Clinical trial · Interventional
Efficacy & Safety Study of Nasalfent (Fentanyl Citrate Nasal Spray) for Treatment of Breakthrough Cancer Pain in Patients Taking Regular Opioids
A Multicenter, Placebo-Controlled, Double-Blind, Two-Phase Crossover Study of Nasalfent (Fentanyl Citrate Nasal Spray) in the Treatment of Breakthrough Cancer Pain (BTCP) in Subjects Taking Regular Opioid Therapy
- 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)
Cancer patients taking regular medication for their pain often still have episodes of severe pain that 'break through' despite their background pain treatment. Fentanyl is a strong, short-acting pain killer often used to treat this 'breakthrough' pain. Nasalfent contains fentanyl in a patented drug delivery system called PecSys and is given via a simple nasal spray. This study will test the efficacy and safety of Nasalfent in the treatment of breakthrough cancer pain.
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 |
|---|---|---|---|
| Cancer Pain | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Nasalfent, Fentanyl Citrate Nasal Spray
- interventionNames
- Drug: Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray)
- type
- PLACEBO_COMPARATOR
- label
- Placebo Spray
- interventionNames
- Drug: Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray)
Primary outcomes (1)
- measure
- Summed pain intensity difference at 30 min
- timeFrame
- 30 min after dosing
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Able and willing to give consent * Women of childbearing potential must have a) negative urine pregnancy test b) not be breast feeding c) agree to practice a reliable form of contraception * Diagnosis of cancer * Taking at least 60mg oral morphine or equivalent as 24 hour treatment for cancer-related pain * Experiencing on average 1 - 4 episodes of breakthrough cancer pain per day usually controlled by rescue pain medication * Able (or via caregiver)to evaluate and record pain relief, assess medication performance at set times after dosing, record adverse events, record each use of the study drug or rescue medication in a diary * Able to be up and about for 50% of the day or greater Exclusion Criteria: * Intolerance to opioids or fentanyl * rapidly increasing/uncontrolled pain * pain that is not cancer related
References
Publications (1)
- DERIVEDTaylor D, Galan V, Weinstein SM, Reyes E, Pupo-Araya AR, Rauck R; Fentanyl Pectin Nasal Spray 043 Study Group. Fentanyl pectin nasal spray in breakthrough cancer pain. J Support Oncol. 2010 Jul-Aug;8(4):184-90. PMID 20822038