Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00458289
Status:
COMPLETED
Last Update Posted:
2019-12-20
First Post:
2007-04-06
Brief Title:
Efficacy of Phosphate Binding in Healthy Volunteers Chewed Versus Crushed Lanthanum Carbonate
Sponsor:
University of Illinois at Chicago
Organization:
University of Illinois at Chicago
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2019-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients with end-stage renal disease ESRD commonly have high concentrations of phosphorous a mineral in the blood hyperphosphatemia This is a result of their inability to excrete phosphorous by the kidneys This in turn may result in the development of a condition known as secondary hyperparathyroidism and renal osteodystrophy or bone disease As such these patients often receive medications known as phosphate binders such as calcium carbonate or acetate sevelamer aluminum hydroxide and lanthanum carbonate to manage and treat hyperphosphatemia
Lanthanum carbonate is a newly available phosphate binding agent that is effective in the management of hyperphosphatemia and preventing secondary hyperparathyroidism It works in the gastrointestinal tract by binding to the phosphorus in the diet ESRD patients taking lanthanum carbonate are counseled to chew the tablets completely before swallowing with or immediately after meals However patients who are intubated or receiving nutrition via feeding tubes are unable to chew the tablets For these patients medications are commonly crushed and administered via the tube Moreover some patients prefer to crush the tablets and mix it with food instead of chewing To date it is not known if crushing the lanthanum carbonate tablets prior to administration and taking it with food would be as effective as chewing them
The purpose of this study is to compare the efficacy of phosphate binding between chewed and crushed lanthanum carbonate tablets
Lanthanum carbonate is a newly available phosphate binding agent that is effective in the management of hyperphosphatemia and preventing secondary hyperparathyroidism It works in the gastrointestinal tract by binding to the phosphorus in the diet ESRD patients taking lanthanum carbonate are counseled to chew the tablets completely before swallowing with or immediately after meals However patients who are intubated or receiving nutrition via feeding tubes are unable to chew the tablets For these patients medications are commonly crushed and administered via the tube Moreover some patients prefer to crush the tablets and mix it with food instead of chewing To date it is not known if crushing the lanthanum carbonate tablets prior to administration and taking it with food would be as effective as chewing them
The purpose of this study is to compare the efficacy of phosphate binding between chewed and crushed lanthanum carbonate tablets
Detailed Description:
None
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