Efficacy and Safety of Norketotifen in Uncomplicated Influenza-like Illness
A Phase 2b Double-blind, Randomized, Placebo-controlled, Parallel-group Study of the Efficacy and Safety of Norketotifen (NKT) in the Treatment of Acute Uncomplicated Influenza-like Illness (ILI)
1 other identifier
interventional
315
1 country
20
Brief Summary
This is a Phase 2b, multi-center, double-blind, randomized, placebo-controlled, parallel-group study of NKT versus placebo in otherwise healthy adults presenting with acute uncomplicated ILI due to influenza or other respiratory viruses in a community setting.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2020
Shorter than P25 for phase_2
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 26, 2020
CompletedFirst Posted
Study publicly available on registry
October 30, 2020
CompletedStudy Start
First participant enrolled
December 14, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 25, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 9, 2022
CompletedJanuary 30, 2023
January 1, 2023
1.1 years
October 26, 2020
January 25, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Time to alleviation of symptoms
Time to alleviation of the symptoms of ILI (headache, feverishness/chills, muscle/joint pain, fatigue, cough, sore throat, nasal congestion)
14 days
Secondary Outcomes (9)
Time to resolution of fever (body temperature equal to or less than 37ºC)
14 days
Proportion of subjects whose symptoms have been alleviated at each time point through Day 14
14 days
Change from baseline in composite symptom score at each time point through Day 14
14 days
Body temperature at each time point through Day 14
14 days
Time to alleviation of individual symptoms (headache, feverishness/chills, muscle/joint pain, fatigue, cough, sore throat, nasal congestion)
14 days
- +4 more secondary outcomes
Study Arms (2)
Norketotifen
EXPERIMENTALNorketotifen oral capsules, twice daily for 7 days
Placebo
PLACEBO COMPARATORPlacebo oral capsules, twice daily for 7 days
Interventions
Eligibility Criteria
You may qualify if:
- Able to understand the study and comply with all study procedures, and willing to provide written informed consent prior to the pre-dose examinations
- Symptoms of ILI including all of the following:
- Fever ≥38º Celsius (oral)
- At least one of the following general systemic symptoms associated with ILI are present with a severity of moderate or greater: headache, feverishness or chills, muscle or joint pain, fatigue
- At least one of the following respiratory symptoms associated with ILI are present with a severity of moderate or greater: cough, sore throat, nasal congestion
- Total symptom severity score (sum of the scores of all 7 individual symptoms) of ≥11 in the predose examinations
- The time interval between the onset of symptoms and the predose examinations is ≤48 hours.
- Females of childbearing potential and males agree to use an appropriate method of contraception as detailed in the protocol
You may not qualify if:
- Known or suspected infection with Severe Acute Respiratory Syndrome-Coronavirus 2 (SARS-CoV2) or Coronavirus Disease 2019 (COVID-19) illness
- Female subjects who are pregnant, 2 weeks post-partum, or breastfeeding
- Severe ILI requiring inpatient treatment
- Any of the following risk factors (according to the CDC's list of People at High Risk for Developing Serious Flu-Related Complications):
- Extreme obesity (body mass index ≥40 kg/m\^2)
- Residents of nursing homes or other long-term care facilities
- American Indians and Alaska natives
- Asthma
- Chronic lung disease (such as chronic obstructive pulmonary disease or cystic fibrosis)
- Neurological and neurodevelopmental conditions (including disorders of the brain, spinal cord, peripheral nerve, and muscle such as cerebral palsy, epilepsy \[seizure disorders\], stroke, intellectual disability, moderate to severe developmental delay, muscular dystrophy, or spinal cord injury)
- Heart disease (such as congenital heart disease, congestive heart failure, or coronary artery disease)
- Blood disorders (such as sickle cell disease)
- Endocrine disorders (such as diabetes mellitus)
- Kidney disorders
- Liver disorders
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Precision Trials AZ
Phoenix, Arizona, 85032, United States
Downtown LA Research Center
Los Angeles, California, 90017, United States
Omega Research Debary
DeBary, Florida, 32713, United States
The Chappel Group Research
Kissimmee, Florida, 34744, United States
South Florida Research Center
Miami, Florida, 33135, United States
Premier Research Associate
Miami, Florida, 33165, United States
Research Institute of South Florida
Miami, Florida, 33173, United States
Horizon Research Group of Opelousas
Eunice, Louisiana, 70535, United States
Continental Clinical Solutions
Towson, Maryland, 21204, United States
Clinical Research of South Nevada
Las Vegas, Nevada, 89121, United States
Relief Integrated Health Care
Louisburg, North Carolina, 27549, United States
Clinical Research Solutions
Middleburg Heights, Ohio, 44130, United States
Frontier Clinical Research
Scottdale, Pennsylvania, 15683, United States
Frontier Clinical Research
Smithfield, Pennsylvania, 15478, United States
Clinovacare Medical Research Center
West Columbia, South Carolina, 29169, United States
Health Concepts
Rapid City, South Dakota, 57702, United States
Clinical Research Solutions
Jackson, Tennessee, 38305, United States
Cedar Health Research
Dallas, Texas, 75251, United States
Advanced Medical Group
Houston, Texas, 77027, United States
Frontier Clinical Research
Morgantown, West Virginia, 26505, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 26, 2020
First Posted
October 30, 2020
Study Start
December 14, 2020
Primary Completion
January 25, 2022
Study Completion
February 9, 2022
Last Updated
January 30, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will not share