Buprenorphine Sublingual Spray for the Treatment of Moderate to Severe Pain

NCT02310581 | Terminated Phase 3 Results

• 1 other identifier: INS-14-026
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

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.

Conditions

Post-operative Pain

Keywords

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 (6)

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

  Baseline and 0 to 4 hours after Time 0

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

  Baseline and 0 to 8 hours after Time 0

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

  Baseline and 0 to 24 hours after Time 0

Study Arms (4)

Buprenorphine 0.5 mg TID

EXPERIMENTAL

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; Drug: Placebo

Buprenorphine 1.0 mg BID

EXPERIMENTAL

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; Drug: Placebo

Buprenorphine 1.0 mg TID

EXPERIMENTAL

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

Drug: Buprenorphine Sublingual Spray; Drug: Placebo

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Buprenorphine Sublingual Spray DRUG

Buprenorphine sublingual spray delivered via single 100 μL spray

Buprenorphine 0.5 mg TID; Buprenorphine 1.0 mg BID; Buprenorphine 1.0 mg TID

Placebo DRUG

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

Buprenorphine 0.5 mg TID; Buprenorphine 1.0 mg BID; Buprenorphine 1.0 mg TID; 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
• 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.

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 (3)

Unknown Facility

Phoenix, Arizona, 85027, United States

Location

Unknown Facility

Pasadena, Maryland, 21122, United States

Location

Unknown Facility

Austin, Texas, 78728, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

This study was terminated early by the sponsor due to business reasons (40 participants enrolled out of 312 planned). Due to this early termination 10 outcome measures originally registered as pre-specified secondary are no longer secondaries.

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 1, 2014
• First Posted: December 8, 2014
• Study Start: February 24, 2015
• Primary Completion: March 19, 2015
• Study Completion: March 19, 2015
• Last Updated: August 9, 2017
• Results First Posted: August 9, 2017

Record last verified: 2017-06

Locations

US (3)