Phase 3
N=45
A Clinical Trial With Intranasal Fentanyl in Cancer Patients With Breakthrough Pain
Break Through Pain · Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01429051 ↗Enrolled (actual)
45
Serious AEs
13.2%
Results posted
Mar 2014
Primary outcome: Primary: Induction Phase: Pain Intensity Difference at 10 Minutes (PID10) After Treatment — 2.5; 1.4 units on a scale — p=0.002
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Intranasal Fentanyl Spray (INFS) (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Takeda
- Primary completion
- Jan 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Induction Phase: Pain Intensity Difference at 10 Minutes (PID10) After Treatment |
2.5; 1.4 | 0.002 sig |
| SECONDARY Incidence of Improvement or Worsening in Nasal Mucosa Sign or Abnormality Score |
0.06; 0.09; 0.09; 0.04; 0.07; 0.07 | — |
| SECONDARY Efficacy Phase: Pain Intensity Difference (PID) at 5, 30, and 60 Minutes After First Dose of Study Drug |
1.3; 0.8; 3.0; 1.8; 3.3; 2.2 | — |
| SECONDARY Efficacy Phase: Sum of Pain Intensity Differences (SPID0-60 and SPID0-30) Derived From PI Scores |
0.6; 0.4; 0.7; 0.5 | — |
| SECONDARY Efficacy Phase: Proportion of BTP Episodes With a Positive Response Defined as a ≥ 1, 2 or 3 Point Reduction in Pain Intensity |
0.61; 0.45; 0.74; 0.55; 0.81; 0.66 | — |
| SECONDARY Efficacy Phase: Proportion of BTP Episodes With a Positive Response Defined as a ≥ 33% or 50% Reduction in Pain Intensity |
0.23; 0.17; 0.44; 0.24; 0.55; 0.34 | — |
| SECONDARY Efficacy Phase: General Impression (GI) Score at 60 Minutes After First Dose |
1.9; 1.1 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) |
23; 6; 22; 14; 4; 6 | — |
Summary
The aim of this clinical trial was to demonstrate the efficacy of a 400 μg dose strength of intranasal fentanyl spray (INFS, Instanyl®) and to evaluate the safety and to establish long term tolerability of treatment with INFS doses of 50, 100, 200 and 400 μg.
Eligibility Criteria
Inclusion Criteria
All inclusion criteria were answered 'yes' for a patient to participate in the clinical trial.
- Is the patient a cancer patient with breakthrough Pain (BTP)?
- Has the patient received either oral opioids or transdermal fentanyl for treatment of background pain (BGP) within the last month prior to the screening visit?
- Is the current dose of prescribed opioids (for BGP) equivalent to 60-1000 mg oral morphine/day?
- Has the patient's BGP for the last 7 days prior to the screening visit been generally stable, and on average controlled to a mild level (defined as ≤ 4 on the 11-point Numerical Rating Scale [NRS])?
- Does the patient (at the time of the screening visit) experience his/her current BTP episodes to be of such severe pain intensity, that he/she in general needs additional analgesia (i.e. on top of the background opioid treatment)?
- Has the patient on average for the last 7 days prior to the screening visit had at least three BTP episodes per week, but no more than four BTP episodes per day?
- Is the patient able to use intranasal drugs?
- Is the life expectancy of the patient at least 3 months from the date of the screening visit?
Exclusion Criteria
- Has the patient had an illicit substance abuse within the last year prior to screening?
- Does the patient have severe hepatic impairment? - defined as alanine aminotransferase (ALT or) aspartate aminotransferase (AST) levels > 3x upper limit of normal (ULN)
- Does the patient have severe renal impairment? - defined as serum creatinine ≥ 3.0 mg/dl (265 micromol/L)
- Has the patient ever had facial radiotherapy or is the patient scheduled to facial radiotherapy?
- Has the patient been treated with any monoamine oxidase (MAO) inhibitors within the last 14 days prior to the screening visit?
- Does the patient have severe impaired respiratory function, which may increase the risk of clinically relevant respiratory depression by BTP fentanyl treatment?
- Is the patient known to be hypersensitive to fentanyl or to other opioids or any of their excipients?
- Does the patient have any head injury, primary brain tumor or other pathological conditions, which could significantly increase the risk of increased intracranial pressure or impaired consciousness?
Data sourced from ClinicalTrials.gov (NCT01429051). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.