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

Cessatech

Status and phase: Completed; Phase 3; Phase 2

Conditions: Pain

Treatments: Drug: Placebo; Drug: Sufentanil; Drug: CT001; Drug: Ketamine

Study type: Interventional

Funder types: Industry

Identifiers

NCT05508594

PDC 01-0205

Details and patient eligibility

About

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.

Enrollment: 220 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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220 participants in 16 patient groups, including a placebo group

CT001

Experimental group

Treatment:

Drug: CT001

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Sufentanil 27 mcg

Active Comparator group

Treatment:

Drug: Sufentanil

Ketamine 27 mg

Active Comparator group

Treatment:

Drug: Ketamine

Sufentanil 13 mcg

Active Comparator group

Treatment:

Drug: Sufentanil

Ketamine 13 mg

Active Comparator group

Treatment:

Drug: Ketamine

Sufentanil 40 mcg

Active Comparator group

Treatment:

Drug: Sufentanil

Ketamine 40 mg

Active Comparator group

Treatment:

Drug: Ketamine

Sufentanil 13 mcg/Ketamine 13 mg

Active Comparator group

Treatment:

Drug: Sufentanil

Drug: Ketamine

Sufentanil 13 mcg/Ketamine 27 mg

Active Comparator group

Treatment:

Drug: Sufentanil

Drug: Ketamine

Sufentanil 13 mcg/Ketamine 40 mg

Active Comparator group

Treatment:

Drug: Sufentanil

Drug: Ketamine

Sufentanil 27 mcg/Ketamine 13 mg

Active Comparator group

Treatment:

Drug: Sufentanil

Drug: Ketamine

Sufentanil 27 mcg/Ketamine 40 mg

Active Comparator group

Treatment:

Drug: Sufentanil

Drug: Ketamine

Sufentanil 40 mcg/Ketamine 13 mg

Active Comparator group

Treatment:

Drug: Sufentanil

Drug: Ketamine

Sufentanil 40 mcg/Ketamine 27 mg

Active Comparator group

Treatment:

Drug: Sufentanil

Drug: Ketamine

Sufentanil 40 mcg/Ketamine 40 mg

Active Comparator group

Treatment:

Drug: Sufentanil

Drug: Ketamine