Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00189878
Status:
TERMINATED
Last Update Posted:
2016-02-19
First Post:
2005-09-11
Brief Title:
A Study of the Use of Methotrexate in the Treatment of Chronic Idiopathic Urticaria
Sponsor:
Barnsley Hospital
Organization:
Barnsley Hospital
Study Overview
Official Title:
Multi-centre Prospective Randomised Double-blind Placebo-controlled Study of Methotrexate in the Treatment of Chronic Idiopathic Urticaria
Status:
TERMINATED
Status Verified Date:
2016-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
unable to recruit
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 methotrexate produces significant improvement in chronic idiopathic urticaria compared with placebo
Detailed Description:
Chronic idiopathic urticaria is thought to affect approximately 01 of the population It can be very disabling and difficult to treat Antihistamines are the only drugs licensed for treatment of urticaria however there is a group of severely affected patients with chronic idiopathic urticaria who fail to respond Previous trials have shown ciclosporin to be beneficial and small studies support the use of intravenous immunoglobulins and plasmapheresis However not only are these options expensive but since chronic idiopathic urticaria may persist for years their prolonged use may be limited by adverse effects We have previously published a report of 2 patients who responded to methotrexate and wish to properly evaluate the efficacy of methotrexate in the treatment of CIU
In the first part of the study patients will be given either placebo or methotrexate for 8 weeks and in the second part of the study non-responders will be offered open labelled methotrexate for 8 weeks
In the first part of the study patients will be given either placebo or methotrexate for 8 weeks and in the second part of the study non-responders will be offered open labelled methotrexate for 8 weeks
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MF 800012375 | None | None | None |