NCT04043923CompletedPhase 2
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)
Emergo Therapeutics, Inc.17 sites in 1 country238 target enrollmentStarted: October 21, 2019Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Emergo Therapeutics, Inc.
- Enrollment
- 238
- Locations
- 17
- Primary Endpoint
- Time to alleviation of symptoms
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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) in the predose examinations or >4 hours after dosing of antipyretics if they were taken
- •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
- •The time interval between the onset of symptoms and the predose examinations is ≤96 hours. The onset of symptoms is defined as either:
- •Time of the first increase in body temperature (an increase of at least 1º Celsius from normal body temperature)
- •Time when the subject experiences at least one general or respiratory symptom
- •Females of childbearing potential and males agree to use an appropriate method of contraception as detailed in the protocol
Exclusion Criteria
- •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):
- •Residents of nursing homes or other long-term care facilities
- •American Indians and Alaska natives
- •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
- •Metabolic disorders (such as inherited metabolic disorders and mitochondrial disorders)
- •Compromised immune system due to disease or medication (such as subjects with human immunodeficiency virus or cancer, or those on chronic steroids)
- •Extreme obesity (body mass index ≥40 kg/m^2)
- •Presence of any severe or uncontrolled medical or psychiatric illness
- •History of or current autoimmune disease
- •History of recurrent lower respiratory tract infection
- •Any concurrent infection requiring systemic antimicrobial and/or antiviral therapy
- •Female subjects who are pregnant or breastfeeding
- •Any clinically significant electrocardiogram test
- •Received baloxavir, oseltamivir, peramivir, zanamivir, rimantadine, or amantadine within 30 days prior to the pre-dose examinations
- •Received an investigational monoclonal antibody for a viral disease in the last year prior to the pre-dose examinations
- •Received ketotifen fumarate, cromolyn sodium, or nedocromil sodium by any route of administration within 30 days prior to the pre-dose examinations
- •Exposure to an investigational drug within 30 days prior to the pre-dose examinations
- •History of allergic reaction to ketotifen
- •Any prior exposure to norketotifen
Arms & Interventions
Norketotifen
Experimental
Norketotifen oral capsules, once daily for 5 days
Intervention: Norketotifen (Drug)
Placebo
Placebo Comparator
Placebo oral capsules, once daily for 5 days
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Time to alleviation of symptoms
Time Frame: 14 days
Time to alleviation of the symptoms of ILI (headache, feverishness/chills, muscle/joint pain, fatigue, cough, sore throat, nasal congestion)
Secondary Outcomes
- Proportion of subjects whose symptoms have been alleviated at each time point through Day 5(5 days)
- Change from baseline in composite symptom score at each time point through Day 5(5 days)
- Time to resolution of fever (body temperature equal to or less than 37ºC)(14 days)
- Time to alleviation of individual symptoms (headache, feverishness/chills, muscle/joint pain, fatigue, cough, sore throat, nasal congestion)(14 days)
- Time to resumption of normal activity(14 days)
- Body temperature at each time point through Day 5(5 days)
- Use of rescue medication (acetaminophen)(14 days)
Investigators
Study Sites (17)
Loading locations...
Similar Trials
Completed
Phase 2
Efficacy and Safety of Norketotifen in Uncomplicated Influenza-like IllnessInfluenzaInfluenza -Like IllnessNCT04610047Emergo Therapeutics, Inc.315
Completed
Phase 2
Evaluation of the Efficacy and Safety of Solabegron Tablets for Treatment of Overactive Bladder in Adult WomenOveractive BladderNCT03475706Velicept Therapeutics, Inc.438
Completed
Phase 2
A Study to Evaluate Once Daily Low Dose and High Dose Solabegron or Placebo Given for 12 Weeks to Treat Women With Symptoms of Overactive Bladder: Sudden Urge to Urinate, Frequent Urination Associated With Wetting Episodes (VEL-2001)Overactive BladderNCT03594058Velicept Therapeutics, Inc.1,413
Completed
Phase 2
A Study to Evaluate the Efficacy and Safety of VX-150 in Treating Subjects With Pain Caused by Small Fiber NeuropathySmall Fiber NeuropathyNCT03304522Vertex Pharmaceuticals Incorporated89
Terminated
Phase 2
Efficacy and Safety Study of GS-9450 Treatment for 6 Months in Patients With Chronic Hepatitis C Virus InfectionHCV InfectionNCT00874796Gilead Sciences307