Detailed Result for NCT00961753
NCT ID: | NCT00961753 |
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NLM Download Date Description: | N/A |
Study First Submitted Date: | 2009-08-18 |
Last Update Submitted Date: | 2014-01-25 |
Last Update Submitted Date: | 2014-01-25 |
Result First Submitted Date: | N/A |
Disposition First Submitted Date: | N/A |
Start Month Year: | August 2009 |
Start Date: | 2009-08-31 |
Start Date Type: | N/A |
Verification Month Year: | January 2014 |
Verification Date: | 2014-01-31 |
Completion Month Year: | October 2010 |
Completion Date: | 2010-10-31 |
Completion Date Type: | Actual |
Primary Completion Month Year: | October 2010 |
Primary Completion Date: | 2010-10-31 |
Primary Completion Date Type: | Actual |
Study first Submitted QC Date: | 2009-08-18 |
Study first posted Date: | 2009-08-19 |
Result first Submitted QC Date: | N/A |
Result First Posted Date: | N/A |
Disposition First Submitted QC Date: | N/A |
Disposition First Posted Date: | N/A |
Last Updated Submitted QC Date: | 2014-01-25 |
Last Updated Posted Date: | 2014-01-28 |
Target Duration: | N/A |
Study Type: | Interventional |
Acronym: | OIDS |
Baseline Population: | N/A |
Brief Title: | Safety/Efficacy Study of Optimizing Ibuprofen Dosing to Achieve Higher PDA Closure Rates |
Official Title: | Safety and Efficacy of an Optimized Ibuprofen Dosing Regimen Versus Standard Dosing for Pharmacologic Closure of Patent Ductus Arteriosus |
Overall Status: | Terminated |
Last Known Status: | N/A |
Phase: | Phase 4 |
Enrollment: | 10 |
Enrollment Type: | Actual |
Source: | OSF Healthcare System |
Limitation and Caveats: | N/A |
Number of Arms: | 2 |
Number of Groups: | N/A |
Why Stopped: | FDA drug recall on July 30, 2010 |
Has Expanded Access: | N/A |
Expanded Access Type Individual: | N/A |
Expanded Access Type Intermediate: | N/A |
Expanded Access Type Treatment: | N/A |
Has DMC: | true |
Is it FDA Regulated Drug: | N/A |
Is it FDA Regulated Device: | N/A |
Is it Unapproved Device: | N/A |
Is PPSD: | N/A |
Is US Export: | N/A |
Is Biospec Retention: | N/A |
Biospec Description: | N/A |
Plan to Share IPD: | N/A |
Plan to Share IPD Description: | N/A |
IPD Time Frame: | N/A |
IPD Access Criteria: | N/A |
IPD URL: | N/A |