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Type(s) of Cancer
Oral Mucositis
Study Phase
Phase 3
Study Completion Date
May 2016
NCT02229539Uploaded 02-10-2021
Access via NCI by Request
PDS UID: nci-data-447
A Phase III Placebo-Controlled, Randomized Three-Arm Study of Doxepin and a Topical Rinse in the Treatment of Acute Oral Mucositis Pain in Patients Receiving Radiotherapy With or Without Chemotherapy
Provider Information
Provider Data DescriptionDataset NCT02229539-D1-Dataset.csv (Fig1_allptchar) is one of 4 datasets associated with PubMed ID 30990550. This dataset contains information that will allow you to reproduce the Table 1, the baseline characteristics.
SponsorAlliance for Clinical Trials in Oncology
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThe 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.
ConditionsAcute Oral Mucositis Pain
Intervention TypeDrug: doxepin hydrochloride oral solution
Drug: DLA (diphenhydramine, lidocaine and antacids) rinse
Other: Placebo
Drug(s)Drug: doxepin hydrochloride oral solution
Drug: DLA (diphenhydramine, lidocaine and antacids) rinse
Total Enrolled275
RandomizationRandomized
Blinding MethodDouble
Arms Interventiondoxepin rinse - Experimental
DLA (diphenhydramine, lidocaine and antacid) rinse - Active Comparator
placebo rinse - Placebo Comparator
Secondary IDU10CA037447
PubMed (PMID)30990550
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Age Range18 Years and older (Adult, Older Adult)
Files: NCT02229539-D1
Data DictionaryNCT02229539-D1-Data-Dictionary_0.pdf
DATANCT02229539-D1-Dataset_0.csv
OTHERREADME.pdf
Files: NCT02229539-D2
Data DictionaryNCT02229539-D2-Data-Dictionary_0.pdf
DATANCT02229539-D2-Dataset_0.csv
OTHERREADME.pdf
Files: NCT02229539-D3
Data DictionaryNCT02229539-D3-Data-Dictionary_0.pdf
DATANCT02229539-D3-Dataset_0.csv
OTHERREADME.pdf
Files: NCT02229539-D4
Data DictionaryNCT02229539-D4-Data-Dictionary_0.pdf
DATANCT02229539-D4-Dataset_0.csv
OTHERREADME.pdf
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