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| Sponsor: | Celtic Pharma Development Services |
|---|---|
| Collaborator: |
Neurobiological Technologies |
| Information provided by: | Celtic Pharma Development Services |
| ClinicalTrials.gov Identifier: | NCT00088166 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain Edema Brain Tumor |
Drug: hCRF Drug: placebo hCRF |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Phase III Randomized, Double-Blind, Dexamethasone-Sparing Study Comparing Human Corticotropin-Releasing Factor (hCRF) to Placebo for Control of Symptoms Associated With Peritumoral Brain Edema in Patients With Malignant Brain Tumor Who Require Chronic Administration of High-Dose Dexamethasone |
| Estimated Enrollment: | 220 |
| Study Start Date: | May 2004 |
| Study Completion Date: | March 2008 |
| Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: I
Patients will take hCRF (XERECEPT) 2mg/day and open label-dexamethasone they are currently taking.
|
Drug: hCRF
hCRF ; open-label dexamethasone that the patient is currently taking
Other Name: XERECEPT (corticorelin acetate injection); hCRF
|
|
Placebo Comparator: II
Patient will receive placebo hCRF and any open-label dexamethasone that they are currently taking
|
Drug: placebo hCRF
placebo hCRF 2mg/day and open-label dexamethasone that they are taking
Other Name: XERECEPT (corticorelin acetate injection)
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XERECEPT® is not a potential treatment for cancer, but may reduce the edema associated with tumors and as a result, decrease neurological symptoms.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 34 Study Locations| Principal Investigator: | William Shapiro, MD | Barrow Neurological Institute |
More Information
| Responsible Party: | Patrick Rossi, MD - Medical Monitor, Celtic Pharma Development Services |
| ClinicalTrials.gov Identifier: | NCT00088166 History of Changes |
| Obsolete Identifiers: | NCT00091013 |
| Other Study ID Numbers: | NTI 0303, XERECEPT®, corticorelin acetate injection |
| Study First Received: | July 20, 2004 |
| Last Updated: | March 7, 2008 |
| Health Authority: | United States: Food and Drug Administration |
|
peritumoral brain edema edema malignant brain tumor astrocytoma |
brain tumor dexamethasone Decadron |
|
Brain Edema Brain Neoplasms Edema Brain Diseases Central Nervous System Diseases Nervous System Diseases Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Neoplasms Signs and Symptoms Corticotropin-Releasing Hormone Dexamethasone Dexamethasone 21-phosphate Dexamethasone acetate |
BB 1101 Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antiemetics Autonomic Agents Peripheral Nervous System Agents Central Nervous System Agents Gastrointestinal Agents Glucocorticoids Antineoplastic Agents, Hormonal Antineoplastic Agents |