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Trial record 10 of 56 for:    insys

Fentanyl Sublingual Spray for the Treatment of Moderate to Severe Post-Operative Pain

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ClinicalTrials.gov Identifier: NCT02915978
Recruitment Status : Completed
First Posted : September 27, 2016
Results First Posted : February 14, 2018
Last Update Posted : February 14, 2018
Sponsor:
Information provided by (Responsible Party):
INSYS Therapeutics Inc

Tracking Information
First Submitted Date  ICMJE September 23, 2016
First Posted Date  ICMJE September 27, 2016
Results First Submitted Date  ICMJE January 19, 2018
Results First Posted Date  ICMJE February 14, 2018
Last Update Posted Date February 14, 2018
Actual Study Start Date  ICMJE December 2016
Actual Primary Completion Date February 10, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 19, 2018)
Numeric Rating Scale (NRS) Summed Pain Intensity Difference (SPID) Over 0 to 48 Hours (NRS SPID-48) After Time 0 [ Time Frame: Over 0 to 48 hours after Time 0 ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 26, 2016)
Numeric Rating Scale (NRS) Summed Pain Intensity Difference (SPID) Over 0 to 48 Hours (NRS SPID-48) After Time 0 [ Time Frame: Over 0 to 48 hours after Time 0 ]
NRS SPID is calculated as a time weighted average of pain rated by the participant from 0 to 10 ("no pain" to "worst pain imaginable").
Change History Complete list of historical versions of study NCT02915978 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 19, 2018)
  • NRS Pain Intensity Difference (NRS PID) at Each Categorical Time Point After Time 0 [ Time Frame: Baseline, 1, 16, and 24 hours ]
    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 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 time point 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. NRS PID is reported as the least squares mean difference.
  • NRS Pain Intensity Score at Each Scheduled Time Point After Time 0 [ Time Frame: Baseline, 1, 16, and 24 hours ]
    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 after Time 0 (time of administration of the first dose of study drug). A lower value indicates improvement in pain.
  • NRS SPID After Time 0 [ Time Frame: 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) ]
    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 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 timepoint], and negative numbers indicate an increase in pain [minimum(min)=-10 at each timepoint]. 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.
  • Total Pain Relief (TOTPAR) After Time 0 [ Time Frame: 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) ]
    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.
  • Time to Onset of Analgesia [ Time Frame: Within 48 hours ]
    Measured as time to perceptible pain relief confirmed by meaningful pain relief using the 2-stopwatch method (2 stopwatches will be started as soon as the first dose of study drug is administered. Each participant will be instructed to stop the first stopwatch when he or she experiences any perceptible pain relief and the second stopwatch when he or she experiences pain relief that is meaningful to them.)
  • Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication) [ Time Frame: 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 ]
    Pain relief is determined on a 5-point categorical scale where 0=none, 1=a little, 2=some, 3=a lot, 4=complete.
  • Peak Pain Relief From Time 0 (First Dose of Study Medication) [ Time Frame: Within 48 hours after Time 0 ]
    The highest level of pain relief achieved on a 5-point categorical scale where 0=none, 1=a little, 2=some, 3=a lot, 4=complete.
  • Time (Minutes) to Peak Pain Relief From Time 0 (First Dose of Study Medication) [ Time Frame: Within 48 hours after Time 0 ]
  • Time (Minutes) to First Perceptible Pain Relief From Time 0 (First Dose of Study Medication) [ Time Frame: Within 48 hours after Time 0 ]
    Time to perceptible and meaningful pain relief will be evaluated using the 2-stopwatch method (after the first dose only) (2 stopwatches will be started as soon as the first dose of study drug is administered. Each participant will be instructed to stop the first stopwatch when he or she experiences any perceptible pain relief and the second stopwatch when he or she experiences pain relief that is meaningful to them.)
  • Time (Minutes) to Meaningful Pain Relief From Time 0 (First Dose of Study Medication) [ Time Frame: Within 48 hours after Time 0 ]
    Time to perceptible and meaningful pain relief will be evaluated using the 2-stopwatch method (after the first dose only) (2 stopwatches will be started as soon as the first dose of study drug is administered. Each participant will be instructed to stop the first stopwatch when he or she experiences any perceptible pain relief and the second stopwatch when he or she experiences pain relief that is meaningful to them.)
  • Number of Participants Using Rescue Medication [ Time Frame: Within 48 hours ]
  • Time (Minutes) to First Use of Rescue Medication (Duration of Analgesia) Following Each Dose of the Investigational Product (IP) [ Time Frame: Within 48 hours ]
  • Number of Participants Using Rescue Analgesia Over 0 to 24 Hours and Over 0 to 48 Hours [ Time Frame: Over 0 to 24 hours; Over 0 to 48 hours ]
  • Participant Global Evaluation of Study Drug [ Time Frame: Within 48 hours ]
    Participants provide a global evaluation of study drug on a 5-point categorical scale where 0=poor, 1=fair, 2=good, 3=very good, and 4=excellent.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 26, 2016)
  • NRS Pain Intensity Difference (NRS PID) at Each Categorical Time Point After Time 0 [ Time Frame: 4 hours, 8 hours and 24 hours ]
  • NRS Pain Intensity Score at Each Scheduled Time Point [ Time Frame: Baseline, 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, and immediately before each use of rescue analgesia ]
  • NRS SPID After Time 0 [ Time Frame: 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) ]
  • Total Pain Relief (TOTPAR) After Time 0 [ Time Frame: 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) ]
  • Time to Onset of Analgesia [ Time Frame: Within 48 hours ]
    Measured as time to perceptible pain relief confirmed by meaningful pain relief using the 2-stopwatch method (2 stopwatches will be started as soon as the first dose of study drug is administered. Each participant will be instructed to stop the first stopwatch when he or she experiences any perceptible pain relief and the second stopwatch when he or she experiences pain relief that is meaningful to them.)
  • Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication) [ Time Frame: 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 ]
    Pain relief is determined on a 5-point categorical scale where 0=none, 1=a little, 2=some, 3=a lot, 4=complete.
  • Peak Pain Relief From Time 0 (First Dose of Study Medication) [ Time Frame: Within 48 hours after Time 0 ]
    The highest level of pain relief achieved on a 5-point categorical scale where 0=none, 1=a little, 2=some, 3=a lot, 4=complete.
  • Time (Minutes) to Peak Pain Relief From Time 0 (First Dose of Study Medication) [ Time Frame: Within 48 hours after Time 0 ]
  • Time (Minutes) to First Perceptible Pain Relief From Time 0 (First Dose of Study Medication) [ Time Frame: Within 48 hours after Time 0 ]
    Time to perceptible and meaningful pain relief will be evaluated using the 2-stopwatch method (after the first dose only) (2 stopwatches will be started as soon as the first dose of study drug is administered. Each participant will be instructed to stop the first stopwatch when he or she experiences any perceptible pain relief and the second stopwatch when he or she experiences pain relief that is meaningful to them.)
  • Time (Minutes) to Meaningful Pain Relief From Time 0 (First Dose of Study Medication) [ Time Frame: Within 48 hours after Time 0 ]
    Time to perceptible and meaningful pain relief will be evaluated using the 2-stopwatch method (after the first dose only) (2 stopwatches will be started as soon as the first dose of study drug is administered. Each participant will be instructed to stop the first stopwatch when he or she experiences any perceptible pain relief and the second stopwatch when he or she experiences pain relief that is meaningful to them.)
  • Percentage of Participants Using Rescue Medication [ Time Frame: Within 48 hours ]
  • Time (Hours) to First Use of Rescue Medication (Duration of Analgesia) Following Each Dose of the Investigational Product (IP) [ Time Frame: Within 48 hours ]
  • Number of Participants Using Rescue Analgesia Over 0 to 24 Hours and Over 0 to 48 Hours [ Time Frame: Over 0 to 24 hours; Over 0 to 48 hours ]
  • Participant Global Evaluation of Study Drug [ Time Frame: Within 48 hours ]
    Participants provide a global evaluation of study drug on a 5-point categorical scale where 0=poor, 1=fair, 2=good, 3=very good, and 4=excellent.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fentanyl Sublingual Spray for the Treatment of Moderate to Severe Post-Operative Pain
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Pain
Intervention  ICMJE
  • Drug: Fentanyl
    Fentanyl delivered via sublingual spray
  • Drug: Placebo
    Matching placebo delivered via sublingual spray
Study Arms  ICMJE
  • Experimental: Lower Dose Fentanyl
    Lower dose Fentanyl delivered via sublingual spray every 4 hours.
    Intervention: Drug: Fentanyl
  • Experimental: Higher Dose Fentanyl Sublingual Spray
    Higher dose Fentanyl delivered via sublingual spray every 4 hours.
    Intervention: Drug: Fentanyl
  • Placebo Comparator: Placebo
    Placebo (matching Fentanyl) delivered via sublingual spray every 4 hours.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 26, 2016)
45
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 10, 2017
Actual Primary Completion Date February 10, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02915978
Other Study ID Numbers  ICMJE INS002-16-092
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party INSYS Therapeutics Inc
Study Sponsor  ICMJE INSYS Therapeutics Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Giovanni DeCastro INSYS Therapeutics Inc
PRS Account INSYS Therapeutics Inc
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP