Clinical trials: Medication Safety
Seizures
Cannabidiol Oral Solution as an Adjunctive Treatment for Treatment-resistant Seizure Disorder
This is a multicenter, open-label trial to assess the long-term safety and efficacy of Cannabidiol Oral Solution as adjunctive therapy for pediatric participants with treatment-resistant seizure disorders, including…
- Trial name
- NCT02318602
- Testing
- Cannabidiol Oral Solution
- Where
- 11 sites in United States
- Volunteers
- 52 people
- Sponsor
- INSYS Therapeutics Inc
Diabetes, Diabetes Mellitus, Type 2
A Trial Investigating the Efficacy and Safety of Insulin Detemir Versus Insulin NPH in Combination With Metformin and Diet/Exercise in Children and Adolescents With Type 2 Diabetes Insufficiently Controlled on Metformin With or Without Other Oral Antidiabetic Drug(s) With or Without Basal Insulin
This trial is conducted globally. The aim of the trial is to investigate the efficacy and safety of insulin detemir versus insulin Neutral Protamine Hagedorn (NPH) in combination with the maximum tolerated dose of metformin and…
- Trial name
- iDEAt2 (NCT02131272)
- Testing
- Insulin detemir, Insulin NPH, Diet/exercise
- Where
- 82 sites in United States, Argentina and 22 more
- Volunteers
- 42 people
- Sponsor
- Novo Nordisk A/S
Asthma
Evaluating the Efficacy and Safety of Fluticasone Furoate Inhalation Powder in the Treatment of Asthma in Adults and Adolescents
A randomised, double-blind, double-dummy, placebo controlled (with rescue medication), multicenter study to evaluate the efficacy and safety of Fluticasone Furoate inhalation powder in the treatment of persistent asthma in adults…
- Trial name
- NCT01159912
- Testing
- Fluticasone propionate, Fluticasone furoate
- Where
- 82 sites in United States, Belgium and 3 more
- Volunteers
- 350 people
- Sponsor
- GlaxoSmithKline
Mild Cognitive Impairment Due to Alzheimer's Disease
Biomarker Qualification for Risk of Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease (AD) and Safety and Efficacy Evaluation of Pioglitazone in Delaying Its Onset
The purpose of this study is to qualify the biomarker risk algorithm for prognosis of the risk of developing Mild Cognitive Impairment due to Alzheimer's Disease (MCI-AD), and also to evaluate the efficacy of pioglitazone…
- Trial name
- TOMMORROW (NCT01931566)
- Testing
- Pioglitazone
- Where
- 55 sites in United States, Australia and 3 more
- Volunteers
- 3,494 people, healthy volunteers welcome
- Sponsor
- Takeda
Locally Advanced or Metastatic Urothelial Carcinoma
A Study of the Safety and Efficacy of Various Combinations of Avelumab as Therapy in Locally Advanced or Metastatic Urothelial Carcinoma (JAVELIN Bladder Medley)
The purpose of this study is to assess the safety and efficacy of avelumab in combination with other anti-tumor agents as a maintenance treatment in participants with bladder cancer.
- Trial name
- NCT05327530
- Testing
- Avelumab, Sacituzumab Govitecan (SG), M6223
- Where
- 98 sites in United States, Australia and 10 more
- Volunteers
- 256 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Arthritis, Rheumatoid
Study to Evaluate Safety and Effects of Tofacitinib and Biologic Disease Modifying Antirheumatic Drugs in People Treated for Rheumatoid Arthritis
This is a secondary structured database observational study conducted in Rheumatoid Arthritis (RA) patients treated with biologic and nonbiologic DMARDs, including tofacitinib, collected as part of the CorEvitas Japan RA…
- Trial name
- NCT05572567
- Where
- Japan
- Volunteers
- 1,972 people
- Sponsor
- Pfizer
Diabetes Mellitus, Type 2
A Type 2 Diabetes Study of the Longer-Term Glycemic Effect of AVANDAMET vs. Metformin
This study will evaluate the longer-term glycemic effect of two medicines approved for initial treatment of type 2 diabetes. The study consists of a 2 week screening period (2 study visits), followed by an 80 week double-blind…
- Trial name
- NCT00386100
- Testing
- Avandamet 6 mg/1500 mg (ttd), Avandamet 4 mg/1000 mg (ttd), Avandamet 2 mg/500 mg (ttd)
- Where
- 116 sites in United States, Argentina and 7 more
- Volunteers
- 688 people
- Sponsor
- GlaxoSmithKline
Seizures
A Trial of the Efficacy and Safety of CVL-865 as Adjunctive Therapy in the Treatment of Focal Onset Seizures
The goal of this clinical trial is to learn if CVL-865, when taken regularly with other anti-seizure medicines, works to prevent seizures in adults with drug-resistant focal onset seizures.
- Trial name
- NCT04244175
- Testing
- CVL-865
- Where
- 76 sites in United States, Australia and 5 more
- Volunteers
- 154 people
- Sponsor
- AbbVie
Immunogenicity, Healthy Volunteers
Comparative Immunogenicity Study of Multiple Doses of Proposed Pegfilgrastim Biosimilar, INTP5 of Intas Pharmaceuticals Ltd., India Against Neulasta of Amgen Inc., USA in Healthy, Adult Human Subjects.
The study was an assessor-blind, balanced, parallel, randomized, two-treatment, comparative immunogenicity study of multiple doses of subcutaneous (SC) Pegfilgrastim injection (6 mg/0.6 mL; Intas Pharmaceuticals Ltd.
- Trial name
- NCT04015232
- Testing
- INTP5, US Neulasta
- Where
- India
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Intas Pharmaceuticals, Ltd.
Pertussis, Whooping Cough
Study of BPZE1 Intranasal Pertussis Vaccine (Administered Via VaxINator(TM)), Prime + Boost, in Healthy Adults
This study evaluates the safety and immunogenicity of the BPZE1 live attenuated pertussis vaccine, intended to prevent nasopharyngeal colonization and pertussis disease, and compares a single (prime) BPZE1 dose or BPZE1 2-dose…
- Trial name
- NCT03942406
- Testing
- BPZE1 pertussis vaccine and VaxINator(TM) Atomization Device
- Where
- 3 sites in United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- ILiAD Biotechnologies
B-cell Acute Lymphoblastic Leukemia, Relapsed B-cell Acute Lymphoblastic Leukemia
Study of Efficacy and Safety of CTL019 in Pediatric ALL Patients
This was a single arm, open-label, multi-center, phase II study to determine the efficacy and safety of an experimental therapy called CTL019 T-cells in pediatric patients with B-cell acute lymphoblastic leukemia, who were…
- Conditions
- B-cell Acute Lymphoblastic Leukemia, Relapsed B-cell Acute Lymphoblastic Leukemia, Refractory B-cell Acute Lymphoblastic Leukemia
- Trial name
- ENSIGN (NCT02228096)
- Testing
- CTL019 T-cells
- Where
- 13 sites in United States
- Volunteers
- 75 people
- Sponsor
- Novartis Pharmaceuticals
Rheumatoid Arthritis, Psoriasis
A Study of Experimental Medication BMS-986251, Taken by Mouth, in Healthy Participants and Patients With Average to Very Serious Psoriasis
The purpose of this study is to investigate experimental medication BMS-986251 taken by mouth in healthy patients and patients with average to very serious Psoriasis (a condition characterized by itchy, dry skin with a scaly…
- Conditions
- Rheumatoid Arthritis, Psoriasis, Ankylosing Spondylitis, Inflammatory Bowel Diseases
- Trial name
- NCT03329885
- Testing
- BMS-986251
- Where
- Netherlands
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Stomach Ulcer, Duodenal Ulcer
A Safety and Efficacy Study of Lansoprazole in Preventing Aspirin-Induced Gastric and Duodenal Ulcers
The purpose of this study is to determine whether lansoprazole, once daily (QD), compared to gefarnate, twice daily (BID), is effective in preventing the recurrence of gastric and duodenal ulcers in patients receiving long term…
- Trial name
- NCT00762359
- Testing
- Lansoprazole, Gefarnate
- Where
- 65 sites in Japan
- Volunteers
- 461 people
- Sponsor
- Takeda
Diabetes Mellitus, Type 2
A Research Study to See How Well the New Weekly Medicine IcoSema, Which is a Combination of Insulin Icodec and Semaglutide, Controls Blood Sugar Level in People With Type 2 Diabetes Compared to Weekly Insulin Icodec
This study will compare the new medicine IcoSema, which is a combination of insulin icodec and semaglutide, taken once a week, to insulin icodec taken once a week in people with type 2 diabetes.
- Trial name
- COMBINE 1 (NCT05352815)
- Testing
- IcoSema, Insulin icodec
- Where
- 281 sites in United States, Australia and 20 more
- Volunteers
- 1,291 people
- Sponsor
- Novo Nordisk A/S
Hypertension
Efficacy and Safety of Azilsartan Medoxomil in Participants With Essential Hypertension
The purpose of this study is to determine the safety and efficacy of azilsartan medoxomil, once daily (QD), compared to placebo and olmesartan in participants with essential hypertension.
- Trial name
- NCT00696241
- Testing
- Azilsartan medoxomil and olmesartan, Olmesartan
- Where
- 85 sites in United States, Argentina and 1 more
- Volunteers
- 1,275 people
- Sponsor
- Takeda
Pain, Nausea
A Study in Opioid-Experienced, Non-Dependent Recreational Drug Users to Determine the Abuse Potential and Safety of CL-108 Tablets Administered Via the Oral Route
The purpose of this study is to assess the abuse potential of CL-108 tablets, including the abuse deterrent effects of promethazine, following oral administration, relative to hydrocodone/acetaminophen (APAP) tablets and placebo…
- Conditions
- Pain, Nausea, Vomiting
- Trial name
- NCT02712554
- Testing
- CL-108, M366
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Charleston Laboratories, Inc
Benign Prostatic Hyperplasia
The Evaluation of the Safety of a New Drug for Benign Prostatic Hyperplasia Used for 9 Months
A new drug for benign prostatic hyperplasia is used for 9 months to determine its long-term safety.
- Trial name
- NCT00224133
- Testing
- Silodosin
- Where
- 79 sites in United States
- Volunteers
- 661 people
- Sponsor
- Watson Pharmaceuticals
Central Nervous System
Pharmacokinetics, Efficacy, and Safety of Perampanel Oral Suspension on Seizure Frequency in Pediatric Subjects Maintained on One to Three Stable Antiepileptic Drugs
This study is designed to evaluate the pharmacokinetics, efficacy, and safety of perampanel oral suspension on seizure frequency in pediatric participants maintained on one to three stable antiepileptic drugs
- Trial name
- NCT01527006
- Testing
- perampanel
- Where
- 23 sites in United States
- Volunteers
- 63 people
- Sponsor
- Eisai Inc.
Cardiovascular Disease
Cardiovascular Safety of Febuxostat and Allopurinol in Participants With Gout and Cardiovascular Comorbidities (CARES)
The purpose of this study is to see whether subjects with gout who receive febuxostat or allopurinol for up to 9 years have a higher rate of serious heart and blood vessel complications (major cardiovascular events).
- Trial name
- CARES (NCT01101035)
- Testing
- Febuxostat, Allopurinol
- Where
- 203 sites in United States, Mexico
- Volunteers
- 6,198 people
- Sponsor
- Takeda
Gout
Febuxostat Versus Allopurinol Control Trial in Subjects With Gout
The purpose of this study is to evaluate the safety and efficacy of febuxostat, once daily (QD), versus allopurinol in subjects with gout.
- Trial name
- FACT (NCT00102440)
- Testing
- Febuxostat, Allopurinol
- Volunteers
- 760 people
- Sponsor
- Takeda
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