Breakthrough Cancer PainQualipecNCT01693328
Patient Satisfaction and Quality of Life Impact - PecFent®
An observational study of Breakthrough Cancer Pain, run by Archimedes Development Ltd at 1 site in France.
Trial summary
National multicenter, prospective, observational study in cancer patients with chronic background pain and breakthrough pain to whom PecFent® has been prescribed under pragmatic condition by a specialist in the treatment of cancer pain conditions. Study objectives include assessment of early treatment satisfaction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breakthrough Cancer Pain
- What is being tested?
- PecFent® (fentanyl) nasal spray
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2012to Mar 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cancer patients with breakthrough pain
Who may be able to join
- Adult (aged ≥18 years) with cancer
- Taking at least 60 mg of oral morphine sulfate or equivalent per day for chronic background pain
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Léon-Bérard
Lyon
Jerome Fayette, MD, +33487785451, jerome.fayette@lyon.unicancer.fr
Jerome Fayette, MD
About this study
Official title: A French, Multicentre, Open-label, Observational Study to Assess Quality of Life and Satisfaction in Subjects Taking PecFent® for the Treatment of Breakthrough Cancer Pain (BTPc)
National multicenter, prospective, observational study in cancer patients with chronic background pain and breakthrough pain to whom PecFent® has been prescribed under pragmatic condition by a specialist in the treatment of cancer pain conditions.
- Study objectives include assessment of early treatment satisfaction.
- Conditions
- Breakthrough Cancer Pain
- Being tested
- PecFent® (fentanyl) nasal spray
- Keywords
- quality of life, PecFent, Lazanda, fentanyl, intranasal, breakthrough cancer pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PecFent® (fentanyl) nasal sprayDrug
| Study group | Role | What they receive |
|---|---|---|
| PecFent® | Not described Receives: Drug: PecFent® (fentanyl) nasal spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction
Satisfaction will be assessed using a 4-point Likert scale.
Measured: Satisfaction will be assessed approximately 1 hour after each BTPc episode treated with PecFent® from completion of titration through Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionMar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breakthrough Cancer 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Archimedes Development Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alain Serrie, MD, Principal investigator, Head of Pain Federation - Palliative Medicine Lariboisiere Hospital, Paris France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01693328
- Sponsor's protocol ID
- CP057/11
- Acronym
- Qualipec
- Status last verified
- Jan 2014
- First submitted
- 20 Sep 2012
- Last updated
- 15 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A French, Multicentre, Open-label, Observational Study to Assess Quality of Life and Satisfaction in Subjects Taking PecFent® for the Treatment of Breakthrough Cancer Pain (BTPc)
- ClinicalTrials.gov ID
- NCT01693328
- Acronym / sponsor ID
- Qualipec / CP057/11
- Conditions
- Breakthrough Cancer Pain
- Keywords
- quality of life, PecFent, Lazanda, fentanyl, intranasal, breakthrough cancer pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Archimedes Development LtdIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Mar 2014 (estimated)
- First posted
- 26 Sep 2012 (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.
National multicenter, prospective, observational study in cancer patients with chronic background pain and breakthrough pain to whom PecFent® has been prescribed under pragmatic condition by a specialist in the treatment of cancer pain conditions.
- Study objectives include assessment of early treatment satisfaction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PecFent® | – | Drug: PecFent® (fentanyl) nasal spray |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cancer patients with breakthrough pain
Key inclusion criteria (2 listed)
- Adult (aged ≥18 years) with cancer
- Taking at least 60 mg of oral morphine sulfate or equivalent per day for chronic background pain
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 |
|---|---|---|
| PecFent® (fentanyl) nasal spray | Drug | PecFent® |
Primary outcome
Satisfaction
Time frame: Satisfaction will be assessed approximately 1 hour after each BTPc episode treated with PecFent® from completion of titration through Day 7
Satisfaction will be assessed using a 4-point Likert scale.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2014.
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A Real-world Observational Study of a Mucosal Contouring Method for Radiation-induced Oropharyngeal Mucositis
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A Mucosal Contouring Method Based on Swallowing-induced Breakthrough Pain for Radiation-induced Oropharyngeal Mucositis
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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.
Alain Serrie, MD principal investigator
Head of Pain Federation - Palliative Medicine Lariboisiere Hospital, Paris France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breakthrough Cancer Pain, run by Archimedes Development Ltd at 1 site in France.
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 2 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: status not confirmed, as of the sponsor's last update on 15 Jan 2014. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sylvie Allouche, MD (+33155702320, sylvieallouchecovarrubias@archimedespharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfaction (time frame: Satisfaction will be assessed approximately 1 hour after each BTPc episode treated with PecFent® from completion of titration through Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jan 2014.