Trial record 2 of 2 for:
SGX942
A Dose Escalating Study of SGX942 for Oral Mucositis in Patients With Head and Neck Cancer
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ClinicalTrials.gov Identifier: NCT02013050 |
Recruitment Status :
Completed
First Posted : December 17, 2013
Results First Posted : July 31, 2017
Last Update Posted : August 28, 2017
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Sponsor:
Soligenix
Information provided by (Responsible Party):
Soligenix
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Tracking Information | |||
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First Submitted Date ICMJE | December 11, 2013 | ||
First Posted Date ICMJE | December 17, 2013 | ||
Results First Submitted Date ICMJE | February 17, 2017 | ||
Results First Posted Date ICMJE | July 31, 2017 | ||
Last Update Posted Date | August 28, 2017 | ||
Study Start Date ICMJE | December 2013 | ||
Actual Primary Completion Date | December 2015 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
Duration of Severe Oral Mucositis (SOM) [ Time Frame: 4 weeks after end of therapy ] Duration of SOM was defined as the number of days from the onset of SOM until resolution of SOM. If the patient did not meet the requirements for resolution of SOM by the 1-month follow up visit, he/she was considered censored at the 1-month follow-up visit (or point of discontinuation of the study, if the patient had discontinued prior to the end of planned treatment). Patients who did not experience SOM were assigned a duration of 0.01. OM was evaluated using the published World Health Organization (WHO) OM grading scale that uses a scale of 0 to 4.
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Original Primary Outcome Measures ICMJE |
Oral Mucositis Symptoms [ Time Frame: 4 weeks after end of therapy ] | ||
Change History | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Not Provided | ||
Current Other Pre-specified Outcome Measures | Not Provided | ||
Original Other Pre-specified Outcome Measures | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | A Dose Escalating Study of SGX942 for Oral Mucositis in Patients With Head and Neck Cancer | ||
Official Title ICMJE | A Phase 2,Double-Blind, Randomized, Placebo-Controlled, Dose Escalating, Multicenter Study of SGX942 For the Attenuation of Oral Mucositis in Patients Being Treated With Concomitant Chemoradiation for the Treatment of Squamous Cell Carcinoma of the Head and Neck | ||
Brief Summary | To evaluate the safety and efficacy of SGX942 in patients receiving chemoradiation treatment for the treatment of head and neck cancer. | ||
Detailed Description | Not Provided | ||
Study Type ICMJE | Interventional | ||
Study Phase ICMJE | Phase 2 | ||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Oral Mucositis | ||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||
* 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 ICMJE | Completed | ||
Actual Enrollment ICMJE |
111 | ||
Original Estimated Enrollment ICMJE |
78 | ||
Actual Study Completion Date ICMJE | September 2016 | ||
Actual Primary Completion Date | December 2015 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||
Accepts Healthy Volunteers ICMJE | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | United States | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT02013050 | ||
Other Study ID Numbers ICMJE | IDR-OM-01 | ||
Has Data Monitoring Committee | No | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement ICMJE | Not Provided | ||
Responsible Party | Soligenix | ||
Study Sponsor ICMJE | Soligenix | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Soligenix | ||
Verification Date | July 2017 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |