Clinical trials: Medication Safety
- Condition Medication Safety
- Funder type Industry (pharma, biotech, devices)
- Age group Children (under 18)
CCR5-tropic HIV-1 Infection
Safety And Efficacy Of Maraviroc In Patients For HIV Patients (Regulatory Post Marketing Commitment Plan)
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors…
- Trial name
- NCT00864474
- Testing
- CELSENTRI® Tablets
- Volunteers
- 68 people
- Sponsor
- ViiV Healthcare
Hepatitis C
An Observational Study of Maviret (Glecaprevir/Pibrentasvir) for Korean Chronic Hepatitis C Genotypes 1 to 6 Patients According to the Standard for Re-examination of New Drugs
Post-marketing surveillance study to evaluate the real world safety and effectiveness of Maviret (Glecaprevir/Pibrentasvir) administered under a normal, routine treatment practice by Korean patients with Chronic Hepatitis C…
- Trial name
- Maviret PMS (NCT03740230)
- Where
- 61 sites in South Korea
- Volunteers
- 3,134 people
- Sponsor
- AbbVie
Dysmenorrhea
Efficacy and Safety Study of NPC-01 to Treat Dysmenorrhea
The purpose of this study is to determine whether NPC-01 is effective in the treatment of dysmenorrhea.
- Trial name
- NCT01129102
- Testing
- NPC-01, IKH-01
- Volunteers
- 215 people
- Sponsor
- Nobelpharma
Partial Epilepsies
Determine Safety and Efficacy of Long-term Oral Lacosamide in Patients With Partial Seizures
The purpose of this trial is to determine whether lacosamide is safe and effective for long-term use in patients with partial-seizures from epilepsy
- Trial name
- NCT00522275
- Testing
- lacosamide
- Where
- 60 sites in United States
- Volunteers
- 308 people
- Sponsor
- UCB BIOSCIENCES, Inc.
Schizophrenia
A Clinical Study to Evaluate the Long-term Safety and Tolerability of an Investigational Drug in People With Schizophrenia
This is a clinical trial to determine the long-term safety and tolerability of an investigational drug in people with schizophrenia. Participants in the study will receive the drug being studied.
- Trial name
- NCT04109950
- Testing
- SEP-363856
- Where
- 78 sites in United States, Bulgaria and 6 more
- Volunteers
- 463 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
HIV Infections
A Multicenter, Open-Label, Randomized, 24-Week Study to Compare the Safety and Activity of Indinavir Sulfate, 800 Mg q 8 h Versus 1,200 Mg q 12 h in Combination With Zidovudine and 3TC
To demonstrate that the antiviral activity and safety/tolerability of a test regimen of indinavir is equivalent to that of a control regimen of indinavir when each is coadministered with zidovudine (ZDV) (or stavudine, d4T) and…
- Trial name
- NCT00002208
- Testing
- Indinavir sulfate, Lamivudine, Stavudine
- Where
- 15 sites in United States
- Volunteers
- 400 people
- Sponsor
- Merck Sharp & Dohme LLC
Asthma
Clinical Study Evaluating Safety and Efficacy of Fluticasone Furoate in People With Asthma
A randomised, double-blind, placebo-controlled (with rescue medication), multi-centre study to evaluate the efficacy and safety of inhaled fluticasone furoate in the treatment of persistent asthma in adults and adolescents not…
- Trial name
- NCT01436071
- Testing
- Fluticasone furoate 50mcg
- Where
- 24 sites in United States, Mexico and 2 more
- Volunteers
- 248 people
- Sponsor
- GlaxoSmithKline
Pompe Disease (Late-onset)
Evaluation of the Safety and Efficacy of Late-onset Pompe Disease Gene Therapy Drug
This study is being conducted to evaluate the safety and effectiveness of GC301 adeno-associated virus vector expressing codon-optimized human acid alpha-glucosidase (GAA) as potential gene therapy for Pompe disease.
- Trial name
- NCT06391736
- Testing
- GC301
- Where
- China
- Volunteers
- 33 people
- Sponsor
- GeneCradle Inc
HIV Infections
The Safety and Effectiveness of Two Forms of Saquinavir Combined With Other Anti-HIV Drugs in HIV-Infected Infants and Children
To determine the pharmacokinetic properties, tolerance and safety of 2 formulations of saquinavir, given in combination with 2 nucleoside antiretroviral drugs (part 1) or in combination with nelfinavir and nucleoside…
- Trial name
- NCT00002380
- Testing
- Nelfinavir mesylate, Saquinavir
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- Hoffmann-La Roche
Infertility, Female
A Post Marketing Observational Study of the Safety and Efficacy of Elonva (Corifollitropin Alfa) in General Practice (P08165)
This observational study will examine the safety and efficacy profile of Elonva (corifollitropin alfa) when administered in Korean women undergoing controlled ovarian stimulation (COS) in combination with a gonadotropin-releasing…
- Trial name
- NCT01408615
- Testing
- corifollitropin alfa
- Volunteers
- 472 people
- Sponsor
- Organon and Co
HIV Infections
A Comparison of Lamivudine and Zidovudine, Used Alone and Together, in HIV-Infected Patients Who Have Not Used Zidovudine in the Past
To evaluate the safety and efficacy of high-dose lamivudine (3TC) alone versus zidovudine (AZT) alone versus 3TC at high and low doses in combination with AZT in HIV-1 infected patients.
- Trial name
- NCT00002320
- Testing
- Lamivudine, Zidovudine
- Where
- 22 sites in United States, Canada and 1 more
- Volunteers
- 320 people
- Sponsor
- Glaxo Wellcome
Pompe Disease Infantile-Onset
Evaluation of the Safety and Efficacy of Infantile-onset Pompe Disease Gene Therapy Drug
This study is being conducted to evaluate the safety and effectiveness of GC301 adeno-associated virus vector expressing codon-optimized human acid alpha-glucosidase (GAA) as potential gene therapy for Pompe disease.
- Trial name
- NCT05793307
- Testing
- GC301
- Where
- 5 sites in China
- Volunteers
- 16 people
- Sponsor
- GeneCradle Inc
Epilepsy, Epilepsy, Focal
A Study of the Efficacy and Safety of RWJ-333369 as add-on Therapy in the Treatment of Partial Onset Seizures.
The purpose of this study is to demonstrate that RWJ-333369 is safe and effective as add-on treatment of partial onset seizures.
- Conditions
- Epilepsy, Epilepsy, Focal, Seizure Disorder, Complex Partial Seizures
- Trial name
- NCT00433667
- Testing
- RWJ-333369
- Volunteers
- 563 people
- Sponsor
- SK Life Science, Inc.
BiPolar
Study to Assess the Safety and Pharmacokinetics of ADASUVE® at Doses of 2.5, 5, or 10 mg in Children and Adolescents (10 Through 17 Years of Age) With Any Condition Warranting Chronic Use of an Antipsychotic Medication
This study is to assess the pharmacokinetics of loxapine and will be using plasma concentration data obtained over 48 hours after administration of the study drug
- Trial name
- NCT02184767
- Testing
- ADASUVE®
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Clostridium Difficile Infection
Bezlotoxumab (MK-6072) Versus Placebo in Children With Clostridium Difficile Infection (CDI) (MK-6072-001)
The primary objectives of this study are to evaluate the pharmacokinetics (PK), safety, and tolerability of bezlotoxumab (MK-6072) in children aged 1 to <18 years of age with a confirmed diagnosis of Clostridium difficile…
- Trial name
- MODIFY III (NCT03182907)
- Testing
- Bezlotoxumab, Antibacterial drug treatment (ABD)
- Where
- 75 sites in United States, Argentina and 15 more
- Volunteers
- 148 people
- Sponsor
- Merck Sharp & Dohme LLC
Epidermolysis Bullosa, Junctional Epidermolysis Bullosa
A Study to Learn About the Safety and Efficacy of the Drug Oleogel-S10 in Japanese Patients With Epidermolysis Bullosa
The goal of this clinical trial is to learn if Oleogel-S10 gel works to treat skin wounds from two types of inherited epidermolysis bullosa (EB): junctional EB (JEB) or dystrophic EB (DEB) in the Japanese population.
- Conditions
- Epidermolysis Bullosa, Junctional Epidermolysis Bullosa, Epidermolysis Bullosa, Dystrophic, Epidermolysis Bullosa, Junctional
- Trial name
- REVIVE (NCT06917690)
- Testing
- Oleogel-S10
- Where
- 6 sites in Japan
- Volunteers
- 6 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Eosinophilic Esophagitis
Safety Study of CC-93538 in Adult and Adolescent Participants With Eosinophilic Esophagitis
This study is an open-label, uncontrolled study design to evaluate the long-term safety and tolerability of treatment with CC-93538.
- Trial name
- NCT04991935
- Testing
- CC-93538
- Where
- 167 sites in United States, Argentina and 13 more
- Volunteers
- 367 people
- Sponsor
- Celgene
Neovascular Glaucoma
Study to Learn More About Safety of Aflibercept Injection in Japanese Patients With Neovascular Glaucoma (NVG)
This is a prospective, observational, multi-center and post-authorization safety study that includes patients with a diagnosis of Neovascular Glaucoma. The investigator will have made the decision to use Eylea for treatment.
- Trial name
- NCT04519619
- Testing
- Aflibercept (Eylea, BAY86-5321)
- Where
- Japan
- Volunteers
- 480 people
- Sponsor
- Bayer
Hand, Foot, and Mouth Disease
Effectiveness and Safety of Chinese Medicine to Treat Hand, Foot, and Mouth Disease
The study is aimed to evaluate the effectiveness and safety of Xiyanping injection,a traditional Chinese medicine (TCM), in the treatment of severe type of hand, foot, and mouth disease (HFMD).
- Trial name
- NCT01554930
- Testing
- Western therapy (mannitol, methylprednisolone, immunoglobulin, febrifuge), Xiyanping injection plus western therapy
- Where
- 3 sites in China
- Volunteers
- 230 people
- Sponsor
- Jiangxi Qingfeng Pharmaceutical Co. Ltd.
Healthy Volunteers Eligible for Study; Drug Being Developed for Allergic Conjunctivitis
Safety Study of Ophthalmic Solution in Healthy, Normal Volunteers
The purpose of this study is to evaluate the safety of R89674 0.25% ophthalmic solution in healthy normal volunteers
- Trial name
- NCT00223951
- Testing
- R89674 (generic name not yet established)
- Where
- 6 sites in United States
- Volunteers
- 900 people, healthy volunteers welcome
- Sponsor
- Vistakon Pharmaceuticals