Clinical trials: Oral Complication
Type 2 Diabetes Mellitus With Diabetic Nephropathy
Safety and Efficacy of Oral GKT137831 in Patient With Type 2 Diabetes and Albuminuria
NADPH oxidase enzymes (NOX) have been implicated in the development of several diabetic complications including diabetic nephropathy. GKT137831 is the first in class NOX1/4 inhibitor.
- Trial name
- NCT02010242
- Testing
- GKT137831
- Where
- 48 sites in United States, Australia and 4 more
- Volunteers
- 136 people
- Sponsor
- Calliditas Therapeutics AB
Diabetic Retinopathy, Diabetic Macular Edema
Study of the Safety and Efficacy of APX3330 in Diabetic Retinopathy
The objective of this study is to evaluate the safety and efficacy of APX3330 to treat diabetic retinopathy (DR) and diabetic macular edema (DME).
- Conditions
- Diabetic Retinopathy, Diabetic Macular Edema, NPDR - Non Proliferative Diabetic Retinopathy, PDR - Proliferative Diabetic Retinopathy
- Trial name
- ZETA-1 (NCT04692688)
- Testing
- APX3330
- Where
- 24 sites in United States
- Volunteers
- 103 people, healthy volunteers welcome
- Sponsor
- Opus Genetics, Inc
Post Operative Pain
Effectiveness, Safety, and Tolerability Study of Oxymorphone Immediate Release (IR) Oral Liquid in Post Surgical Pediatric Subjects
The purpose of this study is to evaluate the effectiveness, tolerability, and safety of oxymorphone immediate release (IR) oral liquid as an analgesic for acute postoperative pain in pediatric subjects.
- Trial name
- NCT01210352
- Testing
- oxymorphone HCl
- Where
- 8 sites in United States
- Volunteers
- 61 people
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company
Non Small Cell Lung Cancer, Urothelial Cancer
Study of INCB086550 in Select Solid Tumors
An open-label, nonrandomized study to evaluate the efficacy and safety of INCB086550, a first-in-class oral inhibitor of PD-L1, as initial immune checkpoint inhibitor therapy in participants with select solid tumors
- Conditions
- Non Small Cell Lung Cancer, Urothelial Cancer, Renal Cell Carcinoma, Hepatocellular Carcinoma
- Trial name
- NCT04629339
- Testing
- INCB086550
- Where
- 20 sites in Bulgaria, Hungary and 3 more
- Volunteers
- 16 people
- Sponsor
- Incyte Corporation
Acute Pain
Nefopam/Paracetamol Fixed Dose Combination in Acute Pain After Impacted Third Molar Extraction
This study aims to evaluate the analgesic efficacy of single and multiple doses of a new fixed dose combination of nefopam hydrochloride 30 mg and paracetamol 500mg taken orally in comparison to each single component.
- Trial name
- NCT04622735
- Testing
- nefopam hydrochloride 30mg / paracetamol 500mg X2, Paracetamol 500 Mg Oral Tablet X2, Nefopam HCl 30 MG Oral Tablet X2
- Where
- 19 sites in Belgium, France and 3 more
- Volunteers
- 321 people
- Sponsor
- Unither Pharmaceuticals, France
Candida Vulvovaginitis
Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis
This is a Phase 3, randomized, multicenter, double-blind, placebo-controlled study to evaluate the efficacy and safety of oral Ibrexafungerp (SCY-078) compared to placebo in female subjects 12 years and older with AVVC.
- Trial name
- Vanish 306 (NCT03987620)
- Testing
- Ibrexafungerp
- Where
- 41 sites in United States, Bulgaria
- Volunteers
- 455 people
- Sponsor
- Scynexis, Inc.
Ovarian Neoplasms, Non-Small-Cell Lung Carcinoma
A Phase I Clinical Study With Investigational Compound LTT462 in Adult Patients With Specific Advanced Cancers.
A phase I study of LTT462 in patients with advanced solid tumors that harbor MAPK pathway alterations.
- Conditions
- Ovarian Neoplasms, Non-Small-Cell Lung Carcinoma, Melanoma, Other Solid Tumors
- Trial name
- NCT02711345
- Testing
- LTT462
- Where
- 7 sites in United States, Germany and 4 more
- Volunteers
- 65 people
- Sponsor
- Novartis Pharmaceuticals
GENITAL HERPES
Efficacy of Oral Famciclovir 125mg Comparing to Aciclovir 200 mg Treatment in Patients With Active Recurrent Genital Herpes
Recurrent genital herpes is a commonly occurring sexually transmitted disease caused by herpes simplex virus (HSV). There are effective oral prescription antiviral medicines available to reduce the discomfort of symptoms, such as…
- Trial name
- NCT01281007
- Testing
- Famciclovir, Aciclovir
- Where
- 9 sites in Brazil
- Volunteers
- 150 people
- Sponsor
- EMS
Venous Thromboembolism
Safety and Pharmacokinetics Study of DU-176b Administered to Patients With Severe Renal Impairment Undergoing Orthopedic Surgery of The Lower Limbs
To assess the safety and pharmacokinetics of DU-176b administered to patients with severe renal impairment undergoing orthopedic surgery of the lower limbs, compared with DU-176b administered to patients with mild renal…
- Trial name
- NCT01857583
- Testing
- 15mg DU-176b, 30mg DU-176b, Fondaparinux
- Where
- Japan
- Volunteers
- 80 people
- Sponsor
- Daiichi Sankyo Co., Ltd.
Anemia Associated With Chronic Kidney Disease (CKD)
Study Evaluating the Efficacy and Safety of Dose Conversion From a Long-acting Erythropoiesis-stimulating Agent (Mircera®) to Three Times Weekly Oral Vadadustat for the Maintenance Treatment of Anemia in Hemodialysis Subjects
This study will be conducted to demonstrate the efficacy and safety of vadadustat administered three times weekly (TIW) compared to a long-acting erythropoiesis-stimulating agent (ESA) (Mircera®) for the maintenance treatment of…
- Trial name
- NCT04707768
- Testing
- Vadadustat, Mircera®
- Where
- 58 sites in United States
- Volunteers
- 456 people
- Sponsor
- Akebia Therapeutics
Chronic Kidney Disease
Safety, Tolerability, and Pharmacokinetics of KBP-5074 Following Oral Administration in Chronic Kidney Disease
This study explores the use of KBP-5074 in patients with advanced stages of Chronic Kidney Disease (CKD) (including patients with severe renal impairment and those on hemodialysis [HD]) and to assess the safety, tolerability, and…
- Trial name
- NCT02837237
- Testing
- KBP-5074
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- KBP Biosciences
Prostate Cancer, Endometriosis
A Phase 1 Study to Evaluate the Effects of Fluconazole and Atorvastatin on the Pharmacokinetics of TAK-385 in Healthy Subjects
This is a nonrandomized, open-label, fixed-sequence, 2-arm study designed to assess the effect of multiple doses of fluconazole or atorvastatin on the single-dose pharmacokinetics of TAK-385 in healthy adult subjects.
- Trial name
- NCT02093390
- Testing
- TAK-385, Fluconazole, Atorvastatin
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Millennium Pharmaceuticals, Inc.
Cancer
Fentanyl Sublingual Spray in Treating Patients With Breakthrough Cancer Pain
This is a phase III, randomized, double-blind, placebo-controlled, multicenter study of the clinical response to fentanyl sublingual spray as a treatment for breakthrough cancer pain.
- Trial name
- NCT00538850
- Testing
- Fentanyl sublingual spray
- Where
- United States
- Volunteers
- 130 people
- Sponsor
- INSYS Therapeutics Inc
Surgical Site Infection
Delafloxacin IV and OS Administration Compared to Best Available Therapy in Patients With Surgical Site Infections
The purpose of this study is to assess the efficacy and safety of delafloxacin administered as IV and oral formulation in comparison with Best Available Therapy (BAT) in patients with superficial or deep incisional surgical site…
- Trial name
- DRESS (NCT04042077)
- Testing
- Delafloxacin, Vancomycin, Linezolid
- Where
- Italy
- Volunteers
- 268 people
- Sponsor
- Menarini Group
Endometriosis
A Study of Pharmacokinetic/Pharmacodynamic Profile of Orally Administered Leuprolide in Healthy Female Volunteers
This Phase 2a, pharmacokinetic/pharmacodynamic study will determine the safety and provide evaluation of the PK/PD metrics of three different oral doses selected upon the results of the study LOPDT-PH1-01 - 4 mg oral tablets…
- Trial name
- NCT02807363
- Testing
- Leuprolide Oral Tablet 4-mg QD, Leuprolide Oral Tablet 4-mg BID, Leuprolide Depot
- Where
- Canada
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Enteris BioPharma Inc.
Chronic Kidney Disease
Equivalence of Calcium Acetate Oral Solution and Sevelamer Carbonate Tablets in Hemodialysis Patients
The purpose of this study is to demonstrate equivalence of calcium acetate oral solution and sevelamer carbonate in maintaining serum phosphorus levels This is a phase IV, multicenter, randomized, open-label, cross-over study to…
- Trial name
- COS-002 (NCT01427907)
- Testing
- Calcium acetate oral solution (COS), Sevelamer carbonate
- Where
- 4 sites in United States
- Volunteers
- 38 people
- Sponsor
- Fresenius Medical Care North America
Metastatic Cancer, Solid Tumors
Arginase Inhibitor INCB001158 as a Single Agent and in Combination With Immune Checkpoint Therapy in Patients With Advanced/Metastatic Solid Tumors
This study is an open-label Phase 1/Phase 2 evaluation of INCB001158 as a single agent and in combination with immune checkpoint therapy in patients with advanced/metastatic solid tumors.
- Conditions
- Metastatic Cancer, Solid Tumors, Colorectal Cancer (CRC), Gastric Cancer
- Trial name
- NCT02903914
- Testing
- INCB001158, Pembrolizumab
- Where
- 20 sites in United States, Italy and 2 more
- Volunteers
- 260 people
- Sponsor
- Incyte Corporation
Anemia, Non-Dialysis-Dependent Chronic Kidney Disease
Study to Evaluate Vadadustat for the Correction of Anemia in Participants With Non-dialysis-dependent Chronic Kidney Disease
A multicenter, randomized, open-label, active-controlled Phase 3 study for the correction of anemia and maintenance of hemoglobin (Hb) in participants with Non-Dialysis-Dependent Chronic Kidney Disease (NDD-CKD)
- Trial name
- NCT02648347
- Testing
- Vadadustat, Darbepoetin alfa
- Where
- 439 sites in United States, Argentina and 18 more
- Volunteers
- 1,751 people
- Sponsor
- Akebia Therapeutics
Anemia, Iron-Deficiency, Kidney Failure, Chronic
Effect of Ferrlecit® Versus Oral Iron on Iron Deficient Chronic Kidney Disease (CKD) Patients Receiving Erythropoietic Agents
This study compares the effect of Ferrlecit® (a form of intravenous iron) to ferrous sulfate (a form of oral iron) in treating anemia and iron deficiency in chronic kidney disease patients who are receiving erythropoietic agents…
- Trial name
- NCT00224042
- Testing
- Sodium Ferric Gluconate complex in sucrose, Ferrous sulfate tablets
- Where
- 24 sites in United States, Puerto Rico
- Volunteers
- 52 people
- Sponsor
- Watson Pharmaceuticals
Urinary Tract Infection, Acute Pyelonephritis
A Study of Oral Tebipenem Pivoxil Hydrobromide (TBP-PI-HBr) Compared to Intravenous Imipenem-cilastatin in Participants With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)
The primary purpose of this study is to assess the efficacy of oral TBP-PI-HBr as compared with intravenous (IV) imipenem-cilastatin with respect to the overall response (combined clinical cure plus microbiological eradication)…
- Trial name
- PIVOT-PO (NCT06059846)
- Testing
- TBP-PI-HBr, Imipenem-cilastatin, Dummy Infusion
- Where
- 85 sites in United States, Argentina and 17 more
- Volunteers
- 1,690 people
- Sponsor
- Spero Therapeutics