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NCT03200340 · ClinicalTrials.gov registry record · Phase 2
EC-18 for Oral Mucositis in Patients With Concomitant Chemoirradiation
A Phase 2 study, sponsored by Enzychem Lifesciences Corporation.
- Completed
- Registry status
- Phase 2
- Development phase
- 105
- Enrollment target
NCT03200340: Completed Phase 2 study, sponsored by Enzychem Lifesciences Corporation.
NCT03200340 is a Phase 2 study that has completed, run by Enzychem Lifesciences Corporation. The registered enrollment target is 105 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (21% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03200340, a Phase 2 study, has completed, sponsored by Enzychem Lifesciences Corporation.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 105 participants
- Enrollment target
Study Summary
This is a Phase 2, randomized, double-blind, placebo-controlled, 2-stage trial in subjects with squamous cell cancers of the mouth, oropharynx, hypopharynx and nasopharynx planned to receive standard fractionated IMRT-delivered radiotherapy with concomitant chemotherapy (cisplatin). Informed consent will be obtained from each subject prior to enrollment. The trial will be performed in 2 stages: Stage 1 will consist of a blinded parallel group safety study of 4 cohorts in which 24 subjects will be randomized (1:1:1:1) into four equally sized groups to receive one of three doses of EC-18 (500 mg, 1000 mg, 2000 mg; unit dose of 500 mg) or placebo. Stage 2 of the study will evaluate both safety and efficacy. Stage 2 will consist of eighty (80) subjects who will be randomized in a 1:1 scheme to receive either placebo or 2000 mg of EC-18 as determined by iDSMB in Stage 1.
Primary Outcome
Duration of Grade 3 or 4 oral mucositis
Interventions
- DRUG Placebo
- DRUG EC-18
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2018-07-03 |
| Est. Completion | 2021-05-14 |
| Phase | Phase 2 |
What the finished NCT03200340 record still lists
NCT03200340 is an interventional study that assigns participants to a tested intervention. The registered 105 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (21% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03200340 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03200340 about?
NCT03200340 is a clinical study titled "EC-18 for Oral Mucositis in Patients With Concomitant Chemoirradiation". This is a Phase 2, randomized, double-blind, placebo-controlled, 2-stage trial in subjects with squamous cell cancers of the mouth, oropharynx, hypopharynx and nasopharynx planned to receive standard fractionated IMRT-delivered radiotherapy with concomitant chemotherapy (cisplatin). Informed consent...
What is the current status of trial NCT03200340?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 105 participants. The study started on 2018-07-03. Estimated completion is 2021-05-14.
What interventions are being tested in trial NCT03200340?
The interventions under investigation include: Placebo (DRUG), EC-18 (DRUG).
Who is sponsoring clinical trial NCT03200340?
This trial is sponsored by Enzychem Lifesciences Corporation, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03200340's enrollment target sits among peer trials
105 650th of 2000 higher than 1,341 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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