Phase 2
Completed N=45
Fentanyl Sublingual Spray for the Treatment of Moderate to Severe Post-Operative Pain
Source: ClinicalTrials.gov NCT02915978 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Feb 2018
Primary outcomePrimary: Numeric Rating Scale (NRS) Summed Pain Intensity Difference (SPID) Over 0 to 48 Hours (NRS SPID-48) After Time 0 — 151.7; 126.4; 149.0 units on a scale
Summary
The primary objective of this trial is to evaluate analgesic efficacy of Fentanyl Sublingual Spray compared with placebo in participants with postoperative pain after a bunionectomy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Numeric Rating Scale (NRS) Summed Pain Intensity Difference (SPID) Over 0 to 48 Hours (NRS SPID-48) After Time 0 |
151.7; 126.4; 149.0 | — |
| SECONDARY NRS Pain Intensity Difference (NRS PID) at Each Categorical Time Point After Time 0 |
6.5; 6.1; 7.1; 3.7; 4.3; 5.8 | 0.0505 |
| SECONDARY NRS Pain Intensity Score at Each Scheduled Time Point After Time 0 |
6.5; 6.1; 7.1; 3.7; 4.3; 5.8 | — |
| SECONDARY NRS SPID After Time 0 |
67.4; 51.7; 51.7; 13.6; 11.2; 8.8 | — |
| SECONDARY Total Pain Relief (TOTPAR) After Time 0 |
98.2; 99.9; 98.2; 43.8; 46.5; 38.3 | — |
| SECONDARY Time to Onset of Analgesia |
5; 184; NA | — |
| SECONDARY Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication) |
9; 9; 11; 4; 3; 2 | — |
| SECONDARY Peak Pain Relief From Time 0 (First Dose of Study Medication) |
2; 0; 0; 0; 1; 2 | — |
| SECONDARY Time (Minutes) to Peak Pain Relief From Time 0 (First Dose of Study Medication) |
300.0; 420.0; 1198 | — |
| SECONDARY Time (Minutes) to First Perceptible Pain Relief From Time 0 (First Dose of Study Medication) |
5; 10; 20 | — |
| SECONDARY Time (Minutes) to Meaningful Pain Relief From Time 0 (First Dose of Study Medication) |
49; 190; 79 | — |
| SECONDARY Number of Participants Using Rescue Medication |
11; 12; 15; 4; 3; 0 | — |
| SECONDARY Time (Minutes) to First Use of Rescue Medication (Duration of Analgesia) Following Each Dose of the Investigational Product (IP) |
204.0; 289.0; 126.0 | — |
| SECONDARY Number of Participants Using Rescue Analgesia Over 0 to 24 Hours and Over 0 to 48 Hours |
11; 12; 15; 11; 12; 15 | — |
| SECONDARY Participant Global Evaluation of Study Drug |
2; 3; 4; 3; 2; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Meets protocol-specified criteria for qualification and contraception
- Willing and able to remain confined in the study unit for the entire duration of each treatment period and comply with restrictions related to food, drink and medications
- Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures
Exclusion Criteria
- History or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters
- Signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:
- the safety or well-being of the participant or study staff;
- the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding);
- the analysis of results
Data sourced from ClinicalTrials.gov (NCT02915978). 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. Informational only — not medical advice.