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Results 31 - 40 of 635

EFFICACY AND SAFETY OF  MELALEUCA ALTERNIFOLIA (TEA TREE) 5% OIL VS. KETOCONAZOLE 2% CREAM IN THE MANAGEMENT OF MILD TO MODERATE FACIAL SEBORRHEIC DERMATITIS

Recruitment Status
Pending
Project Status
Pending
Project Description

Using a randomized, investigator-blinded trial, the study determines to determine the efficacy and safety of 5% Tea Tree Oil vs Ketoconazole 2% cream in the treatment of mild to moderate facial seborrheic dermatitis.

Primary Sponsor
Southern Philippines Medical Center, Department of Dermatology
Study Type
Interventional
Date of Registration
16 May 2022
Date of FIrst Enrollment
30 November -0001
Region
Region XI
Method of Allocation
Randomized
Masking
Single Blind
Assignment
Parallel
Phase
Phase 0
Sources of Monetary or Material Support
Self-funded
Primary Outcomes

The primary outcomes include the following:

1. SEborrheic Dermatitis Area and Severity Index (SEDASI) score

2. Clinical Severity Score

 

 

Key Inclusion and Exclusion Criteria
Inclusion Criteria: Patients above 19 years old Patients who are clinically diagnosed with mild to moderate facial seborrheic dermatitis Participants who are willing to undergo photo-documentation. Participants willing to comply with . . .
Countries of Recruitment
Philippines
Health Condition(s) or Problem(s) Studied
MILD TO MODERATE FACIAL SEBORRHEIC DERMATITIS

A phase 2, randomized, double-blind, placebo controlled, dose-ranging trial to evaluate pharmacokinetics, pharmacodynamics, and safety of AT-752 in patients with Dengue infection

Recruitment Status
Pending
Project Status
Ongoing
Project Description
This study evaluates the safety, PK, and PD of AT-752 and will enroll approximately 60 subjects that meet the inclusion/exclusion criteria. Following screening and informed consent, eligible subjects will be randomized to receive either AT-752 or matching placebo orally 3 times a day (TID) for 5 . . .
Primary Sponsor
Atea Pharmaceuticals, Inc.
Secondary Sponsor
PPD Pharmaceutical Development Philippines Corporation
Study Type
Interventional
Date of Registration
01 March 2022
Date of FIrst Enrollment
30 November -0001
Region
United States of America
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Not Applicable
Phase
Phase II
FDA Clinical Trial Reference (CTR) Number
20211201164943
Sources of Monetary or Material Support
Atea Pharmaceuticals, Inc.
Primary Outcomes

To investigate the antiviral activity of AT-752 versus placebo in terms of reduction of DENV RNA from baseline in adult subjects with confirmed DENV infection

Key Inclusion and Exclusion Criteria
A patient must meet the following criteria to be eligible for participation in this study:1. 18-55 years of age at time of screening2. Fever ≥38°C (or feeling feverish) with onset during the previous 48 hours3. Live/work in or recent travel to dengue endemic area4. Posi . . .
Countries of Recruitment
Brazil, Colombia, India, Malaysia, Peru, Philippines, Taiwan, Thailand, Vietnam
Health Condition(s) or Problem(s) Studied

Dengue Fever


An open-label, non-comparator, multicenter study to describe the pharmacokinetics (PK), pharmacodynamics (PD; viral load) and safety following a single intravenous or intramuscular dose of sotrovimab in pediatric participants with mild to moderate COVID-19 at high risk of disease progression

Recruitment Status
Pending
Project Status
Pending
Project Description

This study is a Phase 2b open-label, non-comparator, multi-center study to evaluate PK,  safety, and PD of IM or IV administration of sotrovimab in pediatric participants aged    from birth to

 

 

Primary Sponsor
GlaxoSmithKline Research & Development Limited (UK)
Secondary Sponsor
PPD Pharmaceutical Development Philippines Corporation
Study Type
Interventional
Date of Registration
17 March 2022
Date of FIrst Enrollment
30 November -0001
Region
United Kingdom
Method of Allocation
Non-Randomized
Masking
Open Label
Assignment
Single
Phase
Phase II
FDA Clinical Trial Reference (CTR) Number
20211215170413
Sources of Monetary or Material Support
GlaxoSmithKline Research & Development Limited (UK)
Primary Outcomes
Body weight-adjusted serum clearance of sotrovimab up to Week 12 Serum PK of sotrovimab administered by IM injection or IV infusion (PK parameters may include Cmax, Tmax, AUCinf, t1/2, Vz, CL, F) up to week 12 Incidence of adverse events . . .
Key Inclusion and Exclusion Criteria
Inclusion Criteria: Age Participant must be 32 weeks estimated gestational age (EGA), day of life (DOL) 0 to assent (if age-appropriate) or parent(s)/legally authorized representative signing the informed consent.  Type of Participa . . .
Countries of Recruitment
Brazil, Colombia, Greece, Philippines, Russia, South Africa, United States, Thailand, Vietnam
Health Condition(s) or Problem(s) Studied

Early treatment of Covid-19


A Phase 3, Randomized, Double-Blind, Active-Controlled, Confirmatory Study to Compare the Immunogenicity, Efficacy, and Safety of KD-414 Vaccine and Vaxzevria Vaccine in Adults Aged 18 years and Older

Recruitment Status
Recruiting
Project Status
Ongoing
Project Description
The study kd414-03 is phase 3, randomized, double-blind, active-controlled, confirmatory study to compare the immunogenicity, efficacy, and safety of KD-414 vaccine (3-dose series) and Vaxzevria vaccine (2-dose series) in adults aged 18 years and older who have no known history of SARS-CoV-2 infe . . .
Primary Sponsor
Meiji Seika Pharma Co., Ltd.
Study Type
Interventional
Date of Registration
20 June 2022
Date of FIrst Enrollment
30 November -0001
Region
Japan
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Single
Phase
Phase III
FDA Clinical Trial Reference (CTR) Number
2022-CT0673
Sources of Monetary or Material Support
Meiji Seika Pharma Co., Ltd.
Primary Outcomes

Geometric mean titer of serum neutralizing antibody against SARS-CoV-2 at 28 days after the third dose of KD-414 (Day 148) as compared with that at 28 days after the second dose of Vaxzevria (Day 57).

Key Inclusion and Exclusion Criteria
Inclusion Criteria: Is capable of understanding the written informed consent, provides signed informed consent, and agrees to comply with protocol requirements. Is aged 18 years or older. Is healthy or medically stable as determined by investigator judgme . . .
Countries of Recruitment
Japan, Philippines, Greece, Philippines, Russia, South Africa, United States, Thailand, Vietnam
Health Condition(s) or Problem(s) Studied

COVID-19


A Phase III, Multicentre, Randomised, Double-blind, Chronic-dosing, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Two Dose Regimens ofMEDI3506 in Participants with Symptomatic Chronic Obstructive Pulmonary Disease (COPD) with a History of COPD Exacerbations (TITANIA)

Recruitment Status
Pending
Project Status
Pending
Project Description

This is a Phase III, multicentre, randomised, double-blind, chronic-dosing, parallel-group, placebo-controlled study to evaluate the efficacy and safety of MEDI3506 300 mg Q8W and 300 mg Q4W administered SC, in adult participants with symptomatic COPD and history of COPD exacerbations.

Primary Sponsor
AstraZeneca AB
Study Type
Interventional
Date of Registration
19 April 2022
Date of FIrst Enrollment
30 November -0001
Region
Sweden
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Parallel
Phase
Phase III
FDA Clinical Trial Reference (CTR) Number
2022-CT0664
Sources of Monetary or Material Support
AstraZeneca Pharmaceuticals (Philippines) Inc.
Primary Outcomes

To evaluate the effect of 2 dose regimens of MEDI3506 as add on to SoC compared with SoC plus placebo on the rate of moderate to severe COPD exacerbations in former smokers.

Key Inclusion and Exclusion Criteria
Inclusion CriteriaParticipants are eligible to be included in the study only if all of the following criteria apply:Age1 Participant must be ≥ 40 years of age at the time of signing the ICF. Type of Participant and Disease Characteristics2 Documented diagnosis of COPD fo . . .
Countries of Recruitment
Australia, Brazil, Chile, China, Colombia, France, Germany, Greece, Israel, Italy, Peru, Philippines, Poland, Romania, Russia, Taiwan, Thailand, United Kingdom, United States
Health Condition(s) or Problem(s) Studied

Symptomatic Chronic Obstructive Pulmonary Disease (COPD) with a History of COPD Exacerbations


A Phase 2/3 Study of S-217622 in Participants Infected with SARS-CoV-2

Recruitment Status
Terminated
Project Status
Terminated
Project Description
This study consists of four parts: Phase 2a Part in participants with mild/moderate or asymptomatic SARS-CoV-2 infection, Phase 2b Part and Phase 3 Part in participants with mild/moderate SARS-CoV-2 infection (cohort to evaluate time to improvement: cohort A), and Phase 2b/3 Part in participants . . .
Primary Sponsor
Shionogi & Co., Ltd.
Secondary Sponsor
PAREXEL Clinical Research (Philippines) Ltd. Corp.
Study Type
Interventional
Date of Registration
02 May 2022
Date of FIrst Enrollment
30 November -0001
Region
Japan
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Parallel
Phase
Phase II/III
FDA Clinical Trial Reference (CTR) Number
2022-CT0665
Sources of Monetary or Material Support
Shionogi & Co., Ltd.
Primary Outcomes
For Phase 2b/3 Part: Primary objectives: To compare the effect of 5-day administration of S-217622 on preventing development or worsening of symptoms with that of placebo in participants with SARS-CoV-2 infection Primary endpoints: Proportion of participants with development/worse . . .
Key Inclusion and Exclusion Criteria
For Phase 2b/3 Part and Phase 3 Part: Inclusion Criteria:1. Participant must be 12 to < 70 years of age, at the time of signing the informed consent/assent. 2. Participants who were diagnosed as SARS-CoV-2 positive by any of the following test within 120 hours before rand . . .
Countries of Recruitment
Japan, Singapore, South Korea, Vietnam, Colombia, France, Germany, Greece, Israel, Italy, Peru, Philippines, Poland, Romania, Russia, Taiwan, Thailand, United Kingdom, United States
Health Condition(s) or Problem(s) Studied

Treatment of SARS-CoV-2


An international, multicenter, randomized, double-blind, placebo-controlled, parallel, phase II pilot study to evaluate the efficacy and safety of recombinant super-compound interferon (rSIFN-co) among healthy subjects in close contact with confirmed COVID-19 case(s) and subjects with mild or asymptomatic COVID-19

Recruitment Status
Pending
Project Status
Pending
Project Description
This is a phase II pilot, international, multicenter, randomized, double-blind, placebo-controlled study that aims to evaluate the safety and preliminary efficacy of rSIFN-co nasal spray in healthy subjects in close contact with confirmed COVID-19 case(s) as well as subjects with mild or asymptom . . .
Primary Sponsor
Sichuan Huiyang Life Science and Technology Corporation
Secondary Sponsor
CMIC Asia-Pacific (Philippines), Inc.
Study Type
Interventional
Date of Registration
06 April 2022
Date of FIrst Enrollment
30 November -0001
Region
China
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Single
Phase
Phase II
FDA Clinical Trial Reference (CTR) Number
2022-CT0667
Sources of Monetary or Material Support
Sichuan Huiyang Life Science and Technology Corporation
Primary Outcomes
Healthy subjects: rSIFN-co treatment will reduce the incidence of laboratory-confirmed SARS-CoV-2 infection in healthy subjects in close contact with confirmed COVID-19 case(s).Note: Healthy subjects are defined as individuals who are free from clinically significant illness or disease as d . . .
Key Inclusion and Exclusion Criteria
Inclusion criteria: 1. Male or female ≥18 and ≤75 years of age at the time of informed consent.2. Willing and able to provide written informed consent/assent for the trial.3. Healthy subjects in close contact with confirmed COVID-19 case(s) or subjects with mild or asymptomatic CO . . .
Countries of Recruitment
Australia, Philippines, Thailand, Vietnam, Colombia, France, Germany, Greece, Israel, Italy, Peru, Philippines, Poland, Romania, Russia, Taiwan, Thailand, United Kingdom, United States
Health Condition(s) or Problem(s) Studied

Covid 19


ImGTS for Patients With Behavioral and Psychological Symptoms of Dementia

Recruitment Status
Completed
Project Status
Ongoing
Project Description
The project is a Phase 1 trial that aims to develop and to test a virtual reality (VR) application for the management of behavioral and psychological symptoms of dementia (BPSD) among healthy adults. The VR application will be delivered through a head-mounted display (HMD) system and through a S . . .
Primary Sponsor
University of the Philippines Manila
Study Type
Interventional
Date of Registration
28 July 2022
Date of FIrst Enrollment
30 November -0001
Region
Philippines
Method of Allocation
Randomized
Masking
Open Label
Assignment
Parallel
Phase
Phase I
Sources of Monetary or Material Support
Philippine Council for Health Research and Development
Primary Outcomes
Safety will be determined by the incidence of cybersickness, which will be assessed using the Virtual Reality Sickness Questionnaire within an hour of completion of the virtual reality game for each session. The acceptability of the design will be measured using the Place Probe ( . . .
Key Inclusion and Exclusion Criteria
Inclusion Criteria: Aged 40 to 59 years old Montreal Cognitive Assessment-Philippine Version (MoCA-P) score > 20 Neuropsychiatric Inventory (NPI) score of 0 Able to understand Filipino and English Exclusion Criteria: . . .
Countries of Recruitment
Philippines, Philippines, Thailand, Vietnam, Colombia, France, Germany, Greece, Israel, Italy, Peru, Philippines, Poland, Romania, Russia, Taiwan, Thailand, United Kingdom, United States
Health Condition(s) or Problem(s) Studied

Behavioral and psychological symptoms of dementia


ImGTS for Patients With Cerebral Palsy and With Mobility Limitations

Recruitment Status
Completed
Project Status
Ongoing
Project Description
The proposed research project aims to answer the question "Are immersive technology systems effective in the rehabilitation management of pediatric patients with cerebral palsy and with mobility limitations?". The current study is the first of three phases, and it aims to create an immersive gami . . .
Primary Sponsor
University of the Philippines Manila
Study Type
Interventional
Date of Registration
28 July 2022
Date of FIrst Enrollment
28 April 2022
Region
Philippines
Method of Allocation
Randomized
Masking
Open Label
Assignment
Parallel
Phase
Phase I
Sources of Monetary or Material Support
Philippine Council for Health Research and Development
Primary Outcomes
Safety, based on the incidence of cybersickness assessed using the Virtual Reality Sickness Questionnaire before and after each session Acceptability, assessed using the Place Probe (a sense of place questionnaire) after each session Usability, assessed during each ses . . .
Key Inclusion and Exclusion Criteria
Inclusion Criteria: Aged 6 to 12 years old Demonstrates fine and gross motor abilities within the norm for the child's age as measured by the Bruininks-Oseretsky Test of Motor Proficiency Test (BOTMP) Exclusion Criteria: Previously diagnosed . . .
Countries of Recruitment
Philippines, Philippines, Thailand, Vietnam, Colombia, France, Germany, Greece, Israel, Italy, Peru, Philippines, Poland, Romania, Russia, Taiwan, Thailand, United Kingdom, United States
Health Condition(s) or Problem(s) Studied

Cerebral palsy


A Safety, Tolerability, and Efficacy Study of IBI314 in Ambulatory Patients with COVID-19

Recruitment Status
Terminated
Project Status
Terminated
Project Description
This is a dose-finding, inferentially seamless Phase 1/2 study to support the development of IBI314 in ambulatory patients with COVID-19. Phase 1 and Phase 2 are in the same study. Phase 1 Phase 1 is a randomized, double-blind, placebo-controlled, single ascending d . . .
Primary Sponsor
Innovent Biologics (Suzhou) Co., Ltd.
Secondary Sponsor
PAREXEL Clinical Research (Philippines) Ltd. Corp.
Study Type
Interventional
Date of Registration
04 March 2022
Date of FIrst Enrollment
30 November -0001
Region
China
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Not Applicable
Phase
Phase I/II
FDA Clinical Trial Reference (CTR) Number
2021-CT0660
Sources of Monetary or Material Support
Innovent Biologics (Suzhou) Co., Ltd.
Primary Outcomes
Phase ISafety Evaluation: Any AEs and SAEs occurring during the study, including clinical symptoms, abnormal vital signs, abnormal laboratory tests (e.g., hematology, blood biochemistry, urinalysis, coagulation function, etc.), infusion-related reactions, hypersensitivity r . . .
Key Inclusion and Exclusion Criteria
Key Inclusion Criteria Each patient must meet the following criteria at screening or enrollment to be eligible for this study:1. First onset of COVID-19 symptoms 2. Have a positive SARS-CoV-2 Reverse Transcription-Polymerase Chain Reaction (RT-PCR) test using an app . . .
Countries of Recruitment
Brazil, Philippines, United States, Vietnam, Colombia, France, Germany, Greece, Israel, Italy, Peru, Philippines, Poland, Romania, Russia, Taiwan, Thailand, United Kingdom, United States
Health Condition(s) or Problem(s) Studied

COVID-19


Results 31 - 40 of 635
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