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

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ClinicalTrials.gov Identifier: NCT05508594
Recruitment Status : Recruiting
First Posted : August 19, 2022
Last Update Posted : November 17, 2022
Sponsor:
Information provided by (Responsible Party):
Cessatech A/S

Tracking Information
First Submitted Date  ICMJE August 17, 2022
First Posted Date  ICMJE August 19, 2022
Last Update Posted Date November 17, 2022
Actual Study Start Date  ICMJE September 5, 2022
Estimated Primary Completion Date April 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 18, 2022)
  • Sum of pain intensity differences at 55 min [ Time Frame: 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 [ Time Frame: 0-180 min ]
    To assess the relationship between analgesic efficacy and the plasma concentrations of intranasal sufentanil, intranasal ketamine and intranasal CT001.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 18, 2022)
  • Maximum Pain intensity difference (PIDmax) [ Time Frame: 0-180 min ]
  • Time to meaningful pain relief [ Time Frame: 0-180 min ]
    Time when participants feel that the pain relief becomes meaningful to them
  • Sum of pain intensity differences at 30 min [ Time Frame: 0-30 min ]
    Derived from pain intensity scores measured on the Numerical Rating Scale (0-10, 0= no pain, 10= worst possible
  • Rescue medication [ Time Frame: 0-180 min ]
    Number of participants receiving rescue medication
  • Number of patients who are considered a responder/non-responder, 30% [ Time Frame: 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% [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 0-180 min ]
    Time when participants feel that the pain relief becomes meaningful to them
  • Time to rescue medication [ Time Frame: 0-180 min ]
  • Mean pain intensity difference (PID) from baseline at rest [ Time Frame: 0-180 min ]
  • Mean pain intensity difference (PID) from baseline on jaw movement [ Time Frame: 0-181 min ]
  • Ramsay sedation score [ Time Frame: 0-179 min ]
    Change from baseline in Ramsay sedation score (1= agitated, anxious, restless, 6= unarousable)
  • Median time to a request for rescue medication [ Time Frame: 0-180 min ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Pharmacokinetic-Pharmacodynamic Relationship of Intranasally Administered Sufentanil, Ketamine, and CT001
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pain
Intervention  ICMJE
  • Drug: CT001
    Intranasal
  • Drug: Placebo
    Intranasal
  • Drug: Sufentanil
    Intranasal
  • Drug: Ketamine
    Intranasal
Study Arms  ICMJE
  • Experimental: CT001
    Intervention: Drug: CT001
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Active Comparator: Sufentanil 27 mcg
    Intervention: Drug: Sufentanil
  • Active Comparator: Ketamine 27 mg
    Intervention: Drug: Ketamine
  • Active Comparator: Sufentanil 13 mcg
    Intervention: Drug: Sufentanil
  • Active Comparator: Ketamine 13 mg
    Intervention: Drug: Ketamine
  • Active Comparator: Sufentanil 40 mcg
    Intervention: Drug: Sufentanil
  • Active Comparator: Ketamine 40 mg
    Intervention: Drug: Ketamine
  • Active Comparator: Sufentanil 13 mcg/Ketamine 13 mg
    Interventions:
    • Drug: Sufentanil
    • Drug: Ketamine
  • Active Comparator: Sufentanil 13 mcg/Ketamine 27 mg
    Interventions:
    • Drug: Sufentanil
    • Drug: Ketamine
  • Active Comparator: Sufentanil 13 mcg/Ketamine 40 mg
    Interventions:
    • Drug: Sufentanil
    • Drug: Ketamine
  • Active Comparator: Sufentanil 27 mcg/Ketamine 13 mg
    Interventions:
    • Drug: Sufentanil
    • Drug: Ketamine
  • Active Comparator: Sufentanil 27 mcg/Ketamine 40 mg
    Interventions:
    • Drug: Sufentanil
    • Drug: Ketamine
  • Active Comparator: Sufentanil 40 mcg/Ketamine 13 mg
    Interventions:
    • Drug: Sufentanil
    • Drug: Ketamine
  • Active Comparator: Sufentanil 40 mcg/Ketamine 27 mg
    Interventions:
    • Drug: Sufentanil
    • Drug: Ketamine
  • Active Comparator: Sufentanil 40 mcg/Ketamine 40 mg
    Interventions:
    • Drug: Sufentanil
    • Drug: Ketamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 18, 2022)
220
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2023
Estimated Primary Completion Date April 30, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jes Trygved +45 93872309 jes.trygved@cessatech.com
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05508594
Other Study ID Numbers  ICMJE PDC 01-0205
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Cessatech A/S
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Cessatech A/S
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Cessatech A/S
Verification Date November 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP