10 completed, 3 terminated, 2 unknown, 1 not yet recruiting. 5 Phase 4, 4 Not applicable, 4 Phase 3, 3 Phase 2, 1 Early Phase 1.
Follow Doxepin: new trials by email Literature Review of Doxepin trials Research Report on Doxepin
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 |
|---|---|---|---|---|---|---|
| Doxepin Alone or Combined With Ramelteon Versus Placebo for Improving Sleep Quality After Primary Total Knee Arthroplasty Doxepin 6 mg, Ramelteon 8 mg, Placebo Tablets - Sleep Quality Post-TKA, Postoperative Knee Function | Phase 4 | Not yet recruiting | University of Washington | 129 | 2026-06-01 | 2026-05-20 |
| A SMART Approach to Evaluating the Benefits of Common Prescription and OTC Medications for Insomnia Sleep Hygiene Education, Melatonin IR, 3 mg, Melatonin IR, 5 mg - Insomnia, Insomnia Disorder | Phase 4 | Recruiting | University of Pennsylvania | 1200 | 2026-05-01 | 2026-09-16 |
| Using Doxepin for Urticaria Doxepin, Diphenhydramine - Urticaria | Phase 3 | Unknown | State University of New York - Upstate Medical University | 160 | 2022-05-23 | 2022-05-18 |
| Characterization of New Human Models of Non-histaminergic Itch and Their Interaction With the TRPM8 Receptor Doxepin Topical, Papain, Histamine - Itch | Not applicable | Completed | Aalborg University | 20 | 2022-03-01 | 2022-07-20 |
| Stigma and Efficacy of Zhizhu Kuanzhong Capsules Zhizhu Kuanzhong capsules (ZZKZ), Doxepin Hydrochloride (Doxepin) - Functional Gastrointestinal Disorders, Dyspepsia | Not applicable | Unknown | RenJi Hospital | 76 | 2021-02-01 | 2022-08-10 |
| Characterization of BAM8-22 as a New Surrogate Model of Non-histaminergic Itch BAM8-22, Histamine, Cowhage (Mucuna Pruriens) - Itch | Not applicable | Completed | Aalborg University | 24 | 2020-10-01 | 2021-07-21 |
| Characterization of the Toll-like Receptor 7-agonist Imiquimod 3.75% As a New Surrogate Model of Itch Zyclara 3.75 % Topical Cream, Prudoxin, Histamine - Itch | Not applicable | Withdrawn | Aalborg University | 2019-11-01 | 2024-11-22 | |
| Comparison of Gabapentin With Doxepin in the Management of Uremic Pruritus Doxepin, Gabapentin - Uremic Pruritus | Phase 4 | Completed | University of Balamand | 14 | 2018-06-01 | 2018-11-29 |
| Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies Lithium Carbonate, Lamotrigine, Valproic Acid - Bipolar Disorder | Terminated | University of New Mexico | 1037352 | 2016-09-01 | 2024-03-12 | |
| Pharmacovigilance in Gerontopsychiatric Patients Phenobarbital, Phenytoin, Carbamazepine - Dementia, Depression | Phase 3 | Terminated | Hannover Medical School | 407 | 2015-01-01 | 2018-02-28 |
| Assess the Effect of Zolpidem, Silenor & Placebo on Arousability, Ataxia/Balance & Cognition in Healthy Volunteers Silenor 6 mg, zolpidem 10 mg, Placebo - Healthy | Phase 4 | Completed | Currax Pharmaceuticals | 52 | 2015-01-01 | 2018-01-02 |
| Doxepin and a Topical Rinse in the Treatment of Acute Oral Mucositis Pain in Patients Receiving Radiotherapy With or Without Chemotherapy doxepin hydrochloride oral solution, DLA (diphenhydramine, lidocaine and antacids) rinse, Placebo - Acute Oral Mucositis Pain | Phase 3 | Completed | Alliance for Clinical Trials in Oncology | 275 | 2014-11-18 | 2025-05-18 |
| Doxepin Hydrochloride in Treating Esophageal Pain in Patients With Thoracic Cancer Receiving Radiation Therapy to the Thorax With or Without Chemotherapy Doxepin Hydrochloride, Placebo, Quality-of-Life Assessment - Esophageal Carcinoma, Hypopharyngeal Carcinoma | Phase 2 | Terminated | Mayo Clinic | 5 | 2014-04-14 | 2019-10-01 |
| Treatments for Insomnia in Patients With Parkinson's Disease Light box (Litebook company), CBT and sleep hygiene, Doxepin and Zopiclone - Parkinson's Disease, Insomnia | Early Phase 1 | Completed | McGill University Health Centre/Research Institute of the McGill University Health Centre | 20 | 2011-01-01 | 2015-04-16 |
| Doxepin Hydrochloride in Treating Oral Mucositis Pain in Patients With Head and Neck Cancer Undergoing Radiation Therapy With or Without Chemotherapy doxepin hydrochloride, placebo - Head and Neck Cancer, Mucositis | Phase 3 | Completed | Alliance for Clinical Trials in Oncology | 155 | 2010-12-01 | 2017-08-09 |
| The Treatment of Insomnia in Patients With HIV Disease Doxepin, Temazepam, Placebo - HIV Infections, Insomnia | Phase 4 | Completed | Duke University | 44 | 2007-03-01 | 2013-07-30 |
| Safety and Efficacy of Ramelteon and Doxepin in Subjects With Chronic Insomnia Ramelteon and doxepin, Ramelteon, Doxepin - Sleep Initiation and Maintenance Disorders | Phase 2 | Completed | Takeda | 472 | 2006-07-01 | 2012-02-28 |
| Effect of Doxepin and Nortriptyline on Irritable Bowel Syndrome Doxepin, Nortriptyline, placebo - Irritable Bowel Syndrome | Phase 2 | Completed | Qom University of Medical Sciences | 2010-12-31 |
Sleep Initiation and Maintenance Disorders (4) · Pruritus (3) · Psychophysiologic Disorders (2) · Anxiety Disorders (1) · Bipolar Disorder (1) · Carcinoma, Non-Small-Cell Lung (1) · Dementia (1) · Depression (1) · Dyspepsia (1) · Esophageal Neoplasms (1) · Esthesioneuroblastoma, Olfactory (1) · Gastrointestinal Diseases (1) · HIV Infections (1) · Head and Neck Neoplasms (1) · Hypopharyngeal Neoplasms (1)
Aalborg University (3) · Alliance for Clinical Trials in Oncology (2) · Currax Pharmaceuticals (1) · Duke University (1) · Hannover Medical School (1) · Mayo Clinic (1) · McGill University Health Centre/Research Institute of the McGill University Health Centre (1) · Qom University of Medical Sciences (1) · RenJi Hospital (1) · State University of New York - Upstate Medical University (1) · Takeda (1) · University of Balamand (1) · University of New Mexico (1) · University of Pennsylvania (1) · University of Washington (1)
United States (9) · Denmark (3) · Canada (1) · China (1) · Germany (1) · Iran (1) · Lebanon (1)
Andrew D Krystal, MD (1) · Chris Drake, PhD (1) · Christophe G Lambert, PhD (1) · Helge Frieling, Prof., MD (1) · Michael L Perlis, PhD (1) · Nicholas M Hernandez, MD (1) · Robert C. Miller, MD (1) · Robert Miller, MD, MS (1) · Roger N Haber, MD (1) · Ronald Postuma, MD, MSc (1) · Sheng-Liang Chen, PhD (1) · Terence Sio (1)
PMID 10221356, PMID 18431116, PMID 20625114, PMID 22131611, PMID 24674944, PMID 24733799, PMID 28575467, PMID 28901625, PMID 29920885, PMID 30207000, PMID 30986735, PMID 30990550, PMID 31237566, PMID 31651956, PMID 31744781, PMID 33049221, PMID 33184967, PMID 33258198, PMID 33484225, PMID 33688834
P30CA015083 (1), U10CA037404 (1), U10CA037447 (1), UG1CA189823 (1)