- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02634788
Study of Buprenorphine Sublingual Spray for the Treatment of Moderate to Severe Pain
August 3, 2017 updated by: INSYS Therapeutics Inc
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
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
322
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arizona
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Phoenix, Arizona, United States, 85023
- Arizona Research Center
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California
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Anaheim, California, United States, 92801
- Anaheim Clinical Trials
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Maryland
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Pasadena, Maryland, United States, 21122
- Chesapeake Research Group
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Utah
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Salt Lake City, Utah, United States, 84124
- Jean Brown Research
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Buprenorphine 0.5 mg TID
Participants received buprenorphine 0.5 mg sublingual (under the tongue) spray three times daily (TID) for two days.
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Buprenorphine sublingual spray delivered via single 100 μL spray
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Experimental: Buprenorphine 0.25 mg TID
Participants received buprenorphine 0.25 mg sublingual spray TID for two days.
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Buprenorphine sublingual spray delivered via single 100 μL spray
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Experimental: Buprenorphine 0.125 mg TID
Participants received buprenorphine 0.125 mg sublingual spray TID for two days.
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Buprenorphine sublingual spray delivered via single 100 μL spray
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Placebo Comparator: Placebo
Participants received placebo-matching buprenorphine sublingual spray TID for two days.
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Placebo-matching buprenorphine sublingual spray delivered via single 100 μL spray
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Numeric Rating Scale (NRS) Summed Pain Intensity Difference (SPID) Over 0 to 48 Hours After Time 0 (NRS SPID-48)
Time Frame: Baseline and 0 to 48 hours after Time 0
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Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain.
Pain intensity scores were collected at Baseline (prior to study drug) and at multiple time points up to 48 hours after Time 0 (administration of first dose of study drug).
Pain intensity difference is calculated by subtracting the pain intensity at each time point from the pain intensity at Time 0. The SPID scores are the sum of the differences at each time point multiplied by the duration in hours since the previous time point.
Positive numbers indicate a reduction in pain [maximum(max)=10 at each time point], and negative numbers indicate an increase in pain [minimum(min)=-10 at each time point].
The overall min and max are -10 and 10 times the number of hours specified; SPID-48 range is -480 to 480.
The NRS SPID-48 was analyzed using an analysis of covariance (ANCOVA) model, which included treatment and site as main effects and Baseline pain intensity as the covariate.
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Baseline and 0 to 48 hours after Time 0
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
NRS Mean Pain Intensity Difference (PID) at 4, 8, 24 and 48 Hours After Time 0
Time Frame: Baseline and 4, 8, 24 and 48 hours after Time 0
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Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain.
Pain intensity scores were collected at Baseline (prior to study drug administration) and at multiple time points up to 48 hours after Time 0 (time of administration of the first dose of study drug).
NRS PID is defined as the difference in pain at each scheduled timepoint relative to Baseline (PID=pain intensity at baseline - pain intensity at time point).
A higher value of NRS PID score indicates a higher decrease in pain from Baseline.
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Baseline and 4, 8, 24 and 48 hours after Time 0
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NRS Mean Pain Intensity Score at 4, 8, 24 and 48 Hours After Time 0
Time Frame: 4, 8, 24 and 48 hours after Time 0
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Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain.
Pain intensity scores were collected at Baseline (prior to study drug administration) and at multiple time points up to 48 hours after Time 0 (time of administration of the first dose of study drug).
A lower value indicates improvement in pain.
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4, 8, 24 and 48 hours after Time 0
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NRS SPID Over 4 Hours (SPID-4), 8 Hours (SPID-8) and 24 Hours (SPID-24) After Time 0
Time Frame: Baseline and 0 to 4, 0 to 8 and 0 to 24 hours after Time 0
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Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain.
Pain intensity scores were collected at Baseline (prior to study drug) and at multiple time points up to 48 hours after Time 0 (administration of first dose of study drug).
Pain intensity difference is calculated by subtracting the pain intensity at each time point from the pain intensity at Time 0. The SPID scores are the sum of the differences at each time point multiplied by the duration in hours since the previous time point.
Positive numbers indicate a reduction in pain [max=10 at each time point] and negative numbers indicate an increase in pain [min=-10 at each time point].
The overall min and max are -10 and 10 times the number of hours specified: SPID-4=(-40 to 40), SPID-8=(-80 to 80) and SPID-24=(-240 to 240).
The NRS SPID-4, 8 and 24 were analyzed using an ANCOVA model which included treatment and site as main effects and Baseline pain intensity as the covariate.
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Baseline and 0 to 4, 0 to 8 and 0 to 24 hours after Time 0
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Total Pain Relief (TOTPAR) Over 4, 8, 24 and 48 Hours After Time 0
Time Frame: 4, 8, 24 and 48 hours after Time 0
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TOTPAR was assessed by the participant using a 5-point NRS (0=no relief, 1=a little, 2=some, 3=a lot, 4=complete relief).
TOTPAR scores were collected at Baseline (prior to study drug) and at multiple time points up to 48 hours after Time 0 (first dose of study drug).
The TOTPAR scores are the sum of the pain relief at each time point multiplied by the duration in hours since the previous time point.
Larger positive numbers indicate more pain relief (maximum=4 at each time point) and smaller positive numbers indicate less pain relief (minimum=0 at each time point).
The overall minimum is 0 for each variable and the overall maximum is 4 times the number of hours specified for the variable: TOTPAR-4=(0 to 16), TOTPAR-8=(0 to 32), TOTPAR-24=(0 to 96) and TOTPAR-48=(0 to 192).
TOTPAR-4, TOTPAR-8, TOTPAR-24 and TOTPAR-48 were analyzed using an ANCOVA model with factors for treatment, site and baseline pain intensity.
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4, 8, 24 and 48 hours after Time 0
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Time to Onset of Analgesia
Time Frame: From Time 0 (first dose of study drug) to time of confirmed meaningful pain relief (up to 64 minutes)
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Time to onset of analgesia was measured as time to first perceptible pain relief confirmed by meaningful pain relief using the 2-stopwatch method.
The study staff started 2 stopwatches as soon as the first dose of study drug was administered.
Each participant was instructed to stop the first stopwatch when he or she experienced any perceptible pain relief and the second stopwatch when he or she experienced pain relief that was meaningful to them.
If the second stopwatch was not stopped, time was censored at the time of the second dose of study drug or the use of rescue medication, whichever came first.
If both stopwatches were not stopped time was censored at the time of the second dose of study drug or the use of rescue medication whichever came first.
Time to onset of analgesia was defined as the time when the first stopwatch was stopped given that the second stopwatch is stopped.
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From Time 0 (first dose of study drug) to time of confirmed meaningful pain relief (up to 64 minutes)
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Percentage of Participants With Scores in Each Pain Relief Category at 4, 8, 24 and 48 Hours After Time 0
Time Frame: 4, 8, 24 and 48 hours after Time 0 (first dose of study drug)
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Pain relief was assessed by the participant using a 5-point NRS (0=no relief, 1=a little, 2=some, 3=a lot, 4=complete relief).
The percentage of participants with scores in each pain relief category are reported.
Missing values were imputed.
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4, 8, 24 and 48 hours after Time 0 (first dose of study drug)
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Percentage of Participants With Peak Scores in Each Pain Relief Category
Time Frame: From Time 0 (first dose of study drug) up to 48 hours
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Peak pain relief is the highest value of pain relief experienced during the study.
Pain relief was assessed by the participant using a 5-point NRS (0=no relief, 1=a little, 2=some, 3=a lot, 4=complete relief).
The percentage of participants with peak scores in each pain relief category are reported.
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From Time 0 (first dose of study drug) up to 48 hours
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Time to Peak Pain Relief
Time Frame: From Time 0 (first dose of study drug) to time of peak pain relief (up to 1437 minutes)
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Time to peak pain relief is the time to the highest value of pain relief experienced during the study.
Pain relief was assessed by the participant using a 5-point NRS (0=no relief, 1=a little, 2=some, 3=a lot, 4=complete relief).
If no pain relief was observed, then the time was censored at the time of the last pain assessment.
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From Time 0 (first dose of study drug) to time of peak pain relief (up to 1437 minutes)
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Time to First Perceptible Pain Relief
Time Frame: From Time 0 (first dose of study drug) to time of first perceptible pain relief (up to 83 minutes)
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Time to first perceptible pain relief was evaluated using the 2 stopwatch method and is defined as the time when the participant stops the first stopwatch.
If it was not stopped time was censored at the time that the second stopwatch was stopped or the time of the second dose or the time that rescue medication was used whichever came first.
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From Time 0 (first dose of study drug) to time of first perceptible pain relief (up to 83 minutes)
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Time to Meaningful Pain Relief
Time Frame: From Time 0 (first dose of study drug) to time of meaningful pain relief (up to 227 minutes)
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Time to meaningful pain relief was evaluated using the 2 stopwatch method and is defined as the time when the participant stops the second stopwatch.
If it was not stopped time was censored at the time that the second stopwatch was stopped or the time of the second dose or the time that rescue medication was used whichever came first.
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From Time 0 (first dose of study drug) to time of meaningful pain relief (up to 227 minutes)
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Percentage of Participants Using Rescue Medication for Pain
Time Frame: From Time 0 (first dose of study drug) up to 48 hours
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The percentage of participants who needed to take an alternate medication for pain relief during the treatment period.
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From Time 0 (first dose of study drug) up to 48 hours
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Time to First Use of Rescue Medication for Pain
Time Frame: From Time 0 to time of first use of rescue medication (up to 280 minutes)
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Time to first use of rescue medication is the time from Time 0 (time of administration of the first dose of study drug) to the first use of rescue medication.
If rescue medication was not taken the time was censored at the time of the last pain assessment.
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From Time 0 to time of first use of rescue medication (up to 280 minutes)
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Total Use of Rescue Medication Over 0 to 24 Hours and 0 to 48 Hours
Time Frame: Over 24 and 48 hours after Time 0 (first dose of study drug)
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Total use of rescue medication is defined as the number of times a participant took rescue medication.
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Over 24 and 48 hours after Time 0 (first dose of study drug)
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Participant's Global Evaluation of Study Drug
Time Frame: End of treatment (Day 3) or early termination
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Global evaluation of study drug was completed at the end of treatment (Day 3) or before early termination if a participant discontinued early.
Participants were asked to provide an overall rating of their study medication in controlling pain on a 5-point NRS, where 0=poor, 1=fair, 2=good, 3=very good, and 4=excellent.
The percentage of participants with scores in each pain relief category are reported.
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End of treatment (Day 3) or early termination
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 29, 2016
Primary Completion (Actual)
June 24, 2016
Study Completion (Actual)
June 24, 2016
Study Registration Dates
First Submitted
December 16, 2015
First Submitted That Met QC Criteria
December 16, 2015
First Posted (Estimate)
December 18, 2015
Study Record Updates
Last Update Posted (Actual)
August 14, 2017
Last Update Submitted That Met QC Criteria
August 3, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- INS005-15-062
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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