Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00228995
Status:
TERMINATED
Last Update Posted:
2011-06-10
First Post:
2005-09-27
Brief Title:
A Phase II Study to Assess Changes in Physical Function in Elderly Patients With Chronic Anemia
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Study to Assess Changes in Physical Function in Elderly Patients With Idiopathic Anemia of Aging IAA Receiving Epoetin Alfa PROCRIT
Status:
TERMINATED
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
This study was stopped due to slow enrollment after enrolling only 9 of 80 patients over 14 months time
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess changes in physical function in elderly patients 65 years of age with chronic anemia Hb 110 gdL due to anemia of unknown cause and receiving weekly subcutaneous doses of Epoetin alfa PROCRITÂ versus placebo
Detailed Description:
Some elderly patients have anemia reduction in hemoglobin level or low red cell count without obvious cause Anemia occurs commonly with aging and is a frequent medical condition in individuals over the age of 65 Physical performance and function is worse in individuals who are anemic This is a randomized double-blind placebo-controlled multi-center study to assess physical function to include falls and fatigue in approximately 80 elderly patients with chronic anemia anemia present for at least 3 months and who are receiving weekly Epoetin alfa The study will also evaluate hemoglobin levels oxygen carrying protein in red blood cells safety fatigue and cognitive function The study hypothesis is to demonstrate the study drug will be more effective in treatment of chronic anemia than placebo resulting in the improvement of physical function and subsequent disabilities with minimal adverse events and the study drug is generally well-tolerated The patients will receive weekly injections of Epoetin alfa PROCRIT or placebo at a starting dose of 10000 units administered subcutaneously under the skin
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None