Clinical Trials
Capsaicin has been evaluated in numerous clinical trials spanning Phase 1 through Phase 4 as well as unassigned phases, focusing on conditions such as peripheral neuropathic pain, painful diabetic neuropathy, coccygodynia, chronic cough, pre-hypertension, and dermal blood flow in healthy volunteers. Conducted globally with varied recruitment statuses—including recruiting, completed, and not yet recruiting—these protocols are sponsored by academic centers, hospital networks, and pharmaceutical entities such as Eli Lilly, Mallinckrodt, Nantes University Hospital, and Skidmore College. Advanced-phase trials focus primarily on evaluating the analgesic efficacy of topical capsaicin formulations.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT03952845 | NOT_YET_RECRUITING | Tolerance; Capsaicin; Rhinitis |
Nova Scotia Health Authority |
2025-08-01 | |
| NCT07443553 | NOT_YET_RECRUITING | Postamputation Pain |
Northwestern University |
2026-10-31 | |
| NCT05997979 | RECRUITING | Neuropathic Pain; Chronic Pain |
University Hospital, Brest |
2024-03-05 | PHASE3 |
| NCT03511846 | ENROLLING_BY_INVITATION | Migraine; Cluster Headache; Trigeminal Autonomic Cephalgia; Hemicrania Continua; Paroxysmal Hemicrania; SUNCT; Short-Lasting Unilateral Neuralgiform Headache With Conjunctival Injection and Tearing |
The University of Texas Health Science Center, Houston |
2018-03-21 | PHASE1 |
| NCT07660510 | NOT_YET_RECRUITING | Neuropathic Pain; Nociplastic Pain |
Nantes University Hospital |
2026-09-01 | |
| NCT05840562 | RECRUITING | Chemotherapy-induced Peripheral Neuropathy |
Institut Cancerologie de l'Ouest |
2023-10-20 | PHASE3 |
| NCT06444919 | RECRUITING | Osteoarthritis Hand; Neuropathic Pain |
University Hospital, Clermont-Ferrand |
2025-03-07 | PHASE4 |
| NCT06744816 | RECRUITING | Peripheral Neuropathy Due to Chemotherapy |
M.D. Anderson Cancer Center |
2025-12-11 | EARLY_PHASE1 |
| NCT07260656 | RECRUITING | Diabetic Neuropathies, Painful; Diabetic Foot; Diabetic Peripheral Neuropathy |
Carilion Clinic |
2025-11-26 | EARLY_PHASE1 |
| NCT06807164 | RECRUITING | Post-Mastectomy Neuropathic Pain Syndrome |
Centre Oscar Lambret |
2026-03-31 | PHASE2 |
| NCT07719868 | NOT_YET_RECRUITING | Pain Management; Capsaicin-Induced Pain; Transcranial Magnetic Stimulation Repetitive; Electroencephalography; Vagus Nerve Stimulation; Neuromodulation; Analgesia |
Second Affiliated Hospital, Zhejiang University, School of Medicine |
2026-07-10 | |
| NCT07602387 | RECRUITING | Patients With Taxane-induced Chronic Neuropathic Pain |
Hospital Ambroise Paré Paris |
2024-03-12 | |
| NCT06023706 | RECRUITING | Coccyx Disorder; Neuropathic Pain; Coccygodynia |
Nantes University Hospital |
2023-11-08 | PHASE3 |
| NCT07755930 | NOT_YET_RECRUITING | Marsili Syndrome |
Aalborg University |
2026-08-01 | |
| NCT07122973 | RECRUITING | Pain; Itch |
Aalborg University |
2025-09-17 | |
| NCT04415892 | RECRUITING | Chemotherapy-induced Peripheral Neuropathy |
Universitaire Ziekenhuizen KU Leuven |
2019-10-01 | |
| NCT07688525 | NOT_YET_RECRUITING | Kinesiophobia (Fear of Movement); Experimental Pain |
Université de Sherbrooke |
2026-08-01 | |
| NCT07406971 | RECRUITING | Ischemic Stroke |
Instituto Mexicano del Seguro Social |
2025-09-01 | PHASE2 |
| NCT07602361 | ACTIVE_NOT_RECRUITING | Overweight and Obesity |
Universidad Autonoma de Baja California |
2026-04-22 | |
| NCT07717918 | RECRUITING | Healthy |
Bausch & Lomb Incorporated |
2026-07-06 | PHASE1 |
| NCT06040190 | COMPLETED | Burning Mouth Syndrome |
Federal University of Minas Gerais |
2023-11-01 | PHASE4 |
| NCT07630571 | COMPLETED | Oral Pain; Oral Pungent Sensation; Capsaicin-Induced Pain; AITC-Induced Irritation; Oral Mucosa Discomfort |
Nakhia Impex LLC |
2026-06-05 | |
| NCT07054840 | RECRUITING | Aging; Older Adults; Pain; Motor Learning |
University of Delaware |
2025-08-26 | |
| NCT07598994 | COMPLETED | Temporomandibular Disorders (TMD); Temporomandibular Pain |
Istanbul University |
2025-08-28 | |
| NCT05958173 | UNKNOWN | Oropharyngeal Dysphagia; Swallowing Disorder |
Hospital de Mataró |
2023-09-01 | |
| NCT06363305 | UNKNOWN | Pre Hypertension; Hypertension |
Skidmore College |
2024-07-08 | |
| NCT06944665 | NOT_YET_RECRUITING | Acute Low Back Pain |
Xiaonan Huang |
2025-05-05 | |
| NCT04967664 | COMPLETED | Post Surgical Neuropathic Pain |
Averitas Pharma, Inc. |
2021-07-13 | PHASE3 |
| NCT07060976 | COMPLETED | Healthy Participants |
Novamed Laboratories Pvt. Ltd. |
2025-07-21 | |
| NCT06612658 | NOT_YET_RECRUITING | None Volunteer |
Hofstra University |
2024-10-01 | |
| NCT06971250 | COMPLETED | Pain |
Stefan Heber |
2025-05-08 | EARLY_PHASE1 |
| NCT07625475 | COMPLETED | Hyperalgesia; Pain Perception; Central Nervous System Sensitization; Pain Threshold |
University of Guelph |
2024-05-01 | |
| NCT04398719 | COMPLETED | CBD; Healthy |
Yale University |
2021-05-07 | EARLY_PHASE1 |
| NCT05726929 | COMPLETED | Breast Cancer; Neuropathic Pain |
Institut Toulousain d'Ostéopathie |
2023-01-11 | |
| NCT05720871 | UNKNOWN | Oropharyngeal Dysphagia; Stroke; Stroke, Complication; Swallowing Disorder |
Hospital de Mataró |
2022-11-28 | |
| NCT04470752 | UNKNOWN | Dysphagia, Late Effect of Stroke |
Georg Kägi, MD |
2021-08-24 | PHASE2 |
| NCT06363305 | Not yet recruiting | Pre Hypertension|Hypertension |
Skidmore College|American Heart Association |
2024-05-01 | Not Applicable |
| NCT05713019 | UNKNOWN | Cough |
Imperial College London |
2023-02-28 | |
| NCT06197529 | COMPLETED | Healthy |
Aalborg University |
2023-11-21 | |
| NCT05649228 | COMPLETED | Pain Management |
Carilion Clinic |
2022-12-13 | EARLY_PHASE1 |
| NCT05813223 | Recruiting | Chronic Cough |
Stuart Mazzone|Merck Sharp & Dohme LLC|Melbourne Health|Monash University|University of Melbourne |
2024-01-01 | Early Phase 1 |
| NCT05059418 | UNKNOWN | Burning Mouth Syndrome |
Malmö University |
2021-11-01 | |
| NCT06809569 | COMPLETED | Healthy |
Merck Sharp & Dohme LLC |
2023-09-25 | PHASE1 |
| NCT05817591 | Recruiting | Peripheral Neuropathic Pain |
Centre Hospitalier Annecy Genevois |
2023-12-14 | -- |
| NCT05735626 | UNKNOWN | Stroke; Stroke, Acute; Oropharyngeal Dysphagia; Swallowing Disorder |
Hospital de Mataró |
2021-07-01 | |
| NCT05093478 | COMPLETED | Non-allergic Rhinitis |
The University of Texas Health Science Center, Houston |
2019-09-10 | PHASE3 |
| NCT05625776 | COMPLETED | Pain, Acute; Cognition |
University of Delaware |
2023-03-22 | |
| NCT04972123 | COMPLETED | Syncope, Vasovagal |
University of Wisconsin, Madison |
2021-07-20 | PHASE2 |
| NCT05835258 | COMPLETED | Bioavailability |
Fundació Eurecat |
2023-05-30 | |
| NCT05654298 | COMPLETED | Migraine |
Universitaire Ziekenhuizen KU Leuven |
2022-03-15 | |
| NCT03794388 | COMPLETED | Breast Cancer Patient |
Institut Cancerologie de l'Ouest |
2019-03-19 | PHASE3 |
| NCT05098067 | COMPLETED | Hyperemesis Gravidarum; Nausea Gravidarum; Vomiting of Pregnancy |
Women and Infants Hospital of Rhode Island |
2022-05-24 | PHASE2 |
| NCT05298202 | COMPLETED | Acute Exercise; Heat Exposure |
University of Nebraska |
2022-05-25 | PHASE4 |
| NCT05543837 | COMPLETED | Cerebral Circulatory Disorder |
Instituto Mexicano del Seguro Social |
2022-09-20 | PHASE2 |
| NCT04125563 | COMPLETED | Cough |
Vastra Gotaland Region |
2019-06-01 | PHASE2 |
| NCT05181852 | UNKNOWN | Pain |
Initiator Pharma |
2022-01-05 | PHASE1 |
| NCT05226299 | COMPLETED | Cough |
University of Montana |
2021-05-01 | PHASE1 |
| NCT04918069 | COMPLETED | Chemotherapy-induced Nausea and Vomiting |
Christian Medical College, Vellore, India |
2019-10-18 | PHASE2 |
| NCT03722849 | COMPLETED | Cough |
Stuart Mazzone |
2019-03-01 | |
| NCT04741620 | COMPLETED | Oropharyngeal Dysphagia; Dysphagia; Swallowing Disorder |
Hospital de Mataró |
2019-01-17 | |
| NCT04283292 | COMPLETED | Cannabinoid Hyperemesis Syndrome |
University of Virginia |
2020-12-01 | PHASE4 |
| NCT04700007 | COMPLETED | Itch |
Aalborg University |
2021-01-18 | |
| NCT05158309 | COMPLETED | Prolonged Pain, EEG, Resting State Functional Connectivity |
Aalborg University |
2021-05-31 | |
| NCT02441660 | COMPLETED | Spinal Cord Injuries; Neuropathic Pain |
The University of Texas Health Science Center at San Antonio |
2016-04 | |
| NCT03348735 | TERMINATED | Neuropathic Pain |
University Hospital, Antwerp |
2018-12-03 | PHASE4 |
| NCT02854670 | TERMINATED | Vestibulodynia |
Centre Hospitalier Universitaire de Besancon |
2016-01-20 | PHASE2; PHASE3 |
| NCT03603522 | COMPLETED | Atopic Asthma |
McMaster University |
2019-07-16 | |
| NCT02869867 | COMPLETED | Localized Neuropathic Pain |
Centre Hospitalier Departemental Vendee |
2017-03-02 | |
| NCT03317613 | COMPLETED | Neuropathic Pain |
Centre Hospitalier Universitaire de Saint Etienne |
2017-11-09 | PHASE2 |
| NCT04485689 | UNKNOWN | Healthy |
Aalborg University |
2020-07-01 | |
| NCT04256733 | COMPLETED | Cough |
University of Montana |
2019-05-01 | EARLY_PHASE1 |
| NCT04545892 | COMPLETED | Stroke |
Juan Manuel Marquez Romero |
2019-12-01 | PHASE1 |
| NCT03944889 | COMPLETED | Central Sensitisation |
Toronto Rehabilitation Institute |
2019-07-01 | EARLY_PHASE1 |
| NCT03330639 | WITHDRAWN | Headache Disorders |
University of Nebraska |
2020-06-23 | |
| NCT03899246 | COMPLETED | Neuropathic Pain; Sickle Cell Disease |
Children's Hospital of Michigan |
2019-07-03 | PHASE1 |
| NCT04399525 | COMPLETED | Pruritus |
Universitaire Ziekenhuizen KU Leuven |
2019-10-28 | |
| NCT04361149 | COMPLETED | Central Sensitisation; Motor Disorders |
Toronto Rehabilitation Institute |
2019-10-01 | PHASE4 |
| NCT04238208 | COMPLETED | Diabetic Nerve Problems; Diabetic Neuropathy; Diabetic Complications Neurological |
Corporacion Parc Tauli |
2019-01-10 | PHASE4 |
| NCT03883880 | TERMINATED | Diet, Food Choice, Taste |
Purdue University |
2019-01-05 | |
| NCT04399148 | COMPLETED | Pruritus |
Universitaire Ziekenhuizen KU Leuven |
2019-06-11 | |
| NCT03587220 | COMPLETED | Capsaicin; Ultaviolet B Light Burn; Neuropathic Pain; Lidocaine |
Aalborg University |
2018-08-01 | |
| NCT03223350 | COMPLETED | Cyclical Vomiting |
Henry Ford Health System |
2017-12-20 | PHASE2 |
| NCT02493257 | COMPLETED | Nonallergic Irritant Rhinitis |
The University of Texas Health Science Center, Houston |
2014-10 | PHASE2 |
| NCT03859583 | UNKNOWN | Obesity; Insulin Resistance |
George Mason University |
2018-05-29 | |
| NCT02551029 | COMPLETED | Irritable Bowel Syndrome; Colonic Diseases, Functional; Dyspepsia; Gastrointestinal Diseases; Abdominal Pain; Visceral Pain |
Maastricht University Medical Center |
2016-02 | |
| NCT02822625 | COMPLETED | Pain |
Institut de Cancérologie de Lorraine |
2016-08-30 | PHASE3 |
| NCT03152578 | COMPLETED | Pain |
Panag Pharma Inc. |
2017-07-01 | PHASE2 |
| NCT03611608 | COMPLETED | Healthy |
Eli Lilly and Company |
2018-08-30 | PHASE1 |
| NCT03102710 | COMPLETED | Pain |
Massachusetts General Hospital |
2016-05 | |
| NCT03122145 | COMPLETED | Healthy |
University of Florida |
2017-05-23 | PHASE1; PHASE2 |
| NCT04052178 | COMPLETED | Swallowing Disorder; Dysphagia; Stroke; Neurophysiologic Abnormality |
Hospital de Mataró |
2016-02-10 | |
| NCT02288156 | COMPLETED | Non-allergic Rhinitis |
Universitaire Ziekenhuizen KU Leuven |
2015-07 | PHASE4 |
| NCT05029297 | COMPLETED | Diabetic Neuropathy, Painful |
Arafarma Group, S.A. |
2010-11-04 | PHASE3 |
| NCT03146689 | COMPLETED | Osteoarthritis, Knee |
University of Nottingham |
2017-08-04 | |
| NCT03528369 | COMPLETED | Osteoarthritis, Knee; Pain |
Propella Therapeutics |
2018-05-14 | PHASE2 |
| NCT03576508 | COMPLETED | Knee Osteoarthritis |
Centrexion Therapeutics |
2018-06-25 | PHASE1 |
| NCT03472677 | COMPLETED | Osteoarthritis, Knee |
Centrexion Therapeutics |
2018-03-21 | PHASE1 |
| NCT03216707 | COMPLETED | Pain |
Assiut University |
2017-09-01 | |
| NCT03281941 | UNKNOWN | Asthma Chronic, Cough |
National Health Service, United Kingdom |
2016-08-06 | |
| NCT02710162 | COMPLETED | Amyotrophic Lateral Sclerosis |
University of Florida |
2016-04 | EARLY_PHASE1 |
| NCT03153813 | TERMINATED | Pain |
Nadine ATTAL |
2015-07 | PHASE3 |
| NCT02710110 | COMPLETED | Amyotrophic Lateral Sclerosis |
University of Florida |
2016-04 | EARLY_PHASE1 |
| NCT03132142 | UNKNOWN | Pain; Pruritus; Neuropathic Pain; Dermatology/Skin - Other |
Aalborg University |
2017-04 | |
| NCT02700815 | COMPLETED | Acute Pain |
Boehringer Ingelheim |
2016-05-09 | PHASE3 |
| NCT03489226 | COMPLETED | Energy Metabolism; Eating; Hunger |
Pennington Biomedical Research Center |
2016-05-02 | |
| NCT03074162 | COMPLETED | Healthy |
Boehringer Ingelheim |
2017-04-20 | PHASE1 |
| NCT03113448 | COMPLETED | Peripheral Diabetic Neuropathy |
Thammasat University |
2017-01-19 | PHASE3 |
| NCT02823912 | UNKNOWN | Dyslipidemia; Overweight or Obesity |
University of Guadalajara |
2016-10 | PHASE2; PHASE3 |
| NCT02390089 | COMPLETED | Parkinson's Disease |
University of Florida |
2015-04 | PHASE1 |
| NCT02603783 | COMPLETED | TRPV1 Protein, Human; Capsaicin; Electric Impedance; Esophagus; Intracellular Space; Pain Measurement; Microscopy, Electron |
Maastricht University Medical Center |
2015-11 | |
| NCT02766517 | COMPLETED | Migraine Disorders |
Eli Lilly and Company |
2016-09-28 | EARLY_PHASE1 |
| NCT02334605 | UNKNOWN | Nasal Hyper Reactivity |
Universitaire Ziekenhuizen KU Leuven |
2015-01 | |
| NCT02377180 | COMPLETED | Healthy |
Insel Gruppe AG, University Hospital Bern |
2014-09 | |
| NCT03124407 | COMPLETED | Osteoarthritis, Knee |
Propella Therapeutics |
2016-07 | PHASE4 |
| NCT02537951 | COMPLETED | Small Fiber Neuropathy |
Erasmus Medical Center |
2015-09 | |
| NCT02769910 | COMPLETED | Pruritus |
Hjalte Holm Andersen |
2016-05 | PHASE1; PHASE2 |
| NCT02678416 | COMPLETED | Pain |
Mallinckrodt |
2015-12-07 | PHASE4 |
| NCT02037464 | UNKNOWN | Prostate Cancer |
Sunnybrook Health Sciences Centre |
2014-01 | PHASE2 |
| NCT01777087 | COMPLETED | Pain |
University of Pittsburgh |
2013-01 | |
| NCT01541436 | COMPLETED | Pain |
Wake Forest University Health Sciences |
2012-03 | EARLY_PHASE1 |
| NCT02138630 | WITHDRAWN | Metabolism; Exercise |
University of Prince Edward Island |
2014-06 | |
| NCT02183519 | COMPLETED | Cough; Parkinson's Disease |
University of Florida |
2014-10 | PHASE1; PHASE2 |
| NCT02346916 | COMPLETED | Chest Pain |
Bassett Healthcare |
2013-10 | |
| NCT02346903 | COMPLETED | Chest Pain |
Bassett Healthcare |
2013-04 | |
| NCT02533076 | COMPLETED | Cystinosis |
Universitaire Ziekenhuizen KU Leuven |
2014-11 | EARLY_PHASE1 |
| NCT02240329 | COMPLETED | TBI; Brain Injury |
University of Florida |
2013-03 | EARLY_PHASE1 |
| NCT02570841 | COMPLETED | Pain |
Medical University of Vienna |
2015-02 | PHASE4 |
| NCT02233699 | COMPLETED | Chronic Idiopathic Cough |
Xention Ltd |
2014-07 | PHASE2 |
| NCT01981395 | COMPLETED | Hyperalgesia; Allodynia |
Laura Cavallone |
2014-01 | PHASE1 |
| NCT02233686 | COMPLETED | Chronic Obstructive Pulmonary Disease |
Xention Ltd |
2014-02 | PHASE2 |
| NCT01862523 | COMPLETED | Rhinitis |
Universitaire Ziekenhuizen KU Leuven |
2012-02 | PHASE4 |
| NCT01854268 | COMPLETED | Cough |
University of Florida |
2013-05 | PHASE1; PHASE2 |
| NCT01533428 | COMPLETED | Diabetic Peripheral Neuropathy; Pain |
Astellas Pharma Inc |
2012-02 | PHASE3 |
| NCT01963910 | COMPLETED | Pain |
University of British Columbia |
2013-12 | |
| NCT01704339 | UNKNOWN | End Stage Renal Failure; Neuropathic Pain |
Emma Aitken |
2012-12 | PHASE4 |
| NCT02882555 | COMPLETED | Cough |
Central Hospital, Nancy, France |
2012-06 | |
| NCT01807832 | UNKNOWN | Chronic Cough |
Tel-Aviv Sourasky Medical Center |
2013-03 | |
| NCT01575106 | COMPLETED | Pain |
Massachusetts General Hospital |
2012-06 | |
| NCT01125215 | UNKNOWN | Painful Diabetic Neuropathy |
Mahidol University |
2009-09 | PHASE2; PHASE3 |
| NCT01974037 | COMPLETED | Volunteers |
Zhiming Zhu |
2013-05 | PHASE4 |
| NCT01699854 | TERMINATED | Persistent Pain After Inguinal Herniotomy |
Rigshospitalet, Denmark |
2012-08 | PHASE3 |
| NCT01797796 | COMPLETED | Healthy |
Pfizer |
2013-04 | PHASE1 |
| NCT01883102 | COMPLETED | Pain |
Mayo Clinic |
2013-06 | PHASE1 |
| NCT01615510 | TERMINATED | Pain; Hyperalgesia; Allodynia |
University Hospital Schleswig-Holstein |
2012-10 | PHASE1 |
| NCT01673529 | COMPLETED | Dermatitis, Atopic |
GlaxoSmithKline |
2012-07-17 | PHASE1 |
| NCT01483846 | COMPLETED | Neuropathic Pain |
VistaGen Therapeutics, Inc. |
2011-12 | PHASE1 |
| NCT00947284 | TERMINATED | Healthy |
University of California, San Francisco |
2010-01 | |
| NCT01595620 | COMPLETED | Pain |
Yale University |
2011-11-09 | EARLY_PHASE1 |
| NCT01884116 | COMPLETED | Myofascial Pain Syndrome of the Upper Trapezius |
Yonsei University |
2011-03 | |
| NCT01231750 | TERMINATED | Stable Angina |
Neal Weintraub |
2010-10 | PHASE3 |
| NCT02695745 | COMPLETED | Pain |
Purdue Pharma LP |
2011-09 | PHASE1 |
| NCT01260454 | COMPLETED | Pulmonary Hypertension; Pulmonary Arterial Hypertension |
University of Rochester |
2010-11 | PHASE2 |
| NCT00993070 | COMPLETED | Diabetic Polyneuropathy |
Thammasat University |
2009-10 | PHASE2; PHASE3 |
| NCT01476098 | COMPLETED | Rhinitis |
GlaxoSmithKline |
2011-04 | PHASE2 |
| NCT01147432 | COMPLETED | Healthy |
Pfizer |
2010-08 | PHASE1 |
| NCT01223820 | COMPLETED | Idiopathic Rhinitis Patients; Healthy Controls |
Universitaire Ziekenhuizen KU Leuven |
2011-01 | PHASE4 |
| NCT01228838 | COMPLETED | Postherpetic Neuralgia; Pain |
NeurogesX |
2010-10 | PHASE2 |
| NCT01540877 | COMPLETED | Ipsi- and Contralateral Hypoesthesia |
Ruhr University of Bochum |
2011-04 | |
| NCT00693407 | COMPLETED | Functional Dyspepsia |
National University Hospital, Singapore |
2008-09 | |
| NCT00771511 | WITHDRAWN | Labor Pain; Pregnancy Loss; Labor Induction |
Columbia University |
2010-10 | PHASE4 |
| NCT01667523 | COMPLETED | Healthy |
Maastricht University Medical Center |
2011-02 | |
| NCT02228928 | COMPLETED | Peripheral Nerve Injury; Postherpetic Neuralgia |
Samyang Biopharmaceuticals Corporation |
2009-02 | PHASE1; PHASE2 |
| NCT01200745 | UNKNOWN | Chronic Neck Pain |
Kyunghee University Medical Center |
2010-09 | |
| NCT00795106 | WITHDRAWN | Myofascial Pain Syndrome |
Stamford Hospital |
2009-11 | PHASE2 |
| NCT00693160 | TERMINATED | Healthy |
Wake Forest University |
2007-12 | PHASE2 |
| NCT00875537 | COMPLETED | Burning Mouth Syndrome |
University of Copenhagen |
2009-01 | |
| NCT01439308 | COMPLETED | Rhinitis |
GlaxoSmithKline |
2009-12 | PHASE2 |
| NCT00962663 | COMPLETED | Healthy |
Pfizer |
2009-08 | PHASE1 |
| NCT00886106 | UNKNOWN | Hyperalgesia |
Medical University of Vienna |
2009-06 | PHASE4 |
| NCT00789386 | UNKNOWN | Hyperalgesia |
Medical University of Vienna |
2008-11 | PHASE4 |
| NCT00916942 | COMPLETED | Postherpetic Neuralgia |
NeurogesX |
2009-06 | PHASE2 |
| NCT00731250 | COMPLETED | Rhinitis |
GlaxoSmithKline |
2008-07-22 | PHASE1 |
| NCT00683267 | TERMINATED | Arthroplasty |
Anesiva, Inc. |
2007-09 | PHASE2 |
| NCT00672568 | TERMINATED | Rotator Cuff Repair of the Shoulder |
Anesiva, Inc. |
2008-07 | PHASE2 |
| NCT00655811 | COMPLETED | Healthy |
Wake Forest University |
2008-02 | PHASE4 |
| NCT00692601 | COMPLETED | Healthy |
Hamilton Health Sciences Corporation |
2008-04 | PHASE1 |
| NCT00692146 | COMPLETED | Capsaicin Evoked Pain; Heat Sensitivity |
AstraZeneca |
2008-01 | PHASE1 |
| NCT00321672 | COMPLETED | Pain; HIV Infections; Peripheral Nervous System Diseases |
NeurogesX |
2006-06 | PHASE3 |
| NCT00471055 | COMPLETED | Osteoarthritis, Knee Joint; Capsicum |
Khon Kaen University |
2007-06 | PHASE3 |
| NCT00004316 | COMPLETED | Interstitial Cystitis; Vulvar Diseases |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
1995-06 | PHASE1; PHASE2 |
| NCT00697034 | TERMINATED | Psoriasis |
Wake Forest University |
2006-06 | PHASE4 |
| NCT00003610 | COMPLETED | Head and Neck Cancer; Radiation Toxicity |
Alliance for Clinical Trials in Oncology |
1998-10 | PHASE3 |
| NCT00061776 | COMPLETED | Herpes Zoster; Neuralgia; Pain; Peripheral Nervous System Diseases; Shingles |
NeurogesX |
PHASE2; PHASE3 | |
| NCT00061152 | UNKNOWN | HIV Infections |
NeurogesX |
PHASE2 | |
| NCT00089557 | TERMINATED | Herpes Zoster; Neuralgia; Pain; HIV Infections; Peripheral Nervous System Diseases; Diabetic Neuropathies; Diabetes Mellitus; Polyneuropathies |
NeurogesX |
PHASE2 | |
| NCT00233155 | COMPLETED | Herpes Zoster; Neuralgia; Pain; HIV Infections; Peripheral Nervous System Diseases |
NeurogesX |
2005-08 | PHASE2 |
| NCT00176969 | COMPLETED | Alopecia Areata |
University of Minnesota |
1997-08 | PHASE4 |
| NCT00088686 | COMPLETED | Healthy; Tooth Extraction |
National Institute of Dental and Craniofacial Research (NIDCR) |
2004-07 | PHASE2 |
| NCT00082316 | COMPLETED | Herpes Zoster; Neuralgia; Pain; HIV Infections; Peripheral Nervous System Diseases; Diabetic Neuropathies; Diabetes Mellitus; Polyneuropathies |
NeurogesX |
PHASE2 | |
| NCT00912262 | COMPLETED | Pain |
NeurogesX |
2008-06 | PHASE1 |
| NCT00373893 | COMPLETED | Pain; Hyperalgesia |
University of California, San Diego |
2005-12 | PHASE1 |
| NCT00008476 | COMPLETED | Facial Pain |
National Institute of Dental and Craniofacial Research (NIDCR) |
2001-01 | PHASE2 |
| NCT00085761 | TERMINATED | HIV Infections; Peripheral Nervous System Diseases; Pain |
NeurogesX |
PHASE3 | |
| NCT00064623 | COMPLETED | HIV Infections; Peripheral Nervous System Diseases; Pain |
NeurogesX |
2003-08 | PHASE3 |
| NCT00528216 | COMPLETED | Pain |
NeurogesX |
PHASE1 | |
| NCT00034710 | COMPLETED | Neuralgia; Pain; Peripheral Nervous System Diseases; Herpes Zoster |
NeurogesX |
2002-03 | PHASE2 |
| NCT00068081 | COMPLETED | Herpes Zoster; Neuralgia; Pain; Peripheral Nervous System Diseases |
NeurogesX |
PHASE3 |
(data from https://clinicaltrials.gov, updated on 2024-08-21)
Compliance for Clinical Use
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
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