Mast Cells in Male Pelvic Pain and and Lower Urinary Tract Dysfunction

NCT03167216 | Completed Early Phase 1 FDA Drug

• 2 other identifiers: STU00202831R01DK083609
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Chronic Prostatitis With Chronic Pelvic Pain Syndrome

Keywords

chronic pain; prostatitis; pelvic pain

Outcome Measures

Primary Outcomes (1)

• 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.

  3 weeks

Secondary Outcomes (2)

• NIH-CPSI score

  3 weeks

• AUA-SI score

  3 weeks

Study Arms (1)

Treatment arm

EXPERIMENTAL

Treated arm with cromolyn sodium and cetirizine hydrochloride

Drug: Cromolyn Sodium; Drug: Cetirizine Hydrochloride

Interventions

Cromolyn Sodium DRUG

Mast cell stabilizer

Also known as: Gastrocrom

Treatment arm

Cetirizine Hydrochloride DRUG

Histamine receptor antagonist

Also known as: Zyrtec

Treatment arm

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwestern University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Northwestern Medical Faculty Foundation

Chicago, Illinois, 60611, United States

Location

Related Publications (3)

• 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.

  PMID: 22341813 RESULT

• Murphy 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.

  PMID: 24686526 RESULT

• Roman 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.

  PMID: 24726923 RESULT

MeSH Terms

Conditions

Prostatitis; Chronic Pain; Pelvic Pain

Interventions

Cromolyn Sodium; Cetirizine

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Hydroxyzine; Piperazines

Study Officials

• Praveen Thumbikat, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Comparison of mast cell tryptase levels and changes in symptom scores after treatment with cromolyn sodium and cetirizine hydrochloride

Study Record Dates

• First Submitted: May 23, 2017
• First Posted: May 25, 2017
• Study Start: August 1, 2017
• Primary Completion: April 1, 2022
• Study Completion: June 30, 2022
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)