NCT00553657

Brief Summary

The purpose of this study is to determine if standardizing fluid intake in a clinic setting will reduce variability of individual voiding parameters and potentially serve as a way to limit patient exposure in the initial assessment of efficacy of compounds being developed for Overactive Bladder.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2007

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 2, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 5, 2007

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

October 26, 2010

Status Verified

October 1, 2010

Enrollment Period

5 months

First QC Date

November 2, 2007

Last Update Submit

October 13, 2010

Conditions

Overactive Bladder

Keywords

Experimental Medicine

Outcome Measures

Primary Outcomes (1)

  • Variability of change from baseline in mean volume per void measured on 3 consecutive days.

    3 consecutive days

Secondary Outcomes (1)

  • Mean change from baseline in volume voided per void. Percent and actual change from baseline in maximum volume voided, number of micturitions, number of incontinence episodes, number of urgency episodes, and time to first void on 3 consecutive days.

    3 consecutive days

Interventions

DETROL LA (drug)DRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Eligible participants will be females who are 18 years of age or older, with Overactive Bladder as evidenced by daily episodes of urgency without incontinence, which may be associated with frequency or nocturia but without bladder pain. At screening, eligible patients must report frequency, defined as at least 8 micturitions per 24 hour period.

You may not qualify if:

  • Any abnormality identified on the screening examination or any other medical condition or circumstance making the patient unsuitable for participation in the study based on the Investigator's and Medical Monitor's assessment
  • Any contraindication to Detrol LA or other anti-muscarinic medications
  • Inability to consume 10 cc/kg of fluid within 30 minutes
  • Regular alcohol consumption averaging ³7 drinks/week for women (1 drink = 100mL of wine or 285mL of beer or 30mL of hard liquor)
  • Positive urine drug or alcohol at screening at screening
  • Average blood pressure measurements systolic ≥140 or diastolic ≥90 at screening at screening
  • QTcB value ≥ 450 msec at screening
  • Poorly-controlled diabetes mellitus or hypertension, as evidenced by a change in medication within the 2 months prior to initiation of the study
  • History of urinary retention or gastric retention
  • Known history of narrow-angle glaucoma
  • History of QT prolongation
  • Known reduction in hepatic or renal function
  • Concomitant Use of loop diuretics (eg. Furosemide)
  • Concomitant use of a medication that is a potent inhibitor of CYP3A4
  • Class IA or Class III antiarrhythmic medications
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GSK Investigational Site

Randwick, Sydney, New South Wales, 2031, Australia

Location

Related Publications (1)

  • Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.

    PMID: 37160401DERIVED

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Tolterodine TartratePharmaceutical Preparations

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenylpropanolaminePropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesBenzhydryl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsCresolsPhenols

Study Officials

  • GSK Clinical Trials, MD

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 2007

First Posted

November 5, 2007

Study Start

August 1, 2007

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

October 26, 2010

Record last verified: 2010-10

Locations

AU(1)