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

NCT02634788 | Completed Phase 3 Results

• 1 other identifier: INS005-15-062
• Study Type: interventional
• Target: 322
• Locations: 1 country
• Sites: 4

Brief Summary

The primary objective of this trial is to evaluate analgesic efficacy of Buprenorphine Sublingual (under the tongue) Spray compared with placebo in participants with postoperative pain after bunionectomy.

Conditions

Pain

Keywords

Post-Surgical Pain; Bunionectomy

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 0 to 48 hours after Time 0

Secondary Outcomes (14)

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

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

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

  4, 8, 24 and 48 hours after Time 0

• NRS SPID Over 4 Hours (SPID-4), 8 Hours (SPID-8) and 24 Hours (SPID-24) After Time 0

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

• Total Pain Relief (TOTPAR) Over 4, 8, 24 and 48 Hours After Time 0

  4, 8, 24 and 48 hours after Time 0

• Time to Onset of Analgesia

  From Time 0 (first dose of study drug) to time of confirmed meaningful pain relief (up to 64 minutes)

Study Arms (4)

Buprenorphine 0.5 mg TID

EXPERIMENTAL

Participants received buprenorphine 0.5 mg sublingual (under the tongue) spray three times daily (TID) for two days.

Drug: Buprenorphine

Buprenorphine 0.25 mg TID

EXPERIMENTAL

Participants received buprenorphine 0.25 mg sublingual spray TID for two days.

Drug: Buprenorphine

Buprenorphine 0.125 mg TID

EXPERIMENTAL

Participants received buprenorphine 0.125 mg sublingual spray TID for two days.

Drug: Buprenorphine

Placebo

PLACEBO COMPARATOR

Participants received placebo-matching buprenorphine sublingual spray TID for two days.

Drug: Placebo

Interventions

Buprenorphine DRUG

Buprenorphine sublingual spray delivered via single 100 μL spray

Buprenorphine 0.125 mg TID; Buprenorphine 0.25 mg TID; Buprenorphine 0.5 mg TID

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• INSYS Therapeutics Inc: lead

Study Sites (4)

Arizona Research Center

Phoenix, Arizona, 85023, United States

Location

Anaheim Clinical Trials

Anaheim, California, 92801, United States

Location

Chesapeake Research Group

Pasadena, Maryland, 21122, United States

Location

Jean Brown Research

Salt Lake City, Utah, 84124, United States

Location

MeSH Terms

Conditions

Pain; Pain, Postoperative

Interventions

Buprenorphine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Director, Clinical Development
• Organization: Insys Therapeutics, Inc.

gdecastro@insysrx.com

480-500-3105

Study Officials

• Giovanni DeCastro

  INSYS Therapeutics Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2015
• First Posted: December 18, 2015
• Study Start: January 29, 2016
• Primary Completion: June 24, 2016
• Study Completion: June 24, 2016
• Last Updated: August 14, 2017
• Results First Posted: August 14, 2017

Record last verified: 2017-06

Locations

US (4)