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Peripheral Nociceptive Effects of Levcromakalim

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ClinicalTrials.gov Identifier: NCT03726242
Recruitment Status : Completed
First Posted : October 31, 2018
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
Mohammad Al-Mahdi Al-Karagholi, Danish Headache Center

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

Condition or disease Intervention/treatment Phase
Pain Levcromakalim Drug: Levcromakalim Drug: Saline Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Parallel, randomized placebo controlled and crossover study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Study of Local Physiological Effects Following Intradermal and Intramuscular Injection of Levcromacalim
Actual Study Start Date : November 1, 2018
Actual Primary Completion Date : January 20, 2019
Actual Study Completion Date : January 20, 2019

Arm Intervention/treatment
Active Comparator: Levcromakalim

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

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

Placebo Comparator: Saline

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

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




Primary Outcome Measures :
  1. 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.


  2. 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.



Secondary Outcome Measures :
  1. 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 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.


  2. 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. ]

    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.


  3. 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 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.

  4. 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. ]

    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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03726242


Locations
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Denmark
Danish headache center
Glostrup, Copenhagen, Denmark, 2600
Sponsors and Collaborators
Danish Headache Center

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Responsible Party: Mohammad Al-Mahdi Al-Karagholi, MD, PhD student, Principal investigator, Danish Headache Center
ClinicalTrials.gov Identifier: NCT03726242     History of Changes
Other Study ID Numbers: Levcromakalim local injection
First Posted: October 31, 2018    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cromakalim
Antihypertensive Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Parasympatholytics
Vasodilator Agents