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NCT00323518 · ClinicalTrials.gov registry record · Phase 2
A Phase II Controlled Trial of Velafermin for Prevention of Oral Mucositis
A Phase 2 study, sponsored by CuraGen Corporation.
- Completed
- Registry status
- Phase 2
- Development phase
- 390
- Enrollment target
NCT00323518 is a Phase 2 study that has completed, run by CuraGen Corporation. The registered enrollment target is 390 participants.
The verdict
NCT00323518, a Phase 2 study, has completed, sponsored by CuraGen Corporation.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 390 participants
- Enrollment target
Study Summary
CG53135-05 (velafermin), a recombinant human fibroblast growth factor-20 (rhFGF-20) protein, is under investigation for the prevention of oral mucositis. Oral mucositis is a commonly occurring side effect of high-dose chemotherapy in patients undergoing autologous hematopoietic stem cell transplant. The objective of this Phase II trial is to confirm the safety and efficacy of CG53135-05 (velafermin) when administered as a single dose to patients at risk for developing oral mucositis.
Interventions
- DRUG placebo
- DRUG velafermin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 390 participants |
| Start Date | 2006-05 |
| Est. Completion | 2008-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00323518
The ClinicalTrials.gov registry entry for NCT00323518 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 390 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is CuraGen Corporation, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00323518 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00323518 about?
NCT00323518 is a clinical study titled "A Phase II Controlled Trial of Velafermin for Prevention of Oral Mucositis". CG53135-05 (velafermin), a recombinant human fibroblast growth factor-20 (rhFGF-20) protein, is under investigation for the prevention of oral mucositis. Oral mucositis is a commonly occurring side effect of high-dose chemotherapy in patients undergoing autologous hematopoietic stem cell transplant....
What is the current status of trial NCT00323518?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 390 participants. The study started on 2006-05. Estimated completion is 2008-08.
What interventions are being tested in trial NCT00323518?
The interventions under investigation include: placebo (DRUG), velafermin (DRUG).
Who is sponsoring clinical trial NCT00323518?
This trial is sponsored by CuraGen Corporation, which has 4 total clinical trials registered on ClinicalTrials.gov.
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