17 completed, 2 unknown, 1 terminated. 11 Phase 3, 5 Not applicable, 4 Phase 2, 1 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 11 | Completed 10, Terminated 1 |
| Not applicable | 5 | Completed 4, Unknown 1 |
| Phase 2 | 4 | Completed 4 |
| Phase 4 | 1 | Unknown 1 |
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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 |
|---|---|---|---|---|---|---|
| Efficacy of Vitex Agnus-castus BNO 1095 (20 mg) in Women With Primary Dysmenorrhea Vitex agnus-castus BNO 1095 (20 mg), Placebo - Primary Dysmenorrhea | Phase 3 | Completed | Bionorica SE | 335 | 2023-12-12 | 2025-07-28 |
| Skin Efficacy and Tolerability of a Cosmetic Product Combination Over 3 Months in Subjects With Atopic Eczema Body Lotion and Intensive Care - Atopic Dermatitis, Eczema-Prone Skin | Not applicable | Unknown | Bionorica SE | 100 | 2023-01-03 | 2023-03-29 |
| Assessment of Skin Tolerance and Efficacy of a Cosmetic Product After 5 Days of Use on Subjects With Atopic Dermatitis Atopi intensive care BNO 3731, Benchmark product - Atopic Diathesis, Eczema-prone Skin | Not applicable | Completed | Bionorica SE | 44 | 2022-02-15 | 2023-04-11 |
| Effect of Bronchipret on Antiviral Immune Response in Patients With Mild COVID-19 Bronchipret - COVID-19 | Phase 2 | Completed | Dr. Frank Behrens | 21 | 2022-01-14 | 2024-08-28 |
| Assessment of Skin Tolerance and Efficacy of a Cosmetic Product After 4 Weeks of Use on Subjects With Atopic Dermatitis Lotion BNO 3732, Body Lotion Benchmark product - Atopic Diathesis, Eczema-Prone Skin | Not applicable | Completed | Bionorica SE | 44 | 2022-01-11 | 2023-03-28 |
| Impact of Silymarin Dosages to Decrease Drug-induced Elevated Liver Enzymes Compared to Placebo Placebo, 2x 140 mg per day, 3x 280 mg per day - Drug-induced Liver Injury | Phase 2 / Phase 3 | Completed | Prof. Dr. Frank Behrens | 19 | 2021-06-23 | 2026-01-14 |
| Treating Nightmares in Posttraumatic Stress Disorder With Dronabinol BX-1, Placebo - Posttraumatic Stress Disorder | Phase 2 | Completed | Charite University, Berlin, Germany | 170 | 2020-10-01 | 2025-08-13 |
| Study of the Effects of Cyclodynon on Reducing the Cumulative Risk of Breast Cancer Development in a Female Aged 40-52 Cyclodynon, Lifestyl modification - Mammographic Breast Density | Phase 4 | Unknown | Dr. Struk Tetiana | 150 | 2020-07-22 | 2020-08-04 |
| Efficacy and Safety of Dronabinol in the Improvement of Chemotherapy-induced and Tumor-related Symptoms in Advanced Pancreatic Cancer Dronabinol in Oral Dosage Form, Placebo in Oral Dosage Form - Pancreatic Cancer Non-resectable, Chemotherapy-induced Nausea and Vomiting | Phase 3 | Completed | Arbeitsgemeinschaft medikamentoese Tumortherapie | 109 | 2019-12-16 | 2025-04-10 |
| Study of Imupret Application in the Technology of Delayed Prescription of Antibiotics in Patients With Acute Tonsillitis Imupret in addition to local NAID, Local NAID (Benzydamin) - Acute Tonsillitis | Not applicable | Completed | Ivano-Frankivsk National Medical University | 200 | 2019-03-20 | 2020-09-03 |
| BX-1 in Spasticity Due to Multiple Sclerosis BX-1, Placebo - Spasticity Due to Multiple Sclerosis | Phase 3 | Completed | Bionorica SE | 397 | 2019-02-18 | 2021-05-05 |
| Determination of Postprandial Glycemic Responses by Continuous Glucose Monitoring in a Real-World Setting Determination of postprandial glucose response by continuous glucose measurement after consuming different carbohydrate containing foods - Postprandial Glucose Response, Glycaemic Index | Not applicable | Completed | West German Center of Diabetes and Health | 12 | 2018-12-01 | 2023-05-03 |
| Sinupret Extract Coated Tablets in Chronic Rhinosinusitis Sinupret extract coated tablets, Placebo coated tablets - Chronic Rhinosinusitis | Phase 3 | Completed | Bionorica SE | 572 | 2016-04-28 | 2018-02-28 |
| Efficacy of CLR Compared to Fosfomycin Trometamol in Acute Lower uUTIs Canephron® N, Fosfomycin trometamol, Canephron® N-placebo - Urinary Tract Infection | Phase 3 | Completed | Bionorica SE | 659 | 2015-12-01 | 2017-07-28 |
| Trial With Bronchipret and Sinupret to Evaluate Acceleration of Mucociliary Clearance (MCC) administration of Sinupret, administration of Bronchipret, administration of Sinupret Placebo - Current Smokers | Phase 2 | Completed | Bionorica SE | 56 | 2013-08-01 | 2014-07-01 |
| Efficacy and Safety of 20 mg (2 Tablets of 10mg)VAC BNO 1095 FCT on Cyclic Mastodynia and PMS 20mg VAC BNO 1095 FCT, Placebo - Premenstrual Syndrome, Mastodynia | Phase 3 | Terminated | Bionorica SE | 96 | 2013-06-01 | 2016-09-14 |
| Efficacy and Safety of Two Dosages of a Herbal Medicinal Product (Dry Extract BNO 1016) in Chronic Rhinosinusitis BNO 1016 - Chronic Sinusitis | Phase 3 | Completed | Bionorica SE | 927 | 2012-09-01 | 2014-07-08 |
| Safety and Efficacy of Canephron® N in the Management of Uncomplicated Urinary Tract Infections (uUTI) Canephron® N - Urinary Tract Infection | Phase 3 | Completed | Bionorica SE | 125 | 2011-10-01 | 2019-02-27 |
| Dose-dependent Effects of VAC BNO 1095 on Cyclic Mastodynia and Premenstrual Syndrome VAC BNO 1095 film coated tablets - Cyclic Mastodynia, Premenstrual Syndrome | Phase 3 | Completed | Bionorica SE | 191 | 2011-03-01 | 2013-07-09 |
| Efficacy and Safety of a Herbal Medicinal Product (Dry Extract BNO 1016) in Patients With Acute Rhinosinusitis BNO 1016, Placebo - Acute Rhinosinusitis | Phase 3 | Completed | Bionorica SE | 386 | 2010-01-01 | 2013-08-02 |
Premenstrual Syndrome (2) · Urinary Tract Infections (2) · COVID-19 (1) · Chemical and Drug Induced Liver Injury (1) · Dermatitis, Atopic (1) · Dysmenorrhea (1) · Mastodynia (1) · Pancreatic Neoplasms (1) · Stress Disorders, Post-Traumatic (1) · Vomiting (1)
BNO 1016 (2) · Sinupret (2) · Critical Care (1) · Dosage Forms (1) · Dronabinol (1) · Fosfomycin (1) · Plant Extracts (1) · Vitex agnus castus extract (1) · imupret (1) · thyme extract and ivy extract drug combination (1)
Germany (14) · Czechia (3) · Poland (3) · Ukraine (3) · Austria (2) · Belgium (2) · Hungary (2) · Spain (1) · Sweden (1)
Sabrina Laing, Dr. (2) · Stephan Schaefer, MD (2) · Andrzej Witek, MD PhD Prof. (1) · Claus Bachert, Prof. Dr. (1) · Claus Bachert, Prof.Dr.Dr. (1) · Dmitry Ivanov (1) · Felix Keil, Prof.MD (1) · Florian Wagenlehner, Prof. (1) · Hannes Herold, Dr. med. (1) · Karel Raus, MD (1) · Katrin Unbereit, Dr. (1) · Luitgard Spitznagel-Schminke (1) · Petra Stute, Prof. Dr. (1) · Rainer Jund, MD (1)
PMID 23193534, PMID 29953055, PMID 30231252, PMID 37147642, PMID 42557458
2009 (1), 2015 (1), 2023 (1)