Ectoin® Mouth Wash for the Prevention and Treatment of Chemotherapy-induced Oral Mucositis
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ClinicalTrials.gov Identifier: NCT02816515 |
Recruitment Status :
Completed
First Posted : June 28, 2016
Last Update Posted : January 18, 2018
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Sponsor:
Bitop AG
Information provided by (Responsible Party):
Bitop AG
Tracking Information | ||||
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First Submitted Date | June 20, 2016 | |||
First Posted Date | June 28, 2016 | |||
Last Update Posted Date | January 18, 2018 | |||
Study Start Date | January 2016 | |||
Actual Primary Completion Date | October 24, 2017 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures |
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Original Primary Outcome Measures |
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Change History | ||||
Current Secondary Outcome Measures |
Number of participants with treatment-related adverse events as assessed by the Suspect Adverse Reaction Report Form (CIOMS Form I). [ Time Frame: within 21 days after starting chemotherapy ] | |||
Original Secondary Outcome Measures | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | Ectoin® Mouth Wash for the Prevention and Treatment of Chemotherapy-induced Oral Mucositis | |||
Official Title | Non Interventional Clinical Investigation of Ectoin® Mouth Wash for the Prevention and Treatment of Chemotherapy-induced Oral Mucositis | |||
Brief Summary | This is a 3-week, non-interventional, observational study of patients undergoing chemotherapy (sutent) designed as a three-arm parallel study. In this study, the efficacy of Ectoin containing mouthwash given prophylactically for the prevention of mucositis in patients before radio- and/or chemotherapy; as well as during radio- and/or chemotherapy for patients with mucositis compared to standard treatment should be investigated. The study doesn't intervene with routine treatment strategy. | |||
Detailed Description | Not Provided | |||
Study Type | Observational | |||
Study Design | Observational Model: Case-Only Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Non-Probability Sample | |||
Study Population | Subjects with radio- and/or chemotherapy-induced mucositis | |||
Condition | Mucositis | |||
Intervention | Not Provided | |||
Study Groups/Cohorts |
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Publications * | Dao VA, Bilstein A, Overhagen S, Géczi L, Baráth Z, Mösges R. Effectiveness, Tolerability, and Safety of Ectoine-Containing Mouthwash Versus Those of a Calcium Phosphate Mouthwash for the Treatment of Chemotherapy-Induced Oral Mucositis: A Prospective, Active-Controlled, Non-interventional Study. Oncol Ther. 2018 Jun;6(1):59-72. doi: 10.1007/s40487-018-0060-z. Epub 2018 May 9. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment |
46 | |||
Original Estimated Enrollment |
80 | |||
Actual Study Completion Date | October 24, 2017 | |||
Actual Primary Completion Date | October 24, 2017 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 99 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Hungary | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT02816515 | |||
Other Study ID Numbers | 2016/EML/NIS | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Current Responsible Party | Bitop AG | |||
Original Responsible Party | Same as current | |||
Current Study Sponsor | Bitop AG | |||
Original Study Sponsor | Same as current | |||
Collaborators | Not Provided | |||
Investigators |
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PRS Account | Bitop AG | |||
Verification Date | January 2018 |