's protocol ID
MAKR/16/Abs-Can/001
Acronym
OASIS
Status last verified
Apr 2022
First submitted
15 Nov 2018
Last updated
5 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Haugen 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.

    PubMed 20236762

  • Davies 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.

    PubMed 18707904

  • Corli 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.

    PubMed 26940689

  • Deandrea 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.

    PubMed 23796584

  • Portenoy RK, Hagen NA. Breakthrough pain: definition, prevalence and characteristics. Pain. 1990 Jun;41(3):273-281. doi: 10.1016/0304-3959(90)90004-W.

    PubMed 1697056

  • Portenoy 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.

    PubMed 10353500

  • Portenoy RK, Hagen NA. Breakthrough pain: definition and management. Oncology (Williston Park). 1989 Aug;3(8 Suppl):25-9.

    PubMed 2484297

  • Zeppetella G, O'Doherty CA, Collins S. Prevalence and characteristics of breakthrough pain in cancer patients admitted to a hospice. J Pain Symptom Manage. 2000 Aug;20(2):87-92. doi: 10.1016/s0885-3924(00)00161-5.

    PubMed 10989246

  • Hong SH, Roh SY, Kim SY, Shin SW, Kim CS, Choi JH, Kim SY, Yim CY, Sohn CH, Song HS, Hong YS. Change in cancer pain management in Korea between 2001 and 2006: results of two nationwide surveys. J Pain Symptom Manage. 2011 Jan;41(1):93-103. doi: 10.1016/j.jpainsymman.2010.03.025. Epub 2010 Sep 26.

    PubMed 20870388

  • Caraceni A, Martini C, Zecca E, Portenoy RK, Ashby MA, Hawson G, Jackson KA, Lickiss N, Muirden N, Pisasale M, Moulin D, Schulz VN, Rico Pazo MA, Serrano JA, Andersen H, Henriksen HT, Mejholm I, Sjogren P, Heiskanen T, Kalso E, Pere P, Poyhia R, Vuorinen E, Tigerstedt I, Ruismaki P, Bertolino M, Larue F, Ranchere JY, Hege-Scheuing G, Bowdler I, Helbing F, Kostner E, Radbruch L, Kastrinaki K, Shah S, Vijayaram S, Sharma KS, Devi PS, Jain PN, Ramamani PV, Beny A, Brunelli C, Maltoni M, Mercadante S, Plancarte R, Schug S, Engstrand P, Ovalle AF, Wang X, Alves MF, Abrunhosa MR, Sun WZ, Zhang L, Gazizov A, Vaisman M, Rudoy S, Gomez Sancho M, Vila P, Trelis J, Chaudakshetrin P, Koh ML, Van Dongen RT, Vielvoye-Kerkmeer A, Boswell MV, Elliott T, Hargus E, Lutz L; Working Group of an IASP Task Force on Cancer Pain. Breakthrough pain characteristics and syndromes in patients with cancer pain. An international survey. Palliat Med. 2004 Apr;18(3):177-83. doi: 10.1191/0269216304pm890oa.

    PubMed 15198130

  • Boceta J, De la Torre A, Samper D, Farto M, Sanchez-de la Rosa R. Consensus and controversies in the definition, assessment, treatment and monitoring of BTcP: results of a Delphi study. Clin Transl Oncol. 2016 Nov;18(11):1088-1097. doi: 10.1007/s12094-016-1490-4.

    PubMed 26856600

  • Coluzzi PH. Cancer pain management: newer perspectives on opioids and episodic pain. Am J Hosp Palliat Care. 1998 Jan-Feb;15(1):13-22. doi: 10.1177/104990919801500105.

    PubMed 9468974

  • Patt RB, Ellison NM. Breakthrough pain in cancer patients: characteristics, prevalence, and treatment. Oncology (Williston Park). 1998 Jul;12(7):1035-46; discussion 1049-52.

    PubMed 9684277

  • Coluzzi PH, Schwartzberg L, Conroy JD, Charapata S, Gay M, Busch MA, Chavez J, Ashley J, Lebo D, McCracken M, Portenoy RK. Breakthrough cancer pain: a randomized trial comparing oral transmucosal fentanyl citrate (OTFC) and morphine sulfate immediate release (MSIR). Pain. 2001 Mar;91(1-2):123-30. doi: 10.1016/s0304-3959(00)00427-9.

    PubMed 11240084

  • Lennernas B, Hedner T, Holmberg M, Bredenberg S, Nystrom C, Lennernas H. Pharmacokinetics and tolerability of different doses of fentanyl following sublingual administration of a rapidly dissolving tablet to cancer patients: a new approach to treatment of incident pain. Br J Clin Pharmacol. 2005 Feb;59(2):249-53. doi: 10.1111/j.1365-2125.2004.02264.x.

    PubMed 15676050

Questions about this trial

What is this clinical trial studying?

An observational study of Breakthrough Cancer Pain, run by A.Menarini Asia-Pacific Holdings Pte Ltd at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Subjects of successful dose titration (time frame: week 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03895762, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2022.

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