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

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. According to ClinicalTrials.gov, the official US trial registry.

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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
Urigen

3 total trials

What the finished NCT00256542 record still lists

NCT00256542 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 359-participant average among 26 other Interstitial Cystitis trials with a reported enrollment target (75% lower).

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 lists 9 locations in 9 states (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.

Similar trials for Interstitial Cystitis

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00256542's enrollment target sits among peer trials

90 14th of 26 higher than 12 of 26 other Interstitial Cystitis trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Interstitial Cystitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00256542, the US trial registry maintained by the National Library of Medicine. NCT00256542 (small enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.