Clinical trials: Management Systems
Gastroesophageal Reflux Disease (GERD)
The EndoGastric Solutions TEMPO Trial
The purpose of this study is to assess the efficacy and safety of Transoral Incisionless Fundoplication (TIF) performed with EsophyX as compared to proton pump inhibitor (PPI) therapy for the treatment of chronic Gastroesophageal…
- Trial name
- TEMPO (NCT01647958)
- Testing
- EsophyX System with SerosaFuse fasteners, PPI
- Where
- United States
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- EndoGastric Solutions
Surgical Wound
AMBULATE Continued Access Protocol to Evaluate the Cardiva Mid-Bore Venous Vascular Closure System (VVCS)
The objective of the trial is to demonstrate the safety and effectiveness of the Cardiva Mid-Bore Venous Vascular Closure System (VVCS) in sealing femoral venous access sites at the completion of catheter-based procedures…
- Trial name
- NCT03573206
- Testing
- Cardiva Mid-Bore Venous Vascular Closure Device (VVCS)
- Where
- 3 sites in United States
- Volunteers
- 168 people
- Sponsor
- Cardiva Medical, Inc.
Erosive Esophagitis
Vonoprazan Study in Patients With Erosive Esophagitis to Evaluate Long-term Safety
The purpose of this study is exploratorily evaluate the effect on gastric mucosal tissue and the safety of long-term administration (260 weeks: 5 years) of vonoprazan 10 mg or 20 mg in patients receiving maintenance treatment…
- Trial name
- NCT02679508
- Testing
- Vonoprazan, Lansoprazole
- Where
- 36 sites in Japan
- Volunteers
- 208 people
- Sponsor
- Takeda
Cryopyrin-Associated Periodic Syndrome
Study of ATI-450 in Patients With Cryopyrin-Associated Periodic Syndrome (CAPS)
This is a Phase 2 study to investigate the safety and efficacy of ATI-450 for the Maintenance of Remission in Patients with Cryopyrin-Associated Periodic Syndrome (CAPS) Previously Managed with Anti-IL-1 Therapy.
- Trial name
- NCT04524858
- Testing
- ATI-450
- Where
- 2 sites in United States
- Volunteers
- 1 people
- Sponsor
- Aclaris Therapeutics, Inc.
Diabetes Mellitus, Type 1
A Study of LY900014 in Japanese Participants With Type 1 Diabetes Mellitus
This study will compare LY900014, a drug that lowers blood sugar, with insulin lispro (Humalog). Both drugs will be given by injection under the skin of the abdomen.
- Trial name
- NCT03407118
- Testing
- LY900014, Insulin Lispro
- Where
- Japan
- Volunteers
- 31 people
- Sponsor
- Eli Lilly and Company
Multiple Myeloma
A Survey on NINLARO Risk Management Plan (RMP) Material Utilization Among Pharmacists in Japan
This is a survey among pharmacists who have instructed NINLARO therapy in ixazomib, lenalidomide and dexamethasone (IRD) dosing to patients with relapsed/refractory multiple myeloma (rrMM).
- Trial name
- NCT05882279
- Testing
- No Intervention
- Where
- Japan
- Volunteers
- 330 people
- Sponsor
- Takeda
Acromegaly
Assessment of BIM23B065, Given as Repeated Subcutaneous Injection in Subjects With Acromegaly
The purpose of the protocol is evaluate the safety, the pharmacodynamics and the pharmacokinetic of repeated administration of BIM23B065 in subjects with acromegaly.
- Trial name
- DOPAACRO 002 (NCT03045302)
- Testing
- BIM23B065
- Where
- 6 sites in Belgium, Hungary and 2 more
- Volunteers
- 4 people
- Sponsor
- Ipsen
Hepatitis C
Drug Interaction Study With BI 201335 and Methadone or Buprenorphine/Naloxone
Otherwise healthy subjects who are currently bein maintained on either methadone or buprenorphine/naloxone for opioid maintenance therapy who have been on a stable dose for at least 30 days will be administered BI 201335 daily to…
- Trial name
- NCT01637922
- Testing
- BI 201335
- Where
- 3 sites in United States
- Volunteers
- 34 people
- Sponsor
- Boehringer Ingelheim
Migraine
Comparing Efficacy and Safety of 2 Dose Regimens of Subcutaneous Administration of TEV-48125 Versus Placebo for the Preventive Treatment of Chronic Migraine
The study is being conducted to evaluate two doses of TEV-48125 in adult patients with chronic migraine
- Trial name
- NCT02621931
- Testing
- Fremanezumab
- Where
- 273 sites in United States, Canada and 7 more
- Volunteers
- 1,130 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Asthma
Study of Mepolizumab Autoinjector in Asthmatics
This study is aimed to assess the correct real-world use of an autoinjector for the repeat self-administration of mepolizumab SC, so to improve subject / physician convenience and to enable repeat dose self injection themselves…
- Trial name
- NCT03099096
- Testing
- Mepolizumab
- Where
- 38 sites in United States, Australia and 5 more
- Volunteers
- 159 people
- Sponsor
- GlaxoSmithKline
Gastrointestinal Diseases
A Bioequivalence Study of Idiazole 20mg DR Tabs and PARIET® 20 mg DR Tabs After a Single Oral Dose Administration Under Fasting Conditions in Healthy Adults
This is an open-label, randomized, single dose, two-sequence, two-period crossover study, separated by 7 days washout interval from the first study drug administration.
- Trial name
- NCT02446483
- Testing
- Idiazole 20mg DR tabs, PARIET 20 mg DR tabs
- Where
- Egypt
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Diabetes Mellitus, Type 1
ACCU-CHEK Connect Personal Diabetes Management Study (PDM CONNECT)
This post-market, interventional, prospective, single arm, the United States (US) based multi-center study will assess the change in treatment satisfaction of participants who utilize the ACCU-CHEK Connect Diabetes Management…
- Trial name
- NCT02600845
- Testing
- ACCU-CHEK
- Where
- 11 sites in United States
- Volunteers
- 122 people
- Sponsor
- Hoffmann-La Roche
Diabetes, Diabetes Mellitus, Type 2
To Compare the Effect of Liraglutide When Given Together With Metformin With the Effect of Metformin Given Alone and With the Effect of Glimepiride and Metformin Given Together
This trial is conducted in Europe, Oceania, Africa, Asia and South America. This trial is designed to show the effect of treatment with liraglutide when adding to existing metformin therapy and to compare it with the effects of…
- Trial name
- LEAD-2 (NCT00318461)
- Testing
- liraglutide, metformin, glimepiride
- Where
- 190 sites in Argentina, Australia and 18 more
- Volunteers
- 1,091 people
- Sponsor
- Novo Nordisk A/S
Insomnia
Driving Performance After Middle of the Night Administration of 3.5 mg Zolpidem Tartrate Sublingual Tablet
A study in healthy volunteers of the next morning driving performance after middle-of-the-night dosing of 3.5 mg zolpidem tartrate sublingual tablet, a sleep aid.
- Trial name
- NCT01106859
- Testing
- zopiclone, zolpidem tartrate sublingual tablet
- Where
- Netherlands
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Transcept Pharmaceuticals
Chronic Hepatitis C Infection
Open-Labeled Study of PSI-7977 and RBV With and Without PEG-IFN in Treatment-Naïve Patients With HCV GT2 or GT3
This study is to assess the safety and tolerability of sofosbuvir (SOF) 400 mg with and without ribavirin (RBV) and/or with and without pegylated interferon alfa-2a (PEG) in subjects with genotype 1, 2 or 3 hepatitis C (HCV)…
- Trial name
- NCT01260350
- Testing
- SOF, RBV, PEG
- Where
- 2 sites in New Zealand
- Volunteers
- 292 people
- Sponsor
- Gilead Sciences
Urea Cycle Disorders
To Evaluate the Safety of Long-term Use of HPN-100 in the Management of Urea Cycle Disorders (UCDs)
This was an open-label, long-term safety study of HPN-100 (RAVICTI; glycerol phenylbutyrate) in participants with a urea cycle disorder (UCD) who completed the safety extensions of HPN-100-005 (NCT00947544; HPN-100-005SE)…
- Trial name
- NCT01257737
- Testing
- HPN-100
- Where
- 16 sites in United States, Canada
- Volunteers
- 88 people
- Sponsor
- Amgen
Hepatitis C, Chronic
An Observational Study of Peginterferon (e.g. Pegasys)-Based Direct Acting Antiviral Triple Therapy in Patients With Chronic Hepatitis C Genotype 1
This prospective observational study will evaluate the efficacy and safety of two approved pegylated interferon-based direct acting antiviral triple therapies in patients with chronic hepatitis C genotype 1.
- Trial name
- NCT01508130
- Where
- 66 sites in United States, Puerto Rico
- Volunteers
- 672 people
- Sponsor
- Hoffmann-La Roche
Persistent Allergic Asthma
Evaluate the Effect of Omalizumab on Markers of Asthma Impairment in Patients With Persistent Allergic Asthma
This study will evaluate the effect of omalizumab on markers of impairment in patients with inadequately controlled persistent allergic asthma on Step 4 or above therapy as defined in the 2007 National Heart, Lung, and Blood…
- Trial name
- NCT00870584
- Testing
- Omalizumab
- Where
- 50 sites in United States
- Volunteers
- 271 people
- Sponsor
- Novartis Pharmaceuticals
Asthma
A Phase IIA FF/VI Study to Measure FeNO in Asthmatic Patients.
For asthmatic subjects, a combination of inhaled corticosteroid (FF) and long-acting beta2 receptor agonist (VI) is recommended for use (once daily) and fraction of exhaled nitric oxide (FeNO) is a non-invasive airway…
- Trial name
- NCT02712047
- Testing
- Fluticasone furoate (FF) (100 mcg), Vilanterol (VI) (25 mcg)
- Where
- New Zealand
- Volunteers
- 28 people
- Sponsor
- GlaxoSmithKline
Huntington Disease
Dose-response Evaluation of the Cellavita HD Product in Patients With Huntington's Disease
Cellavita HD is a stem-cell therapy for Huntington's Disease. This is a prospective, phase II, single-center, randomized (2:2:1), triple-blind, placebo controlled study, with two test doses of Cellavita HD product.
- Trial name
- ADORE-DH (NCT03252535)
- Testing
- Cellavita HD lower dose, Cellavita HD higher dose
- Where
- Brazil
- Volunteers
- 49 people
- Sponsor
- Azidus Brasil