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NCT01642277 · ClinicalTrials.gov registry record · Phase 2

Bacterial Genomic Sequencing in Overactive Bladder

A Phase 2 study of Overactive Bladder, sponsored by Loyola University.

Completed
Registry status
Phase 2
Development phase
134
Enrollment target
1
Study location

NCT01642277 is a Phase 2 study of Overactive Bladder that has completed, run by Loyola University. The registered enrollment target is 134 participants, below the 209-participant average among 45 other Overactive Bladder trials with a reported enrollment target (36% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01642277, a Phase 2 study of Overactive Bladder, has completed, sponsored by Loyola University.

COMPLETED
Registry status
Phase 2
Development phase
134 participants
Enrollment target
1
Study location

Study Summary

No one really knows what causes overactive bladder syndrome (OAB). Urinary tract infection (UTI)causes similar symptoms to OAB with the difference being the presence of bacteria, as evidenced by routine microbiology cultures. Recent work by the group on the genitourinary microbiome (GUM) has shown that female urine, even in the absence of culture evidence of bacteria does have evidence of bacterial DNA. Bacterial 16S rRNA can be isolated from urine and sequenced to identify bacterial species present in urine. From this the investigators can hypothesize that urinary bacteria contribute to urinary symptoms and that there is a difference in the bacterial communities in the urine of women who respond to Solifenacin, a drug used to treat OAB, versus those that do not.

Conditions Studied

Interventions

  • DRUG Solifenacin

Study Locations (1)

Illinois

  • Loyola University Chicago Health Sciences Division - Maywood

Trial Details

FieldValue
Enrollment Target 134 participants
Start Date 2012-07
Est. Completion 2014-08
Phase Phase 2

Sponsor

Loyola University

92 total trials

What the Registry Record Tells You About NCT01642277

The ClinicalTrials.gov registry entry for NCT01642277 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 134 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 209-participant average among 45 other Overactive Bladder trials with a reported enrollment target (36% lower). The listed sponsor is Loyola University, which has 92 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Overactive Bladder appearing as the primary indexed condition, and to 1 intervention - of which Solifenacin is the first listed.

NCT01642277 reports 1 study location spanning 1 distinct geographic area - top geographies include Illinois.

Frequently Asked Questions

What is clinical trial NCT01642277 about?

NCT01642277 is a clinical study titled "Bacterial Genomic Sequencing in Overactive Bladder". No one really knows what causes overactive bladder syndrome (OAB). Urinary tract infection (UTI)causes similar symptoms to OAB with the difference being the presence of bacteria, as evidenced by routine microbiology cultures. Recent work by the group on the genitourinary microbiome (GUM) has shown t...

What is the current status of trial NCT01642277?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 134 participants. The study started on 2012-07. Estimated completion is 2014-08.

What conditions does trial NCT01642277 study?

This clinical trial studies the following conditions: Overactive Bladder.

What interventions are being tested in trial NCT01642277?

The interventions under investigation include: Solifenacin (DRUG).

Who is sponsoring clinical trial NCT01642277?

This trial is sponsored by Loyola University, which has 92 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01642277 being conducted?

This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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