Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2026-03-11 @ 9:13 PM
Study NCT ID:
NCT00486369
Status:
COMPLETED
Last Update Posted:
2007-06-14
First Post:
2007-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SMC021A - Absorption, Efficacy and Tolerance in Patients With Osteoarthritis. A Placebo-Controlled 14-Days Study
Sponsor:
Nordic Bioscience A/S
Organization:
Study Overview
Official Title:
SMC021A - Absorption, Efficacy and Tolerance in Patients With Osteoarthritis. A Placebo-Controlled 14-Days Study.
Status:
COMPLETED
Status Verified Date:
2007-06
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 expose patients with OA to calcitonin and to determine plasma calcitonin levels after administration of 0.6 mg and 0.8 mg oral calcitonin. Also the purpose is to assess the effect of different doses of oral calcitonin (0.6 mg and 0.8 mg oral) compared to placebo on serum CTX-I and CTX-II. Finally to assess the tolerance profile of different doses/formulations of oral calcitonin compared to placebo.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: