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TerminatedNCT02385266UCPPSUpdated May 17, 2023Results posted

Treating Urological Chronic Pelvic Pain Syndrome (UCPPS) Pain

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

Why this study was terminated
The study was closed due to recruitment limitations
Phase
Phase 4
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years and older
Sex
Male
01

Study 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).

Read the 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.

02

Conditions studied

  • Chronic Prostatitis With Chronic Pelvic Pain Syndrome

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Keywords

  • Interstitial cystitis with Painful Bladder Syndrome
  • Urological Chronic Pelvic Pain Syndrome
03

In context

Prostatitis

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

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.

Inclusion criteria

  • Males greater than 18 years of age, with no racial/ethnic restrictions;
  • Meets diagnostic criteria for Interstitial Cystitis with Painful Bladder Syndrome (IC/PBS) and/or Chronic Prostatitis with Chronic Pelvic Pain Syndrome (CP/CPPS);
  • Reports symptoms of discomfort or pain in the pelvic or abdominal region for at least a 3 mo period within the last 6 mo;
  • Must have a Visual Analog Scale (VAS) pain score >40 mm (of 100 mm maximum) at the baseline visit (UCPPS pain moderate to severe);
  • Must be in generally stable health;
  • Must be willing to abstain from drinking alcohol during the course of the study;
  • Must be able to read and speak English and be willing to read and understand instructions as well as questionnaires;
  • Must sign an document after a complete explanation of the study documenting that they understand the purpose of the study, procedures to be undertaken, possible benefits, potential risks, and are willing to participate.

Exclusion criteria

Exclusion Criteria:

  • Urological pain associated with any systemic signs or symptoms, e.g., fever, chills;
  • Evidence of a facultative Gram negative or enterococcus with a value of ≥ 100,000 CFU/ml in mid-stream urine (VB2);
  • Has a second chronic pain condition (e.g., chronic low back pain, temporomandibular joint syndrome, etc.) that would prevent a clear interpretation of the study results;
  • History of tuberculous cystitis, bladder cancer, carcinoma in situ, prostate cancer, or urethral cancer;
  • History of significant pelvic comorbidities, including inflammatory bowel disease (such as Crohn's disease or ulcerative colitis), has undergone pelvic radiation, systemic chemotherapy, or intravesical chemotherapy, or has been treated with intravesical Bacillus Calmette-Guerin (BCG) or unilateral orchialgia without other pelvic symptoms, has an active urethral stricture, ureteral calculi, urethral diverticulum, or has a neurological disease or disorder affecting the bladder;
  • Significant other medical conditions/diseases, such as significant renal disease or a history of renal insufficiency, unstable diabetes mellitus, congestive heart failure, coronary or peripheral vascular disease, chronic obstructive lung disease, or ;
  • Neurologic disorder, including history of seizures;
  • Major psychiatric disorder during the past 6 months;
  • Moderate or severe depression, as determined by the Hospital Anxiety and Depression Scale, or any active suicidal ideation;
  • History of, or current, substance abuse/dependence including alcohol;
  • Known sensitivity to D-cycloserine;
  • Currently taking any of the following medications: ethionamide, dilantin, isoniazid (INH), pyridoxine (vitamin B6)
  • Use of therapeutic doses of antidepressant medications (i.e., tricyclic depressants, Selective Serotonin Reuptake Inhibitor (SSRIs), Serotonin-Norepinephrine Reuptake Inhibitor (SNRIs); low doses used for sleep may be allowed), as these medications can alter pain transmission;
  • Current use of low dose aspirin;
  • Indication that the subject is unlikely to be compliant due to unmanaged medical or psychological condition(s), including neurological, psychological, or speech/language problems that will interfere or prevent with his understanding of consent, his ability to comply with the protocol or ability to complete the study;
  • Any change in medication for urological pain in the last 30 days;
  • High dose opioid prophylaxis, as defined as > 50mg morphine equivalent/day;
  • Any medical condition that in the investigator's judgment may prevent the individual from completing the study or put the individual at undue risk;
  • In the judgment of the investigator, unable or unwilling to follow protocol and instructions;
  • Evidence of poor treatment compliance, in the judgment of the investigator;
  • Intra-axial implants (e.g. spinal cord stimulators or pumps); and
  • All exclusion criteria for Magnetic Resonance (MR) safety: any metallic implants, brain or skull abnormalities, tattoos on large body parts, and claustrophobia.
Terms in these criteria, in plain language(2)

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.

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.

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.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    D-Cycloserine and Acetominophen

    D-cycloserine 200mg/bid and Acetaminophen prn

    Drug: D-Cycloserine

  • Placebo comparator
    Placebo and Acetominophen

    Placebo capsules (lactose)/bid and Acetaminophen prn

    Drug: Placebo (for D-cycloserine)

Interventions

  • 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

  • DrugPlacebo (for D-cycloserine)

    Lactose filled capsules to mimic DCS 200mg capsules

    Also known as: Tylenol

06

What researchers measure

Primary outcomes

  1. 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

07

Results

Posted May 17, 2023
Limitations and caveats
The study was closed due to recruitment limitations. Given the challenges in recruitment, the investigators decided to terminate the study.

Participant flow

Participant flow — Overall Study
MilestoneD-Cycloserine and AcetominophenPlacebo and Acetominophen
Started1212
Completed119
Not completed13
Withdrew: Withdrawal by subject13

Outcome measures

PrimaryVisual 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
Reported as:
Mean · units on a scale
Visual Analog Scale (VAS)
units on a scaleD-Cycloserine and AcetominophenPlacebo and Acetominophen
Visual Analog Scale (VAS)3.2 ± 2.63.0 ± 1.5

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
D-Cycloserine and Acetominophen0/12 (0%)0/12 (0%)0/12 (0%)
Placebo and Acetominophen0/12 (0%)0/12 (0%)0/12 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)D-Cycloserine and AcetominophenPlacebo and AcetominophenTotal
<=18 years000
Between 18 and 65 years121224
>=65 years000
Age, Continuous
Age, Continuous(years)D-Cycloserine and AcetominophenPlacebo and AcetominophenTotal
Mean44.7 ± 14.839.7 ± 10.343.4 ± 12.1
Sex: Female, Male
Sex: Female, Male(Participants)D-Cycloserine and AcetominophenPlacebo and AcetominophenTotal
Female000
Male121224
Region of Enrollment
Region of Enrollment(participants)D-Cycloserine and AcetominophenPlacebo and AcetominophenTotal
United States121224
08

Study locations

1 site
  • Northwestern University
    Chicago, Illinois 60611, United States
09

References and documents

Individual participant data

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.

10

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

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.

Registered
Feb 26, 2015
First posted
Mar 11, 2015
Start
Sep 2013
Primary completionActual
May 2016
CompletionActual
Jun 2016
Results first posted
May 17, 2023
Last update
May 17, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 17, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02385266
Responsible party
Apkar Apkarian (Professor, Northwestern University) — Principal investigator
First posted
Mar 11, 2015
Start date
Sep 2013
Primary completion
May 2016
Completion
Jun 2016
Results posted
May 17, 2023
Last update
May 17, 2023

Study contacts

Vania Apkarian, PhD
principal investigator · Northwestern University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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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

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