Evaluation of DEX-IN During Outpatient Procedures

• Status: Completed
• Trial end date: 2018-01-18
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Recro Pharma, Inc.
• Treatments: Fentanyl

Criteria

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