- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04552431
Chronic Prostatitis Collaborative Research Network Clinical Trial- Ciprofloxacin and Tamsulosin (CPCRN RCT1)
Ciprofloxacin or Tamsulosin in Men With Chronic Prostatitis/Chronic Pelvic Pain Syndrome: a Randomized, Double-blind Trial
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.
Study Overview
Status
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- The study population will consist of men with symptoms of discomfort or pain in the pelvic region for at least a 3-month period within the previous 6 months. Candidates must have at least a "moderate" overall score on the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI), defined as 15 or more points of a potential of 0 to 43 points.
Exclusion Criteria:
- Medical History and Comorbid Conditions: Prostate, bladder, or urethral cancer, seizure disorder. Concurrent history of Inflammatory bowel disease; active urethral stricture; neurologic disease or disorder affecting the bladder; liver disease; neurologic impairment or psychiatric disorder preventing understanding of consent and ability to comply with protocol. Diagnosed with or treated for symptomatic genital herpes in the prior 12 months.
- Urinary tract infection, with a urine culture value of greater than 100,000 colony forming units (CFU)/mL; clinical evidence of urethritis, including urethral discharge or positive culture, diagnostic of sexually transmitted diseases (including gonorrhea, chlamydia, mycoplasma or trichomonas, but not including HIV/AIDS); symptoms of acute or chronic epididymitis in the prior 3 months.
- Prior Treatment: Pelvic radiation, systemic chemotherapy; intravesical chemotherapy; intravesical Bacillus Calmette-Guerin (BCG), transurethral resection of the prostate (TURP), transurethral incision of the prostate (TUIP), transurethral Incision or Resection of the Bladder Neck (TUIBN), transurethral microwave therapy (TUMT), transurethral needle ablation (TUNA), balloon dilation of the prostate, open prostatectomy or any other prostate surgery or treatment such as cryotherapy or thermal therapy; prior treatment for orchialgia without pelvic symptoms; known allergy or sensitivity to ciprofloxacin hydrochloride, tamsulosin hydrochloride, or any of their known components. Prostate biopsy in the prior 3 months.
- Prior or Concurrent Medications: Concurrent use of Theophylline; on-going use of magnesium, aluminum, or calcium-containing antacids. Initiated or stopped finasteride or other androgen hormone inhibitors in the prior 6 months. Tamsulosin hydrochloride, doxazosin mesylate, terazosin HCl, or alpha-blockers; ciprofloxacin hydrochloride; antimicrobial agents (oral or parenteral); started, stopped, or changed dose level of any prostatitis-specific medications in the prior 4 weeks.
- Bioflavonoid agents; zinc or iron supplements; cimetidine in the prior 2 weeks
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Men assigned to placebo
|
Tamsulosin Hydrochloride Placebo (Placebo-TH) one tablet once daily
Other Names:
Ciprofloxacin placebo (Placebo-CF) one tablet twice daily
Other Names:
|
Experimental: Ciprofloxacin alone
Men assigned to Ciprofloxacin alone
|
Tamsulosin Hydrochloride Placebo (Placebo-TH) one tablet once daily
Other Names:
Ciprofloxacin, 500 mg twice daily
Other Names:
|
Experimental: Tamsulosin alone
Men assigned to Tamsulosin alone
|
Ciprofloxacin placebo (Placebo-CF) one tablet twice daily
Other Names:
Tamsulosin Hydrochloride, 0.4 mg once daily
Other Names:
|
Experimental: Combination of ciprofloxacin and tamsulosin
Men assigned to a combination of ciprofloxacin and tamsulosin
|
Ciprofloxacin, 500 mg twice daily
Other Names:
Tamsulosin Hydrochloride, 0.4 mg once daily
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the NIH-CPSI total score
Time Frame: Baseline and 6 weeks
|
Change in the overall NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) total score (range of 0-43 points) from baseline to 6 weeks; a higher score indicates a worse outcome
|
Baseline and 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the 7-point patient-reported global response assessment (GRA)
Time Frame: 6 weeks
|
GRA assesses the change in overall symptoms from baseline to 6 weeks using a 7-point scale which ranges from:(0) markedly worse to (6) markedly improved.
|
6 weeks
|
Change in the physical summary scores on the Medical Outcomes Study 12-Item Short-Form Health Survey (MOS SF-12)
Time Frame: Baseline and 6 weeks
|
Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
Physical health-related domains include General Health (GH), Physical Functioning (PF), Role Physical (RP), and Body Pain (BP).
|
Baseline and 6 weeks
|
Change in the mental summary scores on the Medical Outcomes Study 12-Item Short-Form Health Survey (MOS SF-12)
Time Frame: Baseline and 6 weeks
|
Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
Mental health-related scales include Vitality (VT), Social Functioning (SF), Role Emotional (RE), and Mental Health (MH).
|
Baseline and 6 weeks
|
Change in the pain scores of the NIH-CPSI
Time Frame: Baseline and 6 weeks
|
Change in the pain scores of the NIH-CPSI (range of 0-21 points) from baseline to 6 weeks; a higher score indicates a worse outcome
|
Baseline and 6 weeks
|
Change in the voiding scores of the NIH-CPSI
Time Frame: Baseline and 6 weeks
|
Change in the voiding scores of the NIH-CPSI (range of 0-10 points) from baseline to 6 weeks; a higher score indicates a worse outcome
|
Baseline and 6 weeks
|
Change in the quality of life scores of the NIH-CPSI
Time Frame: Baseline and 6 weeks
|
Change in the quality of life scores of the NIH-CPSI (range of 0-12 points) from baseline to 6 weeks; a higher score indicates a worse outcome
|
Baseline and 6 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Richard J Landis, University of Pennsylvania, Philadelphia
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Pain
- Neurologic Manifestations
- Disease Attributes
- Disease
- Prostatic Diseases
- Syndrome
- Chronic Disease
- Pelvic Pain
- Prostatitis
- Physiological Effects of Drugs
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Urological Agents
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Anti-Bacterial Agents
- Cytochrome P-450 Enzyme Inhibitors
- Cytochrome P-450 CYP1A2 Inhibitors
- Adrenergic alpha-1 Receptor Antagonists
- Adrenergic alpha-Antagonists
- Ciprofloxacin
- Tamsulosin
Other Study ID Numbers
- CPCRN RCT1
- U01DK065209 (NIH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Study Data/Documents
-
Individual Participant Data Set
Information identifier: CPCRN RCT #1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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