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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

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.


Condition or disease Intervention/treatment Phase
Post-operative Pain Drug: Buprenorphine Sublingual Spray Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : February 24, 2015
Actual Primary Completion Date : March 19, 2015
Actual Study Completion Date : March 19, 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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

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.
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

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.
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

Placebo Comparator: Placebo
Participants received placebo-matching buprenorphine sublingual spray four times daily for two days.
Drug: Placebo
Placebo-matching buprenorphine sublingual spray delivered via single 100 μL spray




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02310581


Locations
United States, Arizona
Phoenix, Arizona, United States, 85027
United States, Maryland
Pasadena, Maryland, United States, 21122
United States, Texas
Austin, Texas, United States, 78728
Sponsors and Collaborators
INSYS Therapeutics Inc
Investigators
Study Director: Giovanni DeCastro INSYS Therapeutics Inc

Responsible Party: INSYS Therapeutics Inc
ClinicalTrials.gov Identifier: NCT02310581     History of Changes
Other Study ID Numbers: INS-14-026
First Posted: December 8, 2014    Key Record Dates
Results First Posted: August 9, 2017
Last Update Posted: August 9, 2017
Last Verified: June 2017

Keywords provided by INSYS Therapeutics Inc:
Bunionectomy

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Buprenorphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists