NCT00141128

Brief Summary

SS-RBX will be used to evaluate pharmacodynamic changes in urethral function using a novel methodology

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2005

Shorter than P25 for phase_2

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

First Submitted

Initial submission to the registry

August 29, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 1, 2005

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2005

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

June 1, 2011

Status Verified

May 1, 2011

First QC Date

August 29, 2005

Last Update Submit

May 31, 2011

Conditions

Urinary Incontinence, Stress

Outcome Measures

Primary Outcomes (1)

  • To assess the utility of urethral reflectometry in the detection of pharmacologically induced pressure changes in the female urethra.

Secondary Outcomes (1)

  • To assess the effect of [S,S]-Reboxetine on urethral function in women with SUI.

Interventions

SS-RBXDRUG

Eligibility Criteria

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

You may qualify if:

  • Female
  • Stress urinary incontinence

You may not qualify if:

  • Bladder outflow obstruction
  • Neurological disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Glostrup Municipality, 2600, Denmark

Location

Related Publications (1)

  • Klarskov N, Scholfield D, Soma K, Darekar A, Mills I, Lose G. Measurement of urethral closure function in women with stress urinary incontinence. J Urol. 2009 Jun;181(6):2628-33; discussion 2633. doi: 10.1016/j.juro.2009.01.114. Epub 2009 Apr 16.

    PMID: 19375093DERIVED

Related Links

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

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

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 29, 2005

First Posted

September 1, 2005

Study Start

December 1, 2005

Study Completion

June 1, 2006

Last Updated

June 1, 2011

Record last verified: 2011-05

Locations

DK(1)