Melatonin Supplement
melatonin for Healthy Subjects
Department of Health and Exercise Science, Norman, OK
melatonin +1 morePhase 4RecruitingLed by Jeremy M KellawanResearch Sponsored by University of OklahomaEligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Healthy men and women
Be between 18 and 65 years old
Must not have
Be younger than 18 years old
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up7 minutes of rest and 7 minutes of exercise
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
Study Summary
This trial will see if melatonin affects blood pressure in response to stressors like cold water and exercise.
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
Men and women who are in good health.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7 minutes of rest and 7 minutes of exercise
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 minutes of rest and 7 minutes of exercise
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean Arterial Pressure
Muscle Tissue Oxygenation
Secondary outcome measures
Cardiac Output
Cerebral Oxygenation
Heart Rate
+4 moreSide effects data
From 2017 Phase 3 trial • 709 Patients • NCT0066870716%
Fatgiue
11%
Insomnia
10%
Death
9%
Nausea
9%
Dyspnea
8%
Diarrhea
5%
Postoperative Pain
4%
Cough
4%
Constipation
3%
Headache
3%
Peripheral Neuropathy
3%
Neutropenia
3%
Vomiting
2%
Air Leak
2%
Dizziness
2%
Appetite changes
2%
Chest pain
2%
Cold/Flu Symptoms
1%
Tinnitus
1%
GERD
1%
Pneumonia
1%
Epistaxis
1%
Pneumothorax
1%
Pruritis
1%
Rash
1%
Prolonged Air Leak
1%
Hyperglycemia
1%
Thrush (mouth)
1%
Bonchitis
1%
Syncope
1%
Vertigo
1%
Anorexia
1%
Anxiety
1%
Depression
1%
Hip replacement surgery
1%
Pulmonary embolism
1%
Subcutaneous Emphysema
1%
Anemia
1%
Atrial fibrillation
1%
Acid reflux
1%
Flatulence
1%
Indigestion
1%
Peripheral Edema
1%
Weight loss
1%
Gall bladder attack
1%
C-Difficile
1%
Surgical site infection
1%
Back pain
1%
Fall
1%
Pain
1%
Radiation pneumonitis
1%
Surgical Site Pain
1%
Dry Cough
1%
Pleural effusion
1%
New Neoplasm
1%
New Neoplasm - Lung Cancer
1%
Hypertension
1%
Tachycardia
1%
Dysphagia
1%
Sinus infection
1%
Myalgia
1%
Hearing loss
1%
Hemoptysis
1%
dry mouth
1%
Erythema
100%
80%
60%
40%
20%
0%
Study treatment Arm
Melatonin
Placebo
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: MelatoninExperimental Treatment1 Intervention
5mg commercially available melatonin (MEL) spray will be given sublingually.
Group II: PlaceboPlacebo Group1 Intervention
Placebo (PLA) is 10 sublingual sprays of a diluted (1 microliter/29ml filtered water) mint extract.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
melatonin
2013
Completed Phase 3
~2260
Find a site
Who is running the clinical trial?
University of OklahomaLead Sponsor
443 Previous Clinical Trials
99,622 Total Patients Enrolled
Jeremy M KellawanPrincipal Investigator
University of OklahomaMedia Library
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any new openings for participation in this trial?
"The clinicaltrials.gov database presently indicates that this medical study is not recruiting patients, even though it was first posted in January of 2023 and last updated on October 31st 2022. Fortunately, 841 other trials are currently open for enrolment."
Answered by AI
Does the eligibility for this clinical trial extend to individuals under 55 years old?
"To take part in this medical trial, individuals must be above the age of consent and below 35 years old."
Answered by AI
Am I eligible to be involved in this clinical experiment?
"To qualify for this trial, eligible patients must be hale and of age (18-35). The team is seeking to recruit an approximate total of 100 individuals."
Answered by AI
What is the primary goal of this research endeavor?
"This experiment seeks to measure Mean Arterial Pressure during a 7-minute rest period and again following 7 minutes of exercise. Secondary objectives include quantifying Cerebral Oxygenation, Heart Rate, and Stroke Volume via noninvasive methods."
Answered by AI
Who else is applying?
What state do they live in?
Oklahoma
What site did they apply to?
Department of Health and Exercise Science
What portion of applicants met pre-screening criteria?
Met criteria