Clinical trial NCT05508594: Efficacy and Pharmacokinetic-Pharmacodynamic Relationship of Intranasally Administered Sufentanil, Ketamine, and CT001
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Pain
Lead sponsor: Cessatech A/S
Sponsor class: INDUSTRY
First posted: 2022-08-19
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Sum of pain intensity differences at 55 min
timeFrame: 0-55 min
measure: PK-PD relationship for analgesic efficacy IN sufentanil, IN ketamine and IN CT001
timeFrame: 0-180 min
Secondary outcomes:
measure: Maximum Pain intensity difference (PIDmax)
timeFrame: 0-180 min
measure: Time to meaningful pain relief
timeFrame: 0-180 min
measure: Sum of pain intensity differences at 30 min
timeFrame: 0-30 min
measure: Rescue medication
timeFrame: 0-180 min
measure: Number of patients who are considered a responder/non-responder, 30%
timeFrame: 0-30 min
measure: Number of patients who are considered a responder/non-responder, 50%
timeFrame: 0-30 min
measure: Sum of pain intensity differences at 90 min
timeFrame: 0-90 min
measure: Time to perceptible pain relief
timeFrame: 0-180 min
measure: Time to rescue medication
timeFrame: 0-180 min
measure: Mean pain intensity difference (PID) from baseline at rest
timeFrame: 0-180 min
measure: Mean pain intensity difference (PID) from baseline on jaw movement
timeFrame: 0-181 min
measure: Ramsay sedation score
timeFrame: 0-179 min
measure: Median time to a request for rescue medication
timeFrame: 0-180 min
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: DanTrials
state: NV
Study officials:
References: