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    Clinical Trial Results:
    Analgesic Efficacy and Pharmacokinetic-pharmacodynamic Relationship of Intranasally Administered Sufentanil, Ketamine, and CT001 after Impacted Mandibular Third Molar Extraction

    Summary
    EudraCT number
    		 2021-003258-21
    Trial protocol
    		 DK  
    Global end of trial date
    05 Oct 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Nov 2024
    First version publication date
    29 Nov 2024
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    PDC-01-0205
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05508594
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Cessatech A/S
    Sponsor organisation address
    Strandvejen 60, Hellerup, Denmark, DK-2900
    Public contact
    CEO, Cessatech A/S, +45 93872309, info@cessatech.com
    Scientific contact
    CEO, Cessatech A/S, +45 93872309, info@cessatech.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001739-PIP02-16
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    03 Oct 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    05 Oct 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Oct 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    -To investigate the postoperative analgesic efficacy of intranasal sufentanil, intranasal ketamine and intranasal CT001, in adults following impacted mandibular third molar extraction. - To assess the relationship between analgesic efficacy and the plasma concentrations of intranasal sufentanil, intranasal ketamine and intranasal CT001.
    Protection of trial subjects
    The trial was conducted in accordance with the Declaration of Helsinki, adopted by the 18th World Medical Association (WMA) General Assembly, Helsinki, Finland, June 1964, and subsequent amendments and International Council for Harmonisation (ICH) guideline for Good Clinical Practice E6 (R2)(European Medicines Agency (EMA)/Committee for Medicinal Products for Human Use CHMP)/ICH/135/1995), including archiving of essential documents and the EU Clinical Trial Directive (CTD)2001/20/EC.
    Background therapy
    		 None
    Evidence for comparator
    		 Placebo is used as comparator.
    Actual start date of recruitment
    22 Aug 2023
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 220
    Worldwide total number of subjects
    220
    EEA total number of subjects
    220
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    220
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Study was conducted at a phase I unit in Denmark

    Pre-assignment
    Screening details
    		 Participants were referred to the phase I unit by dental clinics. The patients were randomised into the study if they reached a sufficient pain score within 5 hours after ending the dental procedure.

    Period 1
    Period 1 title
    Treatment period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    Both the test product and comparators were colourless aqueous solutions with no smell, manufactured in identical nasal spray devices. No taste masking of the active product ingredients was performed, since the IMPs was administered as a nasal spray. The test product, active comparators and placebo were supplied to the site in packages containing the appropriate strengths to perform dosing according to the allocated treatment group. PK samples were analysed by a cental laboratory.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Sufentanil/ketamine (40mcg/40mg)
    Arm description
    		 Participants received 2 doses of Sufentanil/ketamine (40mcg/40mg)-4 actuations of sufentanil/ketamine (9 mcg/9 mg) and 1 actuations of sufentanil/ketamine (4.5 mcg/4.5 mg) in both doses.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    CT001 (9mcg/9mg)
    Investigational medicinal product code
    CT001 (9mcg/9mg)
    Other name
    Pharmaceutical forms
    Nasal spray, solution
    Routes of administration
    Nasal use
    Dosage and administration details
    Dose 100 ul in alternating nostrils

    Investigational medicinal product name
    CT001 (4.5mcg/4.5mg)
    Investigational medicinal product code
    CT001 (4.5mcg/4.5mg)
    Other name
    Pharmaceutical forms
    Nasal spray, solution
    Routes of administration
    Nasal use
    Dosage and administration details
    Dose 50 ul in alternating nostrils

    Arm title
    		 sufentanil/ketamine (27 mcg/27 mg)
    Arm description
    		 Participants received 2 doses of Sufentanil/ketamine (27mcg/27mg)- 3 actuations of sufentanil/ketamine (9 mcg/9 mg) and 2 actuations of placebo 50ul in both doses.
    Arm type
    		 Experimental

    Investigational medicinal product name
    CT001 (9mcg/9mg)
    Investigational medicinal product code
    CT001 (9mcg/9mg)
    Other name
    Pharmaceutical forms
    Nasal spray, solution
    Routes of administration
    Nasal use
    Dosage and administration details
    Dose 100 ul in alternating nostrils

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Placebo
    Other name
    Pharmaceutical forms
    Nasal spray, solution
    Routes of administration
    Nasal use
    Dosage and administration details
    Dose 50 ul in alternating nostrils

    Arm title
    		 sufentanil/ketamine (13 mcg/13 mg)
    Arm description
    		 Participants received 2 doses of Sufentanil/ketamine (13mcg/13mg)- 1 actuations of sufentanil/ketamine (9 mcg/9 mg), 1 actuations of sufentanil/ketamine (4.5 mcg/4.5 mg) and 3 actuations of placebo 100ul in both doses.
    Arm type
    		 Experimental

    Investigational medicinal product name
    CT001 (9mcg/9mg)
    Investigational medicinal product code
    CT001 (9mcg/9mg)
    Other name
    Pharmaceutical forms
    Nasal spray, solution
    Routes of administration
    Nasal use
    Dosage and administration details
    Dose 100 ul in alternating nostrils

    Investigational medicinal product name
    CT001 (4.5mcg/4.5mg)
    Investigational medicinal product code
    CT001 (4.5mcg/4.5mg)
    Other name
    Pharmaceutical forms
    Nasal spray, solution
    Routes of administration
    Nasal use
    Dosage and administration details
    Dose 50 ul in alternating nostrils

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Placebo
    Other name
    Pharmaceutical forms
    Nasal spray, solution
    Routes of administration
    Nasal use
    Dosage and administration details
    Dose 50 or 100 ul in alternating nostrils

    Arm title
    		 sufentanil/ketamine (13 mcg/27 mg)
    Arm description
    		 Participants received 2 doses of Sufentanil/ketamine (13mcg/27mg)-1 actuations of sufentanil (9 mcg), 1 actuations of sufentanil (4.5 mcg) and 3 actuations of ketamin (9 mg) in both doses.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sufentanil (9mcg)
    Investigational medicinal product code
    Sufentanil (9mcg)
    Other name
    Pharmaceutical forms
    Nasal spray, solution
    Routes of administration
    Nasal use
    Dosage and administration details
    Dose 100 ul in alternating nostrils

    Investigational medicinal product name
    Sufentanil (4.5mcg)
    Investigational medicinal product code
    Sufentanil (4.5mcg)
    Other name
    Pharmaceutical forms
    Nasal spray, solution
    Routes of administration
    Nasal use
    Dosage and administration details
    Dose 50 ul in alternating nostrils

    Investigational medicinal product name
    Ketamin (9mg)
    Investigational medicinal product code
    Ketamin (9mg)
    Other name
    Pharmaceutical forms
    Nasal spray, solution
    Routes of administration
    Nasal use
    Dosage and administration details
    Dose 100 ul in alternating nostrils

    Arm title
    		 sufentanil/ketamine (13 mcg/40 mg)
    Arm description
    		 Participants received 2 doses of Sufentanil/ketamine (13mcg/40mg)-1 actuations of sufentanil/ketamin (9 mcg/9mg), 1 actuations of sufentanil/ketamin (4.5 mcg/4.5 mg) and 3 actuations of ketamin (9 mg) in both doses.
    Arm type
    		 Experimental

    Investigational medicinal product name
    CT001 (9mcg/9mg)
    Investigational medicinal product code
    CT001 (9mcg/9mg)
    Other name
    Pharmaceutical forms
    Nasal spray, solution
    Routes of administration
    Nasal use
    Dosage and administration details
    Dose 100 ul in alternating nostrils

    Investigational medicinal product name
    CT001 (4.5mcg/4.5mg)
    Investigational medicinal product code
    CT001 (4.5mcg/4.5mg)
    Other name
    Pharmaceutical forms
    Nasal spray, solution
    Routes of administration
    Nasal use
    Dosage and administration details
    Dose 50 ul in alternating nostrils

    Investigational medicinal product name
    Ketamin (9mg)
    Investigational medicinal product code
    Ketamin (9mg)
    Other name
    Pharmaceutical forms
    Nasal spray, solution
    Routes of administration
    Nasal use
    Dosage and administration details
    Dose 100 ul in alternating nostrils

    Arm title
    		 sufentanil/ketamine (27 mcg/13 mg)
    Arm description
    		 Participants received 2 doses of Sufentanil/ketamine (27 mcg/13mg)-3 actuations of sufentanil (9 mcg), 1 actuations of ketamin (9 mg) and 1 actuations of ketamin (4.5 mcg) in both doses.
    Arm type
    		 Experimental

    Investigational medicinal product name
    CT001 (9mcg/9mg)
    Investigational medicinal product code
    CT001 (9mcg/9mg)
    Other name
    Pharmaceutical forms
    Nasal spray, solution
    Routes of administration
    Nasal use
    Dosage and administration details
    Dose 100 ul in alternating nostrils

    Investigational medicinal product name
    CT001 (4.5mcg/4.5mg)
    Investigational medicinal product code
    CT001 (4.5mcg/4.5mg)
    Other name
    Pharmaceutical forms
    Nasal spray, solution
    Routes of administration
    Nasal use
    Dosage and administration details
    Dose 50 ul in alternating nostrils

    Investigational medicinal product name
    Sufentanil (9mcg)
    Investigational medicinal product code
    Sufentanil (9mcg)
    Other name
    Pharmaceutical forms
    Nasal spray, solution
    Routes of administration
    Nasal use
    Dosage and administration details
    Dose 100 ul in alternating nostrils

    Arm title
    		 sufentanil/ketamine (27 mcg/40 mg)
    Arm description
    		 Participants received 2 doses of Sufentanil/ketamine (27mcg/40mg)-3 actuations of sufentanil/ketamin (9 mcg/9mg), 1 actuations of sufentanil (9 mcg) and 1 actuations of sufentanil (4.5 mcg) in both doses.
    Arm type
    		 Experimental

    Investigational medicinal product name
    CT001 (9mcg/9mg)
    Investigational medicinal product code
    CT001 (9mcg/9mg)
    Other name
    Pharmaceutical forms
    Nasal spray, solution
    Routes of administration
    Nasal use
    Dosage and administration details
    Dose 100 ul in alternating nostrils

    Investigational medicinal product name
    Sufentanil (9mcg)
    Investigational medicinal product code
    Sufentanil (9mcg)
    Other name
    Pharmaceutical forms
    Nasal spray, solution
    Routes of administration
    Nasal use
    Dosage and administration details
    Dose 100 ul in alternating nostrils

    Investigational medicinal product name
    Sufentanil (4.5mcg)
    Investigational medicinal product code
    Sufentanil (4.5mcg)
    Other name
    Pharmaceutical forms
    Nasal spray, solution
    Routes of administration
    Nasal use
    Dosage and administration details
    Dose 50 ul in alternating nostrils

    Arm title
    		 Sufentnail (40 mcg)
    Arm description
    		 Participants received 2 doses of Sufentanil (40mcg)-4 actuations of sufentanil (9 mcg) and 1 sufentanil (4.5 mcg) in both doses.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sufentanil (9mcg)
    Investigational medicinal product code
    Sufentanil (9mcg)
    Other name
    Pharmaceutical forms
    Nasal spray, solution
    Routes of administration
    Nasal use
    Dosage and administration details
    Dose 100 ul in alternating nostrils

    Investigational medicinal product name
    Sufentanil (4.5mcg)
    Investigational medicinal product code
    Sufentanil (4.5mcg)
    Other name
    Pharmaceutical forms
    Nasal spray, solution
    Routes of administration
    Nasal use
    Dosage and administration details
    Dose 50 ul in alternating nostrils

    Arm title
    		 Sufentanil (27 mcg)
    Arm description
    		 Participants received 2 doses of Sufentanil (27mcg)-3 actuations of sufentanil (9 mcg/9 mg) and 2 actuations of placebo 50ul in both doses.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sufentanil (9mcg)
    Investigational medicinal product code
    Sufentanil (9mcg)
    Other name
    Pharmaceutical forms
    Nasal spray, solution
    Routes of administration
    Nasal use
    Dosage and administration details
    Dose 100 ul in alternating nostrils

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Placebo
    Other name
    Pharmaceutical forms
    Nasal spray, solution
    Routes of administration
    Nasal use
    Dosage and administration details
    Dose 50 or 100 ul in alternating nostrils

    Arm title
    		 Sufentanil (13 mcg)
    Arm description
    		 Participants received 2 doses of Sufentanil (13 mcg)-3 actuations of sufentanil/ketamine (9 mcg/9 mg) and 2 actuations of placebo 50ul in both doses.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sufentanil (9mcg)
    Investigational medicinal product code
    Sufentanil (9mcg)
    Other name
    Pharmaceutical forms
    Nasal spray, solution
    Routes of administration
    Nasal use
    Dosage and administration details
    Dose 100 ul in alternating nostrils

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Placebo
    Other name
    Pharmaceutical forms
    Nasal spray, solution
    Routes of administration
    Nasal use
    Dosage and administration details
    Dose 50 or 100 ul in alternating nostrils

    Arm title
    		 Ketamin (40 mg)
    Arm description
    		 Participants received 2 doses of Ketamine (40mg)-3 actuations of ketamine (9 mg) and 2 actuations of placebo 50ul in both doses.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ketamin (9mg)
    Investigational medicinal product code
    Ketamin (9mg)
    Other name
    Pharmaceutical forms
    Nasal spray, solution
    Routes of administration
    Nasal use
    Dosage and administration details
    Dose 100 ul in alternating nostrils

    Investigational medicinal product name
    Ketamin (4.5mg)
    Investigational medicinal product code
    Ketamin (4.5mg)
    Other name
    Pharmaceutical forms
    Nasal spray, solution
    Routes of administration
    Nasal use
    Dosage and administration details
    Dose 50 ul in alternating nostrils

    Arm title
    		 Ketamin (27 mg)
    Arm description
    		 Participants received 2 doses of Ketamine (27 mg)-3 actuations of ketamin (9 mg) and 2 actuations of placebo 50ul in both doses.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ketamin (9mg)
    Investigational medicinal product code
    Ketamin (9mg)
    Other name
    Pharmaceutical forms
    Nasal spray, solution
    Routes of administration
    Nasal use
    Dosage and administration details
    Dose 100 ul in alternating nostrils

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Placebo
    Other name
    Pharmaceutical forms
    Nasal spray, solution
    Routes of administration
    Nasal use
    Dosage and administration details
    Dose 50 or 100 ul in alternating nostrils

    Arm title
    		 Ketamin (13 mg)
    Arm description
    		 Participants received 2 doses of Ketamine (13 mg)-3 actuations of sufentanil/ketamine (9 mcg/9 mg) and 2 actuations of placebo 50ul in both doses.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ketamin (9mg)
    Investigational medicinal product code
    Ketamin (9mg)
    Other name
    Pharmaceutical forms
    Nasal spray, solution
    Routes of administration
    Nasal use
    Dosage and administration details
    Dose 100 ul in alternating nostrils

    Investigational medicinal product name
    Ketamin (4.5mg)
    Investigational medicinal product code
    Ketamin (4.5mg)
    Other name
    Pharmaceutical forms
    Nasal spray, solution
    Routes of administration
    Nasal use
    Dosage and administration details
    Dose 50 ul in alternating nostrils

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Placebo
    Other name
    Pharmaceutical forms
    Nasal spray, solution
    Routes of administration
    Nasal use
    Dosage and administration details
    Dose 50 or 100 ul in alternating nostrils

    Arm title
    		 Placebo
    Arm description
    		 Participants received 2 doses of Placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Placebo
    Other name
    Pharmaceutical forms
    Nasal spray, solution
    Routes of administration
    Nasal use
    Dosage and administration details
    Dose 50 or 100 ul in alternating nostrils

    Arm title
    		 sufentanil/ketamine (40 mcg/13 mg)
    Arm description
    		 Participants received 2 doses of Sufentanil/ketamine (40mcg/13 mg)-1 actuations of sufentanil/ketamine (9 mcg/9 mg), 1 actuations of sufentanil/ketamine (4.5 mcg/4.5 mg) and 1 actuations of sufentanil (9 mcg) in both doses.
    Arm type
    		 Experimental

    Investigational medicinal product name
    CT001 (9mcg/9mg)
    Investigational medicinal product code
    CT001 (9mcg/9mg)
    Other name
    Pharmaceutical forms
    Nasal spray, solution
    Routes of administration
    Nasal use
    Dosage and administration details
    Dose 100 ul in alternating nostrils

    Investigational medicinal product name
    CT001 (4.5mcg/4.5mg)
    Investigational medicinal product code
    CT001 (4.5mcg/4.5mg)
    Other name
    Pharmaceutical forms
    Nasal spray, solution
    Routes of administration
    Nasal use
    Dosage and administration details
    Dose 50 ul in alternating nostrils

    Investigational medicinal product name
    Sufentanil (9mcg)
    Investigational medicinal product code
    Sufentanil (9mcg)
    Other name
    Pharmaceutical forms
    Nasal spray, solution
    Routes of administration
    Nasal use
    Dosage and administration details
    Dose 100 ul in alternating nostrils

    Arm title
    		 sufentanil/ketamine (40 mcg/27 mg)
    Arm description
    		 Participants received 2 doses of Sufentanil/ketamine (40mcg/27mg)-3 actuations of sufentanil/ketamine (9 mcg/9 mg) and 1 actuations sufentanil (9 mcg) and sufentanil (4.5 mcg) in both doses.
    Arm type
    		 Experimental

    Investigational medicinal product name
    CT001 (9mcg/9mg)
    Investigational medicinal product code
    CT001 (9mcg/9mg)
    Other name
    Pharmaceutical forms
    Nasal spray, solution
    Routes of administration
    Nasal use
    Dosage and administration details
    Dose 100 ul in alternating nostrils

    Investigational medicinal product name
    Sufentanil (9mcg)
    Investigational medicinal product code
    Sufentanil (9mcg)
    Other name
    Pharmaceutical forms
    Nasal spray, solution
    Routes of administration
    Nasal use
    Dosage and administration details
    Dose 100 ul in alternating nostrils

    Investigational medicinal product name
    Sufentanil (4.5mcg)
    Investigational medicinal product code
    Sufentanil (4.5mcg)
    Other name
    Pharmaceutical forms
    Nasal spray, solution
    Routes of administration
    Nasal use
    Dosage and administration details
    Dose 50 ul in alternating nostrils

    Number of subjects in period 1
    		Sufentanil/ketamine (40mcg/40mg) sufentanil/ketamine (27 mcg/27 mg) sufentanil/ketamine (13 mcg/13 mg) sufentanil/ketamine (13 mcg/27 mg) sufentanil/ketamine (13 mcg/40 mg) sufentanil/ketamine (27 mcg/13 mg) sufentanil/ketamine (27 mcg/40 mg) Sufentnail (40 mcg) Sufentanil (27 mcg) Sufentanil (13 mcg) Ketamin (40 mg) Ketamin (27 mg) Ketamin (13 mg) Placebo sufentanil/ketamine (40 mcg/13 mg) sufentanil/ketamine (40 mcg/27 mg)
    Started
    5
    40
    5
    5
    5
    5
    5
    5
    40
    5
    5
    40
    5
    40
    5
    5
    Completed
    5
    40
    5
    5
    5
    5
    5
    5
    40
    5
    5
    40
    5
    40
    5
    5

    Baseline characteristics

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    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Sufentanil/ketamine (40mcg/40mg)
    Reporting group description
    		 Participants received 2 doses of Sufentanil/ketamine (40mcg/40mg)-4 actuations of sufentanil/ketamine (9 mcg/9 mg) and 1 actuations of sufentanil/ketamine (4.5 mcg/4.5 mg) in both doses.

    Reporting group title
    sufentanil/ketamine (27 mcg/27 mg)
    Reporting group description
    		 Participants received 2 doses of Sufentanil/ketamine (27mcg/27mg)- 3 actuations of sufentanil/ketamine (9 mcg/9 mg) and 2 actuations of placebo 50ul in both doses.

    Reporting group title
    sufentanil/ketamine (13 mcg/13 mg)
    Reporting group description
    		 Participants received 2 doses of Sufentanil/ketamine (13mcg/13mg)- 1 actuations of sufentanil/ketamine (9 mcg/9 mg), 1 actuations of sufentanil/ketamine (4.5 mcg/4.5 mg) and 3 actuations of placebo 100ul in both doses.

    Reporting group title
    sufentanil/ketamine (13 mcg/27 mg)
    Reporting group description
    		 Participants received 2 doses of Sufentanil/ketamine (13mcg/27mg)-1 actuations of sufentanil (9 mcg), 1 actuations of sufentanil (4.5 mcg) and 3 actuations of ketamin (9 mg) in both doses.

    Reporting group title
    sufentanil/ketamine (13 mcg/40 mg)
    Reporting group description
    		 Participants received 2 doses of Sufentanil/ketamine (13mcg/40mg)-1 actuations of sufentanil/ketamin (9 mcg/9mg), 1 actuations of sufentanil/ketamin (4.5 mcg/4.5 mg) and 3 actuations of ketamin (9 mg) in both doses.

    Reporting group title
    sufentanil/ketamine (27 mcg/13 mg)
    Reporting group description
    		 Participants received 2 doses of Sufentanil/ketamine (27 mcg/13mg)-3 actuations of sufentanil (9 mcg), 1 actuations of ketamin (9 mg) and 1 actuations of ketamin (4.5 mcg) in both doses.

    Reporting group title
    sufentanil/ketamine (27 mcg/40 mg)
    Reporting group description
    		 Participants received 2 doses of Sufentanil/ketamine (27mcg/40mg)-3 actuations of sufentanil/ketamin (9 mcg/9mg), 1 actuations of sufentanil (9 mcg) and 1 actuations of sufentanil (4.5 mcg) in both doses.

    Reporting group title
    Sufentnail (40 mcg)
    Reporting group description
    		 Participants received 2 doses of Sufentanil (40mcg)-4 actuations of sufentanil (9 mcg) and 1 sufentanil (4.5 mcg) in both doses.

    Reporting group title
    Sufentanil (27 mcg)
    Reporting group description
    		 Participants received 2 doses of Sufentanil (27mcg)-3 actuations of sufentanil (9 mcg/9 mg) and 2 actuations of placebo 50ul in both doses.

    Reporting group title
    Sufentanil (13 mcg)
    Reporting group description
    		 Participants received 2 doses of Sufentanil (13 mcg)-3 actuations of sufentanil/ketamine (9 mcg/9 mg) and 2 actuations of placebo 50ul in both doses.

    Reporting group title
    Ketamin (40 mg)
    Reporting group description
    		 Participants received 2 doses of Ketamine (40mg)-3 actuations of ketamine (9 mg) and 2 actuations of placebo 50ul in both doses.

    Reporting group title
    Ketamin (27 mg)
    Reporting group description
    		 Participants received 2 doses of Ketamine (27 mg)-3 actuations of ketamin (9 mg) and 2 actuations of placebo 50ul in both doses.

    Reporting group title
    Ketamin (13 mg)
    Reporting group description
    		 Participants received 2 doses of Ketamine (13 mg)-3 actuations of sufentanil/ketamine (9 mcg/9 mg) and 2 actuations of placebo 50ul in both doses.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received 2 doses of Placebo

    Reporting group title
    sufentanil/ketamine (40 mcg/13 mg)
    Reporting group description
    		 Participants received 2 doses of Sufentanil/ketamine (40mcg/13 mg)-1 actuations of sufentanil/ketamine (9 mcg/9 mg), 1 actuations of sufentanil/ketamine (4.5 mcg/4.5 mg) and 1 actuations of sufentanil (9 mcg) in both doses.

    Reporting group title
    sufentanil/ketamine (40 mcg/27 mg)
    Reporting group description
    		 Participants received 2 doses of Sufentanil/ketamine (40mcg/27mg)-3 actuations of sufentanil/ketamine (9 mcg/9 mg) and 1 actuations sufentanil (9 mcg) and sufentanil (4.5 mcg) in both doses.

    Subject analysis set title
    Safety Population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety Population includes all randomised participants who received at least one dose of study treatment. Participants will be analysed according to the study treatment received, where treatment received is defined as the first study medication received.

    Primary: Primary Endpoint - Sum pain intensity difference (SPID) at 55 min

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    End point title
    		 Primary Endpoint - Sum pain intensity difference (SPID) at 55 min [1]
    End point description
    Sum of Pain intensity difference (SPID) at 55 min
    End point type
    Primary
    End point timeframe
    Measure at 55 min after 1st dose
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Not all arms were included in the analysis of the primary endpoint
    End point values
    		 sufentanil/ketamine (27 mcg/27 mg) Sufentanil (27 mcg) Ketamin (27 mg) Placebo
    Number of subjects analysed
    40
    40
    40
    40 [2]
    Units: SPID
        least squares mean (confidence interval 95%)
    -13.59 (-16.58 to -10.60)
    -17.20 (-20.19 to -14.21)
    -5.90 (-8.90 to -2.90)
    -1.00 (-4.11 to 2.10)
    Notes
    [2] - 40
    Statistical analysis title
    		 Primary endpoint
    Comparison groups
    Placebo v sufentanil/ketamine (27 mcg/27 mg)
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -12.59
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -16.89
         upper limit
    		 -8.28
    Statistical analysis title
    		 Primary endpoint
    Comparison groups
    sufentanil/ketamine (27 mcg/27 mg) v Ketamin (27 mg)
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -7.69
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.92
         upper limit
    		 -3.46
    Statistical analysis title
    		 Primary endpoint
    Comparison groups
    sufentanil/ketamine (27 mcg/27 mg) v Sufentanil (27 mcg)
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.094
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    3.61
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.62
         upper limit
    		 7.84

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment emergent adverse events were collected in the study. Collection period from first dose until visit 4 (Day 10 to 14).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    CT001 (sufentanil/ketmain 27 mcg/27 mg)
    Reporting group description
    		 Sufentanil/ketamin (27mcg/27mg)

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    Ketamin (27 mg)
    Reporting group description
    		 -

    Reporting group title
    Sufentanil (27 mcg)
    Reporting group description
    		 -

    Reporting group title
    Other Ketamin groups
    Reporting group description
    		 -

    Reporting group title
    Other Sufentanil groups
    Reporting group description
    		 -

    Reporting group title
    Other Sufentanil/ketamin groups
    Reporting group description
    		 -

    Serious adverse events
    		 CT001 (sufentanil/ketmain 27 mcg/27 mg) Placebo Ketamin (27 mg) Sufentanil (27 mcg) Other Ketamin groups Other Sufentanil groups Other Sufentanil/ketamin groups
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 40 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Post procedural haemorrhage
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Sepsis
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 CT001 (sufentanil/ketmain 27 mcg/27 mg) Placebo Ketamin (27 mg) Sufentanil (27 mcg) Other Ketamin groups Other Sufentanil groups Other Sufentanil/ketamin groups
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    36 / 40 (90.00%)
    22 / 40 (55.00%)
    33 / 40 (82.50%)
    38 / 40 (95.00%)
    5 / 10 (50.00%)
    9 / 10 (90.00%)
    35 / 40 (87.50%)
    Injury, poisoning and procedural complications
    Procedural pain
         subjects affected / exposed
    8 / 40 (20.00%)
    9 / 40 (22.50%)
    9 / 40 (22.50%)
    16 / 40 (40.00%)
    1 / 10 (10.00%)
    3 / 10 (30.00%)
    10 / 40 (25.00%)
         occurrences all number
    8
    9
    9
    16
    1
    3
    10
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    2 / 40 (5.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    24 / 40 (60.00%)
    3 / 40 (7.50%)
    20 / 40 (50.00%)
    33 / 40 (82.50%)
    1 / 10 (10.00%)
    5 / 10 (50.00%)
    23 / 40 (57.50%)
         occurrences all number
    31
    9
    21
    39
    1
    6
    27
    Headache
         subjects affected / exposed
    5 / 40 (12.50%)
    4 / 40 (10.00%)
    3 / 40 (7.50%)
    3 / 40 (7.50%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    4 / 40 (10.00%)
         occurrences all number
    5
    4
    3
    3
    1
    0
    4
    Paraesthesia
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    2 / 40 (5.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    2
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    18 / 40 (45.00%)
    4 / 40 (10.00%)
    8 / 40 (20.00%)
    25 / 40 (62.50%)
    0 / 10 (0.00%)
    4 / 10 (40.00%)
    22 / 40 (55.00%)
         occurrences all number
    19
    4
    8
    26
    0
    4
    23
    Feeling abnormal
         subjects affected / exposed
    10 / 40 (25.00%)
    0 / 40 (0.00%)
    4 / 40 (10.00%)
    6 / 40 (15.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    8 / 40 (20.00%)
         occurrences all number
    10
    0
    4
    6
    0
    1
    8
    Ear and labyrinth disorders
    Ear discomfort
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    2 / 40 (5.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    2 / 40 (5.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    2
    Eye disorders
    Vision blurred
         subjects affected / exposed
    2 / 40 (5.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    2
    0
    1
    0
    0
    0
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    20 / 40 (50.00%)
    1 / 40 (2.50%)
    3 / 40 (7.50%)
    26 / 40 (65.00%)
    2 / 10 (20.00%)
    5 / 10 (50.00%)
    17 / 40 (42.50%)
         occurrences all number
    23
    1
    3
    30
    2
    5
    18
    Vomiting
         subjects affected / exposed
    4 / 40 (10.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    8 / 40 (20.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    9 / 40 (22.50%)
         occurrences all number
    5
    0
    0
    12
    0
    0
    10
    Skin and subcutaneous tissue disorders
    Hyperhidrosis
         subjects affected / exposed
    3 / 40 (7.50%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    2 / 40 (5.00%)
         occurrences all number
    3
    0
    1
    0
    0
    0
    2
    Pruritus
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    2 / 40 (5.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    0
    Infections and infestations
    Post procedural infection
         subjects affected / exposed
    1 / 40 (2.50%)
    1 / 40 (2.50%)
    1 / 40 (2.50%)
    4 / 40 (10.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    3 / 40 (7.50%)
         occurrences all number
    1
    1
    1
    4
    0
    1
    3
    Pharyngitis
         subjects affected / exposed
    0 / 40 (0.00%)
    2 / 40 (5.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None
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