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Chronic Prostatitis Collaborative Research Network Clinical Trial- Ciprofloxacin and Tamsulosin

NCT04552431 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 196

Last updated 2020-09-18

No results posted yet for this study

Summary

Although the cause of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is unknown, physicians sometimes try to treat it with antibiotics or alpha-receptor blockers.

In this multicenter, double-blind factorial trial, 196 men with moderately severe CP/CPPS were randomly assigned to 6 weeks of treatment with ciprofloxacin, tamsulosin, both drugs, or placebo. Neither ciprofloxacin nor tamsulosin substantively reduced symptoms.

Ciprofloxacin and tamsulosin were not effective treatments for CP/CPPS. Patients had long-standing, refractory CP/CPPS and received trial treatments for only 6 weeks. Patients with new diagnoses who are given longer courses of the trial treatments might respond differently.

Conditions

  • Chronic Prostatitis With Chronic Pelvic Pain Syndrome

Interventions

DRUG

Ciprofloxacin

Ciprofloxacin, 500 mg twice daily

DRUG

Tamsulosin Hydrochloride

Tamsulosin Hydrochloride, 0.4 mg once daily

DRUG

Tamsulosin Hydrochloride Placebo

Tamsulosin Hydrochloride Placebo (Placebo-TH) one tablet once daily

DRUG

Ciprofloxacin placebo

Ciprofloxacin placebo (Placebo-CF) one tablet twice daily

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    lead NIH

Principal Investigators

  • Richard J Landis · UNIVERSITY OF PENNSYLVANIA, PHILADELPHIA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
1997-09-30
Primary Completion
2003-08-31
Completion
2003-08-31
FDA Drug
Yes

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04552431 on ClinicalTrials.gov