NCT05508594

Efficacy and Pharmacokinetic-Pharmacodynamic Relationship of Intranasally Administered Sufentanil, Ketamine, and CT001

Analgesic Efficacy and Pharmacokinetic-pharmacodynamic Relationship of Intranasally Administered Sufentanil, Ketamine, and CT001 After Impacted Mandibular Third Molar Extraction - A Double-blind, Randomised, Placebo-controlled Study

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 220 (actual)
• Sponsor: Cessatech A/S · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

A randomised, double-blind, parallel-group, study comparing the analgesic effect of intranasal CT001 to intranasal sufentanil, intranasal ketamine or placebo for treatment of acute pain in adults undergoing surgical removal of an impacted mandibular third molar, where bone removal is judged to be needed.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	CT001	Intranasal
DRUG	Placebo	Intranasal
DRUG	Sufentanil	Intranasal
DRUG	Ketamine	Intranasal

Timeline

• Start date: 2022-09-05
• Primary completion: 2023-10-05
• Completion: 2023-10-05
• First posted: 2022-08-19
• Last updated: 2023-10-18

Locations

1 site across 1 country: Denmark