Ignite Creation Date:
2024-05-06 @ 12:48 AM
Last Modification Date:
2024-10-26 @ 10:55 AM
Study NCT ID:
NCT01660243
Status:
TERMINATED
Last Update Posted:
2022-02-09
First Post:
2012-08-02
Brief Title:
Efficacy and Safety of MT-9938 for Treatment of Uremic Pruritus in Subjects With End-stage Renal Disease Receiving Hemodialysis
Sponsor:
Toray Industries Inc
Organization:
Toray Industries Inc
Study Overview
Official Title:
A Phase 2 Randomized Double-blind Placebo-controlled Fixed-dose Parallel-group Multicenter Efficacy and Safety Study of MT-9938 for Treatment of Uremic Pruritus in Subjects With End-stage Renal Disease Receiving Hemodialysis
Status:
TERMINATED
Status Verified Date:
2021-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
This study has been terminated because of insufficient patient recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is being conducted to investigate the efficacy of MT-9938 compared with placebo after 2 weeks to continue to evaluate efficacy for an additional 6 weeks and to explore the effect of a reduction in itching intensity on health-related Quality of LifeQoL domains especially those which recent research suggests have a positive correlation with overall survival for this patient group The study will consist of the following phases Screening 1 to 2 weeks Run in 1 week double-blind Treatment 8 weeks Washout 1 week culminating in a Follow-up Visit 1 week after the last dose
Detailed Description:
This study has been terminated because of insufficient patient recruitment There were no safety concerns
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