Clinical trials: Double Layer
Gastric Ulcer
A Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PA32540 or Enteric Coated Aspirin 325 mg in Subjects Who Are at Risk for Developing Aspirin-Associated Ulcers
Primary: To demonstrate that PA32540 causes fewer gastric ulcers in subjects at risk for developing aspirin-associated gastric ulcers compared to enteric coated (EC) aspirin 325 mg.
- Trial name
- NCT00961350
- Testing
- PA32540, EC Aspirin 325
- Where
- United States
- Volunteers
- 530 people
- Sponsor
- POZEN
Schizophrenia
Safety and Tolerability of BI 409306 in Patients With Schizophrenia
The primary objective of the current study is to investigate the safety and tolerability of BI 409306 in schizophrenic patients following oral administration of multiple low, medium, and high doses over 14 days.
- Trial name
- NCT01892384
- Testing
- BI 409306
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Boehringer Ingelheim
Post Menopausal Osteoporosis
Phase 2 Study of BA058 (Abaloparatide) Transdermal Delivery in Postmenopausal Women With Osteoporosis
To determine the clinical safety and efficacy of abaloparatide transdermal in otherwise healthy postmenopausal women with osteoporosis as assessed by changes in bone mineral density (BMD) and serum markers of bone metabolism when…
- Trial name
- NCT01674621
- Testing
- Abaloparatide Transdermal (50 mcg), Abaloparatide Transdermal (100 mcg), Abaloparatide Transdermal (150 mcg)
- Where
- 9 sites in United States, Denmark and 2 more
- Volunteers
- 250 people
- Sponsor
- Radius Health, Inc.
Attention Deficit Hyperactivity Disorder (ADHD), Anxiety Disorders and Symptoms
Safety and Efficacy of Mexidol® for ADHD in Children Aged 6-12
The primary objective of this study was to evaluate the efficacy and safety of Mexidol® film-coated tablets (125 mg) compared to a placebo in children aged 6 to 12 years with Attention Deficit Hyperactivity Disorder (ADHD).
- Trial name
- MEGA (NCT06854601)
- Testing
- Mexidol
- Where
- 14 sites in Russia
- Volunteers
- 333 people
- Sponsor
- Pharmasoft
Venous Leg Ulcer
VLU Non-Inferiority Study Comparing a Dual Action Pneumatic Compression Device to Multi-Layer Bandaging
The purpose of the study is to test non-inferiority of chronic Venous Leg Ulcer (VLU) area reduction at 16 weeks with a dual action pneumatic compression device compared to multi-layer bandaging.
- Trial name
- NCT02680834
- Testing
- Dual Action Pneumatic Compression Device, Multi-Layer Bandaging
- Where
- 18 sites in United States
- Volunteers
- 56 people
- Sponsor
- Tactile Medical
Healthy
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Rising Doses of BI 409306
The primary objective of the current study is to investigate the safety and tolerability of BI 409306 in healthy young and elderly male and female volunteers following oral administration of repeated rising doses, given once…
- Trial name
- NCT01611311
- Testing
- BI 409306
- Where
- Germany
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Chronic Cerebral Ischemia
Safety and Efficacy of Sequential Therapy With Mexidol® in Patients With Chronic Cerebral Ischemia
The purpose of this study is to evaluate safety and efficacy of sequential treatment with Mexidol® in patients with chronic cerebral ischemia (CCI).
- Trial name
- MEMO (NCT06834490)
- Testing
- Mexidol
- Where
- 14 sites in Russia, Uzbekistan
- Volunteers
- 318 people
- Sponsor
- Pharmasoft
Healthy
Determine the Bioequivalence of Two Formulations of Hyoscine Butylbromide.
Determine bioequivalence of two forumulations with hyoscine butylbromide 10mg sugar coated tablets.
- Trial name
- NCT02516098
- Testing
- hyoscine butylbromide
- Where
- Canada
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Stable Angina Pectoris, Atherosclerosis
Effect of Molsidomine on the Endothelial (Internal Layer of Blood Vessels) Dysfunction in Patients With Angina Pectoris
Molsidomine used as an add-on treatment on standard care therapy should be superior to placebo used also as an add-on treatment on standard care therapy on improving the endothelial function (endothelium score measured by…
- Trial name
- MEDCOR (NCT01363661)
- Testing
- Coruno
- Where
- Belgium
- Volunteers
- 165 people
- Sponsor
- Therabel Pharma SA/NV
Renal Transplantation
A Study Designed to Compare the Tolerability of an Increased Dose of Enteric-coated Mycophenolate Acid (MPA) in Renal Transplant Patients Whose Dose of Mycophenolate Mofetil (MMF) Was Reduced Due to Gastrointestinal Symptoms
To determine if conversion to enteric coated MPA allows an escalated dose of mycophenolic acid (MPA) to be tolerated in patients experiencing gastrointestinal (GI) symptoms
- Trial name
- NCT00658333
- Testing
- Enteric-coated Mycophenolate Acid (EC-MPA), Mycophenolate Mofetil (MMF)
- Where
- 37 sites in United States
- Volunteers
- 30 people
- Sponsor
- Novartis Pharmaceuticals
Healthy
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Doses
The primary objective of this trial was to investigate safety and tolerability of multiple doses of BI 409306 in healthy young and elderly volunteers.
- Trial name
- NCT01505894
- Testing
- BI 409306
- Where
- Germany
- Volunteers
- 83 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Renal Transplantation
Enteric-coated Mycophenolate Sodium (EC-MPS) and Mycophenolate Mofetil (MMF) in Renal Transplant Patients With Gastrointestinal (GI) Intolerance
Treatment with the immunosuppressive drug mycophenolate mofetil (MMF) may result in gastrointestinal (GI) complications in some patients.
- Trial name
- NCT00400400
- Testing
- Enteric-coated mycophenolate sodium (EC-MPS), Mycophenolate mofetil
- Where
- 53 sites in United States
- Volunteers
- 400 people
- Sponsor
- Novartis Pharmaceuticals
Optic Neuritis
A Randomized, Double-blind, Placebo-controlled, Multicenter Study of the Effects of Glatiramer Acetate (GA) on the Retinal Nerve Fiber Layer (RNFL) and Visual Function in Patients With a First Episode of Acute Optic Neuritis (AON). (Octagon)
The main objective of the study is to determine whether glatiramer acetate 20 mg once daily reduces the amount of axonal loss in the optic nerve after a first event of acute optic neuritis compared to placebo patients and to…
- Trial name
- NCT00856635
- Testing
- Glatiramer Acetate
- Volunteers
- 44 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Nosocomial Infections, Pneumonia, Ventilator-Associated
A Efficacy and Safety Study of Nasal Prongs With Proprietary Surface Coating Aiming to Reduce Bacterial Colonization
The study is a first step in establishing the safety and efficacy of the CytaCoat technology when applied to a medical device such as a nasal prong and the clinical data generated will serve as a basis for continuous studies in…
- Trial name
- NCT02756351
- Testing
- CytaCoat Nasal Prong, Inspiration Healthcare Inspire nCPAP Nasal Prong
- Where
- Sweden
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- CytaCoat AB
Moderate Risk of CVD
A Study to Assess the Efficacy and Safety of Enteric-Coated Acetylsalicylic Acid in Patients at Moderate Risk of Cardiovascular Disease
The use of acetylsalicylic acid in the primary prevention of cardiovascular events has been extensively studied but to a lesser extent in patients with moderate levels of cardiovascular risk.
- Trial name
- ARRIVE (NCT00501059)
- Testing
- Aspirin (Acetylsalicylic acid, BAYE4465)
- Where
- 466 sites in United States, Germany and 6 more
- Volunteers
- 12,546 people
- Sponsor
- Bayer
Anti-Psychotic, Management of Manifestations of Psychotic Disorders
Assessment of Intra-subject Variability in the Bioavailability of Chlorpromazine Hydrochloride
Cycle Pharmaceuticals Ltd. (Cycle) is developing an oral tablet formulation of Chlorpromazine Hydrochloride and intends to conduct bioequivalence trials to demonstrate its similarity to the RLD.
- Conditions
- Anti-Psychotic, Management of Manifestations of Psychotic Disorders, Treatment of Schizophrenia, Control Nausea and Vomiting
- Trial name
- NCT02943213
- Testing
- Chlorpromazine Hydrochloride
- Where
- South Africa
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Cycle Pharmaceuticals Ltd.
Gastroesophageal Reflux
Study Evaluating Pantoprazole in Children With Gastroesophageal Reflux Disease (GERD)
To evaluate the clinical outcomes of treatment with oral pantoprazole in children 1 through 5 years of age with endoscopically proven symptomatic GERD.
- Trial name
- NCT00300755
- Testing
- pantoprazole sodium enteric-coated spheroid
- Where
- 43 sites in United States, Canada
- Volunteers
- 60 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Gastric Ulcer
Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PA32540 or Enteric Coated Aspirin 325 mg in Subjects Who Are at Risk for Developing Aspirin-Associated Ulcers
Primary: To demonstrate that PA32540 causes fewer gastric ulcers in subjects at risk for developing aspirin-associated gastric ulcers compared to enteric coated (EC) aspirin 325 mg.
- Trial name
- NCT00960869
- Testing
- PA32540, EC-Aspirin 325 mg
- Where
- United States
- Volunteers
- 519 people
- Sponsor
- POZEN
Short Bowel Syndrome
Efficacy, Safety and Tolerability of Enteric-Coated Cholestyramine Capsules for Adult Short Bowel Syndrome
A new Enteric-Coated Cholestyramine (ECC) capsule has been developed to manage diarrhea associated with Short Bowel Syndrome (SBS) in adults.
- Trial name
- NCT04046328
- Testing
- Enteric-Coated Cholestyramine (ECC) Capsule
- Where
- 3 sites in Poland
- Volunteers
- 13 people
- Sponsor
- Pharmascience Inc.
Gastroesophageal Reflux
Study Evaluating the Efficacy and Safety of Pantoprazole in Infants With Symptomatic Gastroesophageal Reflux Disease (GERD)
To assess the efficacy of pantoprazole for the treatment of infants with symptomatic Gastroesophageal Reflux Disease (GERD).
- Trial name
- NCT00365300
- Testing
- pantoprazole
- Where
- 38 sites in United States
- Volunteers
- 129 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer