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Buprenorphine Sublingual Spray for the Treatment of Moderate to Severe Pain

Primary Purpose

Post-operative Pain

Status

Terminated

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Buprenorphine Sublingual Spray

Placebo

About this trial

This is an interventional treatment trial for Post-operative Pain focused on measuring Bunionectomy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

Buprenorphine 0.5 mg TID

Buprenorphine 1.0 mg BID

Buprenorphine 1.0 mg TID

Placebo

Arm Description

Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) and placebo-matching buprenorphine sublingual spray once daily (QD) for two days.

Participants received buprenorphine 1.0 mg sublingual spray twice daily (BID) and placebo-matching buprenorphine sublingual spray BID for two days.

Participants received buprenorphine 1.0 mg sublingual spray TID and placebo-matching buprenorphine sublingual spray QD for two days.

Participants received placebo-matching buprenorphine sublingual spray four times daily for two days.

Outcomes

Primary Outcome Measures

Numeric Rating Scale (NRS) Summed Pain Intensity Difference (SPID) Over 0 to 48 Hours After Time 0 (NRS SPID-48)

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

NRS Mean Pain Intensity Difference (PID) at 4, 8, 24 and 48 Hours After Time 0

NRS Mean Pain Intensity Score at 4, 8, 24 and 48 Hours After Time 0

NRS SPID Over 0 to 4 Hours After Time 0 (NRS SPID-4)

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)

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)

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

The percentage of participants who needed to take an alternate medication for pain relief during the study.

Full Information

NCT ID

NCT02310581

First Posted

December 1, 2014

Last Updated

August 3, 2017

Sponsor

INSYS Therapeutics Inc

1. Study Identification

Unique Protocol Identification Number

NCT02310581

Brief Title

Buprenorphine Sublingual Spray for the Treatment of Moderate to Severe Pain

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Terminated

Why Stopped

Business decision

Study Start Date

February 24, 2015 (Actual)

Primary Completion Date

March 19, 2015 (Actual)

Study Completion Date

March 19, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

INSYS Therapeutics Inc

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Post-operative Pain

Keywords

Bunionectomy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Buprenorphine 0.5 mg TID

Arm Type

Experimental

Arm Description

Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) and placebo-matching buprenorphine sublingual spray once daily (QD) for two days.

Arm Title

Buprenorphine 1.0 mg BID

Arm Type

Experimental

Arm Description

Participants received buprenorphine 1.0 mg sublingual spray twice daily (BID) and placebo-matching buprenorphine sublingual spray BID for two days.

Arm Title

Buprenorphine 1.0 mg TID

Arm Type

Experimental

Arm Description

Participants received buprenorphine 1.0 mg sublingual spray TID and placebo-matching buprenorphine sublingual spray QD for two days.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Participants received placebo-matching buprenorphine sublingual spray four times daily for two days.

Intervention Type

Drug

Intervention Name(s)

Buprenorphine Sublingual Spray

Intervention Description

Buprenorphine sublingual spray delivered via single 100 μL spray

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo-matching buprenorphine sublingual spray delivered via single 100 μL spray

Primary Outcome Measure Information:

Title

Numeric Rating Scale (NRS) Summed Pain Intensity Difference (SPID) Over 0 to 48 Hours After Time 0 (NRS SPID-48)

Description

Time Frame

Baseline and 0 to 48 hours after Time 0

Secondary Outcome Measure Information:

Title

NRS Mean Pain Intensity Difference (PID) at 4, 8, 24 and 48 Hours After Time 0

Description

Time Frame

Baseline and 4, 8, 24 and 48 hours after Time 0

Title

NRS Mean Pain Intensity Score at 4, 8, 24 and 48 Hours After Time 0

Description

Time Frame

4, 8, 24 and 48 hours after Time 0

Title

NRS SPID Over 0 to 4 Hours After Time 0 (NRS SPID-4)

Description

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.

Time Frame

Baseline and 0 to 4 hours after Time 0

Title

NRS SPID Over 0 to 8 Hours After Time 0 (NRS SPID-8)

Description

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.

Time Frame

Baseline and 0 to 8 hours after Time 0

Title

NRS SPID Over 0 to 24 Hours After Time 0 (NRS SPID-24)

Description

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.

Time Frame

Baseline and 0 to 24 hours after Time 0

Title

Percentage of Participants Who Used Rescue Medication for Pain

Description

The percentage of participants who needed to take an alternate medication for pain relief during the study.

Time Frame

From Time 0 (first dose of study drug) up to Day 9

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Giovanni DeCastro

Organizational Affiliation

INSYS Therapeutics Inc

Official's Role

Study Director

Facility Information:

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85027

Country

United States

City

Pasadena

State/Province

Maryland

ZIP/Postal Code

21122

Country

United States

City

Austin

State/Province

Texas

ZIP/Postal Code

78728

Country

United States

12. IPD Sharing Statement

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Buprenorphine Sublingual Spray for the Treatment of Moderate to Severe Pain

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