Chronic Prostatitis With Chronic Pelvic Pain SyndromeEarly Phase 1NCT03167216
Mast Cells in Male Pelvic Pain and and Lower Urinary Tract Dysfunction
A Early Phase 1 study testing Cromolyn Sodium and Cetirizine Hydrochloride in people with Chronic Prostatitis With Chronic Pelvic Pain Syndrome, run by Northwestern University at 1 site in United States.
Trial summary
The objective of this study is to evaluate inhibition of mast cells and the histamine 1 receptor (H1R) for treatment of chronic prostatitis (CP) and chronic pelvic pain syndrome (CPPS). Read more about this study
- Who is it for?
- Ages 21 to 80 years, men only
- Conditions the study is for
- Chronic Prostatitis With Chronic Pelvic Pain Syndrome
- What is being tested?
- Cromolyn Sodium and Cetirizine Hydrochloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2017to 30 Jun 2022
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male ages 21-80 years old
- Diagnosed with Category III Chronic Pelvic Pain Syndrome
- Patients reporting pain or discomfort in any of the 8 domains of the NIH_ Chronic Prostatitis Symptom Index (NIH-CPSI).
- CP/CPPS symptoms must have been present for the majority of the time during any 3 months in the previous 6 months.
- Mast cell tryptase levels in EPS above a control threshold of 25ng/ml based on healthy men.
Who cannot join
- Females
- Males <21 and >80 years old
- Patients with a known hypersensitivity to cromolyn sodium or cetirizine hydrochloride
- Patients with impaired renal or hepatic function.
- Mast cell tryptase levels in EPS equal to or below a control threshold of 25ng/ml based on healthy men.
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Medical Faculty Foundation
Chicago, Illinois, 60611
About this study
The objective of this study is to evaluate inhibition of mast cells and the histamine 1 receptor (H1R) for treatment of chronic prostatitis (CP) and chronic pelvic pain syndrome (CPPS).
Read the detailed description
Chronic pelvic pain is a hallmark of patients with CPPS, a non-bacterial category of prostatitis that is a significant source of morbidity in men. The cause of CPPS is unknown and there is a lack of biomarkers for diagnosis of this syndrome. Research in animal models of CP/CPPS have pointed to a role for mast cells and their degranulation constituents including mast cell tryptase in the development of pelvic pain and lower urinary tract symptoms. This study aims to evaluate the ability of FDA approved and marketed drugs to inhibit the release of mast cell tryptase and to ameliorate symptoms in patients with CP/CPPS.
This is an open label study to evaluate the efficacy of Cromolyn Sodium Oral Solution and Cetirizine hydrochloride (tablet) in men with CP/CPPS to reduce mast cell tryptase levels in expressed prostatic fluids and to show improvement in symptoms of CP/CPPS. There is no control group for the study. The difference between pre- and post-treatment levels across individuals will be assessed.
The study will consist of 3 periods: the Screening Period (Days -7 to -1), the Treatment Period (Days 1 to 21), and the Follow-up Period (7 days) after the last dose at Day 21.
During screening, subjects will be admitted to the clinic, undergo specimen (Expressed prostatic secretions (EPS), urine and blood) collection and recording of their baseline questionnaire responses Subjects will provide a basic health history, including current general health, adverse events, medications or treatments within the past 5 years. A physical examination including vital heart rate, breathing rate, blood pressure, temperature, height, weight and body mass will be taken. Subsequently, EPS from eligible subjects will be collected by the clinical team and assayed for the levels of mast cell tryptase within 24 hours of sample collection at the screening visit. 20 subjects with elevated mast cell tryptase will be identified and will be eligible for receiving the study medication from the Investigational pharmacy at Northwestern University.
Eligible subjects will be required to take medication for days 1-21 (Week 1-3), record their symptom scores weekly using the NIH-CPSI, and record all safety related symptoms.
Subjects will return to the clinic after the completion of three weeks of treatment. Expressed prostatic secretions (EPS), blood as well as a voided bladder 1, 2 and 3 (VB1-3) urine specimens will be collected as at baseline and after the last dose at day 21 for evaluating mast cell tryptase levels. A review subject's general health, adverse events, and any medications that have changed since the last visit will be collected. Vital signs (heart rate, breathing rate, blood pressure, temperature, weight and BMI will be collected.
Treated subjects will be contacted by phone 7 days after treatment by the study coordinator to follow up on any study related adverse effects or changes in symptoms.
- Being tested
- Cromolyn Sodium, Cetirizine Hydrochloride
- Keywords
- chronic pain, prostatitis, pelvic pain
- Medical subject headings
- Prostatitis, Chronic Pain, Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cromolyn SodiumDrug
Also called Gastrocrom
Mast cell stabilizer
Cetirizine HydrochlorideDrug
Also called Zyrtec
Histamine receptor antagonist
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Treated arm with cromolyn sodium and cetirizine hydrochloride Receives: Drug: Cromolyn Sodium; Drug: Cetirizine Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mast cell tryptase levels in expressed prostatic secretions
Changes in Mast cell tryptase at the end of treatment compared to levels observed before administration of the study drug.
Measured: 3 weeks
Secondary outcomes (2)
NIH-CPSI score
Change in pelvic pain, urinary symptoms and quality of life after treatment
Measured: 3 weeks
AUA-SI score
Change in symptoms of lower urinary tract dysfunction after treatment
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2017
- Study start1 Aug 2017
- Primary completion1 Apr 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Prostatitis With Chronic Pelvic Pain SyndromeStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Comparison of mast cell tryptase levels and changes in symptom scores after treatment with cromolyn sodium and cetirizine hydrochloride
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Praveen Thumbikat, Northwestern University
- Investigators
- Praveen Thumbikat, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03167216
- Sponsor's protocol ID
- STU00202831
- Other IDs
- R01DK083609
- Status last verified
- Dec 2024
- First submitted
- 23 May 2017
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Done JD, Rudick CN, Quick ML, Schaeffer AJ, Thumbikat P. Role of mast cells in male chronic pelvic pain. J Urol. 2012 Apr;187(4):1473-82. doi: 10.1016/j.juro.2011.11.116. Epub 2012 Feb 17.
PubMed 22341813Murphy SF, Schaeffer AJ, Thumbikat P. Immune mediators of chronic pelvic pain syndrome. Nat Rev Urol. 2014 May;11(5):259-69. doi: 10.1038/nrurol.2014.63. Epub 2014 Apr 1.
PubMed 24686526Roman K, Done JD, Schaeffer AJ, Murphy SF, Thumbikat P. Tryptase-PAR2 axis in experimental autoimmune prostatitis, a model for chronic pelvic pain syndrome. Pain. 2014 Jul;155(7):1328-1338. doi: 10.1016/j.pain.2014.04.009. Epub 2014 Apr 13.
PubMed 24726923
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mast Cells in Male Pelvic Pain and and Lower Urinary Tract Dysfunction
- ClinicalTrials.gov ID
- NCT03167216
- Acronym / sponsor ID
- STU00202831
- Keywords
- chronic pain, prostatitis, pelvic pain
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 25 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate inhibition of mast cells and the histamine 1 receptor (H1R) for treatment of chronic prostatitis (CP) and chronic pelvic pain syndrome (CPPS).
Detailed description
Chronic pelvic pain is a hallmark of patients with CPPS, a non-bacterial category of prostatitis that is a significant source of morbidity in men. The cause of CPPS is unknown and there is a lack of biomarkers for diagnosis of this syndrome. Research in animal models of CP/CPPS have pointed to a role for mast cells and their degranulation constituents including mast cell tryptase in the development of pelvic pain and lower urinary tract symptoms. This study aims to evaluate the ability of FDA approved and marketed drugs to inhibit the release of mast cell tryptase and to ameliorate symptoms in patients with CP/CPPS.
This is an open label study to evaluate the efficacy of Cromolyn Sodium Oral Solution and Cetirizine hydrochloride (tablet) in men with CP/CPPS to reduce mast cell tryptase levels in expressed prostatic fluids and to show improvement in symptoms of CP/CPPS. There is no control group for the study. The difference between pre- and post-treatment levels across individuals will be assessed.
The study will consist of 3 periods: the Screening Period (Days -7 to -1), the Treatment Period (Days 1 to 21), and the Follow-up Period (7 days) after the last dose at Day 21.
During screening, subjects will be admitted to the clinic, undergo specimen (Expressed prostatic secretions (EPS), urine and blood) collection and recording of their baseline questionnaire responses Subjects will provide a basic health history, including current general health, adverse events, medications or treatments within the past 5 years. A physical examination including vital heart rate, breathing rate, blood pressure, temperature, height, weight and body mass will be taken. Subsequently, EPS from eligible subjects will be collected by the clinical team and assayed for the levels of mast cell tryptase within 24 hours of sample collection at the screening visit. 20 subjects with elevated mast cell tryptase will be identified and will be eligible for receiving the study medication from the Investigational pharmacy at Northwestern University.
Eligible subjects will be required to take medication for days 1-21 (Week 1-3), record their symptom scores weekly using the NIH-CPSI, and record all safety related symptoms.
Subjects will return to the clinic after the completion of three weeks of treatment. Expressed prostatic secretions (EPS), blood as well as a voided bladder 1, 2 and 3 (VB1-3) urine specimens will be collected as at baseline and after the last dose at day 21 for evaluating mast cell tryptase levels. A review subject's general health, adverse events, and any medications that have changed since the last visit will be collected. Vital signs (heart rate, breathing rate, blood pressure, temperature, weight and BMI will be collected.
Treated subjects will be contacted by phone 7 days after treatment by the study coordinator to follow up on any study related adverse effects or changes in symptoms.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Comparison of mast cell tryptase levels and changes in symptom scores after treatment with cromolyn sodium and cetirizine hydrochloride
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Drug: Cromolyn Sodium, Drug: Cetirizine HydrochlorideTreated arm with cromolyn sodium and cetirizine hydrochloride |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male ages 21-80 years old
- Diagnosed with Category III Chronic Pelvic Pain Syndrome
- Patients reporting pain or discomfort in any of the 8 domains of the NIH_ Chronic Prostatitis Symptom Index (NIH-CPSI).
- CP/CPPS symptoms must have been present for the majority of the time during any 3 months in the previous 6 months.
- Mast cell tryptase levels in EPS above a control threshold of 25ng/ml based on healthy men.
Key exclusion criteria (5 listed)
- Females
- Males <21 and >80 years old
- Patients with a known hypersensitivity to cromolyn sodium or cetirizine hydrochloride
- Patients with impaired renal or hepatic function.
- Mast cell tryptase levels in EPS equal to or below a control threshold of 25ng/ml based on healthy men.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cromolyn SodiumAlso: GastrocromMast cell stabilizer | Drug | Treatment arm |
| Cetirizine HydrochlorideAlso: ZyrtecHistamine receptor antagonist | Drug | Treatment arm |
Primary outcome
Mast cell tryptase levels in expressed prostatic secretions
Time frame: 3 weeks
Changes in Mast cell tryptase at the end of treatment compared to levels observed before administration of the study drug.
2 secondary outcomes
NIH-CPSI score
Time frame: 3 weeks
AUA-SI score
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Results publication: PubMed 22341813Done JD, Rudick CN, Quick ML, Schaeffer AJ, Thumbikat P. Role of mast cells in male chronic pelvic pain. J Urol. 2012 Apr;187(4):1473-82. doi: 10.1016/j.juro.2011.11.116. Epub 2012 Feb 17.
- Results publication: PubMed 24686526Murphy SF, Schaeffer AJ, Thumbikat P. Immune mediators of chronic pelvic pain syndrome. Nat Rev Urol. 2014 May;11(5):259-69. doi: 10.1038/nrurol.2014.63. Epub 2014 Apr 1.
- Results publication: PubMed 24726923Roman K, Done JD, Schaeffer AJ, Murphy SF, Thumbikat P. Tryptase-PAR2 axis in experimental autoimmune prostatitis, a model for chronic pelvic pain syndrome. Pain. 2014 Jul;155(7):1328-1338. doi: 10.1016/j.pain.2014.04.009. Epub 2014 Apr 13.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Praveen Thumbikat, PhD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Cromolyn Sodium and Cetirizine Hydrochloride in people with Chronic Prostatitis With Chronic Pelvic Pain Syndrome, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mast cell tryptase levels in expressed prostatic secretions (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03167216, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2024.