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Trial record 22 of 56 for:    insys

Buprenorphine Sublingual Spray for the Treatment of Moderate to Severe Pain

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ClinicalTrials.gov Identifier: NCT02310581
Recruitment Status : Terminated (Business decision)
First Posted : December 8, 2014
Results First Posted : August 9, 2017
Last Update Posted : August 9, 2017
Sponsor:
Information provided by (Responsible Party):
INSYS Therapeutics Inc

Tracking Information
First Submitted Date  ICMJE December 1, 2014
First Posted Date  ICMJE December 8, 2014
Results First Submitted Date  ICMJE June 1, 2017
Results First Posted Date  ICMJE August 9, 2017
Last Update Posted Date August 9, 2017
Actual Study Start Date  ICMJE February 24, 2015
Actual Primary Completion Date March 19, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 3, 2017)
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 ]
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: December 4, 2014)
Numerical Rating Scale (NRS) summed pain intensity difference (NRS SPID) (calculated as a time-weighted average) over 0 to 48 hours (NRS SPID-48) after Time 0 [ Time Frame: over 0 to 48 hours after Time 0 ]
Change History Complete list of historical versions of study NCT02310581 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 3, 2017)
  • 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 ]
    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.
  • 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 ]
    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.
  • NRS SPID Over 0 to 4 Hours After Time 0 (NRS SPID-4) [ Time Frame: Baseline and 0 to 4 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 4 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-4 range is -40 to 40. The NRS SPID-4 was analyzed using an analysis of covariance (ANCOVA) model, which included treatment and site as main effects and Baseline pain intensity as the covariate.
  • NRS SPID Over 0 to 8 Hours After Time 0 (NRS SPID-8) [ Time Frame: Baseline and 0 to 8 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 8 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-8 range is -80 to 80. The NRS SPID-8 was analyzed using an analysis of covariance (ANCOVA) model, which included treatment and site as main effects and Baseline pain intensity as the covariate.
  • NRS SPID Over 0 to 24 Hours After Time 0 (NRS SPID-24) [ Time Frame: Baseline and 0 to 24 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 24 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-24 range is -240 to 240. The NRS SPID-24 was analyzed using an analysis of covariance (ANCOVA) model, which included treatment and site as main effects and Baseline pain intensity as the covariate.
  • Percentage of Participants Who Used Rescue Medication for Pain [ Time Frame: From Time 0 (first dose of study drug) up to Day 9 ]
    The percentage of participants who needed to take an alternate medication for pain relief during the study.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2014)
  • NRS pain intensity difference (NRS PID) at each scheduled time point after Time 0 [ Time Frame: within 48 hours after Time 0 ]
  • NRS pain intensity score at each scheduled time point [ Time Frame: at baseline and within 48 hours after Time 0 ]
  • NRS SPID over three time points after Time 0 [ Time Frame: within 24 hours after Time 0 ]
    Categories will be 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) after Time 0
  • Total Pain Relief (TOTPAR) on a 5-point categorical rating scale [ Time Frame: within 48 hours after Time 0 ]
    Categories will be 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) after Time 0
  • Time to onset of analgesia (measured as time to perceptible pain relief confirmed by meaningful pain relief using the 2-stopwatch method) [ Time Frame: within 48 hours after Time 0 ]
    (measured as time to perceptible pain relief confirmed by meaningful pain relief using the 2-stopwatch method)
  • Pain relief score on a 5-point categorical scale at each scheduled time point after Time 0 [ Time Frame: within 48 hours after Time 0 ]
  • Peak pain relief [ Time Frame: within 48 hours after Time 0 ]
  • Time to peak pain relief [ Time Frame: within 48 hours after Time 0 ]
  • Time to first perceptible pain relief [ Time Frame: within 48 hours after Time 0 ]
  • Time to meaningful pain relief [ Time Frame: within 48 hours after Time 0 ]
  • Percentage of participants using rescue medication [ Time Frame: within 9 days after Time 0 ]
  • Time to first use of rescue medication (as a measure of duration of analgesia) [ Time Frame: within 9 days after Time 0 ]
  • Total use of rescue analgesia during treatment period [ Time Frame: within 48 hours after Time 0 ]
    Categories will be over 0 to 24 hours and over 0 to 48 hours
  • Participant's global evaluation of study drug at end of treatment period on a 5-point categorical scale where 0 = poor and 4 = excellent [ Time Frame: within 3 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Buprenorphine Sublingual Spray for the Treatment of Moderate to Severe Pain
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Post-operative Pain
Intervention  ICMJE
  • Drug: Buprenorphine Sublingual Spray
    Buprenorphine sublingual spray delivered via single 100 μL spray
  • Drug: Placebo
    Placebo-matching buprenorphine sublingual spray delivered via single 100 μL spray
Study Arms  ICMJE
  • Experimental: Buprenorphine 0.5 mg TID
    Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) and placebo-matching buprenorphine sublingual spray once daily (QD) for two days.
    Interventions:
    • Drug: Buprenorphine Sublingual Spray
    • Drug: Placebo
  • Experimental: Buprenorphine 1.0 mg BID
    Participants received buprenorphine 1.0 mg sublingual spray twice daily (BID) and placebo-matching buprenorphine sublingual spray BID for two days.
    Interventions:
    • Drug: Buprenorphine Sublingual Spray
    • Drug: Placebo
  • Experimental: Buprenorphine 1.0 mg TID
    Participants received buprenorphine 1.0 mg sublingual spray TID and placebo-matching buprenorphine sublingual spray QD for two days.
    Interventions:
    • Drug: Buprenorphine Sublingual Spray
    • Drug: Placebo
  • Placebo Comparator: Placebo
    Participants received placebo-matching buprenorphine sublingual spray four times daily for two days.
    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 Terminated
Actual Enrollment  ICMJE
 (submitted: May 19, 2015)
40
Original Estimated Enrollment  ICMJE
 (submitted: December 4, 2014)
312
Actual Study Completion Date  ICMJE March 19, 2015
Actual Primary Completion Date March 19, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
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 NCT02310581
Other Study ID Numbers  ICMJE INS-14-026
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 June 2017

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