Clinical trial · Observational
Efficacy and Tolerability of Intranasal Fentanyl Spray for the Treatment of Breakthrough Pain in Cancer Patients Older Than 18 Years
A Prospective Non-interventional/Observational Patient Cohort Study on the Efficacy of Intranasal Fentanyl Spray for the Treatment of Breakthrough Pain in Cancer Patients.
- 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 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
Conditions (2)
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 Pain | — | UNRESOLVED | — |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Instanyl (Intranasal Fentanyl) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- GENISIS
- interventionNames
- Drug: Instanyl (Intranasal Fentanyl)
Primary outcomes (6)
- measure
- Dose of Instanyl
- timeFrame
- during therapy with Instanyl (planned: 28 days)
- description
- Initially prescribed dose/ most efficient single dose of Instanyl at study end
- measure
- Physician: Degree of Maximum Pain Intensity During the Last Days/ Since the Last Examination
- timeFrame
- before and after therapy with Instanyl (first/last visit)
- description
- Scale: 0=no, 1=mild, 2=moderate, 3=strong, 4=very strong, 5=extreme
- measure
- Physician: Assessment of Breakthrough Pain Therapy (Initial Visit: Previous/Last Visit: Instanyl)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: * decision to start treatment with intranasal fentanyl spray * written informed consent Exclusion criteria: * criteria as defined in the Summary of Product Characteristics (Fachinformation Chapter 4.3)
References
Publications (0)
Data not yet available