Breakthrough PainPhase 3ETHYFYLNCT01842893
Efficacy and Safety of Fentanyl ETHYPHARM for Breakthrough Pain in Opioid-treated Patients With Cancer
A Phase 3 study testing Fentanyl Ethypharm in people with Breakthrough Pain and Cancer, run by Ethypharm at 1 site in Czechia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breakthrough Pain, Cancer
- What is being tested?
- Fentanyl Ethypharm
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteCzechia
- Study dates
- Nov 2011to Jul 2012
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- Malignant solid tumor or a hematological malignancy causing cancer-related pain
- Background opioid treatment at a stable dose for at least a week
- One to four episodes of breakthrough pain per day
- Main exclusion criteria:
- Hypersensitivity to fentanyl or to any of the excipients
Show all 10Show fewer
- Intrathecal opioids
- Recent history of substance abuse
- Recent or planned therapy that would alter pain
- Moderate or severe hepatic or renal disease
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Placebo-controlled Study of Fentanyl ETHYPHARM for Breakthrough Pain in Opioid-treated Patients With Cancer
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.
- Conditions
- Breakthrough Pain, Cancer
- Being tested
- Fentanyl Ethypharm
- Keywords
- fentanyl, breakthrough pain, opioid treated cancer patients
- Medical subject headings
- Breakthrough Pain, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fentanyl EthypharmDrug
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)
| Study group | Role | What they receive |
|---|---|---|
| Fentanyl / Placebo | Experimental | 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) Receives: Drug: Fentanyl Ethypharm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Summed Pain Intensity Difference at 30 minutes (SPID30).
Measured: 30 minutes post dose
Secondary outcomes (7)
SPID at 3, 6, 10, 15 and 60 minutes post-dosing
Measured: 3, 6, 10, 15 and 60 minutes post-dosing
SPID at 15 and 30 minutes according to the pathophysiology of the pain (neuropathic, nociceptive)
Measured: 15 and 30 minutes post dose
Pain Intensity Difference at 3, 6, 10, 15, 30 and 60 minutes after dosing
Measured: 3, 6, 10, 15, 30 and 60 minutes after dosing
Pain Relief at 3, 6, 10, 15, 30 and 60 minutes after dosing
Measured: 3, 6, 10, 15, 30 and 60 minutes after dosing
The proportion of episodes of BTP that required rescue medication
Measured: 15 and 30 minutes post dose
the proportion of episodes with more than 33% and 50% of improvement in Pain Intensity scores
Measured: 15 and 30 minutes post dose
Recording of safety data
Adverse events, vital signs, urinary pregnancy test
Measured: During all the study duration, an expected average of 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2013 (estimated)
- Study startNov 2011
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breakthrough PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ethypharm
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01842893
- Sponsor's protocol ID
- FYL/24019/008
- Acronym
- ETHYFYL
- Status last verified
- Apr 2013
- First submitted
- 18 Apr 2013
- Last updated
- 3 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Novotna S, Valentova K, Fricova J, Richterova E, Harabisova S, Bullier F, Trinquet F; ETHYFYL Study Group. A randomized, placebo-controlled study of a new sublingual formulation of fentanyl citrate (fentanyl ethypharm) for breakthrough pain in opioid-treated patients with cancer. Clin Ther. 2014 Mar 1;36(3):357-67. doi: 10.1016/j.clinthera.2014.01.006. Epub 2014 Feb 5.
PubMed 24508417
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Placebo-controlled Study of Fentanyl ETHYPHARM for Breakthrough Pain in Opioid-treated Patients With Cancer
- ClinicalTrials.gov ID
- NCT01842893
- Acronym / sponsor ID
- ETHYFYL / FYL/24019/008
- Conditions
- Breakthrough Pain, Cancer
- Keywords
- fentanyl, breakthrough pain, opioid treated cancer patients
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- EthypharmIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 30 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fentanyl / Placebo | Experimental | Drug: Fentanyl EthypharmAfter 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Written informed consent
- Malignant solid tumor or a hematological malignancy causing cancer-related pain
- Background opioid treatment at a stable dose for at least a week
- One to four episodes of breakthrough pain per day
- Hypersensitivity to fentanyl or to any of the excipients
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fentanyl EthypharmAfter 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 / Placebo |
Primary outcome
Summed Pain Intensity Difference at 30 minutes (SPID30).
Time frame: 30 minutes post dose
7 secondary outcomes
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
Time frame: During all the study duration, an expected average of 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2013.
- Derived from this study: PubMed 24508417Novotna S, Valentova K, Fricova J, Richterova E, Harabisova S, Bullier F, Trinquet F; ETHYFYL Study Group. A randomized, placebo-controlled study of a new sublingual formulation of fentanyl citrate (fentanyl ethypharm) for breakthrough pain in opioid-treated patients with cancer. Clin Ther. 2014 Mar 1;36(3):357-67. doi: 10.1016/j.clinthera.2014.01.006. Epub 2014 Feb 5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fentanyl Ethypharm in people with Breakthrough Pain and Cancer, run by Ethypharm at 1 site in Czechia.
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 10 inclusion and 0 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 3 May 2013. 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 Czechia. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Summed Pain Intensity Difference at 30 minutes (SPID30). (time frame: 30 minutes post dose). 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 NCT01842893, which also lists 1 linked publication.
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 3 May 2013.