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NCT01879683 · ClinicalTrials.gov registry record · Phase 1
A Safety, Tolerability and Preliminary Efficacy Study of LiRIS® 400 mg in Women With Interstitial Cystitis (IC) and Hunner's Lesions
A Phase 1 study of Chronic Interstitial Cystitis, sponsored by Allergan.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
- 2
- Study locations
NCT01879683 is a Phase 1 study of Chronic Interstitial Cystitis that has completed, run by Allergan. The registered enrollment target is 10 participants, below the 108-participant average among 3 other Chronic Interstitial Cystitis trials with a reported enrollment target (91% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT01879683, a Phase 1 study of Chronic Interstitial Cystitis, has completed, sponsored by Allergan.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of the study is to evaluate if LiRIS 400 mg is safe and tolerable when administered to women with Interstitial Cystitis with Hunner's lesions, and to evaluate any change in the bladder or in IC symptoms, following LiRIS administration.
Conditions Studied
Interventions
- DRUG LiRIS® 400 mg
Study Locations (2)
Florida
- Advance Urology Institute - Daytona Beach
Michigan
- William Beaumont Hospital - Royal Oak
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2013-07 |
| Est. Completion | 2014-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01879683
The ClinicalTrials.gov registry entry for NCT01879683 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 108-participant average among 3 other Chronic Interstitial Cystitis trials with a reported enrollment target (91% lower). The listed sponsor is Allergan, which has 314 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Chronic Interstitial Cystitis appearing as the primary indexed condition, and to 1 intervention - of which LiRIS® 400 mg is the first listed.
NCT01879683 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Florida, Michigan.
Frequently Asked Questions
What is clinical trial NCT01879683 about?
NCT01879683 is a clinical study titled "A Safety, Tolerability and Preliminary Efficacy Study of LiRIS® 400 mg in Women With Interstitial Cystitis (IC) and Hunner's Lesions". The purpose of the study is to evaluate if LiRIS 400 mg is safe and tolerable when administered to women with Interstitial Cystitis with Hunner's lesions, and to evaluate any change in the bladder or in IC symptoms, following LiRIS administration.
What is the current status of trial NCT01879683?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2013-07. Estimated completion is 2014-06.
What conditions does trial NCT01879683 study?
This clinical trial studies the following conditions: Chronic Interstitial Cystitis.
What interventions are being tested in trial NCT01879683?
The interventions under investigation include: LiRIS® 400 mg (DRUG).
Who is sponsoring clinical trial NCT01879683?
This trial is sponsored by Allergan, which has 314 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01879683 being conducted?
This trial has 2 study locations across Florida, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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