Clinical trials: Medication Safety
Rheumatoid Arthritis
A Phase III Transition Study of DRL Rituximab to Reference Medicinal Products
The objective of the current study is to assess the immunogenicity and safety of transitioning subjects with RA to DRL_RI from US-rituximab/EU-rituximab to continued treatment with US-rituximab/EU-rituximab.
- Trial name
- RI-01-007 (NCT04268771)
- Testing
- Experimental: Arm A: DRL_RI, Arm B: Rituxan®/Mabthera®
- Where
- 26 sites in United States
- Volunteers
- 140 people
- Sponsor
- Dr. Reddy's Laboratories Limited
Hypertension
Efficacy and Safety of Azilsartan Medoxomil Combined With Chlorthalidone in Participants With Moderate to Severe Hypertension
The purpose of this study is to determine the efficacy and safety of azilsartan medoxomil combined with chlorthalidone, once daily (QD), in participants with moderate to severe hypertension.
- Trial name
- NCT00847626
- Testing
- Azilsartan medoxomil and chlorthalidone, Chlorthalidone, Azilsartan medoxomil
- Where
- 99 sites in United States, Chile and 3 more
- Volunteers
- 1,711 people
- Sponsor
- Takeda
Gastroesophageal Reflux Disease, Erosive Esophagitis
Safety and Efficacy of Dexlansoprazole Delayed-Release Capsules for Healing of Erosive Esophagitis and Maintenance of Healed Erosive Esophagitis and Relief of Heartburn in Adolescents
The purpose of this study is to assess the safety and effectiveness of treatment with once daily oral administration of dexlansoprazole delayed-release capsules in adolescents with erosive esophagitis (EE) and for maintenance of…
- Trial name
- NCT01642615
- Testing
- Dexlansoprazole
- Where
- 60 sites in United States, Belgium and 6 more
- Volunteers
- 63 people
- Sponsor
- Takeda
Diabetes Mellitus, Type 2
Out-Patient Study in Patients With Type 2 Diabetes Mellitus Who Are Taking no Diabetes Medication or Metformin Only
This study is a placebo-controlled study in patients with Type 2 Diabetes Mellitus who are either taking no diabetes medication or who are taking metformin only.
- Trial name
- NCT00518115
- Testing
- Albiglutide (GSK716155) or exenatide
- Where
- 163 sites in United States, Chile and 1 more
- Volunteers
- 361 people
- Sponsor
- GlaxoSmithKline
COVID-19
Study to Evaluate the Effects of RO7496998 (AT-527) in Non-Hospitalized Adult and Adolescent Participants With Mild or Moderate COVID-19
This study will evaluate the efficacy, safety, antiviral activity, and pharmacokinetics of study drug RO7496998 (AT-527) compared to placebo in non-hospitalized adult and adolescent participants with mild to moderate coronavirus…
- Trial name
- MORNINGSKY (NCT04889040)
- Testing
- RO7496998
- Where
- 50 sites in Argentina, Belgium and 10 more
- Volunteers
- 216 people
- Sponsor
- Hoffmann-La Roche
Solid Tumours
Study to Assess the Blood Levels and Safety of Olaparib in Patients With Advanced Solid Tumours and Normal Liver Function or Mild or Moderate Liver Impairment
This is a 2-part study in patients with advanced solid tumours. Part A will investigate the PK of olaparib in patients with mild or moderate hepatic impairment compared to patients with normal hepatic function; Part B will allow…
- Trial name
- NCT01894243
- Testing
- Olaparib tablet dosing
- Where
- 12 sites in Czechia, France and 3 more
- Volunteers
- 31 people
- Sponsor
- AstraZeneca
Arthroscopy, Bunionectomy
A Study of AQUAVAN® Injection in the Presence of Pre-Medication in Patients Undergoing Minor Surgical Procedures
The purpose of this study is to determine the safety, tolerability, and efficacy of AQUAVAN® Injection when used for mild-to-moderate sedation in patients undergoing minor surgical procedures.
- Conditions
- Arthroscopy, Bunionectomy, Osteotomy, Carpal Tunnel
- Trial name
- NCT00209560
- Testing
- fospropofol disodium
- Volunteers
- 168 people
- Sponsor
- Eisai Inc.
Metastatic Pancreatic Cancer, Colorectal Cancer
A Study to Evaluate the Safety, Tolerability, and Activity of TAK-931 in Participants With Metastatic Pancreatic Cancer, Metastatic Colorectal Cancer, and Other Advanced Solid Tumors
The purpose of this study is to confirm the safety and tolerability of TAK-931 in a cohort of Western participants with metastatic solid tumors and to evaluate the anti-tumor activity of TAK-931 in participants with metastatic…
- Conditions
- Metastatic Pancreatic Cancer, Colorectal Cancer, Esophageal Neoplasms, Carcinoma, Non-small-cell Lung
- Trial name
- NCT03261947
- Testing
- TAK-931
- Where
- 10 sites in United States, Japan
- Volunteers
- 101 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
Diabetes, Diabetes Mellitus, Type 2
A Double-blinded Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide and Insulin Degludec Both in Combination With Metformin in Japanese Subjects With Type 2 Diabetes Mellitus Inadequately Controlled With Basal or Pre-mix/Combination Insulin Therapy and Oral Anti-diabetic Drugs
This trial is conducted in Asia. The aim of this trial is to compare the efficacy and safety of insulin degludec/liraglutide and insulin degludec both in combination with metformin in Japanese subjects with type 2 diabetes…
- Trial name
- DUAL™ II Japan (NCT02911948)
- Testing
- Insulin degludec/liraglutide, Insulin degludec
- Where
- 38 sites in Japan
- Volunteers
- 210 people
- Sponsor
- Novo Nordisk A/S
Dysmenorrhea
Efficacy and Safety Study of Low Dose Oral Contraceptive Pill to Treat Primary Dysmenorrhea
The purpose of this study is to determine whether combination oral contraceptive pill of norethindrone and ethinyl estradiol is effective in the treatment of primary dysmenorrhea.
- Trial name
- NCT00746096
- Testing
- IKH-01
- Volunteers
- 115 people
- Sponsor
- Nobelpharma
Limbal Stem Cell Deficiency
Limbal Stem Cell Deficiency (LSCD) Treatment With Cultivated Stem Cell (CALEC) Graft
The main aim of the study is to determine the safety and feasibility of a cultivated autologous limbal epithelial cell (CALEC) transplantation in the treatment of limbal stem cell deficiency.
- Trial name
- CALEC (NCT02592330)
- Testing
- Biopsy to collect limbal epithelial stem cells that will be cultivated into a graft, Cultivation of Limbal epithelial cells into a graft, CALEC Transplant
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- Massachusetts Eye and Ear Infirmary
Gout, Moderate Renal Impairment
Efficacy and Safety of Extended Release and Immediate Release Febuxostat in Participants With Gout and Moderate Renal Impairment
The purpose of this study is to evaluate the efficacy and safety of febuxostat 40 mg extended release (XR) and 80 mg XR in comparison with febuxostat 40 mg immediate release (IR) and 80 mg IR, respectively, in gout participants…
- Trial name
- NCT02128490
- Testing
- Febuxostat IR, Febuxostat XR, Colchicine
- Where
- 89 sites in United States
- Volunteers
- 189 people
- Sponsor
- Takeda
Gonorrhoea
Randomized, Open-label Phase 2 Study of Oral AZD0914 in the Treatment of Gonorrhea
This is a multi-center Phase 2 randomized, open-label study in approximately 180 adult male and female subjects, between the ages of 18 and 55, who are in good health and meet all eligibility criteria.
- Trial name
- NCT02257918
- Testing
- AZD0914, Ceftriaxone
- Where
- 5 sites in United States
- Volunteers
- 180 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Virus, Zika, Zika Virus Disease
Safety, Immunogenicity, and Dose Ranging Study of Inactivated Zika Virus Vaccine in Healthy Participants
The purpose of this study is to describe the safety, tolerability and immunogenicity of two doses of purified inactivated Zika virus vaccine (PIZV) given 28 days apart.
- Conditions
- Virus, Zika, Zika Virus Disease, Flavivirus Infections, Healthy Participants
- Trial name
- NCT03343626
- Testing
- PIZV
- Where
- 9 sites in United States, Puerto Rico
- Volunteers
- 271 people, healthy volunteers welcome
- Sponsor
- Takeda
Beta-Thalassemia Major, Sickle Cell Disease
A Study Evaluating the Safety and Efficacy of LentiGlobin BB305 Drug Product in β-Thalassemia Major (Also Referred to as Transfusion-dependent β-Thalassemia [TDT]) and Sickle Cell Disease
This is a Phase 1/2, open label, safety, and efficacy study of the administration of LentiGlobin BB305 Drug Product to participants with either transfusion dependent beta-thalassemia (TDT) or sickle cell disease (SCD).
- Trial name
- NCT02151526
- Testing
- LentiGlobin BB305 Drug Product
- Where
- France
- Volunteers
- 7 people
- Sponsor
- Genetix Biotherapeutics Inc.
Multiple Myeloma
A Study to Investigate the Efficacy and Safety of Two Doses of GSK2857916 in Participants With Multiple Myeloma Who Have Failed Prior Treatment With an Anti-CD38 Antibody
Multiple myeloma (MM) is an incurable malignancy and accounts for 1 percentage (%) of all cancers and for 10% of all hematologic malignancies.
- Trial name
- NCT03525678
- Testing
- Belantamab mafodotin frozen liquid, Belantamab mafodotin lyophilized powder
- Where
- 59 sites in United States, Australia and 6 more
- Volunteers
- 221 people
- Sponsor
- GlaxoSmithKline
Prostate Cancer
A Phase 2 Study to Evaluate the Safety and Efficacy of TAK-385, Together With a Leuprorelin Observational Cohort, in Participants With Prostate Cancer
The purpose of this study is to evaluate the efficacy of TAK 385 for achieving and maintaining testosterone suppression (<50 ng/dL).
- Trial name
- NCT02083185
- Testing
- Relugolix, Leuprorelin
- Where
- 23 sites in United States, Canada
- Volunteers
- 136 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
Tardive Dyskinesia
Efficacy and Safety of MT-5199 in Subjects With Tardive Dyskinesia
The purpose of this study is to evaluate the efficacy and safety of MT-5199 administered once daily for the treatment of Tardive Dyskinesia (TD) symptoms.
- Trial name
- NCT03176771
- Testing
- MT-5199
- Where
- 82 sites in Japan
- Volunteers
- 256 people
- Sponsor
- Tanabe Pharma Corporation
Schizophrenia
A Study to Determine the Maximum Tolerated Dose of an Investigational Drug in Subjects With Schizophrenia
A study to determine the maximum tolerated dose of an investigational drug in subjects with schizophrenia
- Trial name
- NCT03627195
- Testing
- DSP-1349M
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Sumitomo Pharma America, 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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