PainNCT03726242
Peripheral Nociceptive Effects of Levcromakalim
A study testing Levcromakalim and Saline in people with Pain and Levcromakalim, run by Danish Headache Center at 1 site in Denmark.
Trial summary
Intradermal and intramuscular injection of levcromacalim and placebo (sterile saline) on the forehead and forearm of healthy subjects and the following will be investigated: 1. Prevalence and intensity of pain 2. Prevalence and intensity of itching 3. Occurrence and intensity of local redness and swelling 4. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Levcromakalim
- What is being tested?
- Levcromakalim and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Nov 2018to 20 Jan 2019
- Phase
- Interventional
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers of both sexes.
- 18-60 years.
- 50-100 kg.
- Women of childbearing potential must use adequate contraception.
Who cannot join
- A history of serious somatic disease
- Migraine or any other type of headache (except episodic tension-type headache less than once a month)
- Daily intake of any medication except contraceptives
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Local Physiological Effects Following Intradermal and Intramuscular Injection of Levcromacalim
Intradermal and intramuscular injection of levcromacalim and placebo (sterile saline) on the forehead and forearm of healthy subjects and the following will be investigated:
- Prevalence and intensity of pain
- Prevalence and intensity of itching
- Occurrence and intensity of local redness and swelling
- Occurrence and intensity of local changes in skin temperature and blood flow
- Conditions
- Pain, Levcromakalim
- Being tested
- Levcromakalim, Saline
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevcromakalimDrug
To investigate the role of levcromakalim compared with placebo after intradermal and intramuscular injection.
SalineDrug
To investigate the role of levcromakalim compared with placebo after intradermal and intramuscular injection.
| Study group | Role | What they receive |
|---|---|---|
| Levcromakalim | Active comparator | To investigate the role of levcromakalim compared with placebo after intradermal and intramuscular injection.
To give 0,05 ml intradermal and 0.2 intramuscular of 150 ug/ml levcromakalim after baseline time 0. Receives: Drug: Levcromakalim; Drug: Saline |
| Saline | Placebo comparator | To investigate the role of levcromakalim compared with placebo after intradermal and intramuscular injection.
To give 0,05 ml intradermal and 0.2 intramuscular of saline after baseline time 0. Receives: Drug: Levcromakalim; Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence and change of pain from baseline
Occurrence and intensity of pain after levcromakalim injektion compared to placebo. To measure pain numerical rating scale (NRS) 0-10 will be used.
The outcome measure is pain and the unit that will be used to measure the pain is NRS.
Measured: Before and after injection of levcromakalim compared with before and after injection of saline. Time of measurements is baseline, 5 min, 10 min, 15 min, 20 min, 25 min, 30 min, 35 min, 40 min and 45 min after the injection
Occurrence and change of Itching from baseline
Occurrence and intensity of Itching after levcromakalim injektion compared to placebo. To measure itching numerical rating scale (NRS) 0-10 will be used.
The outcome measure is itching and the unit that will be used to measure the itching is NRS.
Measured: Before and after injection of levcromakalim compared with before and after injection of saline. Time of measurements is baseline, 5 min, 10 min, 15 min, 20 min, 25 min, 30 min, 35 min, 40 min and 45 min after the injection
Secondary outcomes (4)
Occurrence and change of redness from baseline
Occurrence and change of redness after levcromakalim injektion compared to placebo. The areal of the redness will be measured.
The outcome measure is redness and the unit that will be used to measure the redness is areal cm^2.
Measured: Before and after injection of levcromakalim compared with before and after injection of saline. Time of measurements is baseline, 5 min, 10 min, 15 min, 20 min, 25 min, 30 min, 35 min, 40 min and 45 min after the injection.
Occurrence and change of swelling from baseline
Occurrence and change of swelling after levcromakalim injektion compared to placebo. The areal of the swelling will be measured.
The outcome measure is swelling and the unit that will be used to measure the swelling is areal cm^2.
Measured: Before and after injection of levcromakalim compared with before and after injection of saline. Time of measurements is baseline, 5 min, 10 min, 15 min, 20 min, 25 min, 30 min, 35 min, 40 min and 45 min after the injection.
Change of blood flow from baseline
Change of blodflow after levcromakalim injektion compared to placebo. The intensity of the blodd flow will be measured by laser speckle The outcome measure is change of blood flow and the laser speckle will be used to measure the blood flow.
Measured: Before and after injection of levcromakalim compared with before and after injection of saline. Time of measurements is baseline, 5 min, 10 min, 15 min, 20 min, 25 min, 30 min, 35 min, 40 min and 45 min after the injection.
Change of skin temperature from baseline
Change of skin temperature after levcromakalim injektion compared to placebo. The temperature will be measured by thermovision camera.
The outcome measure is the change of skin temperature and the thermovision camera will be used to measure skin temperature.
Measured: Before and after injection of levcromakalim compared with before and after injection of saline. Time of measurements is baseline, 5 min, 10 min, 15 min, 20 min, 25 min, 30 min, 35 min, 40 min and 45 min after the injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2018
- Study start1 Nov 2018
- Primary completion20 Jan 2019
- Study completion20 Jan 2019
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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Parallel, randomized placebo controlled and crossover study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Headache Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Al-Mahdi Al-Karagholi, Danish Headache Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03726242
- Sponsor's protocol ID
- Levcromakalim local injection
- Status last verified
- Jan 2019
- First submitted
- 22 Oct 2018
- Last updated
- 23 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Local Physiological Effects Following Intradermal and Intramuscular Injection of Levcromacalim
- ClinicalTrials.gov ID
- NCT03726242
- Acronym / sponsor ID
- Levcromakalim local injection
- Conditions
- Pain, Levcromakalim
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Danish Headache CenterUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 20 Jan 2019 (actual)
- Study completion
- 20 Jan 2019 (actual)
- First posted
- 31 Oct 2018 (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.
Intradermal and intramuscular injection of levcromacalim and placebo (sterile saline) on the forehead and forearm of healthy subjects and the following will be investigated:
- Prevalence and intensity of pain
- Prevalence and intensity of itching
- Occurrence and intensity of local redness and swelling
- Occurrence and intensity of local changes in skin temperature and blood flow
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel, randomized placebo controlled and crossover study
| Arm | Type | Receives |
|---|---|---|
| Levcromakalim | Active comparator | Drug: Levcromakalim, Drug: SalineTo investigate the role of levcromakalim compared with placebo after intradermal and intramuscular injection. To give 0,05 ml intradermal and 0.2 intramuscular of 150 ug/ml levcromakalim after baseline time 0. |
| Saline | Placebo comparator | Drug: Levcromakalim, Drug: SalineTo investigate the role of levcromakalim compared with placebo after intradermal and intramuscular injection. To give 0,05 ml intradermal and 0.2 intramuscular of saline after baseline time 0. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy volunteers of both sexes.
- 18-60 years.
- 50-100 kg.
- Women of childbearing potential must use adequate contraception.
Key exclusion criteria (3 listed)
- A history of serious somatic disease
- Migraine or any other type of headache (except episodic tension-type headache less than once a month)
- Daily intake of any medication except contraceptives
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 |
|---|---|---|
| LevcromakalimTo investigate the role of levcromakalim compared with placebo after intradermal and intramuscular injection. | Drug | Levcromakalim, Saline |
| SalineTo investigate the role of levcromakalim compared with placebo after intradermal and intramuscular injection. | Drug | Levcromakalim, Saline |
Primary outcome
Occurrence and change of pain from baseline
Time frame: Before and after injection of levcromakalim compared with before and after injection of saline. Time of measurements is baseline, 5 min, 10 min, 15 min, 20 min, 25 min, 30 min, 35 min, 40 min and 45 min after the injection
Occurrence and intensity of pain after levcromakalim injektion compared to placebo. To measure pain numerical rating scale (NRS) 0-10 will be used. The outcome measure is pain and the unit that will be used to measure the pain is NRS.
Occurrence and change of Itching from baseline
Time frame: Before and after injection of levcromakalim compared with before and after injection of saline. Time of measurements is baseline, 5 min, 10 min, 15 min, 20 min, 25 min, 30 min, 35 min, 40 min and 45 min after the injection
Occurrence and intensity of Itching after levcromakalim injektion compared to placebo. To measure itching numerical rating scale (NRS) 0-10 will be used. The outcome measure is itching and the unit that will be used to measure the itching is NRS.
4 secondary outcomes
Occurrence and change of redness from baseline
Time frame: Before and after injection of levcromakalim compared with before and after injection of saline. Time of measurements is baseline, 5 min, 10 min, 15 min, 20 min, 25 min, 30 min, 35 min, 40 min and 45 min after the injection.
Occurrence and change of swelling from baseline
Time frame: Before and after injection of levcromakalim compared with before and after injection of saline. Time of measurements is baseline, 5 min, 10 min, 15 min, 20 min, 25 min, 30 min, 35 min, 40 min and 45 min after the injection.
Change of blood flow from baseline
Time frame: Before and after injection of levcromakalim compared with before and after injection of saline. Time of measurements is baseline, 5 min, 10 min, 15 min, 20 min, 25 min, 30 min, 35 min, 40 min and 45 min after the injection.
Change of skin temperature from baseline
Time frame: Before and after injection of levcromakalim compared with before and after injection of saline. Time of measurements is baseline, 5 min, 10 min, 15 min, 20 min, 25 min, 30 min, 35 min, 40 min and 45 min after the injection.
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 23 Jan 2019.
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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 study testing Levcromakalim and Saline in people with Pain and Levcromakalim, run by Danish Headache Center 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 3 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 23 Jan 2019. 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.
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?
Occurrence and change of pain from baseline (time frame: Before and after injection of levcromakalim compared with before and after injection of saline. Time of measurements is baseline, 5 min, 10 min, 15 min, 20 min, 25 min, 30 min, 35 min, 40 min and 45 min after the injection). 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 23 Jan 2019.