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
1 other identifier
interventional
220
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 pain
Started Sep 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 17, 2022
CompletedFirst Posted
Study publicly available on registry
August 19, 2022
CompletedStudy Start
First participant enrolled
September 5, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 5, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 5, 2023
CompletedOctober 18, 2023
May 1, 2023
1.1 years
August 17, 2022
October 17, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (13)
Maximum Pain intensity difference (PIDmax)
0-180 min
Time to meaningful pain relief
0-180 min
Sum of pain intensity differences at 30 min
0-30 min
Rescue medication
0-180 min
Number of patients who are considered a responder/non-responder, 30%
0-30 min
- +8 more secondary outcomes
Study Arms (16)
CT001
EXPERIMENTALPlacebo
PLACEBO COMPARATORSufentanil 27 mcg
ACTIVE COMPARATORKetamine 27 mg
ACTIVE COMPARATORSufentanil 13 mcg
ACTIVE COMPARATORKetamine 13 mg
ACTIVE COMPARATORSufentanil 40 mcg
ACTIVE COMPARATORKetamine 40 mg
ACTIVE COMPARATORSufentanil 13 mcg/Ketamine 13 mg
ACTIVE COMPARATORSufentanil 13 mcg/Ketamine 27 mg
ACTIVE COMPARATORSufentanil 13 mcg/Ketamine 40 mg
ACTIVE COMPARATORSufentanil 27 mcg/Ketamine 13 mg
ACTIVE COMPARATORSufentanil 27 mcg/Ketamine 40 mg
ACTIVE COMPARATORSufentanil 40 mcg/Ketamine 13 mg
ACTIVE COMPARATORSufentanil 40 mcg/Ketamine 27 mg
ACTIVE COMPARATORSufentanil 40 mcg/Ketamine 40 mg
ACTIVE COMPARATORInterventions
Intranasal
Intranasal
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cessatech A/Slead
Study Sites (1)
DanTrials
Copenhagen, NV, 2400, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 17, 2022
First Posted
August 19, 2022
Study Start
September 5, 2022
Primary Completion
October 5, 2023
Study Completion
October 5, 2023
Last Updated
October 18, 2023
Record last verified: 2023-05