Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
Study NCT ID:
NCT01022060
Status:
COMPLETED
Last Update Posted:
2010-02-04
First Post:
2009-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Renalof in the Dissolution of Renal Calculi in Patients With Recurrent Calcic Lithiasis
Sponsor:
Catalysis SL
Organization:
Study Overview
Official Title:
Efficacy of Renalof in the Dissolution of Renal Calculi in Patients With Recurrent Calcic Lithiasis
Status:
COMPLETED
Status Verified Date:
2010-02
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:
The purpose of this study is to determine whether Renalof administration promotes partial or total dissolution of urinary calculi and improves physicochemical parameters and metabolic activity in patients with recurrent calcic urolithiasis. The duration of this double-blind placebo controlled phase 3 clinical trial will be 12 weeks. The estimated number of patients to be recruited and randomized for the study is 110. Ultrasonographic and humoral parameters will be assessed every 4 weeks.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: