10 completed, 2 unknown, 1 active not recruiting, 1 recruiting. 16 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 4 | 16 | Completed 10, Unknown 2, Active not recruiting 1, Recruiting 1, Terminated 1, Withdrawn 1 |
Follow Safety Issues: new trials by email Literature Review of Safety Issues trials Research Report on Safety Issues
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Effectiveness & Safety of Ovine Enoxaparin Sodium to Originator Enoxaparin in Non-ST-Segment Elevation ACS Patients Enoxaparin sodium injection - Safety Issues, Effect of Drug | Phase 4 | Completed | PT Bio Farma | 220 | 2023-06-01 | 2025-06-06 |
| Safety of Ibuprofen After Major Orthopaedic Surgeries Ibuprofen, Placebo - Pain, Acute, Hip Arthropathy | Phase 4 | Completed | Naestved Hospital | 2904 | 2023-04-17 | 2025-12-19 |
| Post Marketing Surveillance of Diphtheria Antitoxin (DAT) Diphtheria Antitoxin - Safety Issues | Phase 4 | Completed | PT Bio Farma | 68 | 2023-01-31 | 2023-11-18 |
| The Safety of Dapoxetine/Tadalafil Combination Therapy Dapoxetine/Tadalafil 30/20 mg film coated tablet - Premature Ejaculation, Erectile Dysfunction | Phase 4 | Unknown | Neutec Ar-Ge San ve Tic A.Ş | 40 | 2022-12-31 | 2022-05-17 |
| The Safety of Paxlovid in Hemodialysis Patients With Covid-19 Nirmatrelvir and ritonavir stage 1, Nirmatrelvir and ritonavir stage 2 - Safety Issues | Phase 4 | Completed | RenJi Hospital | 18 | 2022-05-06 | 2022-06-14 |
| Tenofovir Alafenamide Switching Therapy in Kidney or Liver Transplant Recipients With Chronic HBV Infection Tenofovir Alafenamide 25 MG - Safety Issues, Chronic Hepatitis B | Phase 4 | Active not recruiting | Taichung Veterans General Hospital | 52 | 2021-06-22 | 2026-05-04 |
| Real World Safety & Efficacy Experience of Empagliflozin With or Without Metformin in T2DM Patients - EASE Study Empagliflozin - Type II Diabetes Mellitus, Efficacy, Self | Phase 4 | Recruiting | Getz Pharma | 2000 | 2021-04-01 | 2026-01-22 |
| COVID-19 CoronaVac in Patients With Autoimmune Rheumatic Diseases and HIV/AIDS CoronaVac - Rheumatic Disease, HIV Infections | Phase 4 | Completed | University of Sao Paulo General Hospital | 2196 | 2021-02-09 | 2024-03-26 |
| Safety of Gebauer's Pain Ease and Gebauer's Ethyl Chloride Gebauer's Pain Ease Top Aerosol Mist Spray, Gebauer's Ethyl Chloride - Spray, Pain | Phase 4 | Completed | Henry Ford Health System | 72 | 2021-01-26 | 2024-03-04 |
| The Effectiveness and Safety of Levosimendan in Patients With Severe Aortic Stenosis and Heart Failure Undergoing Transcatheter Aortic Valve Replacement Levosimendan, Placebo - Aortic Valve Stenosis, Heart Failure | Phase 4 | Unknown | China National Center for Cardiovascular Diseases | 124 | 2020-09-01 | 2020-10-05 |
| Paracetamol Hypothermia Children Paracetamol - Safety Issues | Phase 4 | Completed | Saint George Hospital | 60 | 2019-07-01 | 2021-03-18 |
| Cardiac Safety of Lansoprazole and Domperidon Combination Lansoprazole/Domperidone, Lansoprazole - GERD, Cardiac Event | Phase 4 | Withdrawn | Neutec Ar-Ge San ve Tic A.Ş | 2018-03-01 | 2023-01-05 | |
| Postoperative Safety Outcomes of Intraoperative Intracameral Preservative-Free Moxifloxacin Versus Levofloxacin Levofloxacin Ophthalmic, Moxifloxacin Ophthalmic - Cataract Senile, Endophthalmitis | Phase 4 | Completed | Peregrine Eye and Laser Institute | 114 | 2018-01-02 | 2020-05-27 |
| Reactogenicity and Protectivity Following Measles- Rubella (MR) Routine Immunization in Indonesian Infants and Children Measles-Rubella (MR) Vaccine - Safety Issues, Immunogenicity | Phase 4 | Completed | PT Bio Farma | 590 | 2017-11-16 | 2019-09-12 |
| A Double Blind Randomised Placebo-controlled Trial to Assess the Role of Iron Repletion in Glucose Homeostasis. Ferric Carboxymaltose, 0.9% sodium chloride solution - Iron-deficiency, Iron Toxicity | Phase 4 | Terminated | Prof Gérard WAEBER | 32 | 2017-06-21 | 2020-03-26 |
| Empagliflozin in Renal Transplant Recipients Empagliflozin, Placebo - Diabetes Mellitus, Renal Insufficiency | Phase 4 | Completed | Oslo University Hospital | 49 | 2016-11-07 | 2019-03-15 |
Cardiovascular Diseases (2) · Acquired Immunodeficiency Syndrome (1) · Acute Pain (1) · Agnosia (1) · Anemia, Iron-Deficiency (1) · Aortic Valve Stenosis (1) · Arthritis, Rheumatoid (1) · COVID-19 (1) · Diabetes Mellitus (1) · Diabetes Mellitus, Type 2 (1) · Endophthalmitis (1) · Erectile Dysfunction (1) · Gastroesophageal Reflux (1) · Glucose Metabolism Disorders (1) · HIV Infections (1)
Infections (3) · Metabolic Diseases (3) · Nutritional and Metabolic Diseases (3) · Pathological Conditions, Signs and Symptoms (3) · Urogenital Diseases (3) · Blood-Borne Infections (2) · Communicable Diseases (2) · Digestive System Diseases (2) · Endocrine System Diseases (2) · Genital Diseases (2) · Glucose Metabolism Disorders (2) · Male Urogenital Diseases (2) · Neurologic Manifestations (2) · Pathologic Processes (2) · Signs and Symptoms (2)
empagliflozin (2) · Acetaminophen (1) · Diphtheria Antitoxin (1) · Domperidone (1) · Ethyl Chloride (1) · Ibuprofen (1) · Lansoprazole (1) · Simendan (1) · Sodium Chloride (1) · Tadalafil (1) · Vaccines (1) · dapoxetine (1) · enoxaparin sodium (1) · ferric carboxymaltose (1) · nirmatrelvir (1)
PT Bio Farma (3) · Neutec Ar-Ge San ve Tic A.Ş (2) · China National Center for Cardiovascular Diseases (1) · Getz Pharma (1) · Henry Ford Health System (1) · Naestved Hospital (1) · Oslo University Hospital (1) · Peregrine Eye and Laser Institute (1) · Prof Gérard WAEBER (1) · RenJi Hospital (1) · Saint George Hospital (1) · Taichung Veterans General Hospital (1) · University of Sao Paulo General Hospital (1)
Indonesia (3) · China (2) · Turkey (Türkiye) (2) · Afghanistan (1) · Brazil (1) · Denmark (1) · Kenya (1) · Lebanon (1) · Nigeria (1) · Norway (1) · Pakistan (1) · Philippines (1) · Sri Lanka (1) · Switzerland (1) · Taiwan (1)
Bambang Widyantoro, Ph.D (1) · Dominicus Husada, Dr (1) · Dominicus Husada, MD (1) · Harvey S Uy, MD (1) · Leyi Gu (1) · Ole Mathiesen, Professor (1) · Serhat Bor, Prof Dr (1) · Teng-Yu Lee, MD, PhD (1) · Umar Wahab (1)
PMID 27230467, PMID 28404091, PMID 28404092, PMID 28427875, PMID 29405329, PMID 29696665, PMID 30862658, PMID 31199513, PMID 31271737, PMID 31777965, PMID 32087795, PMID 32282538, PMID 32304611, PMID 32803882, PMID 33217163, PMID 33404182, PMID 34331051, PMID 34664616, PMID 34806342, PMID 34894235, PMID 34901885, PMID 34954325, PMID 35135832, PMID 35193873, PMID 35277389, PMID 35306594, PMID 35639644, PMID 35706490, PMID 35844042, PMID 36150668, PMID 36192386, PMID 36529052, PMID 36870351, PMID 37291679, PMID 42261247
2016 (2)