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NCT01192204 · ClinicalTrials.gov registry record · Phase 1
Clinical Evaluation of Bioadhesive Gels for Oral Cancer Chemoprevention
A Phase 1 study of Intraepithelial Neoplasia and Squamous Cell Carcinoma of Mouth, sponsored by Ohio State University.
- Completed
- Registry status
- Phase 1
- Development phase
- 41
- Enrollment target
- 3
- Study locations
NCT01192204 is a Phase 1 study of Intraepithelial Neoplasia and Squamous Cell Carcinoma of Mouth that has completed, run by Ohio State University. The registered enrollment target is 41 participants. The trial reports 3 study locations across 3 states.
The verdict
NCT01192204, a Phase 1 study of Intraepithelial Neoplasia and Squamous Cell Carcinoma of Mouth, has completed, sponsored by Ohio State University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 41 participants
- Enrollment target
- 3
- Study locations
Study Summary
This is a multicenter placebo-controlled clinical trial to assess the effects of a topically applied gel on precancerous oral epithelial lesions. A total of 41 participants will be enrolled in this trial, and 22 of them will be enrolled at Ohio State. \[The remaining 19 participants will be enrolled at the University of North Carolina (9 participants) and the University of Louisville (8 participants)\]. At all three institutions, half of the participants will randomly be assigned to the 10% FBR gel (0.5 gm four times daily for 3 months), while half will enter the placebo control arm. All trial participants will have a pretreatment (including lesional and perilesional tissue) biopsy taken before and an excisional biopsy after 3 months of treatment. As pretreatment indices are compared to post treatment effects on each patient, patients serve as their own internal control. Pretreatment lesional biopsies are obtained to establish a pretreatment diagnosis and provide a pretreatment baseline for the experimental parameters.
Conditions Studied
Interventions
- DRUG placebo gel
- DRUG 10% FBR containing bioadhesive gel
Study Locations (3)
Kentucky
- University of Louisville, School of Dentistry - Louisville
North Carolina
- University of North Carolina at Chapel Hill - Chapel Hill
Ohio
- The Ohio State University, College of Dentistry - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2010-10 |
| Est. Completion | 2014-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01192204
The ClinicalTrials.gov registry entry for NCT01192204 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 41 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ohio State University, which has 552 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Intraepithelial Neoplasia appearing as the primary indexed condition, and to 2 interventions - of which placebo gel is the first listed.
NCT01192204 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Kentucky, North Carolina, Ohio.
Frequently Asked Questions
What is clinical trial NCT01192204 about?
NCT01192204 is a clinical study titled "Clinical Evaluation of Bioadhesive Gels for Oral Cancer Chemoprevention". This is a multicenter placebo-controlled clinical trial to assess the effects of a topically applied gel on precancerous oral epithelial lesions. A total of 41 participants will be enrolled in this trial, and 22 of them will be enrolled at Ohio State. \[The remaining 19 participants will be enrolled...
What is the current status of trial NCT01192204?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 41 participants. The study started on 2010-10. Estimated completion is 2014-02.
What conditions does trial NCT01192204 study?
This clinical trial studies the following conditions: Intraepithelial Neoplasia, Squamous Cell Carcinoma of Mouth.
What interventions are being tested in trial NCT01192204?
The interventions under investigation include: placebo gel (DRUG), 10% FBR containing bioadhesive gel (DRUG).
Who is sponsoring clinical trial NCT01192204?
This trial is sponsored by Ohio State University, which has 552 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01192204 being conducted?
This trial has 3 study locations across Kentucky, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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