Clinical trials: Delivery Systems
Contraception
Transdermal Contraceptive Delivery System (TCDS), Also Known as AG200-15 Patch Arm
The purpose of the study is to evaluate the efficacy and safety of a low dose transdermal contraceptive delivery system containing ethinyl estradiol and levonorgestrel.
- Trial name
- ATI-CL13 (NCT01236768)
- Testing
- AG200-15, Levora
- Where
- 21 sites in United States
- Volunteers
- 407 people, healthy volunteers welcome
- Sponsor
- Agile Therapeutics
Spinal Muscular Atrophy
A Study of Multiple Doses of Nusinersen (ISIS 396443) Delivered to Infants With Genetically Diagnosed and Presymptomatic Spinal Muscular Atrophy
The primary objective of the study is to examine the efficacy of multiple doses of Nusinersen administered intrathecally in preventing or delaying the need for respiratory intervention or death in infants with genetically…
- Trial name
- NURTURE (NCT02386553)
- Testing
- Nusinersen
- Where
- 21 sites in United States, Australia and 5 more
- Volunteers
- 25 people
- Sponsor
- Biogen
Diarrhea, Atopic Dermatitis
Cesarean Section Study
Effect, tolerance and safety of a supplementation with a probiotic on the risk of gastrointestinal infections, on growth, and on gut microbiota in healthy newborn term infants born by Cesarean section.
- Trial name
- NCT01992497
- Testing
- Probiotic
- Where
- Germany
- Volunteers
- 721 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Diabetes, Diabetes Mellitus, Type 2
Reliability of Dosing With NovoLog® Mix 70/30 FlexPen® Compared With Vial and Syringe
This trial is conducted in the United States of America (USA). The aim of this trial is to compare desired (target) with actual target amounts of insulin dispensed using NovoLog® Mix 70/30 FlexPen® and vial and syringe in…
- Conditions
- Diabetes, Diabetes Mellitus, Type 2, Delivery Systems
- Trial name
- NCT00127296
- Testing
- FlexPen®, vial and syringe
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Novo Nordisk A/S
Duchenne Muscular Dystrophy
Microdystrophin Gene Transfer Study in Adolescents and Children With DMD
This is a controlled, open-label, single-ascending dose study to evaluate the safety and tolerability of SGT-001 in adolescents and children with Duchenne muscular dystrophy (DMD).
- Trial name
- IGNITE DMD (NCT03368742)
- Testing
- SGT-001
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- Solid Biosciences Inc.
Dravet Syndrome
A Clinical Study to Evaluate the Safety and Efficacy of ETX101, an AAV9-Delivered Gene Therapy in Children With SCN1A-positive Dravet Syndrome
EXPEDITION is a Phase 1/2 study in the UK to evaluate the safety and efficacy of ETX101 in participants with SCN1A-positive Dravet Syndrome aged 6 to < 48 months. The study follows and open-label, dose-escalation design.
- Trial name
- UK Only (NCT06283212)
- Testing
- ETX101
- Where
- 3 sites in United Kingdom
- Volunteers
- 5 people
- Sponsor
- Encoded Therapeutics
Amyotrophic Lateral Sclerosis
GM604 Phase 2A Randomized Double-blind Placebo Controlled Pilot Trial in Amyotrophic Lateral Disease (ALS)
GM604 is an endogenous human embryonic stage neural regulatory and signaling peptide that controls the development, monitoring and correction of the human nervous system.
- Trial name
- GALS (NCT01854294)
- Testing
- GM604
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- Genervon Biopharmaceuticals, LLC
Healthy
Bioavailability and Pharmacokinetics Study of Sirukumab in Healthy Male Participants
The purpose of the study is to assess the bioavailability (the extent to which a medication becomes available to the body) of subcutaneously (under the skin using a needle) administered sirukumab and to compare the…
- Trial name
- NCT02079545
- Testing
- Sirukumab (IV infusion), Sirukumab (SC injection with PFS-U), Sirukumab (SC injection with PFS-AI)
- Where
- 2 sites in United States
- Volunteers
- 144 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Non-muscle Invasive Bladder Cancer (NMIBC)
Evaluating the Safety and Performance of the Eight Medical Hyperthermia System IV 1.0 for HIVEC in NMIBC.
The goal of this clinical trial is to evaluate the safety and performance of the Eight Medical Hyperthermia System IV 1.0 when used to deliver recirculating hyperthermic intravesical chemotherapy (HIVEC) with mitomycin C (MMC) in…
- Trial name
- NCT07758881
- Testing
- Hyperthermic intravesical chemotherapy (HIVEC)
- Where
- 2 sites in Belgium
- Volunteers
- 30 people
- Sponsor
- Eight Medical International BV
Diabetes, Healthcare Professionals
Novofine Autocover Safety Needle Versus BD Safety Glide
This trial is conducted in the United States of America (USA). The aim of this trial is to examine whether nurses prefer to use the NovoFine® Autocover Needle or the BD Safety Glide (TM) Syringe (only) in a hospital setting.
- Conditions
- Diabetes, Healthcare Professionals, Delivery Systems
- Trial name
- NCT00121355
- Testing
- safety glide, autocover needle
- Where
- United States
- Volunteers
- 83 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Tricuspid Regurgitation
SQ-Kyrin-T First-in-man Feasibility Study
The goal of this clinical trial is to evaluate the performance, operability and reliability of the SQ-Kyrin-T Transcatheter Edge-to Edge Valve Repair System in treating severe tricuspid regurgitation in Chinese population with…
- Trial name
- NCT06605313
- Testing
- SQ-Kyrin-T Transcatheter Tricuspid Valve Repair System
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Shanghai Shenqi Medical Technology Co., Ltd
Limb Girdle Muscular Dystrophy
A Gene Transfer Single Dose Study to Evaluate the Safety, Tolerability and Efficacy of SRP-9003 in Non-Ambulatory and Ambulatory Participants With Limb Girdle Muscular Dystrophy, Type 2E/R4 (Beta-Sarcoglycan [β-SG] Deficiency)
The primary purpose of this study is to evaluate the safety of SRP-9003 and to quantify expression of β-SG in the skeletal muscle of participants with limb-girdle muscular dystrophy, type 2E/R4 (LGMD2E/R4).
- Trial name
- NCT05876780
- Testing
- SRP-9003
- Where
- 2 sites in United States
- Volunteers
- 6 people
- Sponsor
- Sarepta Therapeutics, Inc.
Migraine
Study Evaluating the Efficacy, Safety, and Tolerability of ASY202 (Dihydroergotamine Mesylate [DHE] Inhalation Powder Delivered Via a Multidose Dry Powder Inhaler) for the Acute Treatment of Migraine in Adult Patients
This study is testing an investigational inhaled migraine medication to see how well it works, how safe it is, and how well people tolerate it.
- Trial name
- NCT07646613
- Testing
- ASY202
- Where
- 20 sites in United States
- Volunteers
- 108 people
- Sponsor
- Aspeya, Inc.
Limb Girdle Muscular Dystrophy, Limb Girdle Muscular Dystrophy Type 2D/R3
Study to Evaluate the Safety, Tolerability, and Efficacy of SRP-9004 Administered by Systemic Infusion in Limb Girdle Muscular Dystrophy Type 2D/R3 Participants in the United States
The primary objective of this study is to evaluate the safety of SRP-9004.
- Trial name
- DISCOVERY (NCT06747273)
- Testing
- SRP-9004
- Where
- 2 sites in United States
- Volunteers
- 4 people
- Sponsor
- Sarepta Therapeutics, Inc.
Angina
Safety Study of Transmyocardial Revascularization (TMR) With Bone Marrow Aspirate (BMAC) for Angina Reduction
The purpose of this study is to determine the safety of injecting autologous bone marrow concentrate with laser transmyocardial revascularization (TMR) for treatment of angina which cannot be treated by direct coronary…
- Trial name
- PHOENIX (NCT01285297)
- Testing
- Bone Marrow Aspirate Concentrate
- Where
- 2 sites in Russia, Spain
- Volunteers
- 7 people
- Sponsor
- Cardiogenesis Corporation, a wholly-owned subsidiary of CryoLife, Inc.
Persistent Asthma
A 12-week Safety and Efficacy Study of Beclomethasone Dipropionate (80 and 160 mcg/Day) Delivered Via Breath-Actuated Inhaler (BAI) in Patients >=12 Years Old With Persistent Asthma
This is a randomized, double-blind, placebo-controlled parallel-group study. Participants will be randomly assigned to receive treatment with beclomethasone dipropionate at a dosage of 80 or 160 mcg/day delivered via a…
- Trial name
- NCT02040779
- Testing
- Beclomethasone dipropionate breath-actuated inhaler, albuterol/salbutamol
- Where
- 47 sites in United States
- Volunteers
- 273 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Pain
Evaluation of the Efficacy and Safety of Fentanyl Delivered by Adhesive Skin Patch in Out-Patients With Chronic Cancer Pain
The purpose of this study is to determine the safety and efficacy of pain control by fentanyl, administered via adhesive skin patches, at doses of 25 to 100 micrograms per hour in 80 out-patients with intense chronic cancer pain.
- Trial name
- NCT00236327
- Testing
- fentanyl
- Volunteers
- 34 people
- Sponsor
- Janssen Cilag S.A.S.
Asthma, Healthy Subjects or Volunteers
A Study of Tralokinumab When Delivered Subcutaneously at Different Flow Rates to Healthy Volunteers
The primary objective of this study is to evaluate the pharmacokinetics (PK) and tolerability of tralokinumab when delivered subcutaneously at different flow rates to healthy volunteers.
- Trial name
- NCT02085473
- Testing
- Tralokinumab 300 mg
- Where
- 2 sites in United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- MedImmune LLC
Crohn's Disease
Multicenter Clinical Efficacy and Safety Study of Delayed Release 6MP in Crohn's Disease
The study is designed to evaluate the clinical efficacy and safety of daily treatment for 12 weeks of oral administration of a delayed release, locally delivered 6MP (mercaptopurine) drug (80 mg), as compared to standard…
- Trial name
- NCT01094613
- Testing
- Delayed Release 6 mercaptopurine, 6 Mercaptopurine
- Where
- 11 sites in Israel
- Volunteers
- 70 people
- Sponsor
- Teva GTC
Vascular Disease, Peripheral
Pilot Study to Evaluate the Safety and Preliminary Efficacy of the Peritec Peritoneal Lined Stent and Delivery System
The occurrence of Peripheral Vascular Disease has been increasing which includes the large artery in the upper leg called Superficial Femoral Artery (SFA).
- Trial name
- NCT00542646
- Testing
- Endovascular Intervention
- Where
- Chile
- Volunteers
- 45 people
- Sponsor
- PeriTec Biosciences Ltd.