Evaluación del efecto de AM3 en el tratamiento de la cistitis recidivante de la mujer

• Conditions: Treatment of the recurrent cystitis in women

• Registration Number: EUCTR2004-001512-31-ES
• Lead Sponsor: Industial Farmacéutica Cantabria S. A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-09-20
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Women with aged between 18-75

Actual diagnosis of recurrent cystitis confirmed with positive urinalysis

Two or more previous cystitis episodies in the last 6 months or three ore more in te last year (diagnosis in urinalysis of more than 1.000 UFC/ml ) treated with antibiotics.

Negative pregnancy test

Adoption of contraceptives devices

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Bladder lithiasis

Infectious lithiasis

Low bladder obstruction

Bladder ureteral flow

Infection of high urinary tract (pyelonephritis)

Disturbances of the bladder-urethral anatomy

Disturbances of the bladder-urethral fuction

Feverish urinary infection

Pregnancy

Breast -feading period

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluation of the efficacy of AM3 (Inmunoferón) in the treatment of the recurrent cysititis in women;Secondary Objective: Reduction of the irritative mictional sintomatology<br><br>Germs most frequently involved in the recurrent cystitis and their sensitivity to the antibiotic treatment<br><br>Evaluate the safety and the tolerability of Inmunoferon <br>;Primary end point(s): Reduction of the recurrences