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

October 17, 2023 updated by: Cessatech A/S

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
220

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Denmark
    • NV
      • Copenhagen, NV, Denmark, 2400
        • DanTrials

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Placebo
Intranasal
Experimental: CT001
Drug: CT001
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
0-55 min
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.
0-180 min

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maximum Pain intensity difference (PIDmax)
Time Frame: 0-180 min
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
0-180 min
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
0-30 min
Rescue medication
Time Frame: 0-180 min
Number of participants receiving rescue medication
0-180 min
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
0-30 min
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
0-30 min
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
0-90 min
Time to perceptible pain relief
Time Frame: 0-180 min
Time when participants feel that the pain relief becomes meaningful to them
0-180 min
Time to rescue medication
Time Frame: 0-180 min
0-180 min
Mean pain intensity difference (PID) from baseline at rest
Time Frame: 0-180 min
0-180 min
Mean pain intensity difference (PID) from baseline on jaw movement
Time Frame: 0-181 min
0-181 min
Ramsay sedation score
Time Frame: 0-179 min
Change from baseline in Ramsay sedation score (1= agitated, anxious, restless, 6= unarousable)
0-179 min
Median time to a request for rescue medication
Time Frame: 0-180 min
0-180 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cessatech A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 5, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 5, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 5, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 17, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 19, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 18, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PDC 01-0205

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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