Study of Buprenorphine Sublingual Spray for the Treatment of Moderate to Severe Pain

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02634788
• Other study ID #: INS005-15-062
• Status: Completed
• Phase: Phase 3
• First received: December 16, 2015
• Last updated: June 28, 2016
• Start date: December 2015
• Est. completion date: June 2016

Study information

• Verified date: June 2016
• Source: INSYS Therapeutics Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The primary objective of this trial is to evaluate analgesic efficacy of Buprenorphine Sublingual Spray compared with placebo in subjects with postoperative pain after bunionectomy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 322
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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:

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Buprenorphine
Buprenorphine delivered via sublingual spray
• Placebo
Matching placebo delivered via sublingual spray

Locations

Country	Name	City	State
United States	Anaheim Clinical Trials	Anaheim	California
United States	Chesapeake Research Group	Pasadena	Maryland
United States	Arizona Research Center	Phoenix	Arizona
United States	Jean Brown Research	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
INSYS Therapeutics Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numeric rating scale (NRS) summed pain intensity difference (SPID) over 0 to 48 hours (NRS SPID 48) 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")	over 0 to 48 hours after Time 0	No
Secondary	NRS pain intensity difference (NRS PID) at each categorical time point after Time 0	Categories: 4 hours, 8 hours, 24 hours, 48 hours	within 48 hours	No
Secondary	NRS pain intensity score at each scheduled time point	Categories: Baseline, 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	within 48 hours	No
Secondary	NRS SPID after Time 0	Categories: 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)	within 24 hours	No
Secondary	Total pain relief (TOTPAR) after Time 0	Categories: 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)	within 48 hours	No
Secondary	Time to onset of analgesia	Measured as time to perceptible pain relief confirmed by meaningful pain relief using the 2-stopwatch method.	within 48 hours	No
Secondary	Pain relief at each scheduled time point after Time 0 (first dose of study medication)	Pain relief is determined on a 5-point categorical scale where 0=none, 1=a little, 2=some, 3=a lot, 4=complete, at 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.	within 48 hours	No
Secondary	Peak pain relief from Time 0 (first dose of study medication)	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	within 48 hours after Time 0	No
Secondary	Time (minutes) to peak pain relief from Time 0 (first dose of study medication)		within 48 hours after Time 0	No
Secondary	Time (minutes) to first perceptible pain relief from Time 0 (first dose of study medication)	Time to perceptible and meaningful pain relief will be evaluated using the 2-stopwatch method (after the first dose only).	within 48 hours after Time 0	No
Secondary	Time (minutes) to meaningful pain relief from Time 0 (first dose of study medication)	Time to perceptible and meaningful pain relief will be evaluated using the 2-stopwatch method (after the first dose only).	within 48 hours after Time 0	No
Secondary	Percentage of participants using rescue medication		within 48 hours	No
Secondary	Time (hours) to first use of rescue medication (duration of analgesia)		within 48 hours	No
Secondary	Number of participants using rescue analgesia over 0 to 24 hours and over 0 to 48 hours	Categories: over 0 to 24 hours; over 0 to 48 hours	within 48 hours	No
Secondary	Participant global evaluation of study drug	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.	within 48 hours	No