Fentanyl Sublingual Spray for the Treatment of Moderate to Severe Post-Operative Pain

NCT02915978 | Completed Phase 2 Results

• 1 other identifier: INS002-16-092
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

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

  Over 0 to 48 hours after Time 0

Secondary Outcomes (14)

• NRS Pain Intensity Difference (NRS PID) at Each Categorical Time Point After Time 0

  Baseline, 1, 16, and 24 hours

• NRS Pain Intensity Score at Each Scheduled Time Point After Time 0

  Baseline, 1, 16, and 24 hours

• NRS SPID After Time 0

  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)

• Total Pain Relief (TOTPAR) After Time 0

  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)

• Time to Onset of Analgesia

  Within 48 hours

Study Arms (3)

Lower Dose Fentanyl

EXPERIMENTAL

Lower dose Fentanyl delivered via sublingual spray every 4 hours.

Drug: Fentanyl

Higher Dose Fentanyl Sublingual Spray

EXPERIMENTAL

Higher dose Fentanyl delivered via sublingual spray every 4 hours.

Drug: Fentanyl

Placebo

PLACEBO COMPARATOR

Placebo (matching Fentanyl) delivered via sublingual spray every 4 hours.

Drug: Placebo

Interventions

Fentanyl DRUG

Fentanyl delivered via sublingual spray

Higher Dose Fentanyl Sublingual Spray; Lower Dose Fentanyl

Placebo DRUG

Matching placebo delivered via sublingual 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 to 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 (2)

Arizona Research Center

Phoenix, Arizona, 85023, United States

Location

Anaheim Clinical Trials

Anaheim, California, 92801, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Fentanyl

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic 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 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2016
• First Posted: September 27, 2016
• Study Start: December 1, 2016
• Primary Completion: February 10, 2017
• Study Completion: February 10, 2017
• Last Updated: February 14, 2018
• Results First Posted: February 14, 2018

Record last verified: 2018-01

Locations

US (2)