Clinical trial NCT02634788: Study of 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 (0.5 mg TID, 0.25 mg TID, and 0.125 mg TID) for the Treatment of Moderate to Severe Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Keywords: Post-Surgical Pain
Bunionectomy
Lead sponsor: INSYS Therapeutics Inc
Sponsor class: INDUSTRY
First posted: 2015-12-18
Enrollment: 322
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: 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.


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:

  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 4 Hours (SPID-4), 8 Hours (SPID-8) and 24 Hours (SPID-24) After Time 0
timeFrame: Baseline and 0 to 4, 0 to 8 and 0 to 24 hours after Time 0
measure: Total Pain Relief (TOTPAR) Over 4, 8, 24 and 48 Hours After Time 0
timeFrame: 4, 8, 24 and 48 hours after Time 0
measure: Time to Onset of Analgesia
timeFrame: From Time 0 (first dose of study drug) to time of confirmed meaningful pain relief (up to 64 minutes)
measure: Percentage of Participants With Scores in Each Pain Relief Category at 4, 8, 24 and 48 Hours After Time 0
timeFrame: 4, 8, 24 and 48 hours after Time 0 (first dose of study drug)
measure: Percentage of Participants With Peak Scores in Each Pain Relief Category
timeFrame: From Time 0 (first dose of study drug) up to 48 hours
measure: Time to Peak Pain Relief
timeFrame: From Time 0 (first dose of study drug) to time of peak pain relief (up to 1437 minutes)
measure: Time to First Perceptible Pain Relief
timeFrame: From Time 0 (first dose of study drug) to time of first perceptible pain relief (up to 83 minutes)
measure: Time to Meaningful Pain Relief
timeFrame: From Time 0 (first dose of study drug) to time of meaningful pain relief (up to 227 minutes)
measure: Percentage of Participants Using Rescue Medication for Pain
timeFrame: From Time 0 (first dose of study drug) up to 48 hours
measure: Time to First Use of Rescue Medication for Pain
timeFrame: From Time 0 to time of first use of rescue medication (up to 280 minutes)
measure: Total Use of Rescue Medication Over 0 to 24 Hours and 0 to 48 Hours
timeFrame: Over 24 and 48 hours after Time 0 (first dose of study drug)
measure: Participant's Global Evaluation of Study Drug
timeFrame: End of treatment (Day 3) or early termination
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Anaheim
country: United States
facility: Anaheim Clinical Trials
state: California
city: Pasadena
country: United States
facility: Chesapeake Research Group
state: Maryland
city: Salt Lake City
country: United States
facility: Jean Brown Research
state: Utah
Study officials:
affiliation: INSYS Therapeutics Inc
name: Giovanni DeCastro
role: STUDY_DIRECTOR
References: