Clinical trials: Patient Safety
Papulopustular Rosacea
Exploration of Safety and Efficacy of AzA 15% Foam Twice a Day in Rosacea
This exploratory study is being performed to determine whether a new form formulation of azelaic acid 15% is effective in the treatment of papulopustular rosecea.
- Trial name
- NCT00617903
- Testing
- Azelaic acid, Vehicle foam
- Where
- 7 sites in United States
- Volunteers
- 83 people
- Sponsor
- LEO Pharma
MPS IV A
A Double-Blind Study to Evaluate the Efficacy and Safety of BMN 110 in Patients With Mucopolysaccharidosis IVA (Morquio A Syndrome)
This Phase 3 study will evaluate the efficacy and safety of 2.0 mg/kg/week BMN 110 and 2.0 mg/kg/every other week BMN 110 in patients with mucopolysaccharidosis IVA (Morquio A Syndrome).
- Trial name
- NCT01275066
- Testing
- BMN 110 Weekly, BMN 110 Every Other Week
- Where
- 28 sites in United States, Argentina and 15 more
- Volunteers
- 177 people
- Sponsor
- BioMarin Pharmaceutical
Haemophilia A Without Inhibitors, Haemophilia B Without Inhibitors
Research Study to Look at How Well the Drug Concizumab Works in Your Body if You Have Haemophilia Without Inhibitors
This study will test how well a new medicine called concizumab works in the body of people with haemophilia A or B without inhibitors. The purpose is to show that concizumab can prevent bleeds in the body and is safe to use.
- Trial name
- explorer8 (NCT04082429)
- Testing
- Concizumab
- Where
- 113 sites in United States, Algeria and 31 more
- Volunteers
- 156 people
- Sponsor
- Novo Nordisk A/S
Major Depressive Disorder, MDD
A Study to Assess the Long- Term Safety of TC-5214 as an Adjunct Therapy in Patients With Major Depressive Disorder
The purpose of this study is to determine if TC-5214 or placebo (a tablet that looks like medicine tablet or capsule, but contains no active medicine) is safe and effective when taken for 52 weeks with another antidepressant…
- Conditions
- Major Depressive Disorder, MDD, Depression
- Trial name
- NCT01152554
- Testing
- TC-5214
- Where
- 94 sites in United States, Puerto Rico
- Volunteers
- 813 people
- Sponsor
- AstraZeneca
Cachexia; Cancer, Non Small Cell Lung Cancer
A Study to Evaluate the Efficacy and Safety of Anamorelin HCl for the Treatment of Malignancy Associated Weight Loss and Anorexia in Adult Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) - 1
The goal of this clinical trial was to compare the efficacy and safety of anamorelin HCl (the investigational drug) to that of placebo (tablet with no drug) in patients with advanced non-small cell lung cancer and cachexia…
- Trial name
- NCT03743051
- Testing
- Anamorelin Hydrochloride
- Where
- 72 sites in United States, Bulgaria and 5 more
- Volunteers
- 318 people
- Sponsor
- Helsinn Healthcare SA
Schizophrenia
Effectiveness and Safety of 3 Fixed Doses (25 mg eq., 100 mg eq., and 150 mg eq.) of Paliperidone Palmitate in Patients With Schizophrenia
The primary objectives of this study are to evaluate the efficacy and safety of 3 fixed doses of paliperidone palmitate administered i.m. after an initial loading dose of 150 mg eq.
- Trial name
- NCT00590577
- Testing
- Paliperidone palmitate 25 mg eq., Paliperidone palmitate 150 mg eq., Paliperidone palmitate 100 mg eq.
- Where
- 66 sites in United States, Malaysia and 6 more
- Volunteers
- 652 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Prostate Cancer
Safety and Pharmacokinetics Study of ODM-201 in Castrate Resistant Prostate Cancer
The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of ODM-201 in patients with castrate resistant prostate cancer.
- Trial name
- NCT01317641
- Testing
- ODM-201
- Where
- 23 sites in United States, Czechia and 4 more
- Volunteers
- 136 people
- Sponsor
- Orion Corporation, Orion Pharma
Dementia of the Alzheimer's Type
A Study of the Safety and Efficacy of Memantine in Moderate to Severe Alzheimer's Disease
The objective of this study is to evaluate the safety, tolerability, and efficacy of memantine compared to placebo in outpatients diagnosed with moderate-to-severe dementia of the Alzheimer's type on a concurrent…
- Trial name
- NCT00322153
- Testing
- memantine ER
- Where
- 83 sites in United States, Argentina and 2 more
- Volunteers
- 677 people
- Sponsor
- Forest Laboratories
Opioid-Induced Constipation
Study Evaluating Subcutaneous Methylnaltrexone For Treatment Of Opioid-Induced Constipation In Patients With Advanced Illness
This study will evaluate the safety and efficacy of methylnaltrexone administered as subcutaneous injections in subjects who have opioid-induced constipation and an advanced illness.
- Trial name
- NCT00672477
- Testing
- Methylnaltrexone
- Where
- 60 sites in United States, Australia and 10 more
- Volunteers
- 237 people
- Sponsor
- Bausch Health Americas, Inc.
Chronic Obstructive Pulmonary Disease (COPD)
Efficacy and Safety of Indacaterol Plus Tiotropium Versus Tiotropium Alone in Patients With Chronic Obstructive Pulmonary Disease
This study assessed the efficacy and safety of indacaterol (150 µg once daily [od]) when combined with tiotropium (18 µg od) versus tiotropium (18 µg od) treatment alone in patients with chronic obstructive pulmonary disease…
- Trial name
- INTRUST2 (NCT00877383)
- Testing
- Indacaterol 150 μg, Tiotropium 18 μg
- Where
- 176 sites in United States, Canada and 7 more
- Volunteers
- 1,142 people
- Sponsor
- Novartis Pharmaceuticals
Diabetes Mellitus, Non-Insulin-Dependent
Study to Assess the Efficacy and Safety of Sitagliptin Added to the Regimen of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (0431-189)
After 24 weeks of treatment, to assess the A1C-lowering efficacy of sitagliptin 100 mg once daily added to the regimen of patients with inadequate glycemic control on metformin monotherapy
- Trial name
- NCT00875394
- Testing
- sitagliptin phosphate, Comparator: metformin, Comparator: Antidiabetic Standard of Care
- Volunteers
- 68 people
- Sponsor
- Merck Sharp & Dohme LLC
Asthma
Montelukast Asthmatic Smoker Study (0476-332)(COMPLETED)
This is a multicenter study to evaluate the efficacy and safety of MK0476 versus placebo in participants with chronic asthma who actively smoke cigarettes.
- Trial name
- NCT00284856
- Testing
- montelukast sodium, Comparator: fluticasone
- Volunteers
- 1,640 people
- Sponsor
- Organon and Co
Metastatic Carcinoma in the Liver, Resectable Mass
Tremelimumab and Durvalumab in Treating Patients With Colorectal Cancer With Liver Metastases That Can Be Removed by Surgery
This phase I trial studies the side effects and how well tremelimumab and durvalumab work in treating patients with colorectal cancer that has spread to the liver and can be removed by surgery.
- Conditions
- Metastatic Carcinoma in the Liver, Resectable Mass, Stage IV Colorectal Cancer AJCC v7, Stage IVA Colorectal Cancer AJCC v7
- Trial name
- NCT02754856
- Testing
- Durvalumab, Laboratory Biomarker Analysis, Therapeutic Conventional Surgery
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- M.D. Anderson Cancer Center
Cerebral Palsy, Neurological Conditions
Safety and Efficacy Study of Oral Glycopyrrolate Liquid for the Treatment of Pathologic (Chronic Moderate to Severe) Drooling in Pediatric Patients 3 to 18 Years of Age With Cerebral Palsy or Other Neurologic Conditions
This is an open-label clinical research study of an oral glycopyrrolate liquid for the treatment of chronic moderate to severe drooling in patients with cerebral palsy or other neurological conditions.
- Conditions
- Cerebral Palsy, Neurological Conditions, Mental Retardation, Sialorrhea
- Trial name
- NCT00491894
- Testing
- Oral Glycopyrrolate Liquid
- Where
- 7 sites in United States
- Volunteers
- 137 people
- Sponsor
- Shionogi
Crohn's Disease
Ciprofloxacin for the Prevention of Postoperative Endoscopic Recurrence in Crohn's Disease
Despite extensive medical treatment, surgical resection is required in approximately 70% of the patients at some time. However, recurrence of the disease after operation occurs in the majority of patients and is a serious…
- Trial name
- NCT00609973
- Testing
- Ciprofloxacin
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- University of North Carolina, Chapel Hill
Congestive Heart Failure
Efficacy and Safety Trial of OPC-61815 Injection Compared With Tolvaptan 15-mg Tablet in Patients With Congestive Heart Failure
To confirm the non-inferiority of OPC-61815 16-mg injection to tolvaptan 15-mg tablet using as the primary endpoint the change in body weight following 5-day intravenous administration of OPC-61815 16-mg injection or 5-day oral…
- Trial name
- NCT03772041
- Testing
- OPC-61815, Tolvaptan Tab 15 MG
- Where
- Japan
- Volunteers
- 294 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Psoriasis
International Clinical Trial to Evaluate Efficacy and Safety of Multiple Subcutaneous Injections of BCD-085 in Various Doses in Patients With Moderate to Severe Plaque Psoriasis
BCD-085-2 is a next step in clinical investigation of BCD-085. BCD-085 is a monoclonal antibody to interleukin 17. During BCD-085-2 trial patients with moderate to severe plaque psoriasis, in whom poor response to previous…
- Trial name
- NCT02762994
- Testing
- BCD-085
- Where
- Russia
- Volunteers
- 120 people
- Sponsor
- Biocad
Deep Vein Thrombosis
Innohep® in Elderly Patients With Impaired Renal Function Treated for Acute Deep Vein Thrombosis
The objective of the study is to compare the safety of innohep® and Unfractionated Heparin (UFH) in terms of clinically relevant bleedings in elderly patients with impaired renal function for initial treatment of acute Deep…
- Trial name
- NCT00277394
- Testing
- innohep®, Heparin
- Where
- 9 sites in Bulgaria, Croatia and 7 more
- Volunteers
- 541 people
- Sponsor
- LEO Pharma
Chronic Obstructive Pulmonary Disease
A Study in Patients With Chronic Obstructive Pulmonary Disease
The primary objective of the study was to demonstrate the superiority of Foster® 100/6 (two puffs b.i.d.) versus Seretide® 500/50 (one inhalation b.i.d.), in terms of pulmonary function (AUC0-30min standardized by time of change…
- Trial name
- FUTURE (NCT01245569)
- Testing
- Beclomethasone Dipropionate - Formoterol, Fluticasone - Salmeterol
- Where
- 68 sites in Denmark, France and 8 more
- Volunteers
- 419 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Anemia
A Study of Intravenous Mircera for the Treatment of Anemia in Dialysis Patients.
This study will assess the efficacy and safety of intravenous (iv) Mircera given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv darbepoetin alfa.
- Trial name
- NCT00077766
- Testing
- Darbepoetin alfa, methoxy polyethylene glycol-epoetin beta [Mircera]
- Where
- 48 sites in Australia, Austria and 10 more
- Volunteers
- 313 people
- Sponsor
- Hoffmann-La Roche
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