Evaluation of DEX-IN During Outpatient Procedures

Baudax Bio

Status and phase: Completed; Phase 2

Conditions: Pain

Treatments: Drug: DEX-IN; Drug: Placebo; Drug: Fentanyl

Study type: Interventional

Funder types: Industry

Identifiers

NCT03348423

REC-17-023

Details and patient eligibility

About

The primary objective of this study is to evaluate the analgesic efficacy of DEX-IN compared with placebo and active control (fentanyl), in subjects undergoing painful outpatient and office based procedures.

Enrollment: 45 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Voluntarily provide written informed consent
• Be planned to undergo a selected office-based or outpatient procedure
• Be naïve to the planned procedure, i.e. no repeated or revision procedures
• Not pregnant or planning to become pregnant, or using appropriate contraceptive measures.

Exclusion criteria

• Known allergy to any study treatment or excipient
• Have another painful physical condition or anxiety related diagnosis that may confound study assessments
• Evidence of a clinically significant finding on physical examination, laboratory assessment, or ECG
• Have signs or a history of significant nasal condition that may interfere with intranasal drug delivery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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45 participants in 3 patient groups, including a placebo group

DEX-IN 50 µg

Experimental group

Description:

Dexmedetomidine Intranasal Spray

Treatment:

Drug: DEX-IN

Fentanyl 50 µg

Active Comparator group

Description:

Intravenous Fentanyl

Treatment:

Drug: Fentanyl

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo