Pain
Conditions
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.
Interventions
Sponsors
Cessatech A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Maximum Pain intensity difference (PIDmax) | 0-180 min | — |
| Time to meaningful 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 |
| 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 |
| Rescue medication | 0-180 min | Number of participants receiving rescue medication |
| Time to rescue medication | 0-180 min | — |
| Mean pain intensity difference (PID) from baseline at rest | 0-180 min | — |
| Mean pain intensity difference (PID) from baseline on jaw movement | 0-181 min | — |
| Ramsay sedation score | 0-179 min | Change from baseline in Ramsay sedation score (1= agitated, anxious, restless, 6= unarousable) |
| Median time to a request for rescue medication | 0-180 min | — |
| Time to perceptible pain relief | 0-180 min | Time when participants feel that the pain relief becomes meaningful to them |
| 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 |
Countries
Denmark
Outcome results
None listed