Efficacy of Sanctura XR (Trospium Chloride) for Reducing Overactive Bladder Symptoms in Female Subjects Refractory to Detrol LA (Tolterodine Tartrate Extended Release) Daily

NCT01089751 | Completed Phase 4 Results

• 1 other identifier: GMA-SXR-09-004
• Study Type: interventional
• Target: 322
• Locations: 1 country
• Sites: 1

Brief Summary

This study will investigate the safety and efficacy of Sanctura XR (trospium chloride) daily in reducing urgency, urinary frequency and urinary urge incontinence in female patients with incontinence refractory to Detrol LA (tolterodine tartrate extended release) 4 mg therapy.

Conditions

Overactive Bladder

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients Continent (PPC)

  PPC is the percentage of patients with complete continence (without any urgency urinary incontinence episodes) during the 3-day bladder diary period associated with the Week 14 visit.

  Week 14

Secondary Outcomes (7)

• Change From Baseline in Continent Days Per Week (CDW)

  Baseline, Week 14

• Change From Baseline in Nocturic Toilet Voids

  Baseline, Week 14

• Change From Baseline in Urgency-Related Toilet Voids

  Baseline, Week 14

• Change From Baseline in Daily Average Overactive Bladder-Symptom Composite Score (OAB-SCS)

  Baseline, Week 14

• Change From Baseline in Voided Volume

  Baseline, Week 14

Study Arms (2)

Sanctura XR®

EXPERIMENTAL

Sanctura XR® (trospium chloride) 60 mg once daily on an empty stomach for 14 weeks.

Drug: trospium chloride

Placebo

PLACEBO COMPARATOR

Placebo once daily on an empty stomach for 14 weeks.

Drug: placebo

Interventions

trospium chloride DRUG

Sanctura XR® (trospium chloride) 60 mg once daily on an empty stomach for 14 weeks

Also known as: Sanctura XR®

Sanctura XR®

placebo DRUG

Placebo once daily on an empty stomach for 14 weeks.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Taking Detrol® LA 4mg daily for a minimum of 1 month prior to Screening/Qualification
• Overactive Bladder syndrome with urgency, urinary frequency and urgency urinary incontinence
• Taking five or more concomitant medications (may be prescription, non-prescription, or supplement/vitamin) daily for indications other than Overactive Bladder (OAB).

You may not qualify if:

• Predominant stress or insensate incontinence
• History of neurogenic bladder
• Two urinary tract infections in the last six months
• Gastric by-pass (Roux-en-Y) surgery (adjustable gastric banding is allowed)
• Donated \>500mL blood in the 30 days prior to the screening visit

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Unknown Facility

La Mesa, California, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

trospium chloride

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Vice President Medical Affairs,
• Organization: Allergan, Inc

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2010
• First Posted: March 19, 2010
• Study Start: March 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: September 26, 2013
• Results First Posted: September 26, 2013

Record last verified: 2013-09

Locations

US (1)