13 withdrawn, 10 completed, 5 unknown, 3 not yet recruiting. 30 Phase 3, 3 Phase 4, 2 Phase 1, 2 Phase 2, 1 Not applicable.
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| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Efficacy and Safety of DNN.63.18.040 for the Treatment of Moderate to Severe Pain Product DNN.63.18.040, Tramal® - Acute Pain | Phase 3 | Not yet recruiting | Ache Laboratorios Farmaceuticos S.A. | 370 | 2026-10-19 | 2026-10-19 |
| Efficacy and Safety of DNN.31.19.026 for Ocular Hypertension or Primary Open-Angle Glaucoma Product DNN.31.19.026, COSOPT® - Ocular Hypertension, Primary Open Angle Glaucoma | Phase 3 | Not yet recruiting | Ache Laboratorios Farmaceuticos S.A. | 336 | 2026-06-01 | 2026-06-01 |
| Efficacy/ Safety of Product DNN.65.21.005 in Patients With Benign Prostatic Hyperplasia Product DNN.65.21.005, Combodart® - Prostatic Hyperplasia, Benign | Phase 3 | Not yet recruiting | Ache Laboratorios Farmaceuticos S.A. | 218 | 2026-01-01 | 2025-12-08 |
| Efficacy/ Safety of Product CM9241GRU in Patients With Perennial Allergic Rhinitis Product CM9241GRU, Placebo - Rhinitis, Allergic, Perennial | Phase 3 | Unknown | Ache Laboratorios Farmaceuticos S.A. | 432 | 2024-09-01 | 2024-08-29 |
| Efficacy/ Safety of DNN.22.17.036 in Male Patients With Pattern Hair Loss DNN.22.17.036, 10573048700 - Alopecia | Phase 4 | Unknown | Ache Laboratorios Farmaceuticos S.A. | 196 | 2024-04-01 | 2024-04-10 |
| Efficacy and Safety of AS012 in Subjects With Non-segmental Vitiligo AS012, Placebo - Non-segmental Vitiligo | Phase 2 | Completed | Ache Laboratorios Farmaceuticos S.A. | 327 | 2021-01-13 | 2025-03-10 |
| To Evaluate the Superiority of Fixed Combination (Orfenadrine 35mg, Acetaminophen 325mg, Caffeine 65mg and Diclofenac Sodium 50mg) Compared to Voltaren® (Diclofenac Sodium 50mg) in the Treatment of Acute Postural Low Back Pain. orphenadrine, acetaminophen, caffeine and diclofenac sodium, Diclofenac Sodium 50 MG, Placebo (for experimental drug) - Postural Low Back Pain, Mechanical Low Back Pain | Phase 3 | Unknown | Ache Laboratorios Farmaceuticos S.A. | 110 | 2021-01-01 | 2020-09-03 |
| Desloratadine,Phenylephrine Hcl,Ibuprofen Compared to Placebo in Treatment of Symptoms Associated With Common Cold/Flu Desloratadine+Phenylephrine+Ibuprofen, Placebo - Cold | Phase 3 | Suspended | Ache Laboratorios Farmaceuticos S.A. | 150 | 2020-12-01 | 2019-07-08 |
| Cefaliv® Compared to Neosaldina® in the Treatment of Migraine Attacks Cefaliv® & Placebo, Neosaldina® & Placebo - Migraine Headache | Phase 3 | Withdrawn | Ache Laboratorios Farmaceuticos S.A. | 2020-10-01 | 2019-04-10 | |
| COVID-19-associated ARDS Treated With Dexamethasone: Alliance Covid-19 Brasil III Dexamethasone - Coronavirus Infection, Pneumonia, Viral | Phase 3 | Terminated | Hospital Sirio-Libanes | 299 | 2020-04-13 | 2020-08-07 |
| Cefalium® Compared to Tylenol® in the Treatment of Migraine Attacks Acetaminophen+Caffeine+Dihydroergotamine+Metoclopramide., Acetaminophen - Migraine | Phase 3 | Suspended | Ache Laboratorios Farmaceuticos S.A. | 336 | 2020-04-01 | 2019-04-10 |
| Security and Efficacy of Dorilax® (Fixed Association of Paracetamol 350 mg, Carisoprodol 150 mg and Caffeine 50 mg) Plus Thermal Band Compared to Placebo Plus Thermal Band in the Treatment of Acute Low Back Pain. Thermal Band, Dorilax®, Placebo - Low Back Pain | Phase 3 | Withdrawn | Ache Laboratorios Farmaceuticos S.A. | 2020-01-01 | 2019-07-08 | |
| Busonid® (Budesonide 200 mcg and 400 mcg) to Treat Asthma Not Controlled or Partially Controlled Busonid (budesonide 200mcg and 400mcg) - Asthma | Phase 3 | Suspended | Ache Laboratorios Farmaceuticos S.A. | 80 | 2019-12-01 | 2019-07-08 |
| Effectiveness Study of Ketoconazole and Betamethasone to Treat Fungal Infection and Dermatophytosis Candicort®, Nizoral®, Baycuten N® - Tinea | Phase 3 | Completed | Ache Laboratorios Farmaceuticos S.A. | 125 | 2019-06-11 | 2021-09-20 |
| Non-inferiority Evaluation of Pain Intensity After Biomatrop (Somatropin) Application in Relation to Hormotrop (Somatropin), in Healthy Subjects Recombinant human growth hormone - Biomatrop, Recombinant human growth hormone - Hormotrop - Healthy Subjects | Phase 4 | Unknown | Ache Laboratorios Farmaceuticos S.A. | 68 | 2018-08-27 | 2018-08-17 |
| Melatonin 3mg and 5mg Compared to Cognitive Behavioral Therapy for Insomnia (CBT-I) in the Treatment of Insomnia CBT-I plus placebo, CBT-I plus Melatonin 3 mg, CBT-I plus Melatonin 5 mg - Insomnia Disorder | Phase 2 / Phase 3 | Unknown | Ache Laboratorios Farmaceuticos S.A. | 307 | 2018-03-22 | 2020-09-03 |
| Efficacy Study of Two Silicon-based Products to Treat Scars Silicon-based aerosol, Silicon-based gel - Scars | Not applicable | Withdrawn | Ache Laboratorios Farmaceuticos S.A. | 2016-01-01 | 2017-02-15 | |
| Extract of Curcuma Longa Complexed With Phosphatidilcholine(Motore®)in the Treatment of Adults With Knee Osteoarthritis Motore, Alivium - Osteoarthritis, Knee | Phase 4 | Completed | Ache Laboratorios Farmaceuticos S.A. | 288 | 2015-06-01 | 2016-08-25 |
| Transpulmin Suppository and Guaiacol Compared to Transpulmin Syrup in Pediatric Participants With Productive Cough Transpulmin suppository, Guaiacol suppository, Transpulmin syrup - Cough | Phase 3 | Terminated | Ache Laboratorios Farmaceuticos S.A. | 270 | 2015-05-05 | 2018-04-13 |
| Study to Assess Tolerability, Safety and Pharmacokinetics of a New Drug ACH15 50 mg, ACH15 250 mg, ACH15 500mg - Healthy | Phase 1 | Terminated | Ache Laboratorios Farmaceuticos S.A. | 22 | 2015-05-01 | 2016-10-31 |
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Common Cold (6) · Headache (4) · Migraine Disorders (4) · Cough (3) · Epilepsy (3) · Inflammation (3) · Nasal Obstruction (3) · Rhinitis (3) · Asthma (2) · Low Back Pain (2) · Osteoarthritis, Knee (2) · Acne Vulgaris (1) · Acute Pain (1) · Alopecia (1) · Cellulitis (1)
Acetaminophen (2) · Budesonide (2) · Caffeine (2) · Calcium Dobesilate (2) · Clotrimazole (2) · Formoterol Fumarate (2) · Naproxen (2) · naratriptan (2) · Acetylcysteine (1) · Adapalene (1) · Brompheniramine (1) · Bulk Drugs (1) · Chondroitin Sulfates (1) · Dexamethasone (1) · Diclofenac (1)
Brazil (18) · India (1) · United States (1)
Mauro Crippa Jr. (2) · Deusvenir S Carvalho (1) · Eduardo A. Junior, MD (1) · Elie Fiss (1) · Elza M Yacubian (1) · Fabio Castro, MD (1) · Flavio Sano, MD (1) · Francisco Fonseca, physician (1) · Francisco Rocha, MD (1) · Luc Weckx, MD (1)