Clinical trials: Medication Safety
Healthy Participants
A Sub Study to Evaluate the Study Medication (Etrasimod) Using Wearable Sensors in Healthy Participants
The purpose of this study is to look at how healthy adults process Etrasimod when assessed by wearable sensors. Etrasimod is taken without food and assessments taken by site staff and then by participants after training.
- Trial name
- NCT06140290
- Testing
- Etrasimod Immediate Release (IR)
- Where
- Belgium
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Pfizer
Thrombocytopenia, Neutropenia
Study of Drug to Reduce Thrombocytopenia in Patients Receiving Chemo for Ovarian, Fallopian Tube or Peritoneal Cancer
This research study will investigate the safety and effectiveness of two different dose levels of a new, unapproved drug to be given along with the chemotherapy regimens gemcitabine and carboplatin or gemcitabine and cisplatin…
- Conditions
- Thrombocytopenia, Neutropenia, Lymphopenia, Anemia
- Trial name
- NCT00771810
- Testing
- TXA127
- Where
- 6 sites in United States
- Volunteers
- 34 people
- Sponsor
- Tarix Pharmaceuticals
Inherited Mitochondrial Disease
A Safety Study for Previously Treated Vatiquinone (PTC743) Participants With Inherited Mitochondrial Disease
The primary objective of this study is to assess the safety of vatiquinone in participants with inherited mitochondrial disease who had prior exposure to vatiquinone in a PTC/BioElectron sponsored (previously Edison) clinical…
- Trial name
- NCT05218655
- Testing
- Vatiquinone
- Where
- 26 sites in United States, France and 5 more
- Volunteers
- 101 people
- Sponsor
- PTC Therapeutics
Hypertension
Safety and Efficacy of Azilsartan Medoxomil in Participants With Mild to Moderate Hypertension
The purpose of this study is to evaluate the safety, efficacy, and tolerability of azilsartan medoxomil, once daily (QD), in individuals with hypertension.
- Trial name
- NCT00362115
- Testing
- Azilsartan Medoxomil, Olmesartan
- Where
- 54 sites in United States, Argentina and 2 more
- Volunteers
- 449 people
- Sponsor
- Takeda
Influenza
A Phase 1/2 Study of a Intramuscular Injection of TAK-850 in Healthy Adult Subjects
This clinical trial is a phase 1/2 study of a single intramuscular injection of TAK-850 in healthy Japanese adult participants
- Trial name
- NCT02111252
- Testing
- TAK-850
- Where
- Japan
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- Takeda
Rheumatoid Arthritis
(C2013-0302) Safety and Efficacy of Escalating Doses of SAN-300 in Patients With Rheumatoid Arthritis
A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Escalating Doses of SAN-300 in Patients with Active Rheumatoid Arthritis with Inadequate Response to Disease-Modifying Anti-rheumatic Drug(s).
- Trial name
- NCT02047604
- Testing
- SAN-300 0.5 mg/kg QW, SAN-300 1.0 mg/kg QW, SAN-300 2.0 mg/kg QOW
- Where
- 12 sites in United States
- Volunteers
- 41 people
- Sponsor
- Bausch Health Americas, Inc.
Kawasaki Disease Refractory to Initial Therapy With Intravenous Immunoglobulin
Clinical Study of TA-650 in Patients With Refractory Kawasaki Disease
The purpose of this study is to evaluate the efficacy and safety of TA-650 in comparison with a control drug Polyethylene Glycol-treated Human Immunoglobulin (VGIH) in patients with Kawasaki disease refractory to initial therapy…
- Trial name
- NCT01596335
- Testing
- TA-650, Polyethylene Glycol-treated Human Immunoglobulin (VGIH)
- Where
- 8 sites in Japan
- Volunteers
- 31 people
- Sponsor
- Tanabe Pharma Corporation
Epilepsy, Partial
Study With Seletracetam (Ucb 44212) in Adult Subjects (18 to 65 Years) With Partial Onset Seizures
This trial will evaluate the efficacy and safety of ucb 44212 as add on therapy in subjects with focal epilepsy.
- Trial name
- NCT00152451
- Testing
- Seletracetam (ucb 44212)
- Where
- 7 sites in United States
- Volunteers
- 31 people
- Sponsor
- UCB S.A. - Pharma Sector
Gastroesophageal Reflux
Study to Evaluate the Pharmacokinetics and Safety of Dexlansoprazole in Pediatric Subjects With Symptomatic Gastroesophageal Reflux Disease
The purpose of this study is to assess the pharmacokinetics and safety of dexlansoprazole, once daily (QD), in pediatric subjects with symptomatic Gastroesophageal Reflux Disease.
- Trial name
- NCT01045096
- Testing
- Dexlansoprazole
- Where
- 4 sites in United States
- Volunteers
- 36 people
- Sponsor
- Takeda
Diabetes Mellitus
Efficacy and Safety of Alogliptin Combined With Metformin in Participants With Type 2 Diabetes Mellitus
The purpose of this study is to evaluate the efficacy and safety of alogliptin, once daily (QD), combined with metformin in adults with type 2 diabetes mellitus.
- Trial name
- NCT00286442
- Testing
- Alogliptin and metformin, Metformin
- Where
- 56 sites in United States, Argentina and 15 more
- Volunteers
- 527 people
- Sponsor
- Takeda
Hypertension
The COREG And Lisinopril Combination Therapy In Hypertensive Subjects (COSMOS) Trial
This is a randomized, double-blind, double-dummy, parallel group trial employing 15 cells of a 4x4 factorial design (no placebo)to compare the hypertensive effects in patients with Stage 1 and Stage 2 hypertension of carvedilol…
- Trial name
- NCT00347360
- Testing
- lisinopril, carvedilol controlled release formulation
- Where
- 151 sites in United States
- Volunteers
- 654 people
- Sponsor
- GlaxoSmithKline
Major Depressive Disorder
Safety and Tolerability of Vortioxetine (Lu AA21004) in Adults With Major Depressive Disorder
The purpose of this study is to determine the long-term efficacy and safety of vortioxetine, once daily (QD), in adults with major depressive disorder.
- Trial name
- NCT00707980
- Testing
- Vortioxetine
- Where
- 92 sites in United States, Australia and 15 more
- Volunteers
- 836 people
- Sponsor
- Takeda
Sleep Initiation and Maintenance Disorders
Safety and Efficacy Study of Ramelteon in Subjects With Chronic Insomnia
The purpose of this study is to determine the safety and efficacy of 4 mg of Ramelteon, once daily (QD), in subjects with chronic insomnia.
- Trial name
- NCT00756002
- Testing
- Ramelteon
- Volunteers
- 259 people
- Sponsor
- Takeda
Solid Tumours
To Assess Safety and Effect of Olaparib on the Pharmacokinetics of Anastrozole, Letrozole & Tamoxifen, and Their Effect on Olaparib, in Patients With Advanced Solid Cancer
This is an open-label 2-part Phase I study in patients with advanced solid tumours. Part A of the study (mandatory) will assess the effect of olaparib on the pharmacokinetics (PK) of anastrozole, letrozole and tamoxifen and vice…
- Trial name
- NCT02093351
- Testing
- Olaparib, Tamoxifen, Anastrozole
- Where
- 14 sites in Belgium, Denmark and 3 more
- Volunteers
- 79 people
- Sponsor
- AstraZeneca
Spasticity
MEDITOXIN® Versus BOTOX® in the Treatment of Post-stroke Spasticity of the Upper Limb Spasticity
This study is a randomized, double blind, multi-center, active drug controlled, phase III clinical trial to compare the efficacy and safety of MEDITOXIN® versus BOTOX® in treatment of post stroke upper limb(wrist, finger, thumb)…
- Trial name
- NCT01313767
- Testing
- Botulinum toxin type A
- Where
- South Korea
- Volunteers
- 196 people
- Sponsor
- Medy-Tox
Acute Depressive Episode
Efficacy and Safety of Ramelteon Sublingual in Adult Patients With Acute Depressive Episodes Associated With Bipolar I Disorder
The purpose of this study is to determine the efficacy and safety of Ramelteon, once daily (QD), sublingual (SL), in adult participants with acute depressive episodes associated with Bipolar I disorder.
- Trial name
- NCT01467700
- Testing
- Ramelteon SL
- Where
- 161 sites in United States, Argentina and 3 more
- Volunteers
- 490 people
- Sponsor
- Takeda
Schizophrenia, Schizophrenic Disorders
Open-label Study of Flexible-dose Paliperidone ER (Extended Release) to Treat Adolescent Schizophrenia.
The purpose of this open-label study is to evaluate the long-term (6-month) safety and tolerability of extended-release paliperidone, an atypical antipsychotic, given in flexible dosages to adolescents with schizophrenia.
- Conditions
- Schizophrenia, Schizophrenic Disorders, Psychotic Disorders, Dementia Praecox
- Trial name
- NCT00488319
- Testing
- Paliperidone ER
- Where
- 53 sites in United States, Belgium and 9 more
- Volunteers
- 400 people
- Sponsor
- Janssen Research & Development, LLC
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
Bladder Neoplasm, Neoplasm Recurrence, Local
Efficacy and Safety Evaluation of EN3348 (Mycobacterial Cell Wall-DNA Complex [MCC]) as Compared With Mitomycin C in the Intravesical Treatment of Subjects With BCG Recurrent/Refractory Non-muscle Invasive Bladder Cancer
This is a phase 3 randomized, active-controlled, open-label, multicenter study that will be conducted in approximately 120 investigational sites worldwide.
- Conditions
- Bladder Neoplasm, Neoplasm Recurrence, Local, Transitional Cell, Carcinoma, Carcinoma in Situ
- Trial name
- EMBARC-RF (NCT01200992)
- Testing
- EN3348, Mitomycin C
- Where
- 72 sites in United States, Canada and 4 more
- Volunteers
- 84 people
- Sponsor
- Bioniche Life Sciences Inc.
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
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