Clinical trials: Medication Safety
Head Lice
Clinical Endpoint Study of Ivermectin 0.5% Lotion
This clinical study is designed to evaluate the clinical (therapeutic) effect of a generic ivermectin lotion 0.5% (Actavis Laboratories UT, Inc.) relative to that of the Food and Drug Administration (FDA) Reference Listed Drug…
- Trial name
- NCT03301649
- Testing
- Generic Ivermectin Lotion 0.5%, Sklice® (Ivermectin) Lotion 0.5%, Vehicle Lotion
- Where
- United States
- Volunteers
- 905 people, healthy volunteers welcome
- Sponsor
- Actavis Inc.
Liver Transplantation
A Study to Assess the Pharmacokinetics of a Modified-release Tacrolimus Based Immunosuppression Regimen in Stable Liver Transplant Patients
A study to assess the pharmacokinetics, safety and effectiveness of tacrolimus in stable liver transplant patients converted from a tacrolimus (Prograf®) based immunosuppression regimen to a modified release tacrolimus based…
- Trial name
- NCT00282243
- Testing
- tacrolimus modified release (MR), tacrolimus
- Where
- 10 sites in United States
- Volunteers
- 70 people
- Sponsor
- Astellas Pharma Inc
Diabetes Mellitus
Study of the Safety and Efficacy of MK-8521 Compared to Placebo and a Diabetes Drug in Participants With Type 2 Diabetes Mellitus (MK-8521-003)
This study will evaluate the safety, efficacy, and pharmacokinetics of MK-8521 given once daily compared to placebo and another diabetes drug in participants with Type 2 diabetes mellitus (T2DM).
- Trial name
- NCT01982630
- Testing
- MK-8521, Liraglutide
- Volunteers
- 87 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Type 2 Diabetes Mellitus
A Study to Examine the Effects of Exenatide Once-Weekly Injection on Glucose Control and Safety in Asian Subjects
Previous studies have suggested that a once-weekly formulation of exenatide may provide sustained glycemic control. These previous studies of exenatide once weekly have been conducted in non-Asian populations, so this study has…
- Trial name
- NCT00917267
- Testing
- exenatide once weekly, exenatide twice daily
- Where
- 42 sites in China, India and 3 more
- Volunteers
- 691 people
- Sponsor
- AstraZeneca
Multiple Myeloma
An Open-label, Dose Escalation Study in Japanese Participants With Relapsed/Refractory Multiple Myeloma Who Have Failed Prior Anti Myeloma Treatments
Belantamab mafodotin (GSK2857916) is a first in class, antibody dependent cellular cytotoxicity (ADCC) enhanced, humanized immunoglobulin G1 (IgG1) antibody-drug conjugate (ADC) which binds specifically to B cell maturation…
- Trial name
- NCT03828292
- Testing
- Belantamab mafodotin, Bortezomib, Dexamethasone
- Where
- 4 sites in Japan
- Volunteers
- 15 people
- Sponsor
- GlaxoSmithKline
Nosocomial Pneumonia (NP), Ventilator-associated Pneumonia (VAP)
A Study Comparing Ceftazidime-Avibactam Versus Meropenem in Hospitalized Adults With Nosocomial Pneumonia
The purpose of the study is to evaluate the effects of Ceftazidime-Avibactam compared to Meropenem for treating hospitalized adults with nosocomial pneumonia including ventilator-associated pneumonia
- Trial name
- NCT01808092
- Testing
- ceftazidim-avibactam (CAZ-AVI, experimental product), meropenem (active comparator)
- Where
- 123 sites in Argentina, Brazil and 24 more
- Volunteers
- 969 people
- Sponsor
- Pfizer
Epilepsy
A Study to Assess the Safety and Efficacy of Lacosamide Versus Placebo (a Pill Without Active Medication) in Patients With Idiopathic Generalised Epilepsy Who Are Already Taking Anti-epileptic Medications
Evaluating efficacy \& safety of lacosamide versus Placebo in a blinded fashion as add-on Therapy for Primary Generalized Tonic-clonic (PGTC) seizures in subject 4 years of age or greater with idiopathic generalized epilepsy…
- Trial name
- VALOR (NCT02408523)
- Testing
- Lacosamide Tablet, Lasosamide Oral Solution
- Where
- 115 sites in United States, Australia and 20 more
- Volunteers
- 242 people
- Sponsor
- UCB BIOSCIENCES, Inc.
C9orf72 Amyotrophic Lateral Sclerosis (ALS), Frontotemporal Dementia
Safety and Therapeutic Potential of the FDA-approved Drug Metformin for C9orf72 ALS/FTD
The primary objective is to assess the safety and tolerability of Metformin in subjects with C9orf72 amyotrophic lateral sclerosis administered for 24 weeks.
- Trial name
- NCT04220021
- Testing
- Metformin
- Where
- United States
- Volunteers
- 41 people
- Sponsor
- University of Florida
Tourette's Disorder
ABF Tourette's Disorder Post Marketing Surveillance Study
This is a Post-Marketing Surveillance study of Abilify® tablets in accordance with Korean regulations on New Drug Re-examination (i.e. New Drug Re-examination Standards: KFDA Notification No. 2010-94 dated 27 December 2010).
- Trial name
- NCT01795105
- Where
- 4 sites in South Korea
- Volunteers
- 692 people
- Sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.
Parkinson Disease
Safety and Efficacy of Long-term Daily Use of Mirapex®-LA Tablets in Patients With Parkinson's Disease
Post-marketing surveillance (PMS) to investigate the safety and efficacy of long-term daily use of Mirapex®-LA Tablets in patients with Parkinson's disease.
- Trial name
- NCT01525641
- Testing
- Mirapex LA
- Where
- 118 sites in Japan
- Volunteers
- 615 people
- Sponsor
- Boehringer Ingelheim
Osteoporosis
Post Marketing Surveillance For General Drug Use To Assess the Safety And Efficacy Profile Of Viviant In Usual Practice
This survey is conducted for preparing application material for re examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, and assessing the safety and efficacy profiles of VIVIANT in usual practice…
- Trial name
- NCT01793142
- Testing
- Viviant
- Where
- 60 sites in South Korea
- Volunteers
- 3,430 people
- Sponsor
- Pfizer
Epilepsy, Dravet Syndrome (DS)
A Study of Soticlestat in Adults and Children With Rare Epilepsies
The main aim is to assess the long-term safety and tolerability of soticlestat when used along with other anti-seizure treatment. Participants will receive soticlestat twice a day.
- Conditions
- Epilepsy, Dravet Syndrome (DS), Lennox-Gastaut Syndrome (LGS)
- Trial name
- Endymion 1 (NCT03635073)
- Testing
- Soticlestat
- Where
- 59 sites in United States, Australia and 6 more
- Volunteers
- 156 people
- Sponsor
- Takeda
β-thalassemia Major
A Study Evaluating the Safety and Efficacy of the LentiGlobin BB305 Drug Product in β-Thalassemia Major Participants
This is a non-randomized, open label, multi-site, single-dose, phase 1/2 study in up to 18 participants (including at least 3 adolescents between 12 and 17 years of age, inclusive) with β-thalassemia major.
- Trial name
- NCT01745120
- Testing
- LentiGlobin BB305 Drug Product
- Where
- 6 sites in United States, Australia and 1 more
- Volunteers
- 19 people
- Sponsor
- Genetix Biotherapeutics Inc.
Type 2 Diabetes Mellitus
Long-term Safety Study of Alogliptin in Participants With Type 2 Diabetes in Japan
The purpose of this study was to evaluate the long-term safety and efficacy of SYR-322, once daily (QD), to an α-glucosidase inhibitor, three times daily (TID), administered for 40 consecutive weeks in participants who completed…
- Trial name
- NCT01263496
- Testing
- Alogliptin, Voglibose
- Volunteers
- 438 people
- Sponsor
- Takeda
Diabetes Mellitus, Type 2, Hyperglycemia
Safety and Efficacy Study of Empagliflozin and Metformin for 24 Weeks in Treatment Naive Patients With Type 2 Diabetes
This study will investigate the efficacy and safety of two doses (high and low) of empagliflozin in combination with metformin (500 mg and 1000 mg) administered twice daily in patients with type 2 diabetes mellitus (T2DM).
- Trial name
- NCT01719003
- Testing
- Metformin 500 mg bid, Metformin 1000 mg bid, Empagliflozin low dose qd
- Where
- 190 sites in United States, Brazil and 19 more
- Volunteers
- 1,413 people
- Sponsor
- Boehringer Ingelheim
Mucositis
Study to See How Safe Curcumin is and How Well it Works When Used to Treat Mucositis in Patients Getting Chemotherapy
Oral mucositis is a common side effect from cancer treatment. Patients receiving chemotherapy and radiotherapy can get very painful sores in their mouth that compromise nutrition and oral hygiene as well as increase risk for…
- Trial name
- NCT02300727
- Testing
- Curcumin-MTD, Mouthwash-standard pharmacy preparation, Curcumin
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Amy Beres
Rheumatoid Arthritis
A Study on Safety and Efficacy of Tocilizumab (RoActemra/Actemra) Alone or in Combination With Non-Biologic Antirheumatics in Participants With Rheumatoid Arthritis
This multi-center, open-label single arm Phase IIIb study will evaluate the safety and efficacy of subcutaneous (SC) tocilizumab administered as monotherapy and/or in combination with methotrexate or other non-biologic disease…
- Trial name
- OSCAR (NCT01987479)
- Testing
- Non-Biologic DMARDs, Tocilizumab, Methotrexate
- Where
- 20 sites in Netherlands
- Volunteers
- 150 people
- Sponsor
- Hoffmann-La Roche
Depressive Disorder, Major
Safety and Tolerability of Vortioxetine (LuAA21004) - Open Label Extension Study
The purpose of this study is to determine the long-term safety and tolerability of vortioxetine, once daily (QD), in participants with major depressive disorder.
- Trial name
- NCT01152996
- Testing
- Vortioxetine
- Volunteers
- 1,075 people
- Sponsor
- Takeda
Type 2 Diabetes
A Study of Dulaglutide in Japanese Participants With Type 2 Diabetes
The main purpose of this study is to evaluate the efficacy and safety of combination therapy with dulaglutide and insulin in Japanese participants with type 2 diabetes.
- Trial name
- NCT02750410
- Testing
- Dulaglutide
- Where
- 25 sites in Japan
- Volunteers
- 159 people
- Sponsor
- Eli Lilly and Company
Adenocarcinoma, Gastric, Neoplasm, Breast
DS-8201a in Patients With Cancer That Tests Positive for Human Epidermal Growth Factor Receptor 2 (HER2) Protein
HER2-positive cancer is a cancer that tests positive for a protein called human epidermal growth factor receptor 2 (HER2). HER2 promotes the growth of certain cancer cells.
- Trial name
- NCT03368196
- Testing
- DS-8201a
- Where
- 2 sites in Taiwan
- Volunteers
- 12 people
- Sponsor
- Daiichi Sankyo Taiwan Ltd., a Daiichi Sankyo Company
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