Clinical trials: Patient Safety
Acute Sinusitis
Safety and Efficacy of Cefecin Tab. in Patients With Acute Sinusitis
This is a multi-center, double-blind, randomized, active controlled, parallel group phase 4 clinical trial to re-confirm the efficacy and safety of cefetamet pivoxil formulation in sinusitis patients
- Trial name
- CASIS (NCT04664803)
- Testing
- Cefecin Tab., Omnicef Cap.
- Volunteers
- 284 people
- Sponsor
- Korea United Pharm. Inc.
Nasal Congestion and Inflammations, Rhinitis
Efficacy and Safety of Combination of Brompheniramine and Phenylephrine for the Symptoms Relief of Rhinitis
This is a multicenter clinical trial, phase III, superiority, controlled by active medicine, double-blind, randomized, enroll 166 children, over 12 years old, with acute inflammation upper airway, characterized by nasal…
- Trial name
- NCT01393561
- Testing
- Group 1, Group 2
- Volunteers
- 167 people
- Sponsor
- Ache Laboratorios Farmaceuticos S.A.
Systemic Lupus, Sjogren's Syndrome
Evaluation of Influenza A/H3N2 Vaccine in Patients With Rheumatologic Diseases
Studies in the literature have shown reduced effectiveness of influenza A (H3N2) virus vaccine (20-40%) when compared to A (H1N1) and influenza B.
- Trial name
- NCT03540823
- Testing
- Inactivated and fragmented influenza vaccine (A / Michigan / 45/2015 (H1N1) pdm09-like virus, A / Singapore / INFIMH-16-0019 / 2016 (H3N2) -like virus; B / Phuket / 3073/2013-like virus)
- Where
- Brazil
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- University of Sao Paulo General Hospital
Alpha-Mannosidosis
Trial on Safety and Efficacy of Velmanase Alfa Treatment in Pediatric Patients With Alpha-Mannosidosis
The main objectives of the study are to evaluate safety and efficacy of repeated treatment with recombinant human alfa-mannosidase of patients with alfa-mannosidosis aged less than 6 years
- Trial name
- rhLaman-08 (NCT02998879)
- Testing
- Velmanase Alfa (e.g. Lamazym)
- Where
- 6 sites in Austria, Denmark and 3 more
- Volunteers
- 5 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Growth Hormone Deficiency in Children, Growth Hormone Deficiency (GHD)
Evaluating the Efficacy and Safety of GB08 Injection in Pediatric Patients With Growth Hormone Deficiency
This study aims to evaluate the efficacy and safety of GB08 injection compared to Norditropin NordiFlex in pediatric patients with growth hormone deficiency (PGHD).
- Conditions
- Growth Hormone Deficiency in Children, Growth Hormone Deficiency (GHD), Growth Hormone
- Trial name
- NCT07126288
- Testing
- GB08, Norditropin NordiFlex
- Where
- 16 sites in China
- Volunteers
- 268 people
- Sponsor
- Shenzhen Kexing Pharmaceutical Co., Ltd.
Diagnostic Self Evaluation, Central Nervous System Diseases
Safety and Efficacy Evaluation of DOTAREM® in MRI of Central Nervous System (CNS) Lesions
The purpose of this study is to look at the safety (what are the side effects)and efficacy (how well does it work) of Dotarem® when used in taking images of the brain / spine.
- Trial name
- SENTIO (NCT01211873)
- Testing
- Dotarem (gadoterate meglumine), Magnevist (gadopentetate dimeglumine)
- Where
- 52 sites in United States, Argentina and 9 more
- Volunteers
- 416 people
- Sponsor
- Guerbet
Botulism
BT-010 Registry for the Evaluation of Safety and Clinical Outcomes in Patients Treated With Botulinum Antitoxin
The purpose of the Registry was to evaluate patient safety following Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) - (Equine) (BAT®) administration in adult and pediatric patients with a confirmed or suspected exposure to…
- Trial name
- NCT02055183
- Testing
- BAT
- Volunteers
- 162 people
- Sponsor
- Emergent BioSolutions
Attention Deficit-Hyperactivity Disorder
Real World Evidence of the Efficacy and Safety of FOQUEST
This study is a four-month, phase IV, open-label study of ADHD symptomatology and functional outcomes in pediatric (6 to 17 years old) and adult (≥18 years or older) patients with ADHD treated with FOQUEST or VYVANSE.
- Trial name
- reFOQus (NCT04152629)
- Testing
- Methylphenidate Hydrochloride, Lisdexamfetamine Dimesylate
- Where
- 12 sites in Canada
- Volunteers
- 257 people
- Sponsor
- Purdue Pharma, Canada
Duchenne Muscular Dystrophy
Efficacy and Safety Study of WVE-210201 (Suvodirsen) With Open-label Extension in Ambulatory Patients With Duchenne Muscular Dystrophy
This is a Phase 2/3, multicenter, randomized, double-blind, placebo-controlled study with an open-label extension period to evaluate the safety and efficacy of WVE-210201 (suvodirsen) in ambulatory male pediatric patients with…
- Trial name
- DYSTANCE 51 (NCT03907072)
- Testing
- WVE-210201 (suvodirsen)
- Where
- 22 sites in United States, Belgium and 6 more
- Volunteers
- 6 people
- Sponsor
- Wave Life Sciences USA, Inc.
Cystic Fibrosis
Absorption and Safety With Sustained Use of RELiZORB Evaluation (ASSURE) Study
Protocol 0000498: Multicenter, open label study to evaluate the effect of sustained RELiZORB (immobilized lipase) cartridge use during enteral feeding on fat absorption, as well as safety and tolerability of sustained RELiZORB…
- Trial name
- ASSURE (NCT02750501)
- Testing
- RELiZORB (immobilized lipase) cartridge, Impact Peptide 1.5
- Where
- 10 sites in United States
- Volunteers
- 49 people
- Sponsor
- Alcresta Therapeutics, Inc.
Chronic Idiopathic Urticaria
A Study to Evaluate the Efficacy, Response Duration and Safety of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Antihistamine Treatment (H1)
The study is a global Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of omalizumab administered subcutaneously as an add-on therapy for the treatment…
- Trial name
- NCT01292473
- Testing
- Omalizumab
- Where
- 61 sites in United States, Denmark and 6 more
- Volunteers
- 323 people
- Sponsor
- Genentech, Inc.
HIV Infections
T-20 in HIV Patients With Prior Drug Treatment and/or Resistance to Each of the Three Classes of Anti-HIV Drugs
The purpose of this study is to show if a dose of T-20 added to an anti-HIV combination (chosen specifically for each patient) lowers viral load by at least a certain level after 24 weeks as compared to an anti-HIV combination…
- Trial name
- NCT00021554
- Testing
- Enfuvirtide
- Where
- 37 sites in Australia, Belgium and 7 more
- Volunteers
- 525 people
- Sponsor
- Hoffmann-La Roche
Low Back Pain
Efficacy and Safety Study of Individualized and Standardized Acupuncture Treatment for Low Back Pain
The purpose of this study is to determine whether acupuncture treatment(Individualized \& Standardized Acupuncture) is more effective than control (sham acupuncture or no treatment) and also whether individualized acupuncture is…
- Trial name
- NCT01570127
- Testing
- Individualized Acupuncture, Standardized Acupuncture, Waiting
- Where
- South Korea
- Volunteers
- 276 people
- Sponsor
- Dongwoo Nam
Primary Immune Deficiency
Study to Evaluate the Pharmacokinetics, Efficacy, Tolerability, and Safety of Subcutaneous Human Immunoglobulin (Newnorm) in Patients With Primary Immunodeficiency Diseases
Prospective, open-label, single-arm, multicentre Phase 3 study to evaluate the pharmacokinetics, efficacy, tolerability, and safety of subcutaneous human immunoglobulin (Newnorm) in patients with primary immunodeficiency diseases
- Trial name
- NCT04640142
- Testing
- Newnorm
- Where
- 23 sites in United States, Germany and 5 more
- Volunteers
- 50 people
- Sponsor
- Octapharma
Dermatitis, Atopic
Intervention Study to Evaluate a Probiotic in Mild Atopic Dermatitis Young Patients
The aim of the study is to evaluate the beneficial effect of a probiotic preparation with an antiinflammatory and modulating activity on immunological processes, with positive results on different inflammatory and atopic…
- Trial name
- NCT02585986
- Testing
- Probiotic
- Where
- Spain
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- Biopolis S.L.
Glycogen Storage Disease Type I, Glucose 6 Phosphatase Deficiency
Safety, Efficacy Evaluation of Empagliflozin Administration for Neutropenia in Glycogenosis Type 1b and G6PC3 Deficiency
Treatment of neutropenia of G6PC3 and Glycogenosis type 1b patients with empagliflozin
- Trial name
- GLYCO-1B (NCT04138251)
- Testing
- Empagliflozin
- Where
- Belgium
- Volunteers
- 5 people
- Sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Handfoot-mouth Disease
Effect of Xiaoer Jiebiao Oral Liquid on Hand-foot-mouth Disease
This is a single-blinded randomized trial aiming to evaluate the effectiveness of Xiaoer Jiebiao Oral liquid in combination with Ribavirin treatment on patients with hand-foot-mouth disease compared with the controlgroup that…
- Trial name
- NCT02328651
- Testing
- Ribavirin plus Xiao'er jiebiao oral liquid, Ribavirin
- Where
- China
- Volunteers
- 24 people
- Sponsor
- Children's Hospital of Fudan University
Hepatitis C Virus
Evaluate the Safety and Effectiveness of Sovaldi in Participants With Chronic Hepatitis C Virus (HCV) Infection in Korea
The objectives of this study are to collect and assess data related to safety and effectiveness of Sovaldi treatment regimens, per the approved prescribing information for Sovaldi, in routine clinical practice and report results…
- Trial name
- NCT02907996
- Testing
- Sofosbuvir
- Where
- 72 sites in South Korea
- Volunteers
- 2,033 people
- Sponsor
- Gilead Sciences
Cystic Fibrosis
Study of Dose Escalation of Liposomal Amikacin for Inhalation (ARIKAYCE™) - Extension Phase
A major factor in the respiratory health of cystic fibrosis (CF) patients is acquisition of chronic Pseudomonas (P.) aeruginosa infections. The infection rate with P.
- Trial name
- NCT03905642
- Testing
- Arikayce™
- Where
- 11 sites in Belgium, Hungary and 5 more
- Volunteers
- 49 people
- Sponsor
- Insmed Incorporated
Hemophilia A
Study of Pharmacokinetics, Efficacy and Safety of a Recombinant and Protein-Free Factor VIII (rAHF-PFM) in Hemophilia A Patients - A Continuation of Clinical Study 069901
The purpose of this study is to evaluate whether rAHF-PFM is safe and effective in the treatment of hemophilia A subjects. The study consists of 2 parts: Part 1 is a pharmacokinetic and safety study, and Part 2 is an evaluation…
- Trial name
- NCT00157053
- Testing
- Antihemophilic factor, recombinant, manufactured protein-free
- Where
- 24 sites in United States, Austria and 7 more
- Volunteers
- 82 people
- Sponsor
- Baxalta now part of Shire
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