Mast Cells in Male Pelvic Pain and and Lower Urinary Tract Dysfunction
CompletedEarly phase 1NCT03167216
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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).
Study details
- Official title
- Mast Cells in Male Pelvic Pain and and Lower Urinary Tract Dysfunction
- Interventions
- Drug: Cromolyn Sodium
- Drug: Cetirizine Hydrochloride
- Sponsor
- Northwestern University
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Start date
- 2017-08-01
- Primary completion
- 2022-04-01
- Sex
- Male
- Age range
- from 21 Years to 80 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03167216