Clinical trials: Major Complications
Ovarian Neoplasm, Fallopian Tube Neoplasms
Relacorilant in Combination With Nab-Paclitaxel in Advanced, Platinum-Resistant, High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian-Tube Cancer
The primary objectives of this study are to evaluate progression-free survival (PFS) by blinded independent central review (BICR) and overall survival (OS) (evaluated independently, as dual primary endpoints) in patients treated…
- Conditions
- Ovarian Neoplasm, Fallopian Tube Neoplasms, Peritoneal Neoplasms
- Trial name
- NCT05257408
- Testing
- Relacorilant 150 mg, Nab-paclitaxel 80 mg/m^2, Nab-paclitaxel 100 mg/m^2
- Where
- 116 sites in United States, Argentina and 12 more
- Volunteers
- 381 people
- Sponsor
- Corcept Therapeutics
Postoperative Pain
OxyNorm Capsules in Post-Operative Pain Study
The efficacy and safety of oxycodone capsules compared with morphine tablets in hospitalized patients with moderate to severe pain following surgery.
- Trial name
- NCT01675635
- Testing
- OxyNorm Capsules, Morphine tablet
- Volunteers
- 240 people
- Sponsor
- Mundipharma (China) Pharmaceutical Co. Ltd
Renal Impairment
Study of a Single Intravenous (IV) Dose of MK-3402 in Participants With Impaired Renal Function and in Healthy Controls (MK-3402-004)
The purpose of this study is to compare the plasma and urine pharmacokinetics (PK) of MK-3402 in participants with impaired renal function and healthy control participants, to investigate the extent to which MK-3402 is removed…
- Trial name
- NCT04678505
- Testing
- MK-3402
- Where
- 2 sites in United States
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
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
Type 2 Diabetes Mellitus, Chronic Kidney Disease Stage 4
A Study to Evaluate Safety and Effects of Sotagliflozin 400 and 200 mg on Glucose Control in Participants With Type 2 Diabetes, Severe Impairment of Kidney Function and Inadequate Blood Sugar Control
Primary Objective: To demonstrate the superiority of sotagliflozin 400 milligrams (mg) versus placebo with respect to hemoglobin A1c (HbA1c) reduction at Week 26 in participants with Type 2 diabetes who have inadequate glycemic…
- Trial name
- SOTA-CKD4 (NCT03242018)
- Testing
- Sotagliflozin
- Where
- 106 sites in United States, Argentina and 13 more
- Volunteers
- 277 people
- Sponsor
- Lexicon Pharmaceuticals
Diabetes Mellitus, Type 2
Post-authorisation Safety Study in Patients With Type 2 Diabetes to Assess the Risk of Liver Injury, Kidney Injury, Urinary Tract and Genital Infections, and Diabetic Ketoacidosis in Patients Treated With Empagliflozin, Compared to DPP-4 Inhibitors
Empagliflozin (Jardiance), a highly potent and selective inhibitor of the sodium-glucose cotransporter 2 (SGLT2), was approved in Europe in May 2014 for the treatment of type 2 diabetes mellitus (T2DM) to improve glycaemic…
- Trial name
- NCT02864914
- Testing
- Empagliflozin, DPP-4 inhibitors
- Where
- United Kingdom
- Volunteers
- 333,580 people
- Sponsor
- Boehringer Ingelheim
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
Ovarian Carcinoma, Breast Cancer
Phase II Study of AZD2281 in Patients With Known BRCA Mutation Status or Recurrent High Grade Ovarian Cancer or Patients With Known BRCA Mutation Status/ Triple Neg Breast Cancer
This is a Phase II, open label, non randomized correlative study of AZD2281 in patients with recurrent breast and ovarian cancer in both BRCA inherited mutation carriers and non-carriers to identify objective response rate and to…
- Trial name
- NCT00679783
- Testing
- AZD2281
- Where
- 6 sites in Canada
- Volunteers
- 99 people
- Sponsor
- AstraZeneca
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.
Postpartum Depression
Evaluate SAGE-547 in Female Participants With Severe Postpartum Depression
This is an open-label proof-of-concept study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of SAGE-547 Injection in adult female participants diagnosed with severe postpartum depression (PPD).
- Trial name
- NCT02285504
- Testing
- SAGE-547
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Supernus Pharmaceuticals, Inc.
Postpartum Depression
A Study to Evaluate Efficacy and Safety of SAGE-547 in Participants With Severe Postpartum Depression (547-PPD-202B)
The purpose of this study was to determine if SAGE-547 Injection infused intravenously at up to 90 micrograms per kilogram per hour (μg/kg/h) for 60 hours reduces depressive symptoms in participants with severe postpartum…
- Trial name
- NCT02942004
- Testing
- SAGE-547 60 μg/kg/h, SAGE-547 90 μg/kg/h
- Where
- 32 sites in United States
- Volunteers
- 138 people
- Sponsor
- Supernus Pharmaceuticals, Inc.
Renal Impairment
Effect of Febuxostat on Renal Function in Patients With Gout and Moderate to Severe Renal Impairment
The purpose of this study is to determine the effect of febuxostat, once daily (QD) or twice daily (BID), on renal function in gout patients with elevated serum urate levels and who have moderate to severe renal impairment.
- Trial name
- NCT01082640
- Testing
- Febuxostat
- Where
- 58 sites in United States
- Volunteers
- 96 people
- Sponsor
- Takeda
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
Epithelial Ovarian Cancer, Peritoneal Cancer
A Study of Mirvetuximab Soravtansine in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression
This study is designed to evaluate the efficacy and safety of mirvetuximab soravtansine (MIRV) in participants with platinum-resistant high-grade serous epithelial ovarian cancer, primary peritoneal, or fallopian tube cancer…
- Conditions
- Epithelial Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer
- Trial name
- SORAYA (NCT04296890)
- Testing
- Mirvetuximab Soravtansine
- Where
- 89 sites in United States, Australia and 9 more
- Volunteers
- 106 people
- Sponsor
- ImmunoGen, 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
Platinum-resistant Ovarian Cancer, Fallopian Tube Cancer
Phase 1b Study of SL-172154 Administered With Combination Agent(s) in Subjects With Ovarian Cancers
SL03-OHD-105 is an open-label, multicenter, phase 1b trial designed to evaluate SL-172154 administered in combination with pegylated liposomal doxorubicin (PLD) or mirvetuximab soravtansine (MIRV) in patients with platinum…
- Conditions
- Platinum-resistant Ovarian Cancer, Fallopian Tube Cancer, Epithelial Ovarian Cancer, Ovarian Cancer
- Trial name
- NCT05483933
- Testing
- Pegylated Liposomal Doxorubicin + SL-172154, Mirvetuximab + SL-172154
- Where
- 21 sites in United States, Canada and 2 more
- Volunteers
- 86 people
- Sponsor
- Shattuck Labs, Inc.
Complicated Skin and Skin Structure Infections, S. Aureus Bacteremia
Study of Daptomycin Safety and Efficacy for Complicated Skin and Skin Structure Infections (cSSSI) and Bacteremia in Renal Impairment
This is a multicenter, randomized, evaluator-blinded, comparator-controlled study. Participants were to be randomized (1:1) to daptomycin or comparator, stratified by degree of renal impairment (creatinine clearance [CLcr] 30 …
- Conditions
- Complicated Skin and Skin Structure Infections, S. Aureus Bacteremia, Renal Impairment
- Trial name
- RENSE (NCT01104662)
- Testing
- Vancomycin, Daptomycin, Semi-Synthetic Penicillin
- Where
- 10 sites in United States
- Volunteers
- 92 people
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Diabetic Retinopathy
Non-proliferative Diabetic Retinopathy Treated With Runcaciguat
This Phase 2 study is conducted to investigate the safety and efficacy of runcaciguat in the treatment of diabetic retinopathy. To assess efficacy, the retinal morphology will be investigated by 7-field color fundus photography…
- Trial name
- NEON-NPDR (NCT04722991)
- Testing
- Runcaciguat (BAY1101042)
- Where
- 55 sites in United States, Bulgaria and 12 more
- Volunteers
- 109 people
- Sponsor
- Bayer
Superficial Bladder Cancer
ADSTILADRIN (=INSTILADRIN) in Patients With High-Grade, Bacillus Calmette-Guerin (BCG) Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC)
Previous multi-dose Phase I and Phase II clinical studies have demonstrated that ADSTILADRIN is a safe and effective treatment for BCG-refractory and recurrent NMIBC.
- Trial name
- NCT02773849
- Testing
- ADSTILADRIN
- Where
- 34 sites in United States
- Volunteers
- 157 people
- Sponsor
- Ferring Pharmaceuticals
Severe Renal Impairment
Safety, Tolerability, and Pharmacokinetic of Single Dose of Pitavastatin 4 mg in Severe Renal Patients Versus Healthy Adult Volunteers
This is a Phase 4, multicenter, open label, 1 period study. A total of 16 subjects are planned (8 subjects in Group A and 8 subjects in Group B): The 2 groups will be comparable in terms of age, gender, and body mass index (BMI)…
- Trial name
- NCT01043094
- Testing
- Pitavastatin 4mg
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Kowa Research Institute, Inc.