NCT00444548

Brief Summary

\[S,S\]-Reboxetine will be used to evaluate pharmacodynamic changes in urethral function in healthy volunteers using a novel methodology

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started May 2007

Shorter than P25 for not_applicable healthy

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

March 6, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 8, 2007

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2007

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

June 1, 2011

Status Verified

May 1, 2011

First QC Date

March 6, 2007

Last Update Submit

May 31, 2011

Conditions

Healthy

Keywords

EquipmentSupplies

Outcome Measures

Primary Outcomes (1)

  • Reflectometry measurements at visit 2, 3, 4 , 5, 6 and 7.

Secondary Outcomes (1)

  • Urethral pressure profile measurements at visit 2, 3, 4, 5, 6 and 7

Interventions

[S,S]-ReboxetineDRUG

Eligibility Criteria

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

You may qualify if:

  • Healthy female subjects, aged 18-65 years.
  • Subjects must be non-pregnant and non-lactating, and be either post menopausal (greater than 1 year without menses), surgically sterilized, or using another acceptable form of contraception.
  • Subjects of child bearing potential must have confirmed negative pregnancy tests at screening and prior to commencing all study periods.

You may not qualify if:

  • Evidence or history of clinically significant disease (including drug allergies, but excluding untreated, asymptomatic,seasonal allergies at time of dosing).
  • Subjects with any clinically significant abnormality following review of laboratory data, urinalysis and physical examination.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Hellerup, 2900, Denmark

Location

Related Links

MeSH Terms

Interventions

O-methyl reboxetine

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 6, 2007

First Posted

March 8, 2007

Study Start

May 1, 2007

Study Completion

July 1, 2007

Last Updated

June 1, 2011

Record last verified: 2011-05

Locations

DK(1)