Breakthrough PainGENISISNCT00994760
Efficacy and Tolerability of Intranasal Fentanyl Spray for the Treatment of Breakthrough Pain in Cancer Patients Older Than 18 Years
An observational study of Breakthrough Pain and Cancer, run by Takeda at 168 sites in Germany.
Trial summary
The aim of the study was to evaluate the safety and efficacy of intranasal fentanyl spray in cancer patients over four weeks, especially during cancer-related breakthrough pain (BTP) attacks. The fentanyl spray was applied into the nose by a metered-spray device. 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?
- Instanyl (Intranasal Fentanyl)
- How many people
- 131 participants
- Where
- 168 sitesGermany
- Study dates
- Sep 2009to Nov 2010
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: Outpatients
Who may be able to join
- decision to start treatment with intranasal fentanyl spray
- written informed consent
Who cannot join
- criteria as defined in the Summary of Product Characteristics (Fachinformation Chapter 4.3)
Trial locations and contacts
168 sites in 1 country.
168 sites in 1 country
Germany168 sites
Nycomed Deutschland GmbH
Aachen, 52074
Nycomed Deutschland GmbH
Adendorf, 21365
Nycomed Deutschland GmbH
Aichach, 86551
Nycomed Deutschland GmbH
Albstadt, 72458
Nycomed Deutschland GmbH
Albstadt-Ebingen, 72458
Nycomed Deutschland GmbH
Altenkirchen, 57610
Nycomed Deutschland GmbH
Aschaffenburg, 63743
Nycomed Deutschland GmbH
Aschersleben, 06449
Nycomed Deutschland GmbH
Augsburg, 86150
Nycomed Deutschland GmbH
Augsburg, 86163
Nycomed Deutschland GmbH
Backnang, 71522
Nycomed Deutschland GmbH
Bad Bevensen, 29545
Nycomed Deutschland GmbH
Bad Dürkheim, 67098
Nycomed Deutschland GmbH
Bad Liebenstein, 36448
Nycomed Deutschland GmbH
Bad Pyrmont, 31812
Nycomed Deutschland GmbH
Bad Schwalbach, 65307
Nycomed Deutschland GmbH
Badel, 39624
Nycomed Deutschland GmbH
Bademühlen, 27404
Nycomed Deutschland GmbH
Bautzen, 02625
Nycomed Deutschland GmbH
Berlin, 10317
Nycomed Deutschland GmbH
Berlin, 10409
Nycomed Deutschland GmbH
Berlin, 10437
Nycomed Deutschland GmbH
Berlin, 10713
Nycomed Deutschland GmbH
Berlin, 10715
Nycomed Deutschland GmbH
Berlin, 10999
Nycomed Deutschland GmbH
Berlin, 12107
Nycomed Deutschland GmbH
Berlin, 12627
Nycomed Deutschland GmbH
Berlin, 13055
Nycomed Deutschland GmbH
Böblingen, 71034
Nycomed Deutschland GmbH
Bochum, 44801
Nycomed Deutschland GmbH
Bonn, 53177
Nycomed Deutschland GmbH
Brandenburg/Havel, 14776
Nycomed Deutschland GmbH
Braunschweig, 38100
Nycomed Deutschland GmbH
Bremen, 28329
Nycomed Deutschland GmbH
Brühl, 50321
Nycomed Deutschland GmbH
Burg, 39288
Nycomed Deutschland GmbH
Burg/Fehmarn, 23769
Nycomed Deutschland GmbH
Burscheid, 51399
Nycomed Deutschland GmbH
Butzbach, 35510
Nycomed Deutschland GmbH
Coburg, 96450
Nycomed Deutschland GmbH
Cochem, 56812
Nycomed Deutschland GmbH
Cologne, 50733
Nycomed Deutschland GmbH
Cologne, 50935
Nycomed Deutschland GmbH
Cologne, 50937
Nycomed Deutschland GmbH
Cologne, 50996
Nycomed Deutschland GmbH
Cologne, 50997
Nycomed Deutschland GmbH
Cologne, 51065
Nycomed Deutschland GmbH
Cologne, 51103
Nycomed Deutschland GmbH
Cottbus, 03050
Nycomed Deutschland GmbH
Cuxhaven, 27472
Nycomed Deutschland GmbH
Cuxhaven, 27474
Nycomed Deutschland GmbH
Dessau, 06846
Nycomed Deutschland GmbH
Dresden, 01127
Nycomed Deutschland GmbH
Dresden, 01307
Nycomed Deutschland GmbH
Dresden, 01309
Nycomed Deutschland GmbH
Duisburg, 47137
Nycomed Deutschland GmbH
Düsseldorf, 40589
Nycomed Deutschland GmbH
Essen, 45326
Nycomed Deutschland GmbH
Etzenricht, 92694
Nycomed Deutschland GmbH
Fehmarn, 23769
Nycomed Deutschland GmbH
Frankfurt, 60311
Nycomed Deutschland GmbH
Frankfurt, 60313
Nycomed Deutschland GmbH
Frankfurt, 60590
Nycomed Deutschland GmbH
Freiburg im Breisgau, 79108
Nycomed Deutschland GmbH
Friedberg, 86316
Nycomed Deutschland GmbH
Geesthacht, 21502
Nycomed Deutschland GmbH
Göppingen, 73033
Nycomed Deutschland GmbH
Görlitz, 02826
Nycomed Deutschland GmbH
Großheirath-Rossach, 96269
Nycomed Deutschland GmbH
Gütersloh, 33330
Nycomed Deutschland GmbH
Hachenburg, 57627
Nycomed Deutschland GmbH
Hainburg, 63512
Nycomed Deutschland GmbH
Halle, 06110
Nycomed Deutschland GmbH
Halle, 06120
Nycomed Deutschland GmbH
Hamburg, 20095
Nycomed Deutschland GmbH
Hamburg, 22765
Nycomed Deutschland GmbH
Hamelin, 31785
Nycomed Deutschland GmbH
Hanover, 30161
Nycomed Deutschland GmbH
Hanover, 30167
Nycomed Deutschland GmbH
Hanover, 30625
Nycomed Deutschland GmbH
Heidelberg, 69115
Nycomed Deutschland GmbH
Hellenthal, 53940
Nycomed Deutschland GmbH
Herne, 44625
Nycomed Deutschland GmbH
Herzlake, 49770
Nycomed Deutschland GmbH
Hohberg, 77749
Nycomed Deutschland GmbH
Hohberg-Hofweiler, 77749
Nycomed Deutschland GmbH
Holzminden, 37603
Nycomed Deutschland GmbH
Husum, 25813
Nycomed Deutschland GmbH
Iserlohn, 58638
Nycomed Deutschland GmbH
Itzehoe, 25524
Nycomed Deutschland GmbH
Jerichow, 39319
Nycomed Deutschland GmbH
Kaiserslautern, 67655
Nycomed Deutschland GmbH
Karlsbad, 76307
Nycomed Deutschland GmbH
Katzhütte, 98746
Nycomed Deutschland GmbH
Kevelaar, 47625
Nycomed Deutschland GmbH
Kiel, 24105
Nycomed Deutschland GmbH
Kiel, 24106
Nycomed Deutschland GmbH
Kiel, 24149
Nycomed Deutschland GmbH
Kirchberg, 08107
Nycomed Deutschland GmbH
Koblenz, 56068
Nycomed Deutschland GmbH
Koblenz, 56072
Nycomed Deutschland GmbH
Köthen, 06366
Nycomed Deutschland GmbH
Krefeld, 47798
Nycomed Deutschland GmbH
Krefeld, 47799
Nycomed Deutschland GmbH
Krefeld, 47803
Nycomed Deutschland GmbH
Laatzen, 30880
Nycomed Deutschland GmbH
Lage/Lippe, 32791
Nycomed Deutschland GmbH
Landshut, 84036
Nycomed Deutschland GmbH
Leipzig, 04159
Nycomed Deutschland GmbH
Leverkusen, 51381
Nycomed Deutschland GmbH
Ludwigshafen, 67071
Nycomed Deutschland GmbH
Magdeburg, 39110
Nycomed Deutschland GmbH
Magdeburg, 39112
Nycomed Deutschland GmbH
Magdeburg, 39116
Nycomed Deutschland GmbH
Mainz, 55116
Nycomed Deutschland GmbH
Mannheim, 63167
Nycomed Deutschland GmbH
Mannheim, 68165
Nycomed Deutschland GmbH
Mayen, 56727
Nycomed Deutschland GmbH
Meinersen, 38536
Nycomed Deutschland GmbH
München, 80538
Nycomed Deutschland GmbH
Nastätten, 56355
Nycomed Deutschland GmbH
Naumburg, 06618
Nycomed Deutschland GmbH
Neubrandenburg, 17022
Nycomed Deutschland GmbH
Neubrandenburg, 17033
Nycomed Deutschland GmbH
Neuss, 41460
Nycomed Deutschland GmbH
Neustadt, 01844
Nycomed Deutschland GmbH
Neustadt, 67434
Nycomed Deutschland GmbH
Nordhorn, 48529
Nycomed Deutschland GmbH
Olpe, 57462
Nycomed Deutschland GmbH
Osloß, 38557
Nycomed Deutschland GmbH
Osnabrück, 49074
Nycomed Deutschland GmbH
Osnabrück, 49076
Nycomed Deutschland GmbH
Pforzheim, 75172
Nycomed Deutschland GmbH
Plate, 19086
Nycomed Deutschland GmbH
Plüderhausen, 73655
Nycomed Deutschland GmbH
Potsdam, 14467
Nycomed Deutschland GmbH
Potsdam-Babelsberg, 14482
Nycomed Deutschland GmbH
Pulheim-Stommeln, 50259
Nycomed Deutschland GmbH
Quedlinburg, 06484
Nycomed Deutschland GmbH
Rheine, 48431
Nycomed Deutschland GmbH
Rosenfeld, 72348
Nycomed Deutschland GmbH
Rostock, 18055
Nycomed Deutschland GmbH
Rostock, 18107
Nycomed Deutschland GmbH
Rostock, 18109
Nycomed Deutschland GmbH
Sangerhausen, 06526
Nycomed Deutschland GmbH
Sankt Michaelisdonn, 25693
Nycomed Deutschland GmbH
Schleswig, 24837
Nycomed Deutschland GmbH
Siegen, 57072
Nycomed Deutschland GmbH
Solingen, 42659
Nycomed Deutschland GmbH
Stendal, 39576
Nycomed Deutschland GmbH
Stuttgart, 70619
Nycomed Deutschland GmbH
Tangermünde, 39590
Nycomed Deutschland GmbH
Ulm, 89073
Nycomed Deutschland GmbH
Ulm, 89075
Nycomed Deutschland GmbH
Ulm, 89077
Nycomed Deutschland GmbH
Varel, 26316
Nycomed Deutschland GmbH
Velbert, 42551
Nycomed Deutschland GmbH
Villingen-Schwenningen, 78054
Nycomed Deutschland GmbH
Wedel, 22880
Nycomed Deutschland GmbH
Weinsberg, 74189
Nycomed Deutschland GmbH
Werdau, 08412
Nycomed Deutschland GmbH
Wesendorf, 29392
Nycomed Deutschland GmbH
Westhausen, 73463
Nycomed Deutschland GmbH
Wiesbaden, 65189
Nycomed Deutschland GmbH
Wiesbaden, 65191
Nycomed Deutschland GmbH
Wilster, 25554
Nycomed Deutschland GmbH
Zwickau, 08056
Nycomed Deutschland GmbH
Zwönitz, 08297
About this study
Official title: A Prospective Non-interventional/Observational Patient Cohort Study on the Efficacy of Intranasal Fentanyl Spray for the Treatment of Breakthrough Pain in Cancer Patients.
The aim of the study was to evaluate the safety and efficacy of intranasal fentanyl spray in cancer patients over four weeks, especially during cancer-related breakthrough pain (BTP) attacks. The fentanyl spray was applied into the nose by a metered-spray device. The study was to provide further data on pharmacoeconomic efficiency of intranasal fentanyl spray.
- Conditions
- Breakthrough Pain, Cancer
- Being tested
- Instanyl (Intranasal Fentanyl)
- Keywords
- intranasal fentanyl spray
- 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.
Instanyl (Intranasal Fentanyl)Drug
This was an observational study. Therefore, the physician decided about dosage according to individual needs.
| Study group | Role | What they receive |
|---|---|---|
| GENISIS | Not described Receives: Drug: Instanyl (Intranasal Fentanyl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose of Instanyl
Initially prescribed dose/ most efficient single dose of Instanyl at study end
Measured: during therapy with Instanyl (planned: 28 days)
Physician: Degree of Maximum Pain Intensity During the Last Days/ Since the Last Examination
Scale: 0=no, 1=mild, 2=moderate, 3=strong, 4=very strong, 5=extreme
Measured: before and after therapy with Instanyl (first/last visit)
Physician: Assessment of Breakthrough Pain Therapy (Initial Visit: Previous/Last Visit: Instanyl)
Scale: 1=very good, 2=good, 3=satisfactory, 4=poor, 5=very poor, 6=insufficient
Measured: before and after therapy with Instanyl (first/last visit)
Physician: To What Extent Did Your Expectations in Instanyl Have Met? (Last Visit)
5=completely, 4=for the most part, 3=partially, 2= more or less, 1=rather not, 0=not at all
Measured: after therapy with Instanyl (planned: 4 weeks)
Physician: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ... (at Last Visit)
Scale: -3= very much improved, -2= much improved, -1= improved, 0= comparable, 1= worsened, 2= much worsened ,3= very much worsened
Measured: after therapy with Instanyl (at last visit)
Physician: What is the Current Treatment Needs of Your Patient Regarding ...
Scale: 0=no, 1=low, 2=medium, 3=high
Measured: before and after therapy with Instanyl (first/last visit)
Secondary outcomes (18)
Physician: Degree of Relief of Breakthrough Pain Achieved by Instanyl at Study End
0=no reduction, 1=slight, 2=medium, 3=strong, 4=very strong, 5=complete
Measured: after therapy with Instanyl (planned: 4 weeks)
Patient: How Many Episodes of Pain You Experience on Average?
Measured: initial visit (before start of therapy with Instanyl)
Patient: Description of Pain at Initial Visit
0=no pain, 10= most intense pain imaginable
Measured: initial visit (before start of therapy with Instanyl)
Patient: How do You Feel Today?
Scale: 1=very bad, 2=bad, 3=mediocre, 4=good, 5=very good
Measured: before and after therapy with Instanyl (first/last visit)
Patient: To What Extent Your Present Condition is Affected by Your Pain Attacks?
Scale: 0=not at all, 10=completely
Measured: before and after therapy with Instanyl (first/last visit)
Patient: Modified Pain Disability Index (mPDI) - Sum - Score (Complete Questionnaires Only)
Scale: 0=no impairment, 70=complete impairment
Measured: before and after therapy with Instanyl (first/last visit)
Patient: Quality-of-Life-Impairment by Pain =QLIP - Sum - Score (Complete Questionnaires Only)
Scale: 0=complete impairment, 43=no impairment
Measured: before and after therapy with Instanyl (first/last visit)
Patient: Quality-of-Life-Impairment by Pain =QLIP - Sum - Score (Complete Questionnaires Only) Conspicuous ≤20
0= conspicuous ≤20
1= inconspicuous >20
Measured: before and after therapy with Instanyl (first/last visit)
Patient: Marburg Questionnaire on Habitual Health (MQHH): Sum - Score (Complete Questionnaires Only)
Scale: 0=worst, 5=best
Measured: before and after therapy with Instanyl (first/last visit)
Patient: Marburg Questionnaire on Habitual Health (MQHH): Sum - Score (Complete Questionnaires Only) Conspicuous <1.5
conspicuous score <1.5 inconspicuous score ≥1.5
Measured: before and after therapy with Instanyl (first/last visit)
Patient: Degree of Relief of Breakthrough Pain Achieved by Instanyl at Study End
0=no reduction, 1=slight, 2=medium, 3=strong, 4=very strong, 5=complete
Measured: after therapy with Instanyl (planned: 4 weeks)
Patient: Assessment of Breakthrough Pain Therapy (Initial Visit: Previous/Last Visit: Instanyl)
Scale: 1=very good, 2=good, 3=satisfactory, 4=poor, 5=very poor, 6=insufficient
Measured: before and after therapy with Instanyl (first/last visit)
Patient: To What Extent Did Your Expectations in Instanyl Have Met With Respect to ... (Last Visit)
5=completely, 4=for the most part, 3=partially, 2=more or less, 1=rather not, 0=not at all
Measured: after therapy with Instanyl (planned: 4 weeks)
Patient: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ...(at Last Visit)
Scale: -3= very much improved, -2= much improved, -1= improved , 0= comparable, 1= worsened, 2= much worsened, 3= very much worsened
Measured: after therapy with Instanyl (at last visit)
Caregiver: Degree of Relief of Breakthrough Pain Achieved by Instany at Study End
0=no reduction, 1=slight, 2=medium, 3=strong, 4=very strong, 5=complete
Measured: after therapy with Instanyl (planned: 4 weeks)
Caregiver: Assessment of Breakthrough Pain Therapy by Instanyl (Last Visit)
Scale: 1=very good, 2=good, 3=satisfactory, 4=poor, 5=very poor, 6=insufficient
Measured: after therapy with Instanyl (first/last visit)
Caregiver: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ... (at Last Visit)
Scale: -3= very much improved, -2= much improved, -1= improved , 0= comparable, 1= worsened, 2= much worsened, 3= very much worsened
Measured: after therapy with Instanyl (at last visit)
Caregiver: To What Extent the Treatment Needs of Your Patient Has Changed by the Use of Instanyl Regarding ...
Scale: -3= very much less, -2= much less, -1= less, 0=comparable, 1= more, 2= much more, 3= very much more
Measured: after therapy with Instanyl (last visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2009 (estimated)
- Study startSep 2009
- Primary completionSep 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breakthrough 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
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Thomas D. Bethke, PhD; MD, Study director, Nycomed Deutschland GmbH, 78467 Konstanz, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00994760
- Sponsor's protocol ID
- FT-1301-401-DE
- Acronym
- GENISIS
- Status last verified
- Aug 2012
- First submitted
- 5 Oct 2009
- Last updated
- 27 Sep 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Non-interventional/Observational Patient Cohort Study on the Efficacy of Intranasal Fentanyl Spray for the Treatment of Breakthrough Pain in Cancer Patients.
- ClinicalTrials.gov ID
- NCT00994760
- Acronym / sponsor ID
- GENISIS / FT-1301-401-DE
- Conditions
- Breakthrough Pain, Cancer
- Keywords
- intranasal fentanyl spray
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 14 Oct 2009 (estimated)
- Results
- Posted 27 Sep 2012
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 the study was to evaluate the safety and efficacy of intranasal fentanyl spray in cancer patients over four weeks, especially during cancer-related breakthrough pain (BTP) attacks. The fentanyl spray was applied into the nose by a metered-spray device. The study was to provide further data on pharmacoeconomic efficiency of intranasal fentanyl spray.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GENISIS | – | Drug: Instanyl (Intranasal Fentanyl) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatients
Key inclusion criteria (2 listed)
- decision to start treatment with intranasal fentanyl spray
- written informed consent
Key exclusion criteria (1 listed)
- criteria as defined in the Summary of Product Characteristics (Fachinformation Chapter 4.3)
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 |
|---|---|---|
| Instanyl (Intranasal Fentanyl)This was an observational study. Therefore, the physician decided about dosage according to individual needs. | Drug | GENISIS |
Primary outcome
Dose of Instanyl
Time frame: during therapy with Instanyl (planned: 28 days)
Initially prescribed dose/ most efficient single dose of Instanyl at study end
Physician: Degree of Maximum Pain Intensity During the Last Days/ Since the Last Examination
Time frame: before and after therapy with Instanyl (first/last visit)
Scale: 0=no, 1=mild, 2=moderate, 3=strong, 4=very strong, 5=extreme
Physician: Assessment of Breakthrough Pain Therapy (Initial Visit: Previous/Last Visit: Instanyl)
Time frame: before and after therapy with Instanyl (first/last visit)
Scale: 1=very good, 2=good, 3=satisfactory, 4=poor, 5=very poor, 6=insufficient
Physician: To What Extent Did Your Expectations in Instanyl Have Met? (Last Visit)
Time frame: after therapy with Instanyl (planned: 4 weeks)
5=completely, 4=for the most part, 3=partially, 2= more or less, 1=rather not, 0=not at all
Physician: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ... (at Last Visit)
Time frame: after therapy with Instanyl (at last visit)
Scale: -3= very much improved, -2= much improved, -1= improved, 0= comparable, 1= worsened, 2= much worsened ,3= very much worsened
Physician: What is the Current Treatment Needs of Your Patient Regarding ...
Time frame: before and after therapy with Instanyl (first/last visit)
Scale: 0=no, 1=low, 2=medium, 3=high
18 secondary outcomes
Physician: Degree of Relief of Breakthrough Pain Achieved by Instanyl at Study End
Time frame: after therapy with Instanyl (planned: 4 weeks)
Patient: How Many Episodes of Pain You Experience on Average?
Time frame: initial visit (before start of therapy with Instanyl)
Patient: Description of Pain at Initial Visit
Time frame: initial visit (before start of therapy with Instanyl)
Patient: How do You Feel Today?
Time frame: before and after therapy with Instanyl (first/last visit)
Patient: To What Extent Your Present Condition is Affected by Your Pain Attacks?
Time frame: before and after therapy with Instanyl (first/last visit)
Patient: Modified Pain Disability Index (mPDI) - Sum - Score (Complete Questionnaires Only)
Time frame: before and after therapy with Instanyl (first/last visit)
Patient: Quality-of-Life-Impairment by Pain =QLIP - Sum - Score (Complete Questionnaires Only)
Time frame: before and after therapy with Instanyl (first/last visit)
Patient: Quality-of-Life-Impairment by Pain =QLIP - Sum - Score (Complete Questionnaires Only) Conspicuous ≤20
Time frame: before and after therapy with Instanyl (first/last visit)
Patient: Marburg Questionnaire on Habitual Health (MQHH): Sum - Score (Complete Questionnaires Only)
Time frame: before and after therapy with Instanyl (first/last visit)
Patient: Marburg Questionnaire on Habitual Health (MQHH): Sum - Score (Complete Questionnaires Only) Conspicuous <1.5
Time frame: before and after therapy with Instanyl (first/last visit)
Patient: Degree of Relief of Breakthrough Pain Achieved by Instanyl at Study End
Time frame: after therapy with Instanyl (planned: 4 weeks)
Patient: Assessment of Breakthrough Pain Therapy (Initial Visit: Previous/Last Visit: Instanyl)
Time frame: before and after therapy with Instanyl (first/last visit)
Patient: To What Extent Did Your Expectations in Instanyl Have Met With Respect to ... (Last Visit)
Time frame: after therapy with Instanyl (planned: 4 weeks)
Patient: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ...(at Last Visit)
Time frame: after therapy with Instanyl (at last visit)
Caregiver: Degree of Relief of Breakthrough Pain Achieved by Instany at Study End
Time frame: after therapy with Instanyl (planned: 4 weeks)
Caregiver: Assessment of Breakthrough Pain Therapy by Instanyl (Last Visit)
Time frame: after therapy with Instanyl (first/last visit)
Caregiver: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ... (at Last Visit)
Time frame: after therapy with Instanyl (at last visit)
Caregiver: To What Extent the Treatment Needs of Your Patient Has Changed by the Use of Instanyl Regarding ...
Time frame: after therapy with Instanyl (last visit)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Dr. Thomas D. Bethke, PhD; MD study director
Nycomed Deutschland GmbH, 78467 Konstanz, Germany
168 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breakthrough Pain and Cancer, run by Takeda at 168 sites in Germany.
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 1 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 27 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 168 sites in Germany. 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?
Yes. Results are posted in the registry (first posted 27 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Dose of Instanyl (time frame: during therapy with Instanyl (planned: 28 days)). The study lists 6 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 27 Sep 2012.