21 completed, 3 recruiting, 3 unknown, 1 not yet recruiting. 16 Phase 3, 7 Phase 2, 4 Phase 4, 1 Not applicable.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 16 | Completed 14, Recruiting 2 |
| Phase 2 | 7 | Completed 3, Not yet recruiting 1, Recruiting 1, Unknown 1, Withdrawn 1 |
| Phase 4 | 4 | Completed 2, Unknown 2 |
| Not applicable | 1 | Completed 1 |
Follow Ketotifen: new trials by email Literature Review of Ketotifen trials Research Report on Ketotifen
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 |
|---|---|---|---|---|---|---|
| Mast Cell Treatment in Post-tick Bite Illness (PTBI) Ketotifen, fexofenadine, Cromolyn Sodium - Post-tick Bite Illness, Mast Cell Stabilizer | Phase 2 | Not yet recruiting | University of North Carolina, Chapel Hill | 50 | 2026-04-30 | 2026-04-13 |
| Topical Ketotifen 0.25% for Secondary Vestibulodynia Ketotifen Fumarate 0.25% Cream, Placebo (Vehicle Cream) - Provoked Vestibulodynia, Secondary Provoked Vestibulodynia | Phase 2 | Recruiting | Center for Vulvovaginal Disorders | 54 | 2026-01-02 | 2026-03-18 |
| Ketotifen in Non-Alcoholic Fatty Liver Disease Patients Ketotifen, Vitamin E - Hepatic Disease | Phase 4 | Completed | Tanta University | 60 | 2023-05-20 | 2026-02-06 |
| Evaluation of the Safety and Pharmacokinetics of Brimonidine Tartrate 0.025%/Ketotifen Fumarate 0.035% Combination Ophthalmic Solution Brimonidine Tartrate 0.025%/Ketotifen Fumarate 0.035% Ophthalmic Solution (Combo), Vehicle of brimonidine tartrate 0.025%/ketotifen fumarate 0.035% ophthalmic solution - Allergic Conjunctivitis | Phase 3 | Completed | Bausch & Lomb Incorporated | 512 | 2023-04-20 | 2025-07-10 |
| Evaluation of Brimonidine Tartrate/Ketotifen Fumarate Combination in Adults With Seasonal Allergic Conjunctivitis Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution, Ketotifen fumarate ophthalmic solution 0.035%, Brimonidine tartrate ophthalmic solution 0.025% - Seasonal Allergic Conjunctivitis | Phase 3 | Completed | Bausch & Lomb Incorporated | 229 | 2022-11-18 | 2025-07-01 |
| The Possible Protective Role of Ketotifen Against Oxaliplatin Induced Peripheral Neuropathy Placebo tablets, Ketotifen Oral Tablet - Neuropathy;Peripheral | Phase 3 | Recruiting | Tanta University | 64 | 2022-11-09 | 2025-05-11 |
| The Efficacy and Safety of Ketotifen in Primary PCI Patients With STEMI Ketotifen Fumarate, standard treatment - ST-segment Elevation Myocardial Infarction (STEMI) | Phase 4 | Unknown | Peking University Third Hospital | 60 | 2022-09-01 | 2022-08-23 |
| Ketotifen and Indomethacin Combination Treatment Clinical Trial for COVID-19 Ketotifen/Indomethacin, Placebo - COVID-19 Respiratory Infection | Phase 3 | Completed | Sen-Jam Pharmaceutical | 150 | 2022-05-03 | 2024-06-24 |
| Influence of Antipruritics on the Dermal Blood Flow Response to Histamine, Cinnamaldehyde and Capsaicin. Desloratadine 5 mg, Aprepitant 125 mg, Ketotifen 1 MG - Pruritus | Not applicable | Completed | Universitaire Ziekenhuizen KU Leuven | 13 | 2019-06-11 | 2020-05-27 |
| PrEvention of Posttraumatic Joint contractuRes With Ketotifen 2 Lactose Placebo, Ketotifen Fumarate 2mg, Ketotifen Fumarate 5mg - Elbow Fracture, Elbow Injury | Phase 3 | Completed | University of Calgary | 395 | 2019-04-26 | 2026-07-27 |
| Ketotifen: as a Cardioprotective Agent in Breast Cancer Patients Receiving Anthracycline-containing Chemotherapy Ketotifen 1 MG - Breast Cancer, Iron Chelation | Completed | Horus University | 111 | 2019-01-14 | 2020-06-17 | |
| 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 |
| Clinical Evaluation of Etafilcon A With Ketotifen etafilcon A with ketotifen, 1-Day ACUVUE - Visual Acuity | Phase 2 | Completed | Johnson & Johnson Vision Care, Inc. | 143 | 2017-12-06 | 2022-03-17 |
| Chronic Widespread Pain and White Blood Cell Activation Ketotifen Fumarate, Placebo, Standard of Care - Widespread Chronic Pain | Phase 3 | Completed | McGill University Health Centre/Research Institute of the McGill University Health Centre | 44 | 2016-12-01 | 2020-02-20 |
| Ketotifen for Children With Functional Dyspepsia in Association With Duodenal Eosinophilia Ketotifen, Placebo - Functional Dyspepsia | Phase 3 | Recruiting | Craig A. Friesen, MD | 40 | 2015-08-01 | 2026-01-09 |
| Ketotifen as a Treatment for Vascular Leakage During Dengue Fever Ketotifen, Placebo - Dengue Fever, Pleural Effusion | Phase 4 | Unknown | National University Hospital, Singapore | 110 | 2015-03-01 | 2016-02-04 |
| Investigations of Mechanisms and Treatment in Post-traumatic Joint Contractures Ketotifen, Placebo - Joint Contractures | Phase 2 | Completed | University of Calgary | 152 | 2013-06-01 | 2018-03-27 |
| A Confirmatory Study of TAU-284 in Pediatric Patients With Atopic Dermatitis Bepotastine besilate, ketotifen fumarate - Dermatitis, Atopic | Phase 3 | Completed | Tanabe Pharma Corporation | 303 | 2013-03-01 | 2026-01-08 |
| Novel Use of (Oral) Ketotifen for the Treatment of Fibromyalgia: A Pilot Study Ketotifen, Placebo (Sugar Pill) - Fibromyalgia | Phase 3 | Completed | Indiana University | 51 | 2012-03-01 | 2016-11-17 |
| Pilot Study to Evaluate the Effect of Ketotifen on the Adverse Events Associated With Peanut Desensitization Ketotifen - Peanut Allergies in Children | Phase 2 | Unknown | Gordon Sussman Clinical Research | 6 | 2011-01-01 | 2012-06-21 |
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Conjunctivitis, Allergic (9) · Breast Neoplasms (1) · Chronic Pain (1) · Conjunctivitis (1) · Contracture (1) · Dengue (1) · Dermatitis (1) · Digestive System Diseases (1) · Elbow Fractures (1) · Elbow Injuries (1) · Eosinophilia (1) · Fibromyalgia (1) · Fractures, Bone (1) · Joint Dislocations (1) · Neuritis (1)
Bausch & Lomb Incorporated (5) · Tanta University (2) · University of Calgary (2) · Vistakon Pharmaceuticals (2) · Campus Bio-Medico University (1) · Center for Vulvovaginal Disorders (1) · Craig A. Friesen, MD (1) · Faes Farma, S.A. (1) · Gordon Sussman Clinical Research (1) · Horus University (1) · Indiana University (1) · Johnson & Johnson Vision Care, Inc. (1) · McGill University Health Centre/Research Institute of the McGill University Health Centre (1) · National University Hospital, Singapore (1) · Novartis (1)
United States (14) · Canada (4) · Egypt (3) · Belgium (1) · China (1) · Italy (1) · Japan (1) · Nepal (1) · Singapore (1)
Brian Pall, OD, MS, FAAO (2) · Alexander T Limkakeng, MD (1) · Andrew T Goldstein, MD (1) · Ashley L St John (1) · Craig A Friesen, MD (1) · Dennis C. Ang, MD (1) · Gail Torkildsen, MD (1) · Gordon L Sussman, MD (1) · Kevin A Hildebrand, MD, FRCSC (1) · Kevin Hildebrand, MD (1) · Laura Trusso (1) · Ming Cui, Doctor (1) · Paul A Tambyah (1) · Scott Commins (1)
PMID 32093652, PMID 32639394, PMID 36811846, PMID 38771467, PMID 42039690, PMID 42096115