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

INSYS Therapeutics

Status and phase: Completed; Phase 3

Conditions: Pain

Treatments: Drug: Buprenorphine; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02634788

INS005-15-062

Details and patient eligibility

About

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.

Enrollment: 322 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 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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322 participants in 4 patient groups, including a placebo group

Buprenorphine 0.5 mg TID

Experimental group

Description:

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

Treatment:

Drug: Buprenorphine

Buprenorphine 0.25 mg TID

Experimental group

Description:

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

Treatment:

Drug: Buprenorphine

Buprenorphine 0.125 mg TID

Experimental group

Description:

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

Treatment:

Drug: Buprenorphine

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo