Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2025-12-28 @ 2:45 PM
Study NCT ID:
NCT02385266
Status:
TERMINATED
Last Update Posted:
2023-05-17
First Post:
2015-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Treating Urological Chronic Pelvic Pain Syndrome (UCPPS) Pain
Sponsor:
Northwestern University
Organization:
Study Overview
Official Title:
Brain Imaging-based Strategies for Treating Urological Chronic Pelvic Pain Syndrome (UCPPS) Pain
Status:
TERMINATED
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was closed due to recruitment limitations
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
UCPPS
Brief Summary:
The purpose of this study is to evaluate the efficacy of D-Cycloserine versus placebo treatment in reducing pain from urological chronic pelvic pain syndrome (UCPPS).
Detailed Description:
This is a double blinded, randomized control trial (RCT) over a 21 week period that aims to evaluate the treatment efficacy of placebo and D-cycloserine(DCS) in men suffering from UCPPS. The brain functional and anatomical properties associated with treatment response will also be examined.
This study will emphasize on comparing, both clinically and by brain imaging, the analgesic response to placebo in both placebo responders and non-responders in addition to a novel treatment (DCS) that targets the brain's pain mechanism for UCPPS.
Subjects will be randomized to 2 arms, in a 1:1 ratio, to a DCS medication group (n=20) and a placebo medication group (n=20). Questionnaire outcomes and brain scans will occur prior to initiating treatment and at the end of the treatment period. The actual visits required are minimized, 9 visits spread out over 21 weeks, as pain, quality of life and pill ingestion timings are collected using a secure study website accessible electronically.
This study will emphasize on comparing, both clinically and by brain imaging, the analgesic response to placebo in both placebo responders and non-responders in addition to a novel treatment (DCS) that targets the brain's pain mechanism for UCPPS.
Subjects will be randomized to 2 arms, in a 1:1 ratio, to a DCS medication group (n=20) and a placebo medication group (n=20). Questionnaire outcomes and brain scans will occur prior to initiating treatment and at the end of the treatment period. The actual visits required are minimized, 9 visits spread out over 21 weeks, as pain, quality of life and pill ingestion timings are collected using a secure study website accessible electronically.
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01DK100924-01 | NIH | None | https://reporter.nih.gov/quic… | View |