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NCT00088166 · ClinicalTrials.gov registry record · Phase 3
XERECEPT® (hCRF) for Patients Requiring Dexamethasone to Treat Edema Associated With Brain Tumors
A Phase 3 study, sponsored by Celtic Pharma Development Services.
- Completed
- Registry status
- Phase 3
- Development phase
- 200
- Enrollment target
NCT00088166: Completed Phase 3 study, sponsored by Celtic Pharma Development Services.
NCT00088166 is a Phase 3 study that has completed, run by Celtic Pharma Development Services. The registered enrollment target is 200 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00088166, a Phase 3 study, has completed, sponsored by Celtic Pharma Development Services.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 200 participants
- Enrollment target
Study 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.
Primary Outcome
The primary efficacy endpoint was the proportion of patients in each treatment group who were Responders at Week 2 and who continued to be Responders at Week 5. Responders were defined as study patients who demonstrated the following: * 50% or greater reduction in dexamethasone dose relative to Baseline * Overall 10-Item Neurological Examination Score unchanged or lower compared to Baseline * Karnofsky Score unchanged or increased relative to Baseline
Interventions
- DRUG hCRF
- DRUG placebo hCRF
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2004-05 |
| Est. Completion | 2008-03 |
| Phase | Phase 3 |
What the finished NCT00088166 record still lists
NCT00088166 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 2 interventions - of which hCRF is the first listed.
NCT00088166 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00088166 about?
NCT00088166 is a clinical study titled "XERECEPT® (hCRF) for Patients Requiring Dexamethasone to Treat Edema Associated With Brain Tumors". 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.
What is the current status of trial NCT00088166?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 200 participants. The study started on 2004-05. Estimated completion is 2008-03.
What interventions are being tested in trial NCT00088166?
The interventions under investigation include: hCRF (DRUG), placebo hCRF (DRUG).
Who is sponsoring clinical trial NCT00088166?
This trial is sponsored by Celtic Pharma Development Services, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00088166's enrollment target sits among peer trials
200 1353rd of 2000 higher than 613 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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