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Last Updated: December 12, 2019

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CLINICAL TRIALS PROFILE FOR DOXEPIN HYDROCHLORIDE

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505(b)(2) Clinical Trials for doxepin hydrochloride

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
OTC NCT02229539 Doxepin and a Topical Rinse in the Treatment of Acute Oral Mucositis Pain in Patients Receiving Radiotherapy With or Without Chemotherapy Completed National Cancer Institute (NCI) Phase 3 2014-11-01 The purpose of this study is to test whether a mouthwash made with a drug called doxepin can reduce the pain caused by mouth sores resulting from radiation therapy. A number of mouth rinse preparations exist for patients with treatment-related oral mucositis pain such as the DLA rinse, an over-the-counter medication. This study will evaluate the effects of doxepin compared to DLA (diphenhydramine, lidocaine and antacids) and placebo.Doxepin is approved by the Food and Drug Administration (FDA) for the treatment of depression, anxiety, long-term pain management, as well as management of rash.
OTC NCT02229539 Doxepin and a Topical Rinse in the Treatment of Acute Oral Mucositis Pain in Patients Receiving Radiotherapy With or Without Chemotherapy Completed Alliance for Clinical Trials in Oncology Phase 3 2014-11-01 The purpose of this study is to test whether a mouthwash made with a drug called doxepin can reduce the pain caused by mouth sores resulting from radiation therapy. A number of mouth rinse preparations exist for patients with treatment-related oral mucositis pain such as the DLA rinse, an over-the-counter medication. This study will evaluate the effects of doxepin compared to DLA (diphenhydramine, lidocaine and antacids) and placebo.Doxepin is approved by the Food and Drug Administration (FDA) for the treatment of depression, anxiety, long-term pain management, as well as management of rash.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for doxepin hydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00280839 Safety and Efficacy Study of Topiramate to Aid in Smoking Cessation Completed Ortho-McNeil Neurologics, Inc. Phase 3 1969-12-31 The purpose of this research study is to determine if topiramate is safe and effective in the treatment of smoking cessation
NCT00280839 Safety and Efficacy Study of Topiramate to Aid in Smoking Cessation Completed University of Cincinnati Phase 3 1969-12-31 The purpose of this research study is to determine if topiramate is safe and effective in the treatment of smoking cessation
NCT00280839 Safety and Efficacy Study of Topiramate to Aid in Smoking Cessation Completed Lindner Center of HOPE Phase 3 1969-12-31 The purpose of this research study is to determine if topiramate is safe and effective in the treatment of smoking cessation
NCT00465972 The Treatment of Insomnia in Patients With HIV Disease Completed Duke University Phase 4 2007-03-01 This study is designed to evaluate the efficacy of two commonly prescribed sleep aids for use in patients who are HIV positive and suffer from insomnia.
NCT00755495 Safety and Efficacy of Ramelteon and Doxepin in Subjects With Chronic Insomnia Completed Takeda Phase 2 2006-07-01 The purpose of this study is to determine the efficacy of ramelteon, once daily (QD), combined with doxepin in treating subjects with insomnia.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for doxepin hydrochloride

Condition Name

Condition Name for doxepin hydrochloride
Intervention Trials
Mucositis 2
Insomnia 2
Malignant Pleural Effusion 1
Chronic Urticaria 1
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Condition MeSH

Condition MeSH for doxepin hydrochloride
Intervention Trials
Sleep Initiation and Maintenance Disorders 3
Mucositis 3
Stomatitis 2
Neoplasms 1
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Clinical Trial Locations for doxepin hydrochloride

Trials by Country

Trials by Country for doxepin hydrochloride
Location Trials
United States 49
Iran, Islamic Republic of 2
Brazil 1
Lebanon 1
Switzerland 1
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Trials by US State

Trials by US State for doxepin hydrochloride
Location Trials
Minnesota 3
North Carolina 2
Michigan 2
Nebraska 2
North Dakota 2
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Clinical Trial Progress for doxepin hydrochloride

Clinical Trial Phase

Clinical Trial Phase for doxepin hydrochloride
Clinical Trial Phase Trials
Phase 4 3
Phase 3 4
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for doxepin hydrochloride
Clinical Trial Phase Trials
Completed 10
Recruiting 3
Active, not recruiting 2
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Clinical Trial Sponsors for doxepin hydrochloride

Sponsor Name

Sponsor Name for doxepin hydrochloride
Sponsor Trials
National Cancer Institute (NCI) 3
Alliance for Clinical Trials in Oncology 2
Fundação de Amparo à Pesquisa do Estado de São Paulo 1
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Sponsor Type

Sponsor Type for doxepin hydrochloride
Sponsor Trials
Other 20
Industry 3
NIH 3
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