Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01429051 | A Clinical Trial With Intranasal Fentanyl in Cancer Patients With Breakthrough Pain | PHASE3 | COMPLETED | 46 | — | — | Aug 1, 2011 | Jan 1, 2013 | Mar 26, 2014 | 11 | Hungary, Norway +1 |
During the efficacy phase participants assessed their pain intensity at each breakthrough pain (BTP) episode at 0 and 10 minutes after first dose using the 11-point Numerical Rating Scale (NRS) on a scale from 0 to 10, where 0 represents the absence of pain and 10 is "worst possible pain". PID10 is calculated as the difference in pain intensity from time 0 to 10 minutes. A positive value is a decrease (improvement) of the pain; a ≥ 2-point difference is considered as clinically important.
| Arm | Type | Description |
|---|---|---|
| Intranasal Fentanyl Spray (INFS) | EXPERIMENTAL | All participants were step-wise titrated to an effective dose of 50, 100, 200 or 400 μg INFS in the Titration Phase (I). Participants titrated to 200 or 400 μg INFS in the Titration Phase were randomized to an 8-spray sequence in the Efficacy Phase (II); 6 BTP episodes were treated with 400 μg INFS and 2 BTP episodes with placebo in a random sequence. Participants entered the Tolerability Phase (III) either directly from the Titration Phase (with an effective dose of 50 or 100 μg) or from the Efficacy Phase (400 μg) and continued with this specific dose, unless adjustment was needed, for a total treatment time of 12 weeks. |
| Name | Type | Description |
|---|---|---|
| Intranasal Fentanyl Spray (INFS) | DRUG | Applied as 1 puff (= 1 dose) in one nostril, or applied as two puffs (= 2 doses, 1 in each nostril) with ten minutes apart. |
| Placebo | DRUG | Matching intranasal placebo spray |
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 th...