Clinical trial · Observational
Instanyl® Non-Interventional Study
A 3 Month Observational Prospective Patient Cohort Study of the Treatment of Breakthrough Pain in Cancer Patients With Instanyl®
NCT01045603CI-TRIAL-00008355INIScompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breakthrough Cancer Pain | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Success of titration (Y/N), defined as reaching a maintenance dose
- timeFrame
- At week 4 and month 3 after baseline
- measure
- Dose level of Instanyl® after titration, defined as the maintenance dose
- timeFrame
- At week 4 and month 3 after baseline
Secondary outcomes (6)
- measure
- Adverse Drug Reactions (ADR)
- timeFrame
- At week 4 and month 3 after baseline
- measure
- Reason and time for Instanyl® termination
- timeFrame
- At week 4 and month 3 after baseline
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
* 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
References
Publications (0)
Data not yet available
No reference posted for this study.