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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.

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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

FieldValue
Enrollment Target 390 participants
Start Date 2006-05
Est. Completion 2008-08
Phase Phase 2

Sponsor

CuraGen Corporation

4 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.