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

Sponsor

Cessatech A/S (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05508594

Collaborator

(none)

220

Enrollment

Location

Arms

5.3

Anticipated Duration (Months)

41.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain	Drug: CT001 Drug: Placebo Drug: Sufentanil Drug: Ketamine	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

220 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Aug 24, 2022

Anticipated Primary Completion Date :

Jan 31, 2023

Anticipated Study Completion Date :

Jan 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CT001	Drug: CT001 Intranasal
Placebo Comparator: Placebo	Drug: Placebo Intranasal
Active Comparator: Sufentanil 27 mcg	Drug: Sufentanil Intranasal
Active Comparator: Ketamine 27 mg	Drug: Ketamine Intranasal
Active Comparator: Sufentanil 13 mcg	Drug: Sufentanil Intranasal
Active Comparator: Ketamine 13 mg	Drug: Ketamine Intranasal
Active Comparator: Sufentanil 40 mcg	Drug: Sufentanil Intranasal
Active Comparator: Ketamine 40 mg	Drug: Ketamine Intranasal
Active Comparator: Sufentanil 13 mcg/Ketamine 13 mg	Drug: Sufentanil Intranasal Drug: Ketamine Intranasal
Active Comparator: Sufentanil 13 mcg/Ketamine 27 mg	Drug: Sufentanil Intranasal Drug: Ketamine Intranasal
Active Comparator: Sufentanil 13 mcg/Ketamine 40 mg	Drug: Sufentanil Intranasal Drug: Ketamine Intranasal
Active Comparator: Sufentanil 27 mcg/Ketamine 13 mg	Drug: Sufentanil Intranasal Drug: Ketamine Intranasal
Active Comparator: Sufentanil 27 mcg/Ketamine 40 mg	Drug: Sufentanil Intranasal Drug: Ketamine Intranasal
Active Comparator: Sufentanil 40 mcg/Ketamine 13 mg	Drug: Sufentanil Intranasal Drug: Ketamine Intranasal
Active Comparator: Sufentanil 40 mcg/Ketamine 27 mg	Drug: Sufentanil Intranasal Drug: Ketamine Intranasal
Active Comparator: Sufentanil 40 mcg/Ketamine 40 mg	Drug: Sufentanil Intranasal Drug: Ketamine Intranasal

Outcome Measures

Primary Outcome Measures

Sum of pain intensity differences at 55 min [0-55 min]
Derived from pain intensity scores measured by the Numerical Rating Scale (0-10, 0= no pain, 10= worst possible pain).
PK-PD relationship for analgesic efficacy IN sufentanil, IN ketamine and IN CT001 [0-180 min]
To assess the relationship between analgesic efficacy and the plasma concentrations of intranasal sufentanil, intranasal ketamine and intranasal CT001.

Secondary Outcome Measures

Maximum Pain intensity difference (PIDmax) [0-180 min]
Time to meaningful pain relief [0-180 min]
Time when participants feel that the pain relief becomes meaningful to them
Sum of pain intensity differences at 30 min [0-30 min]
Derived from pain intensity scores measured on the Numerical Rating Scale (0-10, 0= no pain, 10= worst possible
Rescue medication [0-180 min]
Number of participants receiving rescue medication
Number of patients who are considered a responder/non-responder, 30% [0-30 min]
Number of participants with at least 30% reduction in pain intensity score compared to baseline
Number of patients who are considered a responder/non-responder, 50% [0-30 min]
Participants with at least at least 50% reduction in pain intensity score compared to baseline
Sum of pain intensity differences at 90 min [0-90 min]
Derived from pain intensity scores measured on the Numerical Rating Scale (0-10, 0= no pain, 10= worst possible
Time to perceptible pain relief [0-180 min]
Time when participants feel that the pain relief becomes meaningful to them
Time to rescue medication [0-180 min]
Mean pain intensity difference (PID) from baseline at rest [0-180 min]
Mean pain intensity difference (PID) from baseline on jaw movement [0-181 min]
Ramsay sedation score [0-179 min]
Change from baseline in Ramsay sedation score (1= agitated, anxious, restless, 6= unarousable)
Median time to a request for rescue medication [0-180 min]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	DanTrials	Copenhagen		Denmark	2400

Sponsors and Collaborators

Cessatech A/S

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Cessatech A/S

ClinicalTrials.gov Identifier:

NCT05508594

Other Study ID Numbers:

PDC 01-0205

First Posted:

Aug 19, 2022

Last Update Posted:

Aug 19, 2022

Last Verified:

Aug 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Sufentanil

Ketamine

Study Results

No Results Posted as of Aug 19, 2022