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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01089751
First received: March 17, 2010
Last updated: September 12, 2012
Last verified: September 2012
History of Changes
  Purpose

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 the incontinence refractory to Detrol LA (tolterodine tartrate extended release) 4 mg therapy.


Condition Intervention Phase
Overactive Bladder
 Drug: Trospium Chloride
Drug: Over-encapsulated Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:
  • Change in Percentage Patients Continent (PPC) [ Time Frame: Baseline, Week 14 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Continent Days per Week (CDW) [ Time Frame: Baseline, Week 14 ] [ Designated as safety issue: No ]
  • Change in Nocturic Episodes [ Time Frame: Baseline, Week 14 ] [ Designated as safety issue: No ]
  • Change in Urgency-Related Toilet Voids [ Time Frame: Baseline, Week 14 ] [ Designated as safety issue: No ]
  • Patient Questionnaires [ Time Frame: Baseline, Week 14 ] [ Designated as safety issue: No ]
  • Change in Voided Volume [ Time Frame: Baseline, Week 14 ] [ Designated as safety issue: No ]
  • Change in Urgency Severity [ Time Frame: Baseline, Week 14 ] [ Designated as safety issue: No ]
  • Change in Urinary Urge Incontinence [ Time Frame: Baseline, Week 14 ] [ Designated as safety issue: No ]

Enrollment: 322
Study Start Date: March 2010
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sanctura XR
Sanctura XR (trospium chloride) 60 mg once daily dosed on an empty stomach at 0700 with one cup of water. The patient will fast for 1 hour after ingestion of Sanctura XR.
 Drug: Trospium Chloride
Sanctura XR (trospium chloride) 60 mg once daily dosed on an empty stomach at 0700 with one cup of water. The patient will fast for 1 hour after ingestion of Sanctura XR.
Other Name: Sanctura XR ™60 mg
Placebo Comparator: Placebo
Placebo once daily on an empty stomach at 0700 with one cup of water. The patient will fast for 1 hour after ingestion of placebo.
 Drug: Over-encapsulated Placebo
Placebo once daily on an empty stomach at 0700 with one cup of water. The patient will fast for 1 hour after ingestion of placebo.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01089751

Locations
United States, California
La Mesa, California, United States
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01089751     History of Changes
Other Study ID Numbers: GMA-SXR-09-004
Study First Received: March 17, 2010
Last Updated: September 12, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Trospium chloride
Tolterodine
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Analgesics
Sensory System Agents
Central Nervous System Agents
Therapeutic Uses
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013