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

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.

Timeline

Start

2022-09-05

Primary completion

2023-10-05

Completion

2023-10-05

Outcome

Mixed primary results

release “The 0205 data demonstrated significant reduction in pain scale, and although superiority was not achieved for the sufentanil control arm in adults” cessatech.com ↗

release “the co-primary endpoint of preliminary modelled exposure-response data substantiates that CT001 is superior in children.” cessatech.com ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	CT001	Unknown	—	Intranasal
Comparator	Ketamine	Small molecule	13 mg	Intranasal
Comparator	Ketamine	Small molecule	27 mg	Intranasal
Comparator	Ketamine	Small molecule	40 mg	Intranasal
Comparator	Sufentanil	Other / unclassified	13 ug	Intranasal
Comparator	Sufentanil	Other / unclassified	27 ug	Intranasal
Comparator	Sufentanil	Other / unclassified	40 ug	Intranasal

Indications

No indication recorded.