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XERECEPT® (hCRF) for Patients Requiring Dexamethasone to Treat Edema Associated With Brain Tumors

NCT00088166 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2014-08-13

Study results available
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Summary

The purpose of this study is to compare the safety and efficacy of XERECEPT® to dexamethasone (Decadron) a common treatment for symptoms of brain swelling (edema). This study is specifically aimed at patients who require chronic high doses of dexamethasone to manage symptoms.

Conditions

Interventions

DRUG

hCRF

hCRF ; open-label dexamethasone that the patient is currently taking

DRUG

placebo hCRF

placebo hCRF 2mg/day and open-label dexamethasone that they are taking

Sponsors & Collaborators

  • Neurobiological Technologies

    collaborator INDUSTRY

  • Celtic Pharma Development Services

    lead INDUSTRY

Principal Investigators

  • William Shapiro, MD · Barrow Neurological Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-05-31
Primary Completion
2008-03-31
Completion
2008-03-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00088166 on ClinicalTrials.gov