PainPhase 2/3NCT05508594
Efficacy and Pharmacokinetic-Pharmacodynamic Relationship of Intranasally Administered Sufentanil, Ketamine, and CT001
A Phase 2/3 study testing CT001, Sufentanil and Ketamine in people with Pain, run by Cessatech A/S at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Pain
- What is being tested?
- CT001, Sufentanil and Ketamine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 1 siteDenmark
- Study dates
- 5 Sep 2022to 5 Oct 2023
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT001Drug
Intranasal
PlaceboDrug
Intranasal
SufentanilDrug
Intranasal
KetamineDrug
Intranasal
| Study group | Role | What they receive |
|---|---|---|
| CT001 | Experimental | Not described Receives: Drug: CT001 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Sufentanil 27 mcg | Active comparator | Not described Receives: Drug: Sufentanil |
| Ketamine 27 mg | Active comparator | Not described Receives: Drug: Ketamine |
| Sufentanil 13 mcg | Active comparator | Not described Receives: Drug: Sufentanil |
| Ketamine 13 mg | Active comparator | Not described Receives: Drug: Ketamine |
| Sufentanil 40 mcg | Active comparator | Not described Receives: Drug: Sufentanil |
| Ketamine 40 mg | Active comparator | Not described Receives: Drug: Ketamine |
| Sufentanil 13 mcg/Ketamine 13 mg | Active comparator | Not described Receives: Drug: Sufentanil; Drug: Ketamine |
| Sufentanil 13 mcg/Ketamine 27 mg | Active comparator | Not described Receives: Drug: Sufentanil; Drug: Ketamine |
| Sufentanil 13 mcg/Ketamine 40 mg | Active comparator | Not described Receives: Drug: Sufentanil; Drug: Ketamine |
| Sufentanil 27 mcg/Ketamine 13 mg | Active comparator | Not described Receives: Drug: Sufentanil; Drug: Ketamine |
| Sufentanil 27 mcg/Ketamine 40 mg | Active comparator | Not described Receives: Drug: Sufentanil; Drug: Ketamine |
| Sufentanil 40 mcg/Ketamine 13 mg | Active comparator | Not described Receives: Drug: Sufentanil; Drug: Ketamine |
| Sufentanil 40 mcg/Ketamine 27 mg | Active comparator | Not described Receives: Drug: Sufentanil; Drug: Ketamine |
| Sufentanil 40 mcg/Ketamine 40 mg | Active comparator | Not described Receives: Drug: Sufentanil; Drug: Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 0-180 min
Secondary outcomes (13)
Maximum Pain intensity difference (PIDmax)
Measured: 0-180 min
Time to meaningful pain relief
Time when participants feel that the pain relief becomes meaningful to them
Measured: 0-180 min
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
Measured: 0-30 min
Rescue medication
Number of participants receiving rescue medication
Measured: 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
Measured: 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
Measured: 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
Measured: 0-90 min
Time to perceptible pain relief
Time when participants feel that the pain relief becomes meaningful to them
Measured: 0-180 min
Time to rescue medication
Measured: 0-180 min
Mean pain intensity difference (PID) from baseline at rest
Measured: 0-180 min
Mean pain intensity difference (PID) from baseline on jaw movement
Measured: 0-181 min
Ramsay sedation score
Change from baseline in Ramsay sedation score (1= agitated, anxious, restless, 6= unarousable)
Measured: 0-179 min
Median time to a request for rescue medication
Measured: 0-180 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2022
- Study start5 Sep 2022
- Primary completion5 Oct 2023
- Study completion5 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cessatech A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05508594
- Sponsor's protocol ID
- PDC 01-0205
- Status last verified
- May 2023
- First submitted
- 17 Aug 2022
- Last updated
- 18 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05508594
- Acronym / sponsor ID
- PDC 01-0205
- Conditions
- Pain
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Cessatech A/SIndustry (pharma, biotech, devices)
- Study start
- 5 Sep 2022 (actual)
- Primary completion
- 5 Oct 2023 (actual)
- Study completion
- 5 Oct 2023 (actual)
- First posted
- 19 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 16
| Arm | Type | Receives |
|---|---|---|
| CT001 | Experimental | Drug: CT001 |
| Placebo | Placebo comparator | Drug: Placebo |
| Sufentanil 27 mcg | Active comparator | Drug: Sufentanil |
| Ketamine 27 mg | Active comparator | Drug: Ketamine |
| Sufentanil 13 mcg | Active comparator | Drug: Sufentanil |
| Ketamine 13 mg | Active comparator | Drug: Ketamine |
| Sufentanil 40 mcg | Active comparator | Drug: Sufentanil |
| Ketamine 40 mg | Active comparator | Drug: Ketamine |
| Sufentanil 13 mcg/Ketamine 13 mg | Active comparator | Drug: Sufentanil, Drug: Ketamine |
| Sufentanil 13 mcg/Ketamine 27 mg | Active comparator | Drug: Sufentanil, Drug: Ketamine |
| Sufentanil 13 mcg/Ketamine 40 mg | Active comparator | Drug: Sufentanil, Drug: Ketamine |
| Sufentanil 27 mcg/Ketamine 13 mg | Active comparator | Drug: Sufentanil, Drug: Ketamine |
| Sufentanil 27 mcg/Ketamine 40 mg | Active comparator | Drug: Sufentanil, Drug: Ketamine |
| Sufentanil 40 mcg/Ketamine 13 mg | Active comparator | Drug: Sufentanil, Drug: Ketamine |
| Sufentanil 40 mcg/Ketamine 27 mg | Active comparator | Drug: Sufentanil, Drug: Ketamine |
| Sufentanil 40 mcg/Ketamine 40 mg | Active comparator | Drug: Sufentanil, Drug: Ketamine |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT001Intranasal | Drug | CT001 |
| PlaceboIntranasal | Drug | Placebo |
| SufentanilIntranasal | Drug | Sufentanil 13 mcg, Sufentanil 13 mcg/Ketamine 13 mg, Sufentanil 13 mcg/Ketamine 27 mg, Sufentanil 13 mcg/Ketamine 40 mg, Sufentanil 27 mcg, Sufentanil 27 mcg/Ketamine 13 mg, Sufentanil 27 mcg/Ketamine 40 mg, Sufentanil 40 mcg, Sufentanil 40 mcg/Ketamine 13 mg, Sufentanil 40 mcg/Ketamine 27 mg, Sufentanil 40 mcg/Ketamine 40 mg |
| KetamineIntranasal | Drug | Ketamine 13 mg, Ketamine 27 mg, Ketamine 40 mg, Sufentanil 13 mcg/Ketamine 13 mg, Sufentanil 13 mcg/Ketamine 27 mg, Sufentanil 13 mcg/Ketamine 40 mg, Sufentanil 27 mcg/Ketamine 13 mg, Sufentanil 27 mcg/Ketamine 40 mg, Sufentanil 40 mcg/Ketamine 13 mg, Sufentanil 40 mcg/Ketamine 27 mg, Sufentanil 40 mcg/Ketamine 40 mg |
Primary outcome
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.
13 secondary outcomes
Maximum Pain intensity difference (PIDmax)
Time frame: 0-180 min
Time to meaningful pain relief
Time frame: 0-180 min
Sum of pain intensity differences at 30 min
Time frame: 0-30 min
Rescue medication
Time frame: 0-180 min
Number of patients who are considered a responder/non-responder, 30%
Time frame: 0-30 min
Number of patients who are considered a responder/non-responder, 50%
Time frame: 0-30 min
Sum of pain intensity differences at 90 min
Time frame: 0-90 min
Time to perceptible pain relief
Time frame: 0-180 min
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
Median time to a request for rescue medication
Time frame: 0-180 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing CT001, Sufentanil and Ketamine in people with Pain, run by Cessatech A/S at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sum of pain intensity differences at 55 min (time frame: 0-55 min). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2023; AzTrials last refreshed its copy on 8 Nov 2026.