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NCT00256542 · ClinicalTrials.gov registry record · Phase 2

Study of U101 for Bladder Pain and/or Urgency

A Phase 2 study of Interstitial Cystitis and Pelvic Pain, sponsored by Urigen.

Completed
Registry status
Phase 2
Development phase
90
Enrollment target
9
Study locations

NCT00256542 is a Phase 2 study of Interstitial Cystitis and Pelvic Pain that has completed, run by Urigen. The registered enrollment target is 90 participants, below the 359-participant average among 26 other Interstitial Cystitis trials with a reported enrollment target (75% lower). The trial reports 9 study locations across 9 states.

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The verdict

NCT00256542, a Phase 2 study of Interstitial Cystitis and Pelvic Pain, has completed, sponsored by Urigen.

COMPLETED
Registry status
Phase 2
Development phase
90 participants
Enrollment target
9
Study locations

Study Summary

The purpose of this study is to determine whether intravesical U101 (alkalinized lidocaine-heparin) treatment reduces the symptoms of pelvic pain and/or urgency of bladder origin.

Interventions

  • DRUG Alkalinized Lidocaine-Heparin

Study Locations (9)

California

  • UCSD Medical Center - San Diego

Georgia

  • Georgia Urology - Cartersville

Illinois

  • St. Mary's Good Samaritan - Centralia

Kansas

  • The Urogynecology Center - Overland Park

Michigan

  • Mid-Michigan Health Centers - Jackson

New York

  • Central Park Urology - New York

North Carolina

  • The Urology Center - Greensboro

Oklahoma

  • Urologic Specialists of Oklahoma, Inc. - Tulsa

Trial Details

FieldValue
Enrollment Target 90 participants
Start Date 2006-01
Est. Completion 2006-09
Phase Phase 2

Sponsor

Urigen

3 total trials

What the Registry Record Tells You About NCT00256542

The ClinicalTrials.gov registry entry for NCT00256542 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 359-participant average among 26 other Interstitial Cystitis trials with a reported enrollment target (75% lower). The listed sponsor is Urigen, which has 3 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Interstitial Cystitis appearing as the primary indexed condition, and to 1 intervention - of which Alkalinized Lidocaine-Heparin is the first listed.

NCT00256542 reports 9 study locations spanning 9 distinct geographic areas - top geographies include California, Georgia, Illinois.

Frequently Asked Questions

What is clinical trial NCT00256542 about?

NCT00256542 is a clinical study titled "Study of U101 for Bladder Pain and/or Urgency". The purpose of this study is to determine whether intravesical U101 (alkalinized lidocaine-heparin) treatment reduces the symptoms of pelvic pain and/or urgency of bladder origin.

What is the current status of trial NCT00256542?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 90 participants. The study started on 2006-01. Estimated completion is 2006-09.

What conditions does trial NCT00256542 study?

This clinical trial studies the following conditions: Interstitial Cystitis, Pelvic Pain, Bladder Diseases.

What interventions are being tested in trial NCT00256542?

The interventions under investigation include: Alkalinized Lidocaine-Heparin (DRUG).

Who is sponsoring clinical trial NCT00256542?

This trial is sponsored by Urigen, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00256542 being conducted?

This trial has 9 study locations across California, Georgia, Illinois, Kansas, Michigan. 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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