Clinical trials: Phase III
Vulvovaginal Atrophy, Menopause
Estradiol Vaginal Softgel Capsules in Treating Symptoms of Vulvar and Vaginal Atrophy in Postmenopausal Women
This study will assess the safety and efficacy of a new formulation of vaginal estradiol for the treatment of symptoms of vulvar and vaginal atrophy in postmenopausal women.
- Conditions
- Vulvovaginal Atrophy, Menopause, Dyspareunia, Painful Intercourse
- Trial name
- REJOICE (NCT02253173)
- Testing
- Estradiol
- Where
- 105 sites in United States, Canada
- Volunteers
- 764 people
- Sponsor
- TherapeuticsMD
Respiratory Syncytial Virus (RSV)
A Study to Learn About Revaccination With a Vaccine Called RSVpreF in Older Adults
This study is testing the safety and tolerability of a second dose of Respiratory Syncytial Virus Vaccine (RSVpreF) given approximately 5 years after the initial dose.
- Trial name
- NCT07885956
- Testing
- RSVpreF (Regimen A), RSVpreF (Regimen B)
- Volunteers
- 750 people, healthy volunteers welcome
- Sponsor
- Pfizer
Carcinoma, Small Cell Lung
RRx-001 Sequentially With a Platinum Doublet or a Platinum Doublet in Third-Line or Beyond in Patients With Small Cell Lung Cancer
This Phase 3 study aims to find out whether RRx-001 + platinum chemotherapy is more effective than platinum chemotherapy alone in 3rd line or beyond small cell cancer.
- Trial name
- REPLATINUM (NCT03699956)
- Testing
- RRx-001 + eLOOP Device, Cisplatin/carboplatin plus etoposide
- Where
- 18 sites in United States
- Volunteers
- 18 people
- Sponsor
- EpicentRx, Inc.
Neovascular (Wet) Age-related Macular Degeneration
Efficacy Evaluation Study of BAT5906 and Lucentis® in Patients With Macular Degeneration
A non-inferiority design was used to conduct a randomized, double-blind, parallel-controlled multi-center study. A total of 488 subjects with neovascular (wet) age-related macular degeneration (w-AMD) were planned to be enrolled.
- Trial name
- NCT05439629
- Testing
- BAT5906 injection, Lucentis
- Where
- 48 sites in China
- Volunteers
- 488 people
- Sponsor
- Bio-Thera Solutions
Ulcerative Colitis
A Phase 3 Study to Investigate the Efficacy and Safety of SHR0302 With Moderately to Severely Active Ulcerative Colitis
This is a randomized, double-blind, placebo-controlled, multicenter Phase 3 study that will enroll approximately 368 subjects aged 18 to 75 years old with Moderately to Severely Active Ulcerative Colitis.
- Trial name
- NCT05181137
- Testing
- SHR0302
- Where
- 113 sites in United States, China and 3 more
- Volunteers
- 368 people
- Sponsor
- Reistone Biopharma Company Limited
Cytokine Storm (Covid-19)
Study to Assess the Efficacy and Safety of Ruxolitinib in Patients With COVID-19 Associated Cytokine Storm
This was a randomized, double-blind, placebo-controlled, 29-day, multicenter study to assess the efficacy and safety of ruxolitinib + standard-of-care (SoC) therapy, compared with placebo + SoC therapy, in patients aged ≥12 years…
- Trial name
- RUXCOVID (NCT04362137)
- Testing
- Ruxolitinib
- Where
- 61 sites in United States, Argentina and 10 more
- Volunteers
- 432 people
- Sponsor
- Novartis Pharmaceuticals
Metastatic Pancreatic Ductal Adenocarcinoma
Study of JAB-23E73 in Combination With Chemotherapy in Participants With Metastatic PDAC Harboring KRAS Gene Alterations
The purpose of this study is to determine the safety and efficacy of pan KRAS inhibitor JAB-23E73 in combination with nab-paclitaxel and gemcitabine in participants with metastatic PDAC harboring KRAS gene alterations.
- Trial name
- NCT07640295
- Testing
- JAB-23E73 tablet，nab-paclitaxel，gemcitabine
- Where
- 13 sites in China
- Volunteers
- 80 people
- Sponsor
- Jacobio Pharmaceuticals Co., Ltd.
H1N1 Influenza Virus, Chronic Pulmonary Disease
Immunogenicity, Safety, and Tolerability of an MF59-Adjuvanted Versus Non-Adjuvanted Influenza Vaccines in Patients With Chronic Pulmonary Disease, Chronic Heart Disease, or Diabetes Mellitus
This is a phase III, randomized, controlled, open label study with two vaccine regimens. The study will assess the relative safety and immunogenicity of vaccine regimens comparing adjuvanted versus non-adjuvanted formulations of…
- Conditions
- H1N1 Influenza Virus, Chronic Pulmonary Disease, Chronic Heart Disease, Diabetes Mellitus
- Trial name
- NCT01032395
- Testing
- Focetria®, Fluad®, Begrivac®
- Where
- 2 sites in Brazil
- Volunteers
- 342 people, healthy volunteers welcome
- Sponsor
- Chiltern Pesquisa Clinica Ltda
Myelodysplastic Syndrome
The Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Placebo and Best Supportive Care in Subjects With Red Blood Cell (RBC) Transfusion-Dependent Anemia and Thrombocytopenia Due to International Prognostic Scoring System (IPSS) Low Risk Myelodysplastic Syndrome (MDS)
Evaluation of the Efficacy and Safety of Oral Azacitidine plus Best Supportive care versus Placebo and Best Supportive care in subjects with red blood cell (RBC) transfusion-dependent anemia and thrombocytopenia due to…
- Trial name
- NCT01566695
- Testing
- Oral Azacitidine, Best Supportiv Care (BSC)
- Where
- 196 sites in United States, Australia and 21 more
- Volunteers
- 216 people
- Sponsor
- Celgene
Colorectal Cancer
A Phase II/III Study of HR070803 in Combination With Oxaliplatin, 5-fluorouracil, Calcium Folinate and Bevacizumab Versus FOLFOX in Combination With Bevacizumab for First-line Treatment of Advanced Colorectal Cancer
This is a double-blind, randomized, multi-center, II/III study in at least 606 patients with advanced colorectal cancer. The study is being conducted to evaluate the safety of HR070803 combined with oxaliplatin, 5-FU/LV and…
- Trial name
- NCT05945901
- Testing
- HR070803 plus oxaliplatin, 5-FU/LV, bevacizumab, HR070803 simulator plus oxaliplatin, 5-FU/LV, bevacizumab
- Where
- China
- Volunteers
- 669 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Hypertension
A Study to Investigate Efficacy and Safety of a TCA108 in Participants ≥18 Years With Uncontrolled Hypertension
The purpose of this study if to evaluate the efficacy and safety of TCA108 on treatment of hypertension.
- Trial name
- TRÍADE-HA (NCT07030101)
- Testing
- TCA108, Bramicar HCT, Micardis Anlo
- Volunteers
- 400 people
- Sponsor
- EMS
Breast Cancer
Vepdegestrant (ARV-471/PF-07850327) + Palbociclib vs Letrozole + Palbociclib in ER(+)/HER2(-) Advanced Breast Cancer
The purpose of this study is to understand the safety and effects of the study medicine vepdegestrant (ARV-471/PF-07850327) given together with palbociclib in advanced breast cancer.
- Trial name
- VERITAC-3 (NCT05909397)
- Testing
- Vepdegestrant (ARV-471/PF-07850327), Palbociclib, Letrozole
- Where
- 29 sites in United States, Australia and 8 more
- Volunteers
- 59 people
- Sponsor
- Pfizer
Epithelial Ovarian Cancer, Peritoneal Cancer
A Single-arm Clinical Trial of IMGN853 in Chinese Adult Patients With Platinum-resistant, Epithelial Ovarian Cancer
This Phase III single-arm study is to evaluate the efficacy and safety of IMGN853 in Chinese adult patients with platinum-resistant high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancers (hereafter referred…
- Conditions
- Epithelial Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer
- Trial name
- NCT05622890
- Testing
- Mirvetuximab Soravtansine
- Where
- 28 sites in China
- Volunteers
- 35 people
- Sponsor
- Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Chemotherapy-Induced Nausea and Vomiting
A Safety Study of Oral Netupitant and Palonosetron for the Prevention of Nausea and Vomiting
NETU-10-29 is a clinical study assessing safety of netupitant and palonosetron, two antiemetic drugs, both given with oral dexamethasone.
- Trial name
- NCT01376297
- Testing
- Netupitant and Palonosetron, Aprepitant, Palonosetron
- Where
- 75 sites in United States, Bulgaria and 8 more
- Volunteers
- 413 people
- Sponsor
- Helsinn Healthcare SA
Colonic Diseases, Intestinal Disease
Safety and Efficacy of PBK-1701TC for Bowel Cleansing Before Colonoscopy
This study evaluates the efficacy, safety and tolerability of PBK-1701TC for bowel cleansing before colonoscopy. Half the participants will receive PBK-1701TC and while the other will receive standard oral preparation.
- Conditions
- Colonic Diseases, Intestinal Disease, Gastrointestinal Disease, Digestive System Disease
- Trial name
- NCT03509220
- Testing
- PBK-1701TC, Standard oral preparation
- Where
- 5 sites in South Korea
- Volunteers
- 235 people, healthy volunteers welcome
- Sponsor
- Pharmbio Korea Co., Ltd.
Back Muscle Spasm, Back Pain
Efficacy and Safety of Tolperisone in Subjects With Pain Due to Acute Back Muscle Spasm
This is a double-blind, randomized, placebo-controlled, multicenter study of the efficacy and safety of tolperisone (a non-opioid) or placebo administered in subjects with pain due to acute back muscle spasm.
- Conditions
- Back Muscle Spasm, Back Pain, Back Strain, Back Spasm Upper
- Trial name
- RESUME-1 (NCT04671082)
- Testing
- Tolperisone Hydrochloride
- Where
- 56 sites in United States
- Volunteers
- 1,004 people
- Sponsor
- Neurana Pharmaceuticals, Inc.
Erythropoietic Protoporphyria
A Safety Extension Study in Patients With Erythropoietic Protoporphyria (EPP)
The main objectives of the study were to evaluate the safety and tolerability of afamelanotide by measuring treatment emergent adverse events (AEs) and to determine whether afamelanotide can improve the quality of life of EPP…
- Trial name
- NCT04578496
- Testing
- Afamelanotide
- Volunteers
- 16 people
- Sponsor
- Clinuvel Pharmaceuticals Limited
Hepatitis C Virus Infection
Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination for 12 Weeks in Adults With Chronic HCV Infection and Compensated Cirrhosis
The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of therapy with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) in adults with chronic hepatitis C virus (HCV)…
- Trial name
- NCT04112303
- Testing
- SOF/VEL
- Where
- 22 sites in Japan
- Volunteers
- 37 people
- Sponsor
- Gilead Sciences
Colorectal Cancer
A Study of Napabucasin (BBI-608) in Combination With FOLFIRI in Adult Patients With Previously Treated Metastatic Colorectal Cancer
This is an international multi-center, prospective, open-label, randomized, adaptive design phase 3 trial of the cancer stem cell pathway inhibitor napabucasin plus standard bi-weekly FOLFIRI versus standard bi-weekly FOLFIRI in…
- Trial name
- CanStem303C (NCT02753127)
- Testing
- Napabucasin, Fluorouracil, Leucovorin
- Where
- 211 sites in United States, Australia and 14 more
- Volunteers
- 1,253 people
- Sponsor
- Sumitomo Pharma America, Inc.
Osteoarthritis of the Knee
Extended and Controlled Release Liposomal Formulated Dexamethasone for Chronic Knee OA Pain
Phase 3 randomized, double-blind, placebo- and active comparator-controlled study of TLC599.
- Trial name
- EXCELLENCE (NCT04123561)
- Testing
- TLC599, DSP, Normal Saline
- Where
- 46 sites in United States, Australia
- Volunteers
- 504 people
- Sponsor
- Taiwan Liposome Company