Efficacy and Pharmacokinetic-Pharmacodynamic Relationship of Intranasally Administered Sufentanil, Ketamine, and CT001
- Registration Number
- NCT05508594
- Lead Sponsor
- Cessatech A/S
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 220
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sufentanil 13 mcg/Ketamine 40 mg Ketamine - Sufentanil 40 mcg/Ketamine 40 mg Ketamine - Sufentanil 40 mcg/Ketamine 13 mg Ketamine - CT001 CT001 - Placebo Placebo - Sufentanil 27 mcg Sufentanil - Sufentanil 40 mcg/Ketamine 27 mg Ketamine - Ketamine 27 mg Ketamine - Sufentanil 13 mcg Sufentanil - Ketamine 40 mg Ketamine - Ketamine 13 mg Ketamine - Sufentanil 40 mcg Sufentanil - Sufentanil 13 mcg/Ketamine 13 mg Sufentanil - Sufentanil 13 mcg/Ketamine 13 mg Ketamine - Sufentanil 13 mcg/Ketamine 27 mg Sufentanil - Sufentanil 13 mcg/Ketamine 27 mg Ketamine - Sufentanil 27 mcg/Ketamine 13 mg Sufentanil - Sufentanil 13 mcg/Ketamine 40 mg Sufentanil - Sufentanil 27 mcg/Ketamine 13 mg Ketamine - Sufentanil 27 mcg/Ketamine 40 mg Sufentanil - Sufentanil 27 mcg/Ketamine 40 mg Ketamine - Sufentanil 40 mcg/Ketamine 13 mg Sufentanil - Sufentanil 40 mcg/Ketamine 27 mg Sufentanil - Sufentanil 40 mcg/Ketamine 40 mg Sufentanil -
- Primary Outcome Measures
Name Time Method Sum of pain intensity differences at 55 min 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 0-180 min To assess the relationship between analgesic efficacy and the plasma concentrations of intranasal sufentanil, intranasal ketamine and intranasal CT001.
- Secondary Outcome Measures
Name Time Method Time to meaningful pain relief 0-180 min Time when participants feel that the pain relief becomes meaningful to them
Maximum Pain intensity difference (PIDmax) 0-180 min Time to rescue medication 0-180 min Sum of pain intensity differences at 30 min 0-30 min Derived from pain intensity scores measured on the Numerical Rating Scale (0-10, 0= no pain, 10= worst possible
Mean pain intensity difference (PID) from baseline at rest 0-180 min Median time to a request for rescue medication 0-180 min Rescue medication 0-180 min Number of participants receiving rescue medication
Sum of pain intensity differences at 90 min 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 0-180 min Time when participants feel that the pain relief becomes meaningful to them
Number of patients who are considered a responder/non-responder, 30% 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% 0-30 min Participants with at least at least 50% reduction in pain intensity score compared to baseline
Ramsay sedation score 0-179 min Change from baseline in Ramsay sedation score (1= agitated, anxious, restless, 6= unarousable)
Mean pain intensity difference (PID) from baseline on jaw movement 0-181 min
Trial Locations
- Locations (1)
DanTrials
🇩🇰Copenhagen, NV, Denmark