17 completed, 1 terminated, 1 unknown. 10 Phase 3, 8 Phase 2, 4 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 10 | Completed 8, Terminated 1, Unknown 1 |
| Phase 2 | 8 | Completed 8 |
| Phase 1 | 4 | Completed 4 |
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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 |
|---|---|---|---|---|---|---|
| Phase III Multicentre Trial of Oral Mesalazine in Patients With Mild to Moderate Ulcerative Colitis. Mesalazine - Colitis, Ulcerative | Phase 3 | Unknown | Faes Farma, S.A. | 376 | 2024-03-01 | 2023-12-19 |
| Efficacy and Safety of Hemorrane Plus Versus Hemorrane and Versus Placebo in Patients With Uncomplicated Haemorrhoids Hemorrane plus, Hemorrane, Placebo - Haemorrhoids Without Complication | Phase 3 | Terminated | Faes Farma, S.A. | 21 | 2023-03-30 | 2024-02-28 |
| Study to Assess the Safety, Tolerability and Efficacy of Bilastine Ophthalmic Solution 0.6% in Children Bilastine, Placebo - Allergic Conjunctivitis | Phase 3 | Completed | Faes Farma, S.A. | 59 | 2021-03-26 | 2023-03-16 |
| Efficacy and Safety of Calcifediol vs Placebo in Subjects With Vitamin D Deficiency Calcifediol 75mcg, Calcifediol 100mcg, Calcifediol 125mcg - Vitamin D Deficiency, Vitamin D Insufficiency | Phase 2 / Phase 3 | Completed | Faes Farma, S.A. | 674 | 2020-12-23 | 2023-09-15 |
| Prevention and Treatment With Calcifediol of COVID-19 Induced Acute Respiratory Syndrome BAT + Calcifediol, BAT - SARS-CoV 2, COVID19 | Phase 2 | Completed | Maimónides Biomedical Research Institute of Córdoba | 517 | 2020-05-07 | 2023-03-03 |
| A Study Evaluating Bilastine Ophthalmic Solution 0.6% in the Conjunctival Allergen Challenge (Ora-CAC®) Model. Bilastine Ophthalmic Solution 0.6%, Ketotifen Ophthalmic Solution 0.025% (Zaditen), Vehicle of Bilastine Ophthalmic Solution - Allergic Conjunctivitis | Phase 3 | Completed | Faes Farma, S.A. | 228 | 2018-04-07 | 2023-03-16 |
| A Single-Center, Phase 2 Study Evaluating Bilastine Ophthalmic Solution in the CAC® Model Bilastine 0.2%, Bilastine 0.4%, Bilastine 0.6% - Allergic Conjunctivitis | Phase 2 | Completed | Faes Farma, S.A. | 121 | 2017-07-20 | 2023-03-16 |
| Bilastine Updosing - Characterization of Underlying Mechanisms Bilastine - Cold Contact Urticaria | Phase 2 / Phase 3 | Completed | Charite University, Berlin, Germany | 20 | 2010-09-01 | 2012-05-31 |
| Oral Bioavailability of Bilastine Bilastine - Healthy | Phase 1 | Completed | Faes Farma, S.A. | 12 | 2010-05-01 | 2012-09-26 |
| Pharmacokinetic Study of Bilastine in Children From 2 to < 12 Years of Age With Either Allergic Rhinoconjunctivitis (AR) or Chronic Urticaria (CU) Bilastine - Allergic Rhinoconjunctivitis, Chronic Urticaria | Phase 1 / Phase 2 | Completed | Faes Farma, S.A. | 36 | 2010-01-01 | 2012-09-26 |
| Efficacy, Safety and PK of Once or Twice Daily Bilastine (10 or 20 mg) Compared With Placebo in the Symptomatic Treatment of SAR Bilastine, Placebo - Seasonal Allergic Rhinitis, Hay Fever | Phase 2 | Completed | Faes Farma, S.A. | 805 | 2007-12-01 | 2019-02-15 |
| Human Mass Balance Study With Bilastine [14C]-bilastine - Healthy | Phase 1 | Completed | Faes Farma, S.A. | 6 | 2007-11-01 | 2012-09-26 |
| PK/PD and Steady State Efficacy Study of Bilastine Compared With Placebo Given Orally in the Treatment of the Symptoms of SAR in an EEC Model (5-arm) Bilastine, Placebo - Seasonal Allergic Rhinitis, Hay Fever | Phase 2 | Completed | Faes Farma, S.A. | 502 | 2007-10-01 | 2019-02-15 |
| A Randomized, Double-Blind, 4-way Crossover Study to Evaluate the Efficacy of Bilastine in the Vienna Challenge Chamber Bilastine, Fexofenadine, Cetirizine - Seasonal Allergic Rhinitis | Phase 2 | Completed | Faes Farma, S.A. | 75 | 2006-10-01 | 2012-04-05 |
| A Randomized, Multiple Dose, Double Blind, 5-way Crossover Study of the Electrocardiographic (ECG) Effects of Bilastine bilastine, Bilastine, Bilastine & Ketoconazole - Healthy | Phase 1 | Completed | Faes Farma, S.A. | 30 | 2006-08-01 | 2012-04-05 |
| Efficacy Study for the Symptomatic Treatment of Chronic Idiopathic Urticaria Bilastine, Levocetirizine, Placebo - Urticaria | Phase 3 | Completed | Faes Farma, S.A. | 522 | 2006-07-01 | 2012-04-05 |
| Efficacy Study for the Symptomatic Treatment of Seasonal Allergic Rhinitis bilastine, Cetirizine, Placebo - Seasonal Allergic Rhinitis | Phase 3 | Completed | Faes Farma, S.A. | 683 | 2005-05-01 | 2012-04-05 |
| Efficacy Study for the Symptomatic Treatment of Perennial Allergic Rhinitis With a 1 Year Safety Extension Bilastine, Cetirizine, Placebo - Perennial Allergic Rhinitis | Phase 3 | Completed | Faes Farma, S.A. | 650 | 2004-05-01 | 2012-09-26 |
| A Phase III Efficacy Study of the Symptomatic Treatment of Seasonal Allergic Rhinitis With Bilastine Bilastine, Desloratadine, Placebo - Seasonal Allergic Rhinitis | Phase 3 | Completed | Faes Farma, S.A. | 720 | 2003-04-01 | 2012-04-05 |
Rhinitis, Allergic, Seasonal (7) · Conjunctivitis, Allergic (4) · Rhinitis, Allergic (4) · Urticaria (4) · Nasal Obstruction (3) · Rhinitis (3) · Rhinorrhea (3) · Sneezing (3) · Erythema (2) · Hypersensitivity (2) · Rhinitis, Allergic, Perennial (2) · Bronchiolitis Obliterans Syndrome (1) · COVID-19 (1) · Chronic Urticaria (1) · Cold Urticaria (1)
bilastine (12) · Cetirizine (3) · Calcifediol (2) · Ketoconazole (1) · Ketotifen (1) · Mesalamine (1) · Moxifloxacin (1) · desloratadine (1) · fexofenadine (1) · glycine N-choloyltransferase (1) · levocetirizine (1)
Spain (6) · United States (4) · Germany (3) · France (2) · Argentina (1) · Australia (1) · Austria (1) · Belgium (1) · Bulgaria (1) · Canada (1) · Czechia (1) · Italy (1) · Poland (1) · Romania (1) · Serbia (1)
Ander Sologuren, MD (1) · Belen Sadaba, MD (1) · Deepen Patel, MD, CCFP (1) · Friedrich Horak, Professor (1) · Gunilla Hedlin, Prof. Dr. (1) · Lennart Nordvall, Prof. Dr (1) · Lindsay McGregor (1) · Marcus Maurer, MD (1)
PMID 19132976, PMID 19438584, PMID 19860762, PMID 19943178, PMID 21642470, PMID 22077106, PMID 22393898, PMID 23529786, PMID 34029377, PMID 36811846
2004 (1), 2009 (1)