An Eight- Week Randomized, Double-Blind, Placebo-Controlled, Parallel Group Proof of Concept Study to Assess the Efficacy, Safety and Tolerability as Well as the Pharmacokinetic Profile of Oral Solabegron (GW427353) 125mg and 50mg Administered Twice Daily vs Placebo in Women With Overactive Bladder

CompletadoFase 2ClinicalTrials.gov

ID: NCT00343486Tipo: INTERVENTIONALInicio: 1 de may de 2006

Traducción no disponible, mostrando original

Resumen

This study will test the effectiveness and safety of two doses of solabegron against placebo in reducing the symptoms of overactive bladder.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 80 YearsSexo: FEMALE

Criterios de inclusión

Overactive bladder with symptoms of urgency with urge incontinence and frequency which may be associated with nocturia but without bladder pain.
Body mass index in the range of = 19 kg/m2 to \<35 kg/m2.

Criterios de exclusión

Pregnant
Of childbearing potential or willing to use specific barrier methods outlined in the protocol.
Grade III/IV pelvic organ prolapse with or without cystocele.
History of interstitial cystitis or bladder related pain.
Stress incontinence or mixed incontinence where stress incontinence is the predominant component based on prior history.
History of pelvic prolapse repair (cystocele or rectocele) or urethral diverticulectomy within six months of screening.
Urinary incontinence due to causes other then detrusor over activity (e.g., overflow incontinence).
Nocturnal enuresis only.
Urinary retention, or other evidence of poor detrusor function.
Current or history of Urinary Tract Infection.
Diabetes insipidus.
History of myocardial infarction, unstable angina, or Congestive heart failure.
Chronic severe constipation.
History of prior anti-incontinence surgery.
History of radiation cystitis or a history of pelvic irradiation.
Electrostimulation, biofeedback, or bladder training therapy (behavioral therapy) during the previous month prior to screening, or the intention to initiate such therapies during the study. Pessaries and implants are also excluded.
Received any investigational product within 30 days of enrollment into the study.

Intervenciones

drug

Solabegron

Ubicaciones

GSK Investigational Site

Av Córdoba 2424, Buenos Aires, Argentina

GSK Investigational Site

Bahía Blanca, Buenos Aires, Argentina

GSK Investigational Site

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

GSK Investigational Site

Ciudad de Buenos Aires, Buenos Aires, Argentina

GSK Investigational Site

Córdoba, Córdoba Province, Argentina

GSK Investigational Site

Córdoba, Córdoba Province, Argentina

GSK Investigational Site

Buenos Aires, Argentina

Patrocinadores

PrincipalGlaxoSmithKline

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

An Eight- Week Randomized, Double-Blind, Placebo-Controll... | EligiMed