Clinical trials: Medication Safety
Delayed Graft Function
A Pilot Study Comparing the Safety and Efficacy of Everolimus With Other Medicines in Recipients of ECD/DCD Kidneys
The purpose of this pilot study is to evaluate concentration-controlled everolimus with low dose tacrolimus compared to early conversion to CNI-free regimen and MMF/MPA with standard dose tacrolimus in de novo renal transplant…
- Trial name
- Evered (NCT01878786)
- Testing
- Everolimus, Tacrolimus, Mycophenolate mofetil (MMF/MPA)
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Matthew Cooper
Proctitis, Proctosigmoiditis
Efficacy and Safety of Budesonide Foam for Participants With Active Mild to Moderate Ulcerative Proctitis or Proctosigmoiditis
The purpose of this study is to establish the efficacy profile of rectally administered budesonide foam, as compared to an equivalent volume of rectally administered placebo foam over the same dosing schedule, in participants who…
- Trial name
- NCT01008423
- Testing
- Budesonide
- Where
- 62 sites in United States
- Volunteers
- 281 people
- Sponsor
- Bausch Health Americas, Inc.
Asthma
Study B2C112060: A Study of the Efficacy and Safety of Vilanterol Inhalation Powder in Adults and Adolescents With Persistent Asthma
The objective of this study is to evaluate the efficacy and safety of vilanterol inhalation powder administered once daily in the evening in adolescent and adult subjects 12 years of age and older with persistent asthma over a…
- Trial name
- NCT01181895
- Testing
- Vilanterol, Salmeterol Inhalation Powder
- Where
- 34 sites in United States, Germany and 3 more
- Volunteers
- 348 people
- Sponsor
- GlaxoSmithKline
Drug-resistant Epilepsy, Focal-Onset Seizures
Study to Test the Efficacy and Safety of Padsevonil as Adjunctive Treatment of Focal-onset Seizures in Adults With Drug-resistant Epilepsy
The purpose of the study is to characterize the dose-response relationship with respect to efficacy of Padsevonil administered concomitantly with up to 3 anti-epileptic drugs (AEDs) for treatment of observable focal-onset…
- Trial name
- ARISE (NCT03373383)
- Testing
- Padsevonil
- Where
- 148 sites in United States, Australia and 17 more
- Volunteers
- 411 people
- Sponsor
- UCB Biopharma S.P.R.L.
Healthy Volunteers
A Study to Determine the Effect Food Has on TAK-721 (Budesonide Oral Suspension) in the Body of Healthy Adults
The main aim of this study is to check what the body of a healthy adult who either fasted or had eaten does to TAK-721 and how TAK-721 is distributed in and removed from the body.
- Trial name
- NCT06268301
- Testing
- Budesonide
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Takeda
Centronuclear Myopathy
Early Phase Human Drug Trial to Investigate Dynamin 101 (DYN101) in Patients ≥ 16 Years With Centronuclear Myopathies
There are no available treatments aside from supportive care for patients with Centronuclear myopathy (CNM). This trial will assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD)/preliminary efficacy of…
- Trial name
- Unite-CNM (NCT04033159)
- Testing
- DYN101
- Where
- 8 sites in Belgium, Denmark and 4 more
- Volunteers
- 14 people
- Sponsor
- Dynacure
Diabetes Mellitus, Type 2
Efficacy and Safety of 3 Doses of BI1356 (Linagliptin) in Type 2 Diabetes Patients
The objective of the current study is to investigate the efficacy, safety and tolerability of several doses of BI 1356 BS (0.5, 2.5 and 5 mg daily) compared to placebo over 12 weeks of treatment in patients with Type 2 diabetes…
- Trial name
- NCT00328172
- Testing
- BI 1356 dose 3 once daily, BI 1356 dose 2 once daily, BI 1356 dose 1 once daily
- Where
- 71 sites in United States, Australia and 4 more
- Volunteers
- 302 people
- Sponsor
- Boehringer Ingelheim
Trigeminal Neuralgia
Research Study to Test Safety and Effectiveness of Investigational Drug in Patients With Trigeminal Neuralgia
This research study will look at the safety (e.g., the occurrence of side effects) and efficacy (how well the drug works in reducing trigeminal neuralgia attacks) of a drug called lamotrigine in adults with trigeminal neuralgia.
- Trial name
- NCT00203229
- Testing
- lamotrigine
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Thomas Jefferson University
Highly Drug-resistant Focal Epilepsy
A Study of UCB0942 in Adult Patients With Highly Drug-resistant Focal Epilepsy
This study is to assess the efficacy, safety, and tolerability of the investigational drug UCB0942in adult subjects with drug-resistant focal epilepsy across multiple centers in Europe.
- Trial name
- NCT02495844
- Testing
- UCB0942
- Where
- 18 sites in Belgium, Bulgaria and 4 more
- Volunteers
- 55 people
- Sponsor
- UCB Biopharma S.P.R.L.
COVID-19
Treatment of COVID-19 Patients With Anti-interleukin Drugs
The purpose of this study is to test the safety and effectiveness of individually or simultaneously blocking IL-6 and IL-1 versus standard of care on blood oxygenation and systemic cytokine release syndrome in patients with…
- Trial name
- COV-AID (NCT04330638)
- Testing
- Usual Care, Anakinra, Siltuximab
- Where
- 15 sites in Belgium
- Volunteers
- 342 people
- Sponsor
- University Hospital, Ghent
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
Diabetes Mellitus, Type 2
A Study In Patients With Type 2 Diabetes Mellitus
This study evaluates the effect of medicines for type 2 diabetes and lipids control. This study will require about 6 office visits for lab tests and examinations.
- Trial name
- NCT00256867
- Testing
- GSK523338
- Where
- 85 sites in United States, Australia and 4 more
- Volunteers
- 369 people
- Sponsor
- GlaxoSmithKline
Tardive Dyskinesia
NBI-98854 Dose Titration Study for the Treatment of Tardive Dyskinesia
The purpose of this study is to evaluate the efficacy, safety, and tolerability of NBI-98854 (titrated to a subject's optimal dose in the range of 25 to 75 mg) administered once daily for the treatment of Tardive Dyskinesia (TD)…
- Trial name
- NCT01733121
- Testing
- NBI-98854
- Where
- 22 sites in United States, Puerto Rico
- Volunteers
- 102 people
- Sponsor
- Neurocrine Biosciences
Attention Deficit Hyperactivity Disorder
Study to Evaluate Safety & Efficacy of d-Amphetamine Transdermal System vs Placebo in Children & Adolescents With ADHD
This study will evaluate safety and efficacy of d-Amphetamine Transdermal System for the treatment of Attention Deficit Hyperactivity Disorder in children and adolescents.
- Trial name
- NCT01711021
- Testing
- d-Amphetamine Transdermal Patch
- Where
- 3 sites in United States
- Volunteers
- 110 people
- Sponsor
- Noven Pharmaceuticals, Inc.
Type 2 Diabetes Mellitus
Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Basal Insulin Alone or in Combination With Oral Antidiabetic Drug(s)
Primary Objective: To demonstrate the superiority of once weekly injection of efpeglenatide in comparison to placebo in glycated hemoglobin (HbA1c) change in participants with type 2 diabetes mellitus (T2DM) inadequately…
- Trial name
- AMPLITUDE-L (NCT03713684)
- Testing
- Efpeglenatide SAR439977, Background therapy
- Where
- 47 sites in United States, China and 1 more
- Volunteers
- 370 people
- Sponsor
- Sanofi
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
Vaginal Infection
Multi-Center Study of New Medications to Treat Vaginal Infections
The purpose of this study is to evaluate the safety and efficacy of metronidazole gel in the treatment of vaginal infections.
- Trial name
- SMART GIVES (NCT02308033)
- Testing
- Metronidazole, Gel vehicle
- Where
- 35 sites in United States
- Volunteers
- 204 people
- Sponsor
- Curatek Pharmaceuticals, LLC
HIV Infection
Evaluating the Safety and Tolerability of Antiretroviral Drug Regimens Used as Pre-Exposure Prophylaxis to Prevent HIV Infection in At-Risk Men Who Have Sex With Men and in At-Risk Women
Pre-exposure prophylaxis (PrEP) is a method of preventing HIV infection through the use of antiretroviral (ARV) medications before exposure to HIV.
- Trial name
- NCT01505114
- Testing
- Maraviroc, Emtricitabine, Tenofovir disoproxil fumarate
- Where
- 13 sites in United States, Puerto Rico
- Volunteers
- 594 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Drug Toxicity Psychotropic Agents Psychostimulants
Efficacy and Safety Study of Ryanodex as Adjuvant Treatment in Subjects With Psychostimulant Drug-Induced Toxicity (PDIT)
Ryanodex is being investigated as a potential adjuvant treatment for people suffering from psychostimulant drug-induced toxicity (PDIT), a life-threatening medical condition that results mainly from the abuse of certain illicit…
- Trial name
- NCT03189433
- Testing
- Ryanodex (dantrolene sodium) for injectable suspension
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Eagle Pharmaceuticals, Inc.
Epilepsy, Focal Seizures, Partial Seizures
Phase 2 Efficacy, Safety, and Tolerability Study of Natalizumab in Focal Epilepsy
The primary efficacy objective of the study is to determine if adjunctive therapy of natalizumab 300 mg intravenous (IV) every 4 weeks reduces the frequency of seizures in adult participants with drug-resistant focal epilepsy.
- Trial name
- OPUS (NCT03283371)
- Testing
- Natalizumab
- Where
- 31 sites in United States
- Volunteers
- 67 people
- Sponsor
- Biogen
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