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

NCT03895762 | Completed

• 1 other identifier: MAKR/16/Abs-Can/001
• Study Type: observational
• Target: 143
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breakthrough Cancer Pain

Outcome Measures

Primary Outcomes (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.

  week 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.

  week 4

• 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.

  week 12

Secondary Outcomes (7)

• Status of achievement of Numeric Rating Scale goal

  week 1

• Abstral ODT maintenance dose

  week 1(dose titration)

• Abstral ODT maintenance dose

  week 4

• Abstral ODT maintenance dose

  week 12

• Brief Pain Inventory-Korean and Pain Diary values and changes

  week 1

Study Arms (1)

Abstral Oral Disintegrating Tablet (ODT)

Abstral Oral Disintegrating Tablet (ODT)

Drug: Abstral Oral Disintegrating Tablet (ODT)

Interventions

Abstral Oral Disintegrating Tablet (ODT) DRUG

Opioid(Fentanyl)

Also known as: Fentanyl

Abstral Oral Disintegrating Tablet (ODT)

Eligibility Criteria

• Age: 19 Years+
• Gender Eligibility Details: Male and female patient aged 19 and over
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• A.Menarini Asia-Pacific Holdings Pte Ltd: lead

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

Location

Related Publications (18)

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• Rauck RL, Tark M, Reyes E, Hayes TG, Bartkowiak AJ, Hassman D, Nalamachu S, Derrick R, Howell J. Efficacy and long-term tolerability of sublingual fentanyl orally disintegrating tablet in the treatment of breakthrough cancer pain. Curr Med Res Opin. 2009 Dec;25(12):2877-85. doi: 10.1185/03007990903368310.

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• Takigawa C, Goto F, Tanda S, Shima Y, Yomiya K, Matoba M, Adachi I, Yoshimoto T, Eguchi K. Breakthrough pain management using fentanyl buccal tablet (FBT) in combination with around-the-clock (ATC) opioids based on the efficacy and safety of FBT, and its relationship with ATC opioids: results from an open-label, multi-center study in Japanese cancer patients with detailed evaluation. Jpn J Clin Oncol. 2015 Jan;45(1):67-74. doi: 10.1093/jjco/hyu167. Epub 2014 Nov 7.

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  PMID: 22226371 BACKGROUND

MeSH Terms

Interventions

Fentanyl

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jin-Seok Ahn

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2018
• First Posted: March 29, 2019
• Study Start: July 4, 2017
• Primary Completion: June 28, 2019
• Study Completion: June 28, 2019
• Last Updated: May 5, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)