Clinical trial NCT02915978: Fentanyl Sublingual Spray for the Treatment of Moderate to Severe Post-Operative Pain
Official title: A Phase 2 Multicenter, Randomized, Double-Blind, Multiple-Dose, Parallel-Group, Placebo-Controlled Study of Fentanyl Sublingual Spray for the Treatment of Moderate to Severe Post-Operative Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain
Lead sponsor: INSYS Therapeutics Inc
Sponsor class: INDUSTRY
First posted: 2016-09-27
Enrollment: 45
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 Fentanyl Sublingual Spray compared with placebo in participants with postoperative pain after a 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 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:

  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 (NRS SPID-48) After Time 0
timeFrame: Over 0 to 48 hours after Time 0
Secondary outcomes:
measure: NRS Pain Intensity Difference (NRS PID) at Each Categorical Time Point After Time 0
timeFrame: Baseline, 1, 16, and 24 hours
measure: NRS Pain Intensity Score at Each Scheduled Time Point After Time 0
timeFrame: Baseline, 1, 16, and 24 hours
measure: NRS SPID After Time 0
timeFrame: Over 0 to 4 hours (NRS SPID-4), over 0 to 8 hours (NRS SPID-8), and over 0 to 24 hours (NRS SPID-24)
measure: Total Pain Relief (TOTPAR) After Time 0
timeFrame: Over 0 to 4 hours (TOTPAR-4), over 0 to 8 hours (TOTPAR-8), over 0 to 24 hours (TOTPAR-24), and over 0 to 48 hours (TOTPAR-48)
measure: Time to Onset of Analgesia
timeFrame: Within 48 hours
measure: Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
timeFrame: 2.5, 5, 15, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 32, 40, and 48 hours, as well as immediately before each use of rescue analgesia
measure: Peak Pain Relief From Time 0 (First Dose of Study Medication)
timeFrame: Within 48 hours after Time 0
measure: Time (Minutes) to Peak Pain Relief From Time 0 (First Dose of Study Medication)
timeFrame: Within 48 hours after Time 0
measure: Time (Minutes) to First Perceptible Pain Relief From Time 0 (First Dose of Study Medication)
timeFrame: Within 48 hours after Time 0
measure: Time (Minutes) to Meaningful Pain Relief From Time 0 (First Dose of Study Medication)
timeFrame: Within 48 hours after Time 0
measure: Number of Participants Using Rescue Medication
timeFrame: Within 48 hours
measure: Time (Minutes) to First Use of Rescue Medication (Duration of Analgesia) Following Each Dose of the Investigational Product (IP)
timeFrame: Within 48 hours
measure: Number of Participants Using Rescue Analgesia Over 0 to 24 Hours and Over 0 to 48 Hours
timeFrame: Over 0 to 24 hours; Over 0 to 48 hours
measure: Participant Global Evaluation of Study Drug
timeFrame: Within 48 hours
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
Study officials:
affiliation: INSYS Therapeutics Inc
name: Giovanni DeCastro
role: STUDY_DIRECTOR
References: