Peripheral Nociceptive Effects of Levcromakalim

NCT03726242 | Completed DMC

• 1 other identifier: Levcromakalim local injection
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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. 1.Prevalence and intensity of pain
2. 2.Prevalence and intensity of itching
3. 3.Occurrence and intensity of local redness and swelling
4. 4.Occurrence and intensity of local changes in skin temperature and blood flow

Conditions

Pain; Levcromakalim

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• Occurrence and change of redness from baseline

  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

  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

  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

  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.

Study Arms (2)

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.

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.

Drug: Levcromakalim; Drug: Saline

Interventions

Levcromakalim DRUG

To investigate the role of levcromakalim compared with placebo after intradermal and intramuscular injection.

Levcromakalim; Saline

Saline DRUG

To investigate the role of levcromakalim compared with placebo after intradermal and intramuscular injection.

Levcromakalim; Saline

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy volunteers of both sexes.
• years.
• kg.
• Women of childbearing potential must use adequate contraception.

You may not qualify if:

• 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

Sponsors & Collaborators

• Danish Headache Center: lead

Study Sites (1)

Danish headache center

Glostrup Municipality, Copenhagen, 2600, Denmark

Location

MeSH Terms

Conditions

Pain

Interventions

Cromakalim; Sodium Chloride

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzopyrans; Pyrans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD student, Principal investigator

Model Details: Parallel, randomized placebo controlled and crossover study

Study Record Dates

• First Submitted: October 22, 2018
• First Posted: October 31, 2018
• Study Start: November 1, 2018
• Primary Completion: January 20, 2019
• Study Completion: January 20, 2019
• Last Updated: January 23, 2019

Record last verified: 2019-01

Locations

DK (1)