Clinical trial NCT02310581: Buprenorphine Sublingual Spray for the Treatment of Moderate to Severe Pain
Official title: A Phase 3, Randomized, Double-Blind, Multiple-Dose, Parallel-Group, Placebo-Controlled Study of Buprenorphine Sublingual Spray for the Treatment of Moderate to Severe Pain
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Post-operative Pain
Keywords: Bunionectomy
Lead sponsor: INSYS Therapeutics Inc
Sponsor class: INDUSTRY
First posted: 2014-12-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a phase 3, multicenter, randomized, double-blind, multiple-dose, parallel-group, placebo-controlled study to evaluate the safety and efficacy of up to 3 dosing regimens of Buprenorphine Sublingual (under the tongue) Spray and/or matching placebo in participants with moderate to severe postoperative pain after bunionectomy. The study will comprise 4 periods: the Screening Period, the Surgical Period, the Treatment Period, and the Follow-up Period.

Participants will be admitted to the study site on the morning of the scheduled surgery, will remain at the study site until postoperative Day 3 (a total of 3 nights at the study site), and will return for the Follow-up Visit 5 to 9 days after surgery.


Eligibility criteria: Inclusion Criteria:

* Meets protocol-specified criteria for qualification and contraception
* Is able to speak and understand the language in which the study is being conducted, is able to understand the procedures and study requirements and has voluntarily signed and dated an informed consent form approved by the Institutional Review Board before the conduct of any study procedure
* Is willing and able to comply with study requirements (including diet, alcohol, and smoking restrictions), complete the pain evaluations, remain at the study site for three days, and return for follow up between 7 and 9 days after surgery.

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:

  1. the safety or well-being of the participant or study staff
  2. the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding)
  3. the analysis of results

Primary outcomes:
measure: Numeric Rating Scale (NRS) Summed Pain Intensity Difference (SPID) Over 0 to 48 Hours After Time 0 (NRS SPID-48)
timeFrame: Baseline and 0 to 48 hours after Time 0
Secondary outcomes:
measure: NRS Mean Pain Intensity Difference (PID) at 4, 8, 24 and 48 Hours After Time 0
timeFrame: Baseline and 4, 8, 24 and 48 hours after Time 0
measure: NRS Mean Pain Intensity Score at 4, 8, 24 and 48 Hours After Time 0
timeFrame: 4, 8, 24 and 48 hours after Time 0
measure: NRS SPID Over 0 to 4 Hours After Time 0 (NRS SPID-4)
timeFrame: Baseline and 0 to 4 hours after Time 0
measure: NRS SPID Over 0 to 8 Hours After Time 0 (NRS SPID-8)
timeFrame: Baseline and 0 to 8 hours after Time 0
measure: NRS SPID Over 0 to 24 Hours After Time 0 (NRS SPID-24)
timeFrame: Baseline and 0 to 24 hours after Time 0
measure: Percentage of Participants Who Used Rescue Medication for Pain
timeFrame: From Time 0 (first dose of study drug) up to Day 9
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Pasadena
country: United States
state: Maryland
city: Austin
country: United States
state: Texas
Study officials:
affiliation: INSYS Therapeutics Inc
name: Giovanni DeCastro
role: STUDY_DIRECTOR
References: