Clinical trials: Patient Comfort and Safety
Dyskinesia, Levodopa Induced Dyskinesia (LID)
ADS-5102 for the Treatment of Levodopa Induced Dyskinesia (EASE LID Study)
This is a multi-center, randomized, double-blind, placebo-controlled, 2-arm, parallel group study to evaluate the efficacy and safety of ADS-5102 extended release (ER) capsules, an investigational formulation of amantadine, dosed…
- Conditions
- Dyskinesia, Levodopa Induced Dyskinesia (LID), Parkinson's Disease
- Trial name
- EASE LID (NCT02136914)
- Testing
- ADS-5102
- Where
- 46 sites in United States, Canada
- Volunteers
- 126 people
- Sponsor
- Adamas Pharmaceuticals, Inc.
Dyskinesia, Levodopa-Induced Dyskinesia (LID)
Efficacy and Safety Study of ADS-5102 in PD Patients With Levodopa-Induced Dyskinesia
This is a multi-center, randomized, double-blind, placebo-controlled, 2-arm, parallel group study to evaluate the efficacy and safety of ADS-5102 extended release (ER) capsules, an investigational formulation of amantadine, dosed…
- Conditions
- Dyskinesia, Levodopa-Induced Dyskinesia (LID), Parkinson's Disease (PD)
- Trial name
- EASE LID 3 (NCT02274766)
- Testing
- ADS-5102
- Where
- 51 sites in United States, Austria and 3 more
- Volunteers
- 77 people
- Sponsor
- Adamas Pharmaceuticals, Inc.
Short Bowel Syndrome (SBS)
Efficacy and Safety Evaluation of Glepaglutide in Treatment of Short Bowel Syndrome
The purpose of this study is to understand the safety and efficacy of twice weekly glepaglutide 10 mg in adult patients with short bowel syndrome (SBS), who were previously enrolled in the EASE SBS 2 or EASE SBS 3 trials.
- Trial name
- EASE SBS 6 (NCT07228403)
- Testing
- Glepaglutide 10 mg
- Where
- 16 sites in United States, Belgium and 5 more
- Volunteers
- 28 people
- Sponsor
- Zealand Pharma
Respiratory Failure, Respiratory Insufficiency
Evaluating Safety and Efficacy of Umbulizer in Patients Requiring Intermittent Positive Pressure Ventilation
Randomized, control crossover study comparing Umbulizer's efficacy to traditional mechanical ventilators
- Conditions
- Respiratory Failure, Respiratory Insufficiency, Respiratory Arrest
- Trial name
- NCT04030208
- Testing
- Umbulizer, Traditional Mechanical Ventilator
- Where
- Pakistan
- Volunteers
- 24 people
- Sponsor
- Umbulizer LLC
Patient Comfort and Safety
Iodixanol Versus Iopamidol in Patients Undergoing Contrast-Enhanced Computed Tomographic Imaging of Abdomen/Pelvis
The purpose of this study is to evaluate and compare overall patient comfort profile between the Iso-osmolar contrast media (IOCM), iodixanol 320 mg I/mL, and a Low-osmolar contrast media (LOCM), iopamidol 370 mg I/mL in patients…
- Trial name
- NCT01376089
- Testing
- Iodixanol, Iopamidol
- Where
- United States
- Volunteers
- 304 people
- Sponsor
- GE Healthcare
Diabetes Mellitus Type 2
Ease of Use and Safety of the New U300 Pen Injector in Insulin-Naïve Patients With T2DM
Primary Objective: To demonstrate the ease of use of the U300 pen injector in pen-naïve and insulin-naïve type 2 diabetes mellitus (T2DM) patients in a 4-week once-daily dosing regimen with HOE901-U300.
- Trial name
- NCT02227212
- Testing
- Insulin glargine U300 (new formulation of insulin glargine) HOE901
- Where
- 7 sites in Germany
- Volunteers
- 40 people
- Sponsor
- Sanofi
Skin Laxity
Simulines Non-Inferiority Pivotal Study
Up to 260 subjects presenting with skin laxity on the face and neck will be randomized to one of two treatment groups. Subjects meeting all entrance criteria will receive study treatment, then complete two post treatment phone…
- Trial name
- NCT02736825
- Testing
- Ulthera System with standard transducer, Ulthera System with prototype 2 simulines transducer
- Where
- 8 sites in United States
- Volunteers
- 262 people, healthy volunteers welcome
- Sponsor
- Ulthera, Inc
Vascular Diseases
EndovascuLar RegIstry Evaluating SafeTy, Efficacy and Patient Comfort (ELITE)
A single-center, prospective, cohort analysis of the Femoral Introducer Sheath and Hemostasis (FISH) vascular closure device will study 100 consecutive patients on which the device will be used to close the femoral artery after…
- Trial name
- ELITE (NCT03412942)
- Testing
- FISH SP
- Where
- 3 sites in United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Morris Innovative Incorporated
Drug Safety
Comparing Patient Comfort and Safety Between Iodixanol and Iopamidol in Patients Undergoing Peripheral Arteriography
The purpose of this study is to evaluate and compare overall patient comfort profile between an Iso-osmolar contrast media (IOCM), iodixanol 320 mg I/mL, and a Low-osmolar contrast media (LOCM), iopamidol 370 mg I/mL in patients…
- Trial name
- NCT01475097
- Testing
- Iodixanol, Iopamidol
- Where
- United States
- Volunteers
- 255 people
- Sponsor
- GE Healthcare
End Stage Renal Failure on Dialysis, End Stage Renal Disease on Dialysis
Human Factors Validation Testing for the Peripal System; a Manual Connection Assist Device for Peritoneal Dialysis Devices
It is estimated that there are currently over 3 million patients receiving dialysis treatment worldwide. With effective pre-dialysis counselling, a majority of patients choose the home-based therapy peritoneal dialysis (PD) but…
- Conditions
- End Stage Renal Failure on Dialysis, End Stage Renal Disease on Dialysis, Renal Failure, Peritoneal Dialysis
- Trial name
- NCT04292210
- Testing
- Perisafe
- Where
- United Kingdom
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Peripal AG
Erythromelalgia
EASE (Efficacy of ATX01 Study in Erythromelalgia)
The goal of this two-center, randomized, double-blinded, parallel-group, placebo-controlled clinical study is designed to compare the efficacy of twice daily applications of ATX01 versus placebo during two consecutive 3-week…
- Trial name
- EASE (NCT05917912)
- Testing
- Amitriptyline Hydrochloride
- Where
- 2 sites in United States, Germany
- Volunteers
- 14 people
- Sponsor
- AlgoTherapeutix
Short Stature, Idiopathic, Infant, Small for Gestational Age
Evaluation of the Ease of Use, Preference, and Safety of EutropinPen Inj.
The purpose of this study is to assess the ease of use, preference, and safety after 8 weeks subcutaneous administration of EutropinPen Inj. in patients pretreated with recombinant human growth hormone by reusable device.
- Conditions
- Short Stature, Idiopathic, Infant, Small for Gestational Age, Growth Hormone Deficiency, Chronic Renal Failure
- Trial name
- NCT03015909
- Testing
- Somatropin
- Where
- South Korea
- Volunteers
- 116 people
- Sponsor
- LG Life Sciences
Type II Diabetes Mellitus, Efficacy, Self
Real World Safety & Efficacy Experience of Empagliflozin With or Without Metformin in T2DM Patients - EASE Study
Study Objective To evaluate the safety and tolerability of Empagliflozin with or without metformin in patients with Type II Diabetes Mellitus in the Pakistani population.
- Conditions
- Type II Diabetes Mellitus, Efficacy, Self, Safety Issues
- Trial name
- EASE (NCT05164263)
- Testing
- Empagliflozin
- Where
- 6 sites in Afghanistan, Kenya and 3 more
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- Getz Pharma
Xerostomia, Hyposalivation
A New Oral salIvary equivAlent Compared to Two moisturizinG Mouth sprAys in Patients With xeRostomiA: NIAGARA Study
The purpose of this study is to evaluate the clinical efficacy, safety and acceptability of our new oral salivary equivalent in the relief of signs and symptoms related to mouth dryness as compared to two distinct moisturizing…
- Conditions
- Xerostomia, Hyposalivation, Head and Neck Cancer, Sjögren Syndrome
- Trial name
- NIAGARA (NCT02049112)
- Testing
- Salivary equivalent, Aequasyal, Biotene
- Where
- France
- Volunteers
- 210 people
- Sponsor
- Unither Pharmaceuticals, France
Short Bowel Syndrome
Evaluation of Long Term Safety and Efficacy of Glepaglutide in Treatment of SBS - Extension Trial
This trial is an extension trial to EASE SBS 2. The study looks at whether glepaglutide is a safe treatment for participants with Short Bowel Syndrome (SBS), as well as how well effectiveness is maintained during long term…
- Trial name
- EASE SBS 3 (NCT04881825)
- Testing
- Glepaglutide
- Where
- 19 sites in United States, Belgium and 6 more
- Volunteers
- 84 people
- Sponsor
- Zealand Pharma