Ignite Creation Date:
2024-05-05 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00412256
Status:
COMPLETED
Last Update Posted:
2006-12-18
First Post:
2006-12-15
Brief Title:
Omegaven in Patients With Rheumatoid Arthritis ORA-Trial
Sponsor:
Humanis Klinikum Niederosterreich
Organization:
Humanis Klinikum Niederosterreich
Study Overview
Official Title:
Clinical Trial to Evaluate the Effect of Parenteral Supplementation With Omega-3-Fatty Acids in Patients With Rheumatoid Arthritis
Status:
COMPLETED
Status Verified Date:
2006-12
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:
The primary hypothesis constitutes that the fish-oil preparation Omegaven is superior to the preparation based on Soja-oil Lipovenösto reduce signs and symptoms in patients with active rheumatoid arthritis
Detailed Description:
The study can be considered a phase III trial comparison of two licensed preparations in a non-approved indication This controlled double blind trial aims to compare the effect of parenterally applied fat emulsions on the disease activity of RA patients as expressed by changes of the DAS28
To test for the hypothesis patients are randomized and treated with 2mlkg bodyweight of both preparations for seven consecutive days These treatment cycles are repeated four times at monthly intervals For not improving patients DAS28 decrease 06 escapes before the third and the fourth treatment cycle are foreseen In case of escape patients are treated with Omegaven in an open manner
Efficacy parameters comprise the DAS28 the ACR-criteria the M-HAQ the SF-36 and the co-medication consumption To assess safety laboratory parameters comprising LFT KFT CBC fasting glucose cholesterol HDL LDL neutral fat and urinary analysis are performed Moreover blood pressure control and clinically examinations are performed on a regular basis
Study recruitment started in fall 2004 and was completed in November 2006
To test for the hypothesis patients are randomized and treated with 2mlkg bodyweight of both preparations for seven consecutive days These treatment cycles are repeated four times at monthly intervals For not improving patients DAS28 decrease 06 escapes before the third and the fourth treatment cycle are foreseen In case of escape patients are treated with Omegaven in an open manner
Efficacy parameters comprise the DAS28 the ACR-criteria the M-HAQ the SF-36 and the co-medication consumption To assess safety laboratory parameters comprising LFT KFT CBC fasting glucose cholesterol HDL LDL neutral fat and urinary analysis are performed Moreover blood pressure control and clinically examinations are performed on a regular basis
Study recruitment started in fall 2004 and was completed in November 2006
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