Breakthrough Cancer PainINISNCT01045603
Instanyl® Non-Interventional Study
An observational study of Breakthrough Cancer Pain, run by Takeda at 65 sites in 7 countries.
Trial summary
The aim of this study is to describe the use of Instanyl® (Intranasal fentanyl spray) in the treatment of breakthrough pain (BTP) in cancer patients by success of dose titration and distribution of dose strength. Data will be collected at three different time points over a 3 month period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breakthrough Cancer Pain
- How many people
- 309 participants
- Where
- 65 sitesin 7 countries
- Study dates
- Dec 2009to Apr 2012
- 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: Adult cancer patients (in- or out-patients) that are suffering from BTP who have not been treated with Instanyl for one month prior to Baseline.
- Adult cancer patients suffering from BTP
- Instanyl should be prescribed in accordance with the Summary of Product Characteristics (SPC) and none of the stated contradictions applies
- The decision to prescribe should be made independently of the study
- All patients must provide signed Informed Consent prior to inclusion
Trial locations and contacts
65 sites in 7 countries.
65 sites in 7 countries
France32 sites
Investigational site
Aix-en-Provence, 13616
Investigational site
Amiens, 80054
Investigational site
Argenteuil, 95107
Investigational site
Auxerre, 89011
Investigational site
Besançon, 25030
Investigational site
Blois, 41000
Investigational site
Bobigny, 93009
Investigational site
Bordeaux, 33076
Investigational site
Brest, 29609
Investigational site
Colmar, 68024
Investigational site
Eaubonne, 95602
Investigational site
Frelinghien, 59236
Investigational site
Grenoble, 38700
Investigational site
Lisieux, 14107
Investigational site
Lorient, 56324
Investigational site
Lyon, 69008
Investigational site
Montbéliard, 25200
Investigational site
Mulhouse, 68100
Investigational site
Nancy, 54100
Investigational site
Nantes, 44202
Investigational site
Orléans, 45031
Investigational site
Paris, 75010
Investigational site
Paris, 75181
Investigational site
Paris, 75970
Investigational site
Pierre-Bénite, 69495
Investigational site
Pontoise, 95303
Investigational site
Saint-Herblain, 44805
Investigational site
Strasbourg, 67000
Investigational site
Strasbourg, 67065
Investigational site
Tarbes, 65000
Investigational site
Toulouse, 31059
Investigational site
Vandœuvre-lès-Nancy, 54511
Norway12 sites
Investigational site
Bergen, 5009
Investigational site
Bergen, 5012
Investigational site
Bodø, 8092
Investigational site
Fredrikstad, 1603
Investigational site
Haugesund, 5504
Investigational site
Kristiansand, 4910
Investigational site
Lørenskog, 1478
Investigational site
Oslo, 0310
Investigational site
Oslo, 0407
Investigational site
Oslo, 0514
Investigational site
Stavanger, 4068
Investigational site
Tromsø, 9038
United Kingdom7 sites
Investigational site
Belfast, BT5 6NF
Investigational site
Lanarkshire, ML6 6DJ
Investigational site
Luton, LU4 0DT
Investigational site
Manchester, M20 4BX
Investigational site
Middlesex, HA6 2RN
Investigational site
Suffolk, IP3 8LX
Investigational site
Wiltshire, BA15 2LE
Sweden6 sites
Investigational site
Alingsås, 441 83
Investigational site
Stockholm, 112 35
Investigational site
Sundsvall, 852 40
Investigational site
Täby, 187 77
Investigational site
Uppsala, 751 85
Investigational site
Västervik, 593 81
Denmark4 sites
Investigational site
Copenhagen, 2100
Investigational site
Herning, 7400
Investigational site
Hillerød, 3400
Investigational site
Randers, 8930
Greece2 sites
Investigational site
Athens, 11527
Investigational site
Athens, 18547
About this study
Official title: A 3 Month Observational Prospective Patient Cohort Study of the Treatment of Breakthrough Pain in Cancer Patients With Instanyl®
The aim of this study is to describe the use of Instanyl® (Intranasal fentanyl spray) in the treatment of breakthrough pain (BTP) in cancer patients by success of dose titration and distribution of dose strength. Data will be collected at three different time points over a 3 month period.
- Conditions
- Breakthrough Cancer Pain
- Keywords
- Instanyl, non-interventional, breakthrough cancer pain, BTP, BTCP, Intranasal fentanyl spray
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of titration (Y/N), defined as reaching a maintenance dose
Measured: At week 4 and month 3 after baseline
Dose level of Instanyl® after titration, defined as the maintenance dose
Measured: At week 4 and month 3 after baseline
Secondary outcomes (6)
Adverse Drug Reactions (ADR)
Measured: At week 4 and month 3 after baseline
Reason and time for Instanyl® termination
Measured: At week 4 and month 3 after baseline
Change in Instanyl® maintenance dose
Measured: At week 4 and month 3 after baseline
Change in level of background medication (standardised daily dose)
Measured: At week 4 and month 3 after baseline
Pain, pain relief and impact of pain of daily life
Measured: At baseline and week 4
Treatment satisfaction
Measured: At baseline and week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2010 (estimated)
- Study startDec 2009
- Primary completionApr 2012
- Study completionApr 2012
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.
- More trials run by TakedaThe sponsor's other registered studies.
- 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
- 309 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nycomed Clinical Trial Operations, Study chair, Headquarters
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01045603
- Sponsor's protocol ID
- FT-1301-034-SP
- Other IDs
- U1111-1136-4251
- Acronym
- INIS
- Status last verified
- Oct 2012
- First submitted
- 8 Jan 2010
- Last updated
- 29 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 3 Month Observational Prospective Patient Cohort Study of the Treatment of Breakthrough Pain in Cancer Patients With Instanyl®
- ClinicalTrials.gov ID
- NCT01045603
- Acronym / sponsor ID
- INIS / FT-1301-034-SP
- Conditions
- Breakthrough Cancer Pain
- Keywords
- Instanyl, non-interventional, breakthrough cancer pain, BTP, BTCP, Intranasal fentanyl spray
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 309 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 11 Jan 2010 (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 aim of this study is to describe the use of Instanyl® (Intranasal fentanyl spray) in the treatment of breakthrough pain (BTP) in cancer patients by success of dose titration and distribution of dose strength. Data will be collected at three different time points over a 3 month period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult cancer patients (in- or out-patients) that are suffering from BTP who have not been treated with Instanyl for one month prior to Baseline.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Success of titration (Y/N), defined as reaching a maintenance dose
Time frame: At week 4 and month 3 after baseline
Dose level of Instanyl® after titration, defined as the maintenance dose
Time frame: At week 4 and month 3 after baseline
6 secondary outcomes
Adverse Drug Reactions (ADR)
Time frame: At week 4 and month 3 after baseline
Reason and time for Instanyl® termination
Time frame: At week 4 and month 3 after baseline
Change in Instanyl® maintenance dose
Time frame: At week 4 and month 3 after baseline
Change in level of background medication (standardised daily dose)
Time frame: At week 4 and month 3 after baseline
Pain, pain relief and impact of pain of daily life
Time frame: At baseline and week 4
Treatment satisfaction
Time frame: At baseline and week 4
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 29 Oct 2012.
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Paediatric Breakthrough Pain Assessment
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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.
Nycomed Clinical Trial Operations study chair
Headquarters
65 sites in 7 countries: 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 Takeda at 65 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 29 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 65 sites in France, Norway, United Kingdom, Sweden, Denmark and 2 more countries. 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?
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?
Success of titration (Y/N), defined as reaching a maintenance dose (time frame: At week 4 and month 3 after baseline). The study lists 2 primary outcomes in all. 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 29 Oct 2012.