Evaluation of DEX-IN During Outpatient Procedures
| Status: | Recruiting |
|---|---|
| Conditions: | Chronic Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 11/22/2017 |
| Start Date: | November 15, 2017 |
| End Date: | April 2018 |
| Contact: | Stewart McCallum, MD |
| Email: | smccallum@recropharma.com |
| Phone: | 484-395-2470 |
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Evaluation of the Efficacy and Safety of DEX-IN Following Painful Outpatient Procedures
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.
with placebo and active control (fentanyl), in subjects undergoing painful outpatient and
office based procedures.
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
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