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NCT00250198 · ClinicalTrials.gov registry record · Phase 2
The Immunological and Blood Effects of STA-5326 Mesylate on Patients With Crohn's Disease
A Phase 2 study of Crohn's Disease, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT00250198 is a Phase 2 study of Crohn's Disease that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 12 participants, below the 2,394-participant average among 105 other Crohn's Disease trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00250198, a Phase 2 study of Crohn's Disease, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will test whether a new experimental drug called STA-5326 mesylate will decrease inflammatory chemicals called cytokines in patients with Crohn's disease. The drug has prevented gut inflammation in mice and rats and has improved symptoms in humans with active Crohn's disease. Patients with Crohn's Disease between 18 and 75 years of age and who have active disease symptoms may be eligible for this study. Candidates are screened with a review of their medical records, a medical history and physical examination, electrocardiogram, blood and urine tests, chest x-ray and tuberculin skin test. They fill out diary cards for 7 days (measuring their symptoms on the Crohn's Disease Activity Index, or CDAI) and complete a 32-item Inflammatory Bowel Disease Questionnaire (IBDQ) that surveys how their disease affects their live and activities. Participants have a colonoscopy (an examination of the colon using a lighted tube) before starting the study medication. Colon tissue samples are biopsied during the procedure. Following the colonoscopy, patients are randomly assigned to receive either STA-5326 mesylate or placebo (sugar or dummy pill). They take four tablets a day and are seen in the clinic once a week (days 1, 8, 15, 22 and 29) for the following tests and procedures: * Physical examination - Days 1, 8, 15, 22, 29 * Blood tests - Days 1, 8, 15, 22, 29 * Pharmacodynamic study (blood collected before the first dose of medicine and again after 1, 2, 4, 6 and 8 hours to measure levels of the drug in the blood) - Day 1 * CDAI and IBDQ - Days 1, 15, 29 * Review of medications and symptoms - Days 1, 8, 15, 22, 29 * EKG - Days 8, 29 * Pregnancy test for women of child-bearing potential - Days 15, 29 * Urine test - Day 29 After patients complete the above treatment and tests, they undergo a second colonoscopy within 48 hours of their last dose of study medication and may be offered another 1-week supply of medication. Those for whom additional treatment is deemed po
Conditions Studied
Interventions
- DRUG STA-5326
Study Locations (1)
Maryland
- National Institute of Allergy and Infectious Diseases (NIAID) - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2005-11-03 |
| Est. Completion | 2006-09-05 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00250198
The ClinicalTrials.gov registry entry for NCT00250198 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,394-participant average among 105 other Crohn's Disease trials with a reported enrollment target (99% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Crohn's Disease appearing as the primary indexed condition, and to 1 intervention - of which STA-5326 is the first listed.
NCT00250198 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00250198 about?
NCT00250198 is a clinical study titled "The Immunological and Blood Effects of STA-5326 Mesylate on Patients With Crohn's Disease". This study will test whether a new experimental drug called STA-5326 mesylate will decrease inflammatory chemicals called cytokines in patients with Crohn's disease. The drug has prevented gut inflammation in mice and rats and has improved symptoms in humans with active Crohn's disease. Patients wi...
What is the current status of trial NCT00250198?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2005-11-03. Estimated completion is 2006-09-05.
What conditions does trial NCT00250198 study?
This clinical trial studies the following conditions: Crohn's Disease.
What interventions are being tested in trial NCT00250198?
The interventions under investigation include: STA-5326 (DRUG).
Who is sponsoring clinical trial NCT00250198?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00250198 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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