Clinical trial NCT03726242: Peripheral Nociceptive Effects of Levcromakalim
Official title: Study of Local Physiological Effects Following Intradermal and Intramuscular Injection of Levcromacalim
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Levcromakalim
Lead sponsor: Danish Headache Center
Sponsor class: OTHER
First posted: 2018-10-31
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Parallel, randomized placebo controlled and crossover study
Primary purpose: OTHER

Brief 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


Eligibility criteria: 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

Primary outcomes:
measure: Occurrence and change of pain from baseline
timeFrame: 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
measure: Occurrence and change of Itching from baseline
timeFrame: 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:
measure: Occurrence and change of redness from baseline
timeFrame: 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.
measure: Occurrence and change of swelling from baseline
timeFrame: 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.
measure: Change of blood flow from baseline
timeFrame: 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.
measure: Change of skin temperature from baseline
timeFrame: 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.
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Danish headache center
state: Copenhagen
Study officials:
References: