Treating Urological Chronic Pelvic Pain Syndrome (UCPPS) Pain (UCPPS)
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|ClinicalTrials.gov Identifier: NCT02385266|
Recruitment Status : Completed
First Posted : March 11, 2015
Last Update Posted : September 30, 2016
|Condition or disease||Intervention/treatment||Phase|
|Chronic Prostatitis With Chronic Pelvic Pain Syndrome||Drug: D-Cycloserine Drug: Placebo (for D-cycloserine)||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Brain Imaging-based Strategies for Treating Urological Chronic Pelvic Pain Syndrome (UCPPS) Pain|
|Study Start Date :||September 2013|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||June 2016|
Experimental: D-Cycloserine and Acetominophen
D-cycloserine 200mg/bid and Acetaminophen prn
Pharmaceutical intervention aimed at altering central nervous system function takes place over 4.5 months with daily use of d-Cycloserine.
Other Name: Seromycin
Placebo Comparator: Placebo and Acetominophen
Placebo capsules (lactose)/bid and Acetaminophen prn
Drug: Placebo (for D-cycloserine)
Lactose filled capsules to mimic DCS 200mg capsules
Other Name: Tylenol
- Visual Analog Scale (VAS) [ Time Frame: 18 weeks after baseline visit ]A horizontal line, 100 mm in length, anchored by no pain at left end of line and worst possible pain at the right end of line. VAS score is later determined by measuring in millimeters from the left hand to the point where the patient marks.
- McGill Pain Questionnaire [ Time Frame: 18 weeks after baseline visit ]Includes a numeric/descriptor scale, a visual analogue scale (VAS), and a body map to localize the pain.
- Functional Magnetic Resonance Imaging (fMRI) connectivity [ Time Frame: 12 weeks after baseline visit ]A type of brain scan that uses magnetic fields and radio waves to make an image of changes in blood flow in your brain while you do certain tasks.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02385266
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Vania Apkarian, PhD||Northwestern University|