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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-05

Study Completion Date

2023-10-05

Brief Summary

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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.

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Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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CT001

Group Type EXPERIMENTAL

CT001

Intervention Type DRUG

Intranasal

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Intranasal

Sufentanil 27 mcg

Group Type ACTIVE_COMPARATOR

Sufentanil

Intervention Type DRUG

Intranasal

Ketamine 27 mg

Group Type ACTIVE_COMPARATOR

Ketamine

Intervention Type DRUG

Intranasal

Sufentanil 13 mcg

Group Type ACTIVE_COMPARATOR

Sufentanil

Intervention Type DRUG

Intranasal

Ketamine 13 mg

Group Type ACTIVE_COMPARATOR

Ketamine

Intervention Type DRUG

Intranasal

Sufentanil 40 mcg

Group Type ACTIVE_COMPARATOR

Sufentanil

Intervention Type DRUG

Intranasal

Ketamine 40 mg

Group Type ACTIVE_COMPARATOR

Ketamine

Intervention Type DRUG

Intranasal

Sufentanil 13 mcg/Ketamine 13 mg

Group Type ACTIVE_COMPARATOR

Sufentanil

Intervention Type DRUG

Intranasal

Ketamine

Intervention Type DRUG

Intranasal

Sufentanil 13 mcg/Ketamine 27 mg

Group Type ACTIVE_COMPARATOR

Sufentanil

Intervention Type DRUG

Intranasal

Ketamine

Intervention Type DRUG

Intranasal

Sufentanil 13 mcg/Ketamine 40 mg

Group Type ACTIVE_COMPARATOR

Sufentanil

Intervention Type DRUG

Intranasal

Ketamine

Intervention Type DRUG

Intranasal

Sufentanil 27 mcg/Ketamine 13 mg

Group Type ACTIVE_COMPARATOR

Sufentanil

Intervention Type DRUG

Intranasal

Ketamine

Intervention Type DRUG

Intranasal

Sufentanil 27 mcg/Ketamine 40 mg

Group Type ACTIVE_COMPARATOR

Sufentanil

Intervention Type DRUG

Intranasal

Ketamine

Intervention Type DRUG

Intranasal

Sufentanil 40 mcg/Ketamine 13 mg

Group Type ACTIVE_COMPARATOR

Sufentanil

Intervention Type DRUG

Intranasal

Ketamine

Intervention Type DRUG

Intranasal

Sufentanil 40 mcg/Ketamine 27 mg

Group Type ACTIVE_COMPARATOR

Sufentanil

Intervention Type DRUG

Intranasal

Ketamine

Intervention Type DRUG

Intranasal

Sufentanil 40 mcg/Ketamine 40 mg

Group Type ACTIVE_COMPARATOR

Sufentanil

Intervention Type DRUG

Intranasal

Ketamine

Intervention Type DRUG

Intranasal

Interventions

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CT001

Intranasal

Intervention Type DRUG

Placebo

Intranasal

Intervention Type DRUG

Sufentanil

Intranasal

Intervention Type DRUG

Ketamine

Intranasal

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No