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

• Status: Not yet recruiting
• Trial end date: 2023-01-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cessatech A/S
• Treatments: Ketamine; Sufentanil

Criteria

Inclusion Criteria:

• Healthy (The American Society of Anaesthesiologists' Physical Classification System (ASA) I-II) male or female participants scheduled for surgical removal of an impacted mandibular third molar, where bone removal is judged to be needed

• Age: ≥ 18 and < 56 years

• Body Mass index above (>)18.5 or below (<) 30.0 kg/m2

• Prior to randomisation: Numeric Pain Rating Scale (NRS anchored by 0 = "no pain", 10 = "worst pain imaginable") ≥ 5 at rest within 4 hours after the administration of the last dose of local anaesthetic

Exclusion Criteria:

• Current or history of any clinically significant disease or disorder, which, in the opinion of the investigator, may put the potential subject at risk when participating in the study, or influence the potential subject's ability to participate in the study or influence the study results.

• Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the administration of investigational product that is likely to introduce additional risk factors, jeopardize study integrity, or to interfere with the study assessments or procedure

• History of increased bleeding tendency

• Clinically significant mental illness

• Opioid Risk Tool score of >3

• Pain Catastrophizing Scale score, total points >30

• Hospital Anxiety and Depression Scale (HADS), points ≥ 11 for anxiety or ≥ 11 points for depression

• Daily intake of analgesics

• History of alcohol or drug abuse or use of illicit drugs or positive screen for drugs of abuse at screening or on admission to the Clinic prior to the administration of the investigational product.

• Abnormal nasal cavity/airway