Clinical trials: Delivery Systems
Healthy
A Study to Assess the Pharmacokinetics of Sorafenib in Mesoporous Magnesium Carbonate (DPH001) Compared to Nexavar® (sorafenib) in Healthy Volunteers
The study aims to assess the pharmacokinetics and safety of DPH001, an amorphous formulation of sorafenib, compared to Nexavar® in healthy volunteers.
- Trial name
- NCT06797427
- Testing
- DPH001, Nexavar (Sorafenib)
- Where
- Sweden
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Disruptive Pharma
Neuromyelitis Optica Spectrum Disorder, Pregnancy Related
Observational Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® During Pregnancy
This is an observational study to monitor female participants exposed to UPLIZNA during pregnancy. This study requires voluntary reporting of pregnancies in female participants with NMOSD exposed to UPLIZNA during pregnancy or…
- Trial name
- NCT05909761
- Testing
- UPLIZNA
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Amgen
X-Linked Myotubular Myopathy
A Study of AT132 in Young Children With X-Linked Myotubular Myopathy (XLMTM)
X-linked myotubular myopathy (XLMTM) is a rare and serious condition present at birth where the muscles do not work properly. There are currently no therapies for this serious condition.
- Trial name
- ASPIRO (NCT03199469)
- Testing
- Resamirigene bilparvovec
- Where
- 6 sites in United States, Canada and 2 more
- Volunteers
- 27 people
- Sponsor
- Astellas Gene Therapies
Type 2 Diabetes, Type 2 Diabetes Mellitus (T2DM)
Embecta AID System in Adults With Type 2 Diabetes
This is a multi-center, randomized control study that will evaluate the safety and effectiveness of the embecta Automated Insulin Delivery System in adults with Type 2 diabetes requiring insulin therapy
- Conditions
- Type 2 Diabetes, Type 2 Diabetes Mellitus (T2DM), Type 2 DM, T2DM With Inadequate Glycemic Control
- Trial name
- EMBRACE-T2D (NCT06692153)
- Testing
- An AID System., Standard of Care (SC)
- Where
- 9 sites in United States
- Sponsor
- Embecta Corp.
Asthma
Evaluating the Efficacy and Safety of Fluticasone Furoate/Vilanterol Trifenatate in the Treatment of Asthma in Adolescent and Adult Subjects of Asian Ancestry
A randomised, double-blind, double-dummy, parallel group study to evaluate the efficacy and safety of fluticasone furoate/vilanterol trifenatate (FF/VI) inhalation powder delivered once daily in the treatment of asthma in…
- Trial name
- NCT01498653
- Testing
- GW685698/GW642444, CCI18781
- Where
- 24 sites in China, Philippines and 1 more
- Volunteers
- 313 people
- Sponsor
- GlaxoSmithKline
Parkinson's Disease
Study of AAV-GAD Gene Transfer Into the Subthalamic Nucleus for Parkinson's Disease
The purpose of this study is to determine the safety and efficacy of AAV-GAD gene transfer into the subthalamic nucleus (STN) region of the brain.
- Trial name
- NCT00643890
- Testing
- Bilateral surgical infusion of AAV-GAD into the subthalamic nucleus
- Where
- 7 sites in United States
- Volunteers
- 44 people
- Sponsor
- Neurologix, Inc.
Arthritis, Rheumatoid, Arthritis, Psoriatic
Study of Intra-articular Delivery of tgAAC94 in Inflammatory Arthritis Subjects
The 13G01 clinical trial is a Phase I/II dose escalation study designed to be conducted in adults with inflammatory arthritis who have persistent moderate or severe swelling in one or more joints, without a disease severe enough…
- Conditions
- Arthritis, Rheumatoid, Arthritis, Psoriatic, Ankylosing Spondylitis
- Trial name
- NCT00126724
- Testing
- tgAAC94 gene therapy vector
- Where
- 22 sites in United States
- Volunteers
- 120 people
- Sponsor
- Targeted Genetics Corporation
Duchenne Muscular Dystrophy
A Study Of PGN-EDO51 In Participants With Duchenne Muscular Dystrophy Amenable To Exon 51-Skipping Treatment
The study consists of 3 periods: A Screening Period (up to 45 days), a Multiple Ascending Dose (MAD) Period (16 weeks), and a Long-Term Extension (LTE) Period (108 weeks).
- Trial name
- CONNECT1-EDO51 (NCT06079736)
- Testing
- PGN-EDO51
- Where
- 5 sites in Canada
- Volunteers
- 7 people
- Sponsor
- PepGen Inc
OME - Otitis Media With Effusion, AOM - Acute Otitis Media
In-Office Tympanostomy Tube Placement in Children (OTTER)
A prospective, single-arm, multicenter study to evaluate effectiveness and safety of Tymbion iontophoresis and tympanostomy tube placement using the Tula Iontophoresis and Tube Delivery Systems for children in an office setting.
- Trial name
- OTTER (NCT03323736)
- Testing
- Iontophoresis & tube placement, Tube placement
- Where
- 19 sites in United States, Canada
- Volunteers
- 370 people
- Sponsor
- Tusker Medical
Diabetes, Diabetes Mellitus, Type 1
Comparison of NovoFine® Needles (4 mm vs. 6 mm)
This trial is conducted in Europe. The aim of this investigation is to explore the safety of a 4 mm needle compared to a 6 mm needle when injected in children and lean adults with diabetes.
- Conditions
- Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Delivery Systems
- Trial name
- NCT00343343
- Testing
- NovoFine® needle 6 mm, NovoFine® needle 4 mm
- Where
- 2 sites in Denmark
- Volunteers
- 62 people
- Sponsor
- Novo Nordisk A/S
Nicotine Vaping, Nicotine
Nicotine Pharmacokinetics Following Use of the P4M3 Gen 2.0 E-Cigarette Compared to Smoking Cigarettes
This is a single-center, randomized, controlled, open-label, cross-over study with healthy adult smokers. The study will investigate the nicotine pharmacokinetic (PK) profiles of two e-liquid variants used with the P4M3 Gen 2.0…
- Conditions
- Nicotine Vaping, Nicotine, Vaping
- Trial name
- NCT05383508
- Testing
- CA35, CM35, Cig
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Philip Morris Products S.A.
Aortic Valve Stenosis
Long Term Follow-up of the 23mm Portico™ Aortic Valve Implant and the St. Jude Medical Transfemoral Delivery System
Collect and evaluate the long term safety data.
- Trial name
- NCT01497418
- Where
- 2 sites in Canada
- Volunteers
- 2 people
- Sponsor
- Abbott Medical Devices
Phenylketonuria, Inborn Errors of Metabolism
Evaluation of PKU Start
To evaluate the acceptability, tolerance and effect on metabolic control of PKU Start, a new Phe free protein substitute for the dietary management of PKU in infants from birth.
- Trial name
- PKU Start (NCT03058848)
- Testing
- PKU Start
- Where
- 3 sites in United Kingdom
- Volunteers
- 10 people
- Sponsor
- Vitaflo International, Ltd
Healthy Female Participants, Postmenopause
A Study to Assess the Bioavailability and Adhesion of Estradiol/Levonorgestrel TDS in Healthy Post-Menopausal Female Participants
The purpose of this study is to compare the bioequivalence and adhesion performance of a test estradiol/levonorgestrel transdermal delivery system (TDS) with the reference product, Climara Pro® (estradiol/levonorgestrel…
- Trial name
- NCT07851649
- Testing
- Test Estradiol/Levonorgestrel Transdermal Delivery System, Climara Pro® (Estradiol/Levonorgestrel Transdermal System)
- Where
- India
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Corium Innovations, Inc.
Intracranial Aneurysm
Safety and Effectiveness of ENTERPRISE 2 Device in the Endovascular Treatment of Intracranial Aneurysms
The study is designed to evaluate the safety and effectiveness of ENTERPRISE 2 vascular reconstruction device and delivery system (hereinafter referred to as ENTERPRISE 2) to facilitate endovascular coil embolization of…
- Trial name
- EMPOWER (NCT04289480)
- Testing
- ENTERPRISE 2 device
- Where
- 10 sites in China
- Volunteers
- 164 people
- Sponsor
- Medos International SARL
Growth Hormone Disorder, Growth Hormone Deficiency in Children
Observational Study of Norditropin NordiFlex® With NordiFlex PenMate™
This study is conducted in Europe. The aim of this study is to evaluate ease of injection of growth hormone in patients using Norditropin NordiFlex® with NordiFlex PenMate™.
- Conditions
- Growth Hormone Disorder, Growth Hormone Deficiency in Children, Delivery Systems
- Trial name
- NCT01500486
- Testing
- NordiFlex PenMate™
- Where
- 4 sites in Germany, Netherlands and 1 more
- Volunteers
- 84 people
- Sponsor
- Novo Nordisk A/S
Glioblastoma Multiforme
The PRECISE Trial: Study of IL13-PE38QQR Compared to GLIADEL Wafer in Patients With Recurrent Glioblastoma Multiforme
The purpose of the PRECISE trial is to determine whether overall survival duration, safety, and quality of life are improved for patients treated with IL13-PE38QQR compared to patients treated with GLIADEL® Wafer following…
- Trial name
- NCT00076986
- Testing
- IL13-PE38QQR, surgery and catheter placement (2 procedures), prolifespan 20 with carmustine implant (GLIADEL® Wafer)
- Where
- 60 sites in United States, Canada and 4 more
- Volunteers
- 300 people
- Sponsor
- INSYS Therapeutics Inc
Gastroesophageal Reflux
A Pharmacokinetics, Pharmacodynamics and Safety Study of Rabeprazole in New Born Infants With Gastroesophageal Reflux Disease (GERD)
The purpose of this study is to evaluate the pharmacokinetics, pharmacodynamics, and the safety of rabeprazole sodium for the treatment of gastroesophageal reflux disease (GERD) in newborns and pre-term infants.
- Trial name
- NCT00855361
- Testing
- Rabeprazole sodium
- Where
- 19 sites in United States, Germany and 2 more
- Volunteers
- 69 people
- Sponsor
- Janssen Research & Development, LLC
Parkinson Disease
Assessment of Actigraphy Procedures on the Initiation of an Apomorphine Treatment Delivered Through a Pump to Patients With Parkinson's Disease
The goal of the study is to compare the impact of different actigraphy procedures on the healthcare organization of Parkinson's disease (PK) patients using an apomorphine pump.
- Trial name
- @ctipark (NCT03213379)
- Testing
- Actimetry measures
- Volunteers
- 190 people
- Sponsor
- Orkyn'
Parkinson Disease, Movement Disorders
Clinical Study to Test the Safety of CDNF by Brain Infusion in Patients With Parkinson's Disease
This study evaluates the safety and tolerability of CDNF in patients with Parkinson's disease, when dosed directly into the brain using an implanted investigational drug delivery system (DDS).
- Conditions
- Parkinson Disease, Movement Disorders, Neurodegenerative Diseases, Nervous System Diseases
- Trial name
- NCT03295786
- Testing
- Cerebral Dopamine Neurotrophic Factor, Renishaw Drug Delivery System
- Where
- 3 sites in Finland, Sweden
- Volunteers
- 17 people
- Sponsor
- Herantis Pharma Plc.