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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05508594
• Other study ID #: PDC 01-0205
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: September 5, 2022
• Est. completion date: October 5, 2023

Study information

• Verified date: May 2023
• Source: Cessatech A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: October 5, 2023
• Est. primary completion date: October 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• CT001
Intranasal
• Placebo
Intranasal
• Sufentanil
Intranasal
• Ketamine
Intranasal

Locations

Country	Name	City	State
Denmark	DanTrials	Copenhagen	NV

Sponsors (1)

Lead Sponsor	Collaborator
Cessatech A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sum of pain intensity differences at 55 min	Derived from pain intensity scores measured by the Numerical Rating Scale (0-10, 0= no pain, 10= worst possible pain).	0-55 min
Primary	PK-PD relationship for analgesic efficacy IN sufentanil, IN ketamine and IN CT001	To assess the relationship between analgesic efficacy and the plasma concentrations of intranasal sufentanil, intranasal ketamine and intranasal CT001.	0-180 min
Secondary	Maximum Pain intensity difference (PIDmax)		0-180 min
Secondary	Time to meaningful pain relief	Time when participants feel that the pain relief becomes meaningful to them	0-180 min
Secondary	Sum of pain intensity differences at 30 min	Derived from pain intensity scores measured on the Numerical Rating Scale (0-10, 0= no pain, 10= worst possible	0-30 min
Secondary	Rescue medication	Number of participants receiving rescue medication	0-180 min
Secondary	Number of patients who are considered a responder/non-responder, 30%	Number of participants with at least 30% reduction in pain intensity score compared to baseline	0-30 min
Secondary	Number of patients who are considered a responder/non-responder, 50%	Participants with at least at least 50% reduction in pain intensity score compared to baseline	0-30 min
Secondary	Sum of pain intensity differences at 90 min	Derived from pain intensity scores measured on the Numerical Rating Scale (0-10, 0= no pain, 10= worst possible	0-90 min
Secondary	Time to perceptible pain relief	Time when participants feel that the pain relief becomes meaningful to them	0-180 min
Secondary	Time to rescue medication		0-180 min
Secondary	Mean pain intensity difference (PID) from baseline at rest		0-180 min
Secondary	Mean pain intensity difference (PID) from baseline on jaw movement		0-181 min
Secondary	Ramsay sedation score	Change from baseline in Ramsay sedation score (1= agitated, anxious, restless, 6= unarousable)	0-179 min
Secondary	Median time to a request for rescue medication		0-180 min