Not provided
Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1136-4251 | Registry Identifier | WHO |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Success of titration (Y/N), defined as reaching a maintenance dose | At week 4 and month 3 after baseline | |
| Dose level of Instanyl® after titration, defined as the maintenance dose | At week 4 and month 3 after baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Drug Reactions (ADR) | At week 4 and month 3 after baseline | |
| Reason and time for Instanyl® termination | At week 4 and month 3 after baseline | |
| Change in Instanyl® maintenance dose |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nycomed Clinical Trial Operations | Headquarters | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational site | Copenhagen | 2100 | Denmark | |||
| Investigational site |
Not provided
Not provided
Not provided
Not provided
| At week 4 and month 3 after baseline |
| Change in level of background medication (standardised daily dose) | At week 4 and month 3 after baseline |
| Pain, pain relief and impact of pain of daily life | At baseline and week 4 |
| Treatment satisfaction | At baseline and week 4 |
| Herning |
| 7400 |
| Denmark |
| Investigational site | Hillerød | 3400 | Denmark |
| Investigational site | Randers | 8930 | Denmark |
| Investigational site | Aix-en-Provence | 13616 | France |
| Investigational site | Amiens | 80054 | France |
| Investigational site | Argenteuil | 95107 | France |
| Investigational site | Auxerre | 89011 | France |
| Investigational site | Besançon | 25030 | France |
| Investigational site | Blois | 41000 | France |
| Investigational site | Bobigny | 93009 | France |
| Investigational site | Bordeaux | 33076 | France |
| Investigational site | Brest | 29609 | France |
| Investigational site | Colmar | 68024 | France |
| Investigational site | Eaubonne | 95602 | France |
| Investigational site | Frelinghien | 59236 | France |
| Investigational site | Grenoble | 38700 | France |
| Investigational site | Lisieux | 14107 | France |
| Investigational site | Lorient | 56324 | France |
| Investigational site | Lyon | 69008 | France |
| Investigational site | Montbéliard | 25200 | France |
| Investigational site | Mulhouse | 68100 | France |
| Investigational site | Nancy | 54100 | France |
| Investigational site | Nantes | 44202 | France |
| Investigational site | Orléans | 45031 | France |
| Investigational site | Paris | 75010 | France |
| Investigational site | Paris | 75181 | France |
| Investigational site | Paris | 75970 | France |
| Investigational site | Pierre-Bénite | 69495 | France |
| Investigational site | Pontoise | 95303 | France |
| Investigational site | Saint-Herblain | 44805 | France |
| Investigational site | Strasbourg | 67000 | France |
| Investigational site | Strasbourg | 67065 | France |
| Investigational site | Tarbes | 65000 | France |
| Investigational site | Toulouse | 31059 | France |
| Investigational site | Vandœuvre-lès-Nancy | 54511 | France |
| Investigational site | Athens | 11527 | Greece |
| Investigational site | Athens | 18547 | Greece |
| Investigational site | Cork | Ireland |
| Investigational site | Kilkenny | Ireland |
| Investigational site | Bergen | 5009 | Norway |
| Investigational site | Bergen | 5012 | Norway |
| Investigational site | Bodø | 8092 | Norway |
| Investigational site | Fredrikstad | 1603 | Norway |
| Investigational site | Haugesund | 5504 | Norway |
| Investigational site | Kristiansand | 4910 | Norway |
| Investigational site | Lørenskog | 1478 | Norway |
| Investigational site | Oslo | 0310 | Norway |
| Investigational site | Oslo | 0407 | Norway |
| Investigational site | Oslo | 0514 | Norway |
| Investigational site | Stavanger | 4068 | Norway |
| Investigational site | Tromsø | 9038 | Norway |
| Investigational site | Alingsås | 441 83 | Sweden |
| Investigational site | Stockholm | 112 35 | Sweden |
| Investigational site | Sundsvall | 852 40 | Sweden |
| Investigational site | Täby | 187 77 | Sweden |
| Investigational site | Uppsala | 751 85 | Sweden |
| Investigational site | Västervik | 593 81 | Sweden |
| Investigational site | Belfast | BT5 6NF | United Kingdom |
| Investigational site | Lanarkshire | ML6 6DJ | United Kingdom |
| Investigational site | Luton | LU4 0DT | United Kingdom |
| Investigational site | Manchester | M20 4BX | United Kingdom |
| Investigational site | Middlesex | HA6 2RN | United Kingdom |
| Investigational site | Suffolk | IP3 8LX | United Kingdom |
| Investigational site | Wiltshire | BA15 2LE | United Kingdom |