Sanctura Muscarinic Receptor Antagonist Resists Transport (SMART-II) Trial

Allergan

Status and phase: Completed; Phase 4

Conditions: Overactive Bladder

Treatments: Drug: oxybutynin IR; Drug: trospium chloride; Drug: oxybutynin IR placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01178827

MA-SXR-09-005

Details and patient eligibility

About

This study will evaluate the cerebrospinal fluid levels of trospium chloride (Sanctura XR®) and oxybutynin immediate release (Oxybutynin IR) on memory performance in patients with overactive bladder and age associated memory impairment.

Enrollment: 20 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient presents symptoms of overactive bladder
• Patient has age associated memory impairment
• No acute or unstable medical conditions

Exclusion criteria

• History of alcohol or substance abuse within 1 year prior to study
• Has donated in excess of 500mL of blood or plasma in the 30 days prior to study
• Has known bleeding disorder (hemophilia)
• Previous abdominal bypass surgery for obesity

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 3 patient groups, including a placebo group

Sanctura XR®

Experimental group

Description:

Sanctura XR® (trospium chloride), 60mg once daily for 10 days

Treatment:

Drug: trospium chloride

Oxybutynin IR

Active Comparator group

Description:

Oxybutynin IR (oxybutynin immediate release), 5 mg three times daily for 2 days

Treatment:

Drug: oxybutynin IR

Oxybutynin IR placebo

Placebo Comparator group

Description:

Oxybutynin IR placebo three times daily for 2 days

Treatment:

Drug: oxybutynin IR placebo