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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT001 | Experimental |
| |
| Placebo | Placebo Comparator |
| |
| Sufentanil 27 mcg | Active Comparator |
| |
| Ketamine 27 mg | Active Comparator |
| |
| Sufentanil 13 mcg | Active Comparator |
| |
| Ketamine 13 mg | Active Comparator |
| |
| Sufentanil 40 mcg | Active Comparator |
| |
| Ketamine 40 mg | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT001 | Drug | Intranasal |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Sum of pain intensity differences at 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 | To assess the relationship between analgesic efficacy and the plasma concentrations of intranasal sufentanil, intranasal ketamine and intranasal CT001. | 0-180 min |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Pain intensity difference (PIDmax) | 0-180 min | |
| Time to meaningful pain relief | Time when participants feel that the pain relief becomes meaningful to them | 0-180 min |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DanTrials | Copenhagen | NV | 2400 | Denmark |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D017409 | Sufentanil |
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D005283 | Fentanyl |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Sufentanil 13 mcg/Ketamine 13 mg | Active Comparator |
|
| Sufentanil 13 mcg/Ketamine 27 mg | Active Comparator |
|
| Sufentanil 13 mcg/Ketamine 40 mg | Active Comparator |
|
| Sufentanil 27 mcg/Ketamine 13 mg | Active Comparator |
|
| Sufentanil 27 mcg/Ketamine 40 mg | Active Comparator |
|
| Sufentanil 40 mcg/Ketamine 13 mg | Active Comparator |
|
| Sufentanil 40 mcg/Ketamine 27 mg | Active Comparator |
|
| Sufentanil 40 mcg/Ketamine 40 mg | Active Comparator |
|
| Drug |
Intranasal |
|
| Sufentanil | Drug | Intranasal |
|
| Ketamine | Drug | Intranasal |
|
| Sum of pain intensity differences at 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 | Number of participants receiving rescue medication | 0-180 min |
| Number of patients who are considered a responder/non-responder, 30% | 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% | 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 | 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 when participants feel that the pain relief becomes meaningful to them | 0-180 min |
| 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 | Change from baseline in Ramsay sedation score (1= agitated, anxious, restless, 6= unarousable) | 0-179 min |
| Median time to a request for rescue medication | 0-180 min |
| D003510 |
| Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |