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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: Completed Phase 1 study of Chronic Interstitial Cystitis, sponsored by Allergan.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The appearance of the Hunner's lesions was assessed by the investigator using video capture of the bladder mucosa during the cystoscopic examinations. Complete responders (CR)=no lesions observed at day of last LiRIS removal; Partial responders (PR)=presence of residual lesions on day of last LiRIS removal however there is cystoscopic evidence of a decrease in either: i) the affected area as calculated by size and dimension of individual lesions summed together or ii) the lesion number or iii) t
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 |
What the finished NCT01879683 record still lists
NCT01879683 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 108-participant average among 3 other Chronic Interstitial Cystitis trials with a reported enrollment target (91% lower).
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 a single indexed study location in 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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