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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 is a Phase 2 study that has completed, run by Enzychem Lifesciences Corporation. The registered enrollment target is 105 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03200340
The ClinicalTrials.gov registry entry for NCT03200340 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 105 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Enzychem Lifesciences Corporation, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03200340 reports 0 study locations.
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.
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