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XERECEPT® (hCRF) for Primary Glioma Patients Requiring Dexamethasone to Treat Peritumoral Brain Edema
Plain-language guide to NCT00226668: phase 3 randomized trial of CRH (Corticotropin-Releasing Hormone), 120 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00226668
- Phase
- phase 3
- Status
- withdrawn
- Start
- 2006-01
- Completion (planned or actual)
- 2008-01
- Participants
- 120 (estimated)
- Design
- randomized, triple-blind, treatment
- Conditions studied
- Brain Edema; Brain Tumor
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 3) is built around CRH (Corticotropin-Releasing Hormone).
It had two arms (groups): I (experimental) and II (placebo comparator).
The registry classes the interventions as drug.
Who Took Part
The registry lists 120 planned participants were the target.
It was open to people of any sex aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Histologically confirmed diagnosis of a primary malignant glioma. Presence of peritumoral brain edema confirmed by MRI scan or comparable diagnostic technology obtained within 21 days of Baseline. Capable of self-administration of subcutaneous injections twice daily for 8 weeks or availability of assistance from caregiver.
The full record lists 5 inclusion and 6 exclusion criteria; among the exclusions: need for surgery, radiosurgery or radiation therapy or the introduction of new chemotherapeutic regime within 2 weeks of study treatment; systemic steroid use for any other indication than peritumoral brain edema; patients on dexamethasone or anticonvulsant therapy.
How the Study Was Run
Design: randomized, parallel-group and triple-blind.
Because people in this CRH (Corticotropin-Releasing Hormone) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
The CRH (Corticotropin-Releasing Hormone) group and the comparison group ran side by side rather than switching.
Blinding on both sides kept the participants and researchers unaware of who received CRH (Corticotropin-Releasing Hormone).
Those kept unaware of assignments: participant, care provider and investigator.
It started in 2006-01 with completion listed for 2008-01.
It ran at 26 sites in United States (24) and Canada (2).
Its stated primary purpose is treatment.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of CRH (Corticotropin-Releasing Hormone) in 120 people.
It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the CRH (Corticotropin-Releasing Hormone) compound page, all human trials.
Our Notes on the Compound
CRH (Corticotropin-Releasing Hormone): The 41-amino-acid hypothalamic hormone that triggers ACTH release; corticorelin is used diagnostically.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.