Clinical trials: Respect
In-stent Coronary Artery Restenosis, Coronary Artery Restenosis
Resveratrol Excipient Paclitaxel Coated Balloon for Coronary Treatment
The objective of this study is to establish reasonable assurance of safety and effectiveness to support an FDA premarket approval (PMA) application for the SeQuent® Please ReX™ Drug Coated PTCA Balloon Catheter as indicated.
- Conditions
- In-stent Coronary Artery Restenosis, Coronary Artery Restenosis, In-stent Restenosis
- Trial name
- RESPECT-ISR (NCT05093244)
- Testing
- SeQuent Please ReX, Plain old balloon angioplasty (POBA)
- Sponsor
- B. Braun Medical Inc.
Healthy Volunteers
A Bioequivalence Study of the Fixed Dose Combination Tablets of Canagliflozin and Metformin Extended Release (XR) With Respect to the Individual Components
The purpose of this study is to assess the bioequivalence of the fixed dose combination (two components combined in one tablet) of canagliflozin and metformin extended release (XR) tablet (dose of 2 X 50 mg/500 mg) with respect…
- Trial name
- NCT02065752
- Testing
- Canagliflozin, 100 mg, Metformin XR, 500 mg, CANA/MET XR FDC, Formulation 1, 50 mg/500 mg
- Where
- United States
- Volunteers
- 2 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Gastroesophageal Reflux Disease, Hiatal Hernia
Randomized EsophyX Versus Sham / Placebo Controlled TIF Trial: The RESPECT Study
The objective of the study is to evaluate the relative merits, safety and effectiveness of the EsophyX transoral device in performing an advanced TIF procedure in patients with "troublesome symptoms" as defined by the Montreal…
- Trial name
- RESPECT (NCT01136980)
- Testing
- TIF Transoral Fundoplication
- Where
- 9 sites in United States
- Volunteers
- 129 people
- Sponsor
- EndoGastric Solutions
Sensorineural Hearing Loss
Esteem New Subject Enrollment Post Approval Study
The New Enrollment Post-Approval Study is designed to evaluate the safety and efficacy of the Esteem Totally Implantable Hearing System in subjects suffering from moderate to severe hearing loss.
- Trial name
- NCT02689349
- Testing
- Implantation of Esteem
- Where
- 6 sites in United States
- Volunteers
- 117 people, healthy volunteers welcome
- Sponsor
- Envoy Medical Corporation
Healthy
Phase I, Exploratory, Single Centre, Single Oral Dose AZD9668 and Intravenous Microdose of [C14] AZD9668, Healthy Subject
The primary objective of this study is to assess the absolute bioavailability and to evaluate pharmacokinetic parameters of a single oral dose and a radiolabelled intravenous microdose of [14C]AZD9668 in healthy male subjects.
- Trial name
- NCT01161355
- Testing
- AZD9668
- Where
- 2 sites in United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Candidemia, Mycoses
Study of Rezafungin Compared to Standard Antimicrobial Regimen for Prevention of Invasive Fungal Diseases in Adults Undergoing Allogeneic Blood and Marrow Transplantation
The purpose of this pivotal study is to determine if intravenous Rezafungin is efficacious and safe in the prevention of invasive fungal diseases when compared to the standard antimicrobial regimen.
- Conditions
- Candidemia, Mycoses, Fungal Infection, Fungemia
- Trial name
- ReSPECT (NCT04368559)
- Testing
- Rezafungin for Injection, Posaconazole, Fluconazole
- Where
- 53 sites in United States, Belgium and 7 more
- Volunteers
- 602 people
- Sponsor
- Mundipharma Research Limited
Peyronie's Disease
An Open-label Study to Assess the Safety and Effectiveness of AA4500 in Combination With the ErecAid® Esteem® Manual Vacuum Therapy System in Treating Men With Peyronie's Disease
Enrollment will include approximately 30 AA4500 naïve subjects. Subjects will be divided by degree of penile curvature and then randomized in a 1:1 ratio to one of the following treatment groups: AA4500 with investigator modeling…
- Trial name
- NCT02267460
- Testing
- AA4500, ErecAid® Esteem® Manual Vacuum Therapy System, Investigator Modeling
- Where
- United Kingdom
- Volunteers
- 30 people
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company
Diabetes, Healthy
Within-subject Variability of Insulin Detemir in Healthy Volunteers
This trial is conducted in Europe. The aim of this trial is to compare the within-subject variability of insulin detemir to that of another basal insulin analogue, insulin glargine in healthy volunteers.
- Trial name
- NCT01497535
- Testing
- insulin detemir, insulin glargine
- Where
- Germany
- Volunteers
- 40 people
- Sponsor
- Novo Nordisk A/S
Vaginosis, Bacterial
Safety, Tolerability and Efficacy of Vaginal Suppository WO3191 in the Post-treatment of Bacterial Vaginosis
Bacterial Vaginosis (BV) is a common infectious disorder and is characterized by a disturbance in the vaginal microbiological milieu.
- Trial name
- NCT02687789
- Testing
- Medical Device: WO3191, Medical Device: Vagisan® Lactic Acid
- Where
- 13 sites in Germany
- Volunteers
- 43 people
- Sponsor
- Dr. August Wolff GmbH & Co. KG Arzneimittel
Healthy
A Study to Assess the Bioequivalence of a New ULTRACET Extended Release (ER) Tablet With Respect to a Marketed ULTRACET ER Tablet Under Fasted Condition
The purpose of this study is to evaluate the bioequivalence of a newly developed ULTRACET extended-release (ER) tablet of tramadol hydrochloride and acetaminophen, to the current marketed ULTRACET ER tablet, in healthy…
- Trial name
- NCT01778075
- Testing
- Tramadol HCl 75 mg/Acetaminophen 650 mg (Newly developed ULTRACET ER), Tramadol HCl 75 mg/Acetaminophen 650 mg (Marketed ULTRACET ER)
- Where
- South Korea
- Volunteers
- 56 people
- Sponsor
- Janssen Korea, Ltd., Korea
Asthma
Retrospective Analysis to Describe Patient Profiles, Current Treatment Patterns and Economic Burden for Asthma Patients in UAE. A Descriptive Analysis of the Asthma Patient Population in the Emirate of Dubai With Respect to Healthcare Resource Utilization, Costs, and Asthma-related Treatment Pattern
This Retrospective cohort study with an overall objective of to perform a descriptive analysis of the asthma patient population in the Emirate of Dubai with respect to healthcare resource utilization, costs, and asthma-related…
- Trial name
- NCT03963141
- Where
- United Arab Emirates
- Volunteers
- 40,541 people
- Sponsor
- AstraZeneca
Healthy Volunteers
A Bioequivalence Study of the Fixed Dose Combination Tablets of Canagliflozin and Metformin Extended Release (XR) With Respect to the Individual Components
The purpose of this study is to assess the bioequivalence of the fixed dose combination (two components combined in one tablet) of canagliflozin and metformin extended release (XR) tablet (dose of 2 X 150 mg/1,000 mg) with…
- Trial name
- NCT02073227
- Testing
- Canagliflozin, 300 mg, Metformin XR, 500 mg, CANA/MET XR FDC, Formulation 1, 150 mg/1,000 mg
- Where
- United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Healthy
A Study to Assess the Bioequivalence of the Metformin Component of the Fixed Dose Combination Tablet of Canagliflozin and Metformin Extended Release With Respect to Metformin XR Tablet Co-administered With Canagliflozin in Healthy Fed and Fasted Participants
The purpose of this study is to evaluate bioequivalence of the metformin component of the Fixed Dose Combination (FDC) tablet compared with the metformin Extended Release (XR) tablet co-administered with canagliflozin in healthy…
- Trial name
- NCT02846506
- Testing
- Canagliflozin and Metformin Extended Release (XR) Fixed Dose Combination [FDC], Canagliflozin 50 mg, Canagliflozin 100 mg
- Where
- United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Attention Deficit/Hyperactivity Disorder (ADHD)
The Efficacy and Safety of Phosphatidylserine-Omega3 in Children With Attention-Deficit/ Hyperactivity Disorder
The primary objective of this trial is to determine whether an oral administration of Phosphatidylserine-Omega3 would significantly improve the clinical symptoms of children suffering from ADHD.
- Trial name
- NCT00418184
- Testing
- Phosphatidylserine-Omega3, Colored cellulose tainted with fishy odor
- Where
- Israel
- Volunteers
- 200 people
- Sponsor
- Enzymotec
Body Image, Self Esteem
The Effectiveness on an Application-Based Lifestyle Change Program on Health in Women
The purpose of this study will be to examine the effectiveness of an application-based lifestyle change program on body composition, body shape, body, image, and self-esteem in females following a 6-week period.
- Conditions
- Body Image, Self Esteem, Weight Loss, Health Behavior
- Trial name
- NCT05813548
- Testing
- FASTer Way Intervention, Control Group Intervention
- Where
- United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Applied Science & Performance Institute
Oncology
A Phase I, Open-label Study to Assess Bioavailability of a Single Oral Dose of AZD9291 vs an IV Dose of [14C]AZD9291
The Sponsor is developing the study drug, AZD9291, for the potential treatment of nonsmall cell lung cancer. Lung cancer has been the most common cancer in the world for several decades and represents 12.8% of all new cancer…
- Trial name
- NCT02491944
- Testing
- AZD9291, [14C]AZD9291
- Where
- United Kingdom
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy
Bioequivalence Study of Abiraterone Acetate Coated and Uncoated Tablet Formulations in Healthy Male Participants
The purpose of this study is to determine the bioequivalence (equivalence of pharmacokinetic parameters) of 2 abiraterone acetate coated tablet formulations with respect to the current commercial abiraterone acetate uncoated…
- Trial name
- NCT02230046
- Testing
- Abiraterone acetate (Treatment A), Abiraterone acetate (Treatment B)
- Where
- United States
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Pain
Oxycodone/Naloxone (OXN) Combination in Moderate to Severe Non-malignant Pain
The main objective of the study is to evaluate the patient preference for pain treatment with respect to quality of life in patients with moderate to severe non malignant pain.
- Trial name
- NCT01167699
- Testing
- Oxycodone and naloxone
- Where
- Belgium
- Volunteers
- 174 people
- Sponsor
- Mundipharma Pharmaceuticals B.V.
Systemic Juvenile Idiopathic Arthritis
Single-dose Study to Assess Efficacy of Canakinumab (ACZ885) in Patients With Active Juvenile Idiopathic Arthritis (SJIA)
This study assessed the initial efficacy and safety of canakinumab over a 4 week period in patients with systemic juvenile idiopathic arthritis (SJIA) having a flare.
- Trial name
- β-SPECIFIC 1 (NCT00886769)
- Testing
- Canakinumab
- Where
- 91 sites in United States, Argentina and 20 more
- Volunteers
- 84 people
- Sponsor
- Novartis Pharmaceuticals
Cerebrovascular Circulation
Imaging Study to Compare Effects of Darolutamide and Enzalutamide With Respect to Placebo on the Blood Flow in the Brain in Healthy Male Volunteers.
The current study would investigate the effects of a single dose of darolutamide and enzalutamide compared with placebo and compared to each other on human brain blood flow using arterial spin labeling magnetic resonance imaging…
- Trial name
- NCT03704519
- Testing
- Darolutamide (BAY1841788), Enzalutamide
- Where
- United Kingdom
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Bayer