Clinical trials: RANDOMIZED
Gallbladder
A Parallel Study Evaluating the Effect of A-F Betafood® on Gallbladder and Liver Function.
Gallstone formation is multifactorial: immutable risk factors include genetics and ethnicity, age and being female, and mutable risk factors include obesity, and metabolic syndrome, diet, rapid weight loss, and other conditions…
- Trial name
- NCT01981343
- Testing
- A-F Betafood
- Where
- Canada
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- KGK Science Inc.
Non Small Cell Lung Cancer
Comparing the Efficacy and Safety of a New Additional Treatment With Tislelizumab in Non-Small Cell Lung Cancer (NSCLC)
The primary objective of this study is to evaluate and compare major pathological response(MPR) rate and event-free survival (EFS) in participants receiving tislelizumab plus platinum-based doublet chemotherapy as the new…
- Trial name
- NCT04379635
- Testing
- Tislelizumab, Cisplatin injection, Paclitaxel injection
- Where
- 44 sites in China
- Volunteers
- 453 people
- Sponsor
- BeiGene
Type 2 Diabetes Mellitus
Study Examining Exenatide Long-Acting Release in Subjects With Type 2 Diabetes
Exenatide LAR is a long-acting release formulation of exenatide, which is a twice-daily dosage form currently under investigation as a potential treatment for people with type 2 diabetes mellitus.
- Trial name
- NCT00103935
- Testing
- Exenatide LAR
- Where
- 7 sites in United States
- Volunteers
- 45 people
- Sponsor
- AstraZeneca
Healthy
AZD1305 Single and Multiple Ascending Dose Study in Healthy Japanese and Caucasian Subjects
This is a phase I, single-blind, randomized, placebo-controlled single and repeated ascending dose study to assess the safety, tolerability and pharmacokinetics with oral doses of AZD1305 extended-release capsules in healthy male…
- Trial name
- JMAD (NCT00935025)
- Testing
- AZD1305
- Where
- 2 sites in United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Smallpox
Study Evaluating the Bioequivalence of Brincidofovir Form H and Form II Tablets in Healthy Adults
The goal of this clinical trial is to evaluate whether both Form H and Form II, 100mg brincidofovir tablets are bioequivalent, when given under fasting conditions in healthy adults.
- Trial name
- BCV-001 (NCT05935917)
- Testing
- Brincidofovir
- Where
- United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Emergent BioSolutions
Chronic Hepatitis C Virus
Safety and Efficacy of LDV/SOF Fixed-Dose Combination (FDC) ± Ribavirin in HCV Genotype 1 Subjects
This study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin (RBV), administered for 8 or 12 weeks of treatment in…
- Trial name
- NCT01726517
- Testing
- LDV/SOF, RBV
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Gilead Sciences
Anesthesia, Sedation
A Study Evaluating the Safety and Pharmacokinetics/Pharmacodynamics of HSK3486
This is a Phase I, single-center, open-label, randomized,two-way crossover, propofol-controlled, two-stage study evaluating the safety and pharmacokinetics/pharmacodynamics of IV maintenance dose after an initial dose and IV…
- Trial name
- NCT03745625
- Testing
- HSK3486, Propofol
- Where
- China
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Sichuan Haisco Pharmaceutical Group Co., Ltd
Dry Eye Disease
Evaluating the Safety, Tolerability, and Efficacy of GRF312 5% in Participants With Dry Eye Disease (DED).
This is a Phase 2, multi-site, double-masked, randomized, vehicle-controlled, study designed to evaluate the safety, tolerability, and efficacy in adult participants with DED.
- Trial name
- NCT07264517
- Testing
- GRF312 5%
- Where
- 10 sites in United States
- Volunteers
- 103 people
- Sponsor
- Instituto Grifols, S.A.
Major Depressive Disorder With Excessive Daytime Sleepiness Symptoms
Clinical Assessment of Response in the Treatment of Depression With Daytime Sleepiness Using Solriamfetol
CLARITY (Clinical Assessment of Response in the Treatment of Depression with Daytime Sleepiness Using Solriamfetol) is a Phase 3, double-blind, placebo-controlled, multicenter randomized withdrawal trial in patients with major…
- Trial name
- CLARITY (NCT07484217)
- Testing
- Solriamfetol 150 MG
- Where
- 40 sites in United States
- Volunteers
- 508 people
- Sponsor
- Axsome Therapeutics, Inc.
Knee Osteoarthritis
Micronized dHACM vs. Saline in the Treatment of Osteoarthritis of the Knee
The purpose of this study is to determine the safety and effectiveness of micronized dehydrated human amnion chorion membrane as compared to the 0.9% Sodium Chloride Injection, USP placebo control for the treatment of knee…
- Trial name
- NCT03485157
- Testing
- Micronized dHACM, Saline
- Where
- 17 sites in United States
- Volunteers
- 447 people
- Sponsor
- MiMedx Group, Inc.
Healthy Volunteers
A First-in-Human Single and Multiple Ascending Dose Study of MT-501
First-in-human Study to Assess the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) with Single and Multiple Ascending Oral Doses of MT-501 in Healthy Adults.
- Trial name
- NCT06762457
- Testing
- MT-501
- Where
- United States
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Mirador Therapeutics, Inc.
Suspected or Documented Gram-negative Bacterial Infection
Safety, Tolerability, Efficacy and Pharmacokinetics of Imipenem/Cilastatin/Relebactam (MK-7655A) in Pediatric Participants With Gram-negative Bacterial Infection (MK-7655A-021)
The primary purpose of this study is to evaluate the safety and tolerability of imipenem/cilastatin/relebactam (IMI/REL) in participants from birth to less than 18 years of age with confirmed or suspected gram-negative bacterial…
- Trial name
- NCT03969901
- Testing
- IMI/REL, Active Control, Oral Switch
- Where
- 67 sites in United States, Bulgaria and 16 more
- Volunteers
- 115 people
- Sponsor
- Merck Sharp & Dohme LLC
Hereditary Angioedema, Angioneurotic Edema
Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema
Hereditary angioedema ("HAE") is a genetic disorder characterized by sudden recurrent attacks of local swelling (angioedema). These attacks are often painful and disabling, and, in some cases, life-threatening.
- Conditions
- Hereditary Angioedema, Angioneurotic Edema, Genetic Disorders
- Trial name
- NCT00262301
- Testing
- recombinant human C1 inhibitor
- Where
- 2 sites in Netherlands, Romania
- Volunteers
- 75 people
- Sponsor
- Pharming Technologies B.V.
Asthma
Foster 100/6 mg NEXThaler Versus Foster 100/6mg Pressurized Metered-dose Inhaler (pMDI) in Patients With Controlled Asthma.
Primary Objective To demonstrate the non-inferiority of Foster® NEXThaler® 100/6 µg versus (vs.) Foster® pressurised metered dose inhaler (pMDI) 100/6 µg in terms of pulmonary function (change from baseline to the entire…
- Trial name
- FORTUNE (NCT03453112)
- Testing
- Foster 100/6µg NEXThaler, Foster 100/6µg pMDI
- Where
- 51 sites in China
- Volunteers
- 494 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Adult Attention Deficit Hyperactivity Disorder
The Safety and Efficacy of OPC-64005 in the Treatment of Adult Attention-deficit/Hyperactivity Disorder
A trial to assess the safety and efficacy of OPC-64005 in the treatment of adult attention-deficit/hyperactivity disorder.
- Trial name
- NCT03324581
- Testing
- OPC-64005, Atomoxetine
- Where
- 26 sites in United States
- Volunteers
- 239 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Healthy
Pharmacokinetic Study of SP-103 in Healthy Adult Human Subjects
This study will assess the systemic exposure and pharmacokinetic parameters of SP-103 topical system following one, two, or three topical system applications and compare to the pharmacokinetics of ZTlido.
- Trial name
- NCT04819581
- Testing
- SP-103, ZTlido
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Scilex Pharmaceuticals, Inc.
Pharmacokinetics
Fasting Bioequivalence Study of 2 Metformin 1000 mg Prolonged Release Tablets in 28 Healthy Male and Female Volunteers
The primary objective was to compare the rate and extent of absorption of Metformin XR after administration of a Test Product Metformin 1000 mg Prolonged Release Tablets (JSC Farmak, Ukraine) and Reference Product Glucophage® XR…
- Trial name
- NCT05123781
- Testing
- Metformin 1000 mg Prolonged Release Tablets (JSC Farmak, Ukraine), Glucophage® XR 1000 mg Prolonged Release Tablets (Merck Serono Ltd, UK)
- Where
- Czechia
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Joint Stock Company "Farmak"
Relapsing Multiple Sclerosis
Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS) (REMODEL-2)
To compare the efficacy and safety of remibrutinib versus teriflunomide in patients with relapsing multiple sclerosis (RMS)
- Trial name
- NCT05156281
- Testing
- Remibrutinib, Teriflunomide
- Where
- 223 sites in United States, Argentina and 25 more
- Volunteers
- 1,007 people
- Sponsor
- Novartis Pharmaceuticals
Healthy
Pilot Study on the Effect of a XOS95 on the Human Gut Microbiome
The purpose of this clinical trial is to assess the efficacy of a novel prebiotic, XOS95, at two different dosages, in comparison to a placebo by assessing shifts in microbial populations after 8 weeks of supplementation…
- Trial name
- NCT03074019
- Testing
- Xylooligosaccacharide, Maltodextrin
- Where
- Canada
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Prenexus Health
Diabetes Mellitus, Type 2
Efficacy and Safety of Alogliptin in Participants With Type 2 Diabetes
The purpose of the study is to determine the efficacy of alogliptin compared to placebo when given alone or as add-on therapy to metformin or add-on to pioglitazone (with or without metformin).
- Trial name
- NCT01289119
- Testing
- Alogliptin, Metformin, Pioglitazone
- Where
- 21 sites in China, Hong Kong and 1 more
- Volunteers
- 506 people
- Sponsor
- Takeda
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