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

INSYS Therapeutics

Status and phase: Completed; Phase 2

Conditions: Pain

Treatments: Drug: Fentanyl; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02915978

INS002-16-092

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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 to 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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45 participants in 3 patient groups, including a placebo group

Lower Dose Fentanyl

Experimental group

Description:

Lower dose Fentanyl delivered via sublingual spray every 4 hours.

Treatment:

Drug: Fentanyl

Higher Dose Fentanyl Sublingual Spray

Experimental group

Description:

Higher dose Fentanyl delivered via sublingual spray every 4 hours.

Treatment:

Drug: Fentanyl

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo