Clinical trials: Medication Safety
Healthy Volunteers
A Study of TAK-227 in Healthy Adults
The main aim of this study is to test the effects of food consumption with sponsor compound TAK-227 in healthy participants. The study will also measure side effects, and to check how much TAK-227 stays in the blood over time to…
- Trial name
- NCT05818956
- Testing
- TAK-227
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Takeda
Rheumatoid Arthritis
A Study of Tocilizumab (RoActemra/Actemra) in Monotherapy or in Combination With Methotrexate or Other Non-Biologic DMARDs in Participants With Active Rheumatoid Arthritis and an Inadequate Response to Current Non-Biologic DMARD Therapy or the First Anti-TNF Biologic Agent
This open-label study will evaluate the efficacy and safety of tocilizumab as monotherapy or in combination with methotrexate or other non-biologic disease modifying anti-rheumatic drugs (DMARDs) in participants with active…
- Trial name
- ACT-MOVE (NCT02046603)
- Testing
- Tocilizumab, DMARDs, Oral Corticosteroids
- Where
- 38 sites in United Kingdom
- Volunteers
- 162 people
- Sponsor
- Hoffmann-La Roche
COVID-19
Four Different Experimental Drug Regimens to Standard of Care for the Treatment of Symptomatic Outpatients With COVID-19
This exploratory study is a randomized, single center, open label study of four different experimental treatment arms versus standard of care for the treatment of SARS-CoV-2 infection in symptomatic outpatients with mild disease…
- Trial name
- NCT04532931
- Testing
- Paracetamol, Artesunate-amodiaquine, Pyronaridine-artesunate
- Where
- South Africa
- Volunteers
- 192 people
- Sponsor
- Shin Poong Pharmaceutical Co. Ltd.
Drug-specific Antibodies, Diabetes Mellitus
Evaluate the Immunogenicity of a Novel Glucagon Formulation
This study provides information on immunogenicity of Nasal Glucagon (AMG504-1) with regards to the potential development of treatment-emergent anti-glucagon antibodies.
- Trial name
- NCT01959334
- Testing
- Nasal Glucagon (NG), Glucagon IM
- Where
- Canada
- Volunteers
- 75 people
- Sponsor
- Eli Lilly and Company
Healthy
A Study to Learn About the Study Medicine Called Zavegepant in Healthy Chinese Adult Participants
The purpose of this study is to learn about: how Zavegepant is changed and removed from the body after taken. safety of Zavegepant.
- Trial name
- NCT05960032
- Testing
- Zavegepant
- Where
- China
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Pfizer
Non-small Cell Lung Cancer
A Study Comparing MB02 and Avastin® in Subjects With Stage IIIB/IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
This is a multicenter, multinational, double-blind, 1:1 randomized, parallel-group, equivalence Phase 3 study to compare the efficacy and safety of MB02 plus chemotherapy (carboplatin and paclitaxel) versus Avastin® plus…
- Trial name
- STELLA (NCT03296163)
- Testing
- MB02 (Bevacizumab Biosimilar Drug), EU-approved Avastin®, Carboplatin
- Where
- 118 sites in Brazil, Bulgaria and 16 more
- Volunteers
- 627 people
- Sponsor
- mAbxience Research S.L.
Polypharmacy, Insomnia
MIDAS Cluster Randomized Controlled Trial of Implementation Strategies to Optimize Use of Medications in VA Clinical Settings
Scientific advances are constantly leading to better treatments. However, it is quite challenging for healthcare systems, including VA, to ask very busy providers to change the way they practice.
- Conditions
- Polypharmacy, Insomnia, Anticoagulants
- Trial name
- MIDAS cRCT (NCT05065502)
- Testing
- Academic Detailing (AD), LEAP
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- VA Office of Research and Development
Primary Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH)
Vytorin Reexamination Study (0653A-174)
This survey is conducted for preparing application material for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of VYTORIN through collecting…
- Trial name
- NCT01070966
- Volunteers
- 2,089 people
- Sponsor
- Organon and Co
Schizophrenia
Long-term Study of Cariprazine in Patients With Schizophrenia
The objective of this study is to evaluate the long-term safety, tolerability, and pharmacokinetics of cariprazine in patients with schizophrenia.
- Trial name
- NCT01104792
- Testing
- Cariprazine
- Where
- 86 sites in United States, Colombia and 4 more
- Volunteers
- 752 people
- Sponsor
- Forest Laboratories
Healthy Volunteers
Efficacy, Safety and Immunogenicity of Takeda's Tetravalent Dengue Vaccine (TDV) in Healthy Children
The main purpose of this study is to evaluate the efficacy of 2 doses of Tetravalent Dengue Vaccine Candidate (TDV) in preventing symptomatic dengue fever of any severity and due to any of the four dengue virus serotypes in 4 to…
- Trial name
- TIDES (NCT02747927)
- Testing
- Tetravalent Dengue Vaccine (TDV)
- Where
- 28 sites in Brazil, Colombia and 6 more
- Volunteers
- 20,099 people, healthy volunteers welcome
- Sponsor
- Takeda
Rheumatoid Arthritis
A Phase III Transition Study of DRL Rituximab to Reference Medicinal Products
The objective of the current study is to assess the immunogenicity and safety of transitioning subjects with RA to DRL_RI from US-rituximab/EU-rituximab to continued treatment with US-rituximab/EU-rituximab.
- Trial name
- RI-01-007 (NCT04268771)
- Testing
- Experimental: Arm A: DRL_RI, Arm B: Rituxan®/Mabthera®
- Where
- 26 sites in United States
- Volunteers
- 140 people
- Sponsor
- Dr. Reddy's Laboratories Limited
Multiple Myeloma
A Study of Modakafusp Alfa on Adult Participants With Relapsed/Refractory Multiple Myeloma
The main aims of this 3-part study are as follows: Part 1: To determine any side effects from modakafusp alfa single treatment and how often they occur.
- Trial name
- iinnovate-1 (NCT03215030)
- Testing
- Modakafusp alfa, Dexamethasone
- Where
- 94 sites in United States, Canada and 14 more
- Volunteers
- 272 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D LLC
Complicated Intra-abdominal Infection, Hosptial Acquired Pneumonia
A Study to Determine the Efficacy, Safety and Tolerability of Aztreonam-Avibactam (ATM-AVI) ± Metronidazole (MTZ) Versus Meropenem (MER) ± Colistin (COL) for the Treatment of Serious Infections Due to Gram Negative Bacteria.
A Phase 3 comparative study to determine the efficacy, safety and tolerability of Aztreonam-Avibactam (ATM-AVI) ± Metronidazole (MTZ) versus Meropenem (MER) ± Colistin (COL) for the treatment of serious infections due to Gram…
- Conditions
- Complicated Intra-abdominal Infection, Hosptial Acquired Pneumonia, Ventilator Associated Pneumonia
- Trial name
- REVISIT (NCT03329092)
- Testing
- ATM-AVI, MTZ, MER
- Where
- 157 sites in United States, Argentina and 19 more
- Volunteers
- 422 people
- Sponsor
- Pfizer
Tuberculosis
To Evaluate the Safety, Tolerability, and Efficacy of TMC207 as Part of an Individualized Multi-drug Resistant Tuberculosis (MDR-TB) Treatment Regimen in Participants With Sputum Smear-positive Pulmonary MDR-TB.
The purpose of this study is to evaluate the safety, tolerability and effectiveness of TMC207 in combination with an individualized background regimen (BR) of antibacterial drugs as treatment for MDR-TB
- Trial name
- NCT00910871
- Testing
- TMC207, Background Regimen (BR) for MDR-TB
- Where
- 27 sites in China, Estonia and 10 more
- Volunteers
- 241 people
- Sponsor
- Janssen Infectious Diseases BVBA
Multiple Sclerosis, Colitis, Ulcerative
A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics (PD) of GSK3888130B in Healthy Participants
This is a first time in human study designed to assess the safety, tolerability, pharmacokinetics and PD of GSK3888130B over a range of dose levels in healthy participants.
- Trial name
- NCT05131971
- Testing
- GSK3888130B
- Where
- United Kingdom
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Refractory Epilepsy
Bioavailability, Safety and Tolerability of Diazepam Nasal Spray Versus Diazepam Rectal Gel (Diastat®)
This is a multi-center, open-label, crossover, pharmacokinetic, bio-availability study involving adolescents and adults with refractory (drug-resistant) epilepsy.
- Trial name
- NCT02474407
- Testing
- diazepam nasal spray, diazepam rectal gel
- Where
- 22 sites in United States
- Volunteers
- 78 people
- Sponsor
- Acorda Therapeutics
Ototoxicity
SPI-1005 for Prevention and Treatment of Tobramycin Induced Ototoxicity
The primary objective of this study is to determine the safety and efficacy of SPI-1005 treatment in CF patients with active pulmonary exacerbation that are receiving an IV course of tobramycin, determined by comparing hearing…
- Trial name
- NCT02819856
- Testing
- SPI-1005 Ebselen 200mg Capsule x1, SPI-1005 Ebselen 200mg Capsule x2, SPI-1005 Ebselen 200mg Capsule x3
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Sound Pharmaceuticals, Incorporated
Friedreich's Ataxia
(+) Epicatechin to Treat Friedreich's Ataxia
This 24-week study will test the safety and effectiveness of synthetically produced (+) Epicatechin in treating patients who have Friedreich's Ataxia, a neurological disorder.
- Trial name
- NCT02660112
- Testing
- (+)-Epicatechin
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Ralitza Gavrilova
Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant
A Trial to Evaluate the Male Reproductive Safety of Pretomanid in Adult Male Participants With Drug Resistant Pulmonary Tuberculosis
Pretomanid is being used in an antimicrobial combination regimen(s) to treat patients with pulmonary tuberculosis (TB). The primary purpose of the Male Reproductive Safety - "BPaMZ/SEM"- clinical study is to evaluate the…
- Conditions
- Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant, Tuberculosis, MDR, Tuberculosis
- Trial name
- PaSEM (NCT04179500)
- Testing
- Pretomanid, Bedaquiline, moxifloxacin
- Where
- 4 sites in Georgia, South Africa
- Volunteers
- 26 people
- Sponsor
- Global Alliance for TB Drug Development
Coronary Artery Disease
The EVOLVE II Clinical Trial To Assess the SYNERGY Stent System for the Treatment of Atherosclerotic Lesion(s)
The purpose of this study is to assess the safety and effectiveness of the SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System for the treatment of subjects with atherosclerotic lesion(s) ≤ 34 mm in length (by…
- Trial name
- NCT01665053
- Testing
- PROMUS Element Plus, SYNERGY
- Where
- 126 sites in United States, Australia and 14 more
- Volunteers
- 1,684 people
- Sponsor
- Boston Scientific Corporation
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