CompletedNot Applicable

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

South Korea143 participantsStarted 2017-07-04

Plain-language 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.

Who can participate

Age range19 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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 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.

Exclusion criteria

✕. 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

What they're measuring

Number of Subjects of successful dose titration

Timeframe: week 1

Number of Subjects of successful dose titration

Timeframe: week 4

Number of Subjects of successful dose titration

Timeframe: week 12

Trial details

NCT IDNCT03895762

SponsorA.Menarini Asia-Pacific Holdings Pte Ltd

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2019-06-28

View on ClinicalTrials.gov More Breakthrough Cancer Pain trials

Plain-language summary

Who can participate

Age range19 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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 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.

Exclusion criteria

✕. 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