Phase 3
Completed N=322
Study of Buprenorphine Sublingual Spray for the Treatment of Moderate to Severe Pain
Source: ClinicalTrials.gov NCT02634788 ↗Enrolled (actual)
322
Serious AEs
0.3%
Results posted
Aug 2017
Primary outcomePrimary: Numeric Rating Scale (NRS) Summed Pain Intensity Difference (SPID) Over 0 to 48 Hours After Time 0 (NRS SPID-48) — 89.40; 171.33; 125.58; 124.85 units on a scale — p=<0.0001
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The primary objective of this trial is to evaluate analgesic efficacy of Buprenorphine Sublingual (under the tongue) Spray compared with placebo in participants with postoperative pain after bunionectomy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Numeric Rating Scale (NRS) Summed Pain Intensity Difference (SPID) Over 0 to 48 Hours After Time 0 (NRS SPID-48) |
89.40; 171.33; 125.58; 124.85 | <0.0001 sig |
| SECONDARY NRS Mean Pain Intensity Difference (PID) at 4, 8, 24 and 48 Hours After Time 0 |
-0.1; 2.6; 0.9; 1.1; 0.5; 2.5 | — |
| SECONDARY NRS Mean Pain Intensity Score at 4, 8, 24 and 48 Hours After Time 0 |
6.5; 4.1; 5.5; 5.6; 5.9; 4.2 | — |
| SECONDARY NRS SPID Over 4 Hours (SPID-4), 8 Hours (SPID-8) and 24 Hours (SPID-24) After Time 0 |
0.67; 7.70; 3.67; 3.74; 1.32; 17.57 | — |
| SECONDARY Total Pain Relief (TOTPAR) Over 4, 8, 24 and 48 Hours After Time 0 |
2.50; 6.23; 4.07; 4.38; 5.48; 13.85 | — |
| SECONDARY Time to Onset of Analgesia |
NA; 43.0; NA; NA | — |
| SECONDARY Percentage of Participants With Scores in Each Pain Relief Category at 4, 8, 24 and 48 Hours After Time 0 |
60.8; 24.7; 43.8; 41.5; 21.5; 16.0 | — |
| SECONDARY Percentage of Participants With Peak Scores in Each Pain Relief Category |
6.3; 0; 1.3; 3.7; 11.4; 2.5 | — |
| SECONDARY Time to Peak Pain Relief |
1200.0; 360.0; 720.0; 1200.0 | — |
| SECONDARY Time to First Perceptible Pain Relief |
29.0; 23.0; 15.0; 27.0 | — |
| SECONDARY Time to Meaningful Pain Relief |
238.0; 92.0; 122.0; 166.0 | — |
| SECONDARY Percentage of Participants Using Rescue Medication for Pain |
97.5; 55.6; 87.5; 87.8 | — |
| SECONDARY Time to First Use of Rescue Medication for Pain |
107.0; 937.0; 219.5; 193.0 | — |
| SECONDARY Total Use of Rescue Medication Over 0 to 24 Hours and 0 to 48 Hours |
3.8; 2.2; 2.6; 2.9; 5.6; 2.9 | — |
| SECONDARY Participant's Global Evaluation of Study Drug |
25.3; 2.5; 5.0; 14.6; 25.3; 7.4 | — |
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 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 (NCT02634788). 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.