Peripheral Nociceptive Effects of Levcromakalim

Pain Clinical Trial

Official title:

Study of Local Physiological Effects Following Intradermal and Intramuscular Injection of Levcromacalim

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03726242
• Other study ID #: Levcromakalim local injection
• Status: Completed
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: January 20, 2019

Study information

• Verified date: January 2019
• Source: Danish Headache Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Occurrence and intensity of local changes in skin temperature and blood flow

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 20, 2019
• Est. primary completion date: January 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Healthy volunteers of both sexes.

2. 18-60 years.

3. 50-100 kg.

4. Women of childbearing potential must use adequate contraception.

Exclusion Criteria:

1. A history of serious somatic disease

2. Migraine or any other type of headache (except episodic tension-type headache less than once a month)

3. Daily intake of any medication except contraceptives

Related Conditions & MeSH terms

• Levcromakalim
• Pain

Intervention

Drug:
• Levcromakalim
To investigate the role of levcromakalim compared with placebo after intradermal and intramuscular injection.
• Saline
To investigate the role of levcromakalim compared with placebo after intradermal and intramuscular injection.

Locations

Country	Name	City	State
Denmark	Danish headache center	Glostrup	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Danish Headache Center

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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
Primary	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.	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	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.	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	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.	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	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.	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	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.	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.