Who is sponsoring NCT00323518?

NCT00323518 is sponsored by CuraGen Corporation.

What condition does NCT00323518 study?

NCT00323518 studies Oral Mucositis, Stomatitis.

What drugs are being tested in NCT00323518?

Interventions: velafermin, placebo.

What is the status of NCT00323518?

NCT00323518 is currently COMPLETED.

Last reviewed 2016-03-14 · How we verify

A Phase II Randomized Double Blind Placebo Controlled Trial to Assess Safety and Efficacy of Velafermin for Prevention of Oral Mucositis in Hematologic Cancer Patients Receiving Autologous Stem Cell Transplant

NCT00323518 Phase 2 COMPLETED

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.

Details

Lead sponsor	CuraGen Corporation
Phase	Phase 2
Status	COMPLETED
Enrolment	390
Start date	2006-05
Completion	2008-08

Conditions

Oral Mucositis
Stomatitis

Interventions

velafermin
placebo

Primary outcomes

the incidence of grade 3/4 oral mucositis using WHO grading system — evaluated throughout the study

Countries

United States