A Phase 4 interventional study of D-Cycloserine and Placebo (for D-cycloserine) in Chronic Prostatitis With Chronic Pelvic Pain Syndrome, sponsored by Northwestern University. Terminated at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-17.
Sponsored by Northwestern University · Phase 4, Interventional, and Treatment
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).
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.
88 studies on the registry are indexed under Prostatitis; 11 are open to participants now.
This study's enrollment of 24 is below the median of 60 across 73 interventional studies indexed under Prostatitis.
Browse Prostatitis studies →Northwestern University is the lead sponsor of 1,423 studies on the registry; 198 are open to participants now.
Of its 105 completed or terminated interventional studies of FDA-regulated products, 78 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
D-cycloserine 200mg/bid and Acetaminophen prn
Drug: D-Cycloserine
Placebo capsules (lactose)/bid and Acetaminophen prn
Drug: Placebo (for D-cycloserine)
Pharmaceutical intervention aimed at altering central nervous system function takes place over 4.5 months with daily use of d-Cycloserine.
Also known as: Seromycin
Lactose filled capsules to mimic DCS 200mg capsules
Also known as: Tylenol
Visual Analog Scale (VAS)
The visual analog scale (VAS) is a measurement tool used to assess the level of pain experienced by a patient. The scale is a 100 mm horizontal line, with one end representing "no pain" and the other end representing "worst pain imaginable." The patient is asked to mark on the line the point that best represents their level of pain. The minimum score is 0 mm, indicating no pain, while the maximum score is 100 mm, indicating the worst pain imaginable. Higher scores on the VAS indicate a worse outcome, while lower scores indicate a better outcome. The VAS score can be determined by measuring the distance in millimeters from the left end of the line to the point marked by the patient. The range of scores can be used to interpret the level of pain experienced by the patient, with higher scores indicating greater pain severity.
Time frame: 18 weeks after baseline visit
| Milestone | D-Cycloserine and Acetominophen | Placebo and Acetominophen |
|---|---|---|
| Started | 12 | 12 |
| Completed | 11 | 9 |
| Not completed | 1 | 3 |
| Withdrew: Withdrawal by subject | 1 | 3 |
The visual analog scale (VAS) is a measurement tool used to assess the level of pain experienced by a patient. The scale is a 100 mm horizontal line, with one end representing "no pain" and the other end representing "worst pain imaginable." The patient is asked to mark on the line the point that best represents their level of pain. The minimum score is 0 mm, indicating no pain, while the maximum score is 100 mm, indicating the worst pain imaginable. Higher scores on the VAS indicate a worse outcome, while lower scores indicate a better outcome. The VAS score can be determined by measuring the distance in millimeters from the left end of the line to the point marked by the patient. The range of scores can be used to interpret the level of pain experienced by the patient, with higher scores indicating greater pain severity.
| units on a scale | D-Cycloserine and Acetominophen | Placebo and Acetominophen |
|---|---|---|
| Visual Analog Scale (VAS) | 3.2 ± 2.6 | 3.0 ± 1.5 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| D-Cycloserine and Acetominophen | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Placebo and Acetominophen | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Age, Categorical(Participants) | D-Cycloserine and Acetominophen | Placebo and Acetominophen | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 12 | 12 | 24 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | D-Cycloserine and Acetominophen | Placebo and Acetominophen | Total |
|---|---|---|---|
| Mean | 44.7 ± 14.8 | 39.7 ± 10.3 | 43.4 ± 12.1 |
| Sex: Female, Male(Participants) | D-Cycloserine and Acetominophen | Placebo and Acetominophen | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 12 | 12 | 24 |
| Region of Enrollment(participants) | D-Cycloserine and Acetominophen | Placebo and Acetominophen | Total |
|---|---|---|---|
| United States | 12 | 12 | 24 |
Plan to share: Yes — Following publication of primary analyses, de-identified scan and clinical data will be posted to NIH-sponsored Open Pain database.
No publications or documents are linked to this record.
The record gives a start of Sep 2013, a primary completion of May 2016 and a completion of Jun 2016. It does not say whether these dates are actual or estimated.
Results were first posted in May 2023, 7 years after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cycloserine