A Phase 3 interventional study of Fentanyl Ethypharm in Breakthrough Pain and Cancer, sponsored by Ethypharm. Completed at 1 site in Czech Republic. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-05-03.
Sponsored by Ethypharm · Phase 3, Interventional, and Treatment
The purpose of the study is to assess the clinical effectiveness of Fentanyl ETHYPHARM when used to relieve breakthrough pain (BTP) in opioid-treated cancer patients.
34 studies on the registry are indexed under Breakthrough Pain; 4 are open to participants now.
This study's enrollment of 91 is close to the median of 91 across 21 interventional studies indexed under Breakthrough Pain.
Browse Breakthrough Pain studies →Ethypharm is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion criteria:
Main 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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
After an open-label titration to identify an optimal dose, patients were randomized to 1 of 13 prespecified sequences of 9 tablets (6 fentanyl and 3 placebo)
Drug: Fentanyl Ethypharm
After an open-label titration to identify an optimal dose, patients were randomized to 1 of 13 prespecified sequences of 9 tablets (6 fentanyl and 3 placebo)
Summed Pain Intensity Difference at 30 minutes (SPID30).
Time frame: 30 minutes post dose
SPID at 3, 6, 10, 15 and 60 minutes post-dosing
Time frame: 3, 6, 10, 15 and 60 minutes post-dosing
SPID at 15 and 30 minutes according to the pathophysiology of the pain (neuropathic, nociceptive)
Time frame: 15 and 30 minutes post dose
Pain Intensity Difference at 3, 6, 10, 15, 30 and 60 minutes after dosing
Time frame: 3, 6, 10, 15, 30 and 60 minutes after dosing
Pain Relief at 3, 6, 10, 15, 30 and 60 minutes after dosing
Time frame: 3, 6, 10, 15, 30 and 60 minutes after dosing
The proportion of episodes of BTP that required rescue medication
Time frame: 15 and 30 minutes post dose
the proportion of episodes with more than 33% and 50% of improvement in Pain Intensity scores
Time frame: 15 and 30 minutes post dose
Recording of safety data
Adverse events, vital signs, urinary pregnancy test
Time frame: During all the study duration, an expected average of 8 weeks
This study is completed, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.
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