Chronic Prostatitis Collaborative Research Network Clinical Trial- Ciprofloxacin and Tamsulosin

NCT04552431 | Completed Phase 2 DMC FDA Drug

• 2 other identifiers: CPCRN RCT1U01DK065209
• Study Type: interventional
• Target: 196
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in the NIH-CPSI total score

  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 Outcomes (6)

• Change in the 7-point patient-reported global response assessment (GRA)

  6 weeks

• Change in the physical summary scores on the Medical Outcomes Study 12-Item Short-Form Health Survey (MOS SF-12)

  Baseline and 6 weeks

• Change in the mental summary scores on the Medical Outcomes Study 12-Item Short-Form Health Survey (MOS SF-12)

  Baseline and 6 weeks

• Change in the pain scores of the NIH-CPSI

  Baseline and 6 weeks

• Change in the voiding scores of the NIH-CPSI

  Baseline and 6 weeks

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Men assigned to placebo

Drug: Tamsulosin Hydrochloride Placebo; Drug: Ciprofloxacin placebo

Ciprofloxacin alone

EXPERIMENTAL

Men assigned to Ciprofloxacin alone

Drug: Ciprofloxacin; Drug: Tamsulosin Hydrochloride Placebo

Tamsulosin alone

EXPERIMENTAL

Men assigned to Tamsulosin alone

Drug: Tamsulosin Hydrochloride; Drug: Ciprofloxacin placebo

Combination of ciprofloxacin and tamsulosin

EXPERIMENTAL

Men assigned to a combination of ciprofloxacin and tamsulosin

Drug: Ciprofloxacin; Drug: Tamsulosin Hydrochloride

Interventions

Ciprofloxacin DRUG

Ciprofloxacin, 500 mg twice daily

Also known as: CF

Ciprofloxacin alone; Combination of ciprofloxacin and tamsulosin

Tamsulosin Hydrochloride DRUG

Tamsulosin Hydrochloride, 0.4 mg once daily

Also known as: TH

Combination of ciprofloxacin and tamsulosin; Tamsulosin alone

Tamsulosin Hydrochloride Placebo DRUG

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

Also known as: Placebo-TH

Ciprofloxacin alone; Placebo

Ciprofloxacin placebo DRUG

Ciprofloxacin placebo (Placebo-CF) one tablet twice daily

Also known as: Placebo-CF

Placebo; Tamsulosin alone

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Related Publications (1)

• Propert KJ, Alexander RB, Nickel JC, Kusek JW, Litwin MS, Landis JR, Nyberg LM, Schaeffer AJ; Chronic Prostatitis Collaborative Research Network. Design of a multicenter randomized clinical trial for chronic prostatitis/chronic pelvic pain syndrome. Urology. 2002 Jun;59(6):870-6. doi: 10.1016/s0090-4295(02)01601-1.

  PMID: 12031372 BACKGROUND

MeSH Terms

Conditions

Prostatitis

Interventions

Ciprofloxacin; Tamsulosin

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Officials

• Richard J Landis

  UNIVERSITY OF PENNSYLVANIA, PHILADELPHIA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2020
• First Posted: September 17, 2020
• Study Start: September 30, 1997
• Primary Completion: August 31, 2003
• Study Completion: August 31, 2003
• Last Updated: September 18, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share