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NCT01877421 · ClinicalTrials.gov registry record · Phase 1
Safety and Tolerability of Antiplaque Chewing Gum in a Gingivitis Population
A Phase 1 study, sponsored by U.S. Army Medical Research and Development Command.
- Completed
- Registry status
- Phase 1
- Development phase
- 135
- Enrollment target
NCT01877421: Completed Phase 1 study, sponsored by U.S. Army Medical Research and Development Command.
NCT01877421 is a Phase 1 study that has completed, run by U.S. Army Medical Research and Development Command. The registered enrollment target is 135 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (125% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01877421, a Phase 1 study, has completed, sponsored by U.S. Army Medical Research and Development Command.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 135 participants
- Enrollment target
Study Summary
This study is to assess the safety and tolerability of single doses and multiple doses in reducing plaque and gingivitis when delivered in a chewing gum formulation.
Primary Outcome
Occurrence of local oral mucosal reactions, systemic reactions such as fever, nausea, headache, and changes in blood pressure, clinical laboratory measures of safety, and serious total body reactions will be assessed (AEs and SAEs)
Interventions
- DRUG 2 mg KSL-W
- DRUG 4 mg KSL-W
- DRUG 6 mg KSL-W
- DRUG 10 mg KSL-W
- DRUG 20 mg KSL-W
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 135 participants |
| Start Date | 2014-02-25 |
| Est. Completion | 2016-03 |
| Phase | Phase 1 |
What the finished NCT01877421 record still lists
NCT01877421 is an interventional study that assigns participants to a tested intervention. The registered 135 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (125% higher).
The record links to 0 conditions, and to 5 interventions - of which 2 mg KSL-W is the first listed.
NCT01877421 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01877421 about?
NCT01877421 is a clinical study titled "Safety and Tolerability of Antiplaque Chewing Gum in a Gingivitis Population". This study is to assess the safety and tolerability of single doses and multiple doses in reducing plaque and gingivitis when delivered in a chewing gum formulation.
What is the current status of trial NCT01877421?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 135 participants. The study started on 2014-02-25. Estimated completion is 2016-03.
What interventions are being tested in trial NCT01877421?
The interventions under investigation include: 2 mg KSL-W (DRUG), 4 mg KSL-W (DRUG), 6 mg KSL-W (DRUG), 10 mg KSL-W (DRUG), 20 mg KSL-W (DRUG).
Who is sponsoring clinical trial NCT01877421?
This trial is sponsored by U.S. Army Medical Research and Development Command, which has 77 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01877421's enrollment target sits among peer trials
135 425th of 2000 higher than 1,574 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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