Suspended

A Phase 2 Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study Evaluating Safety, Tolerability and Efficacy of LiRIS® 400 mg in Women With Interstitial Cystitis Followed by an Open Label Extension

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

LiRIS 400 mg

+ LiRIS Placebo

DrugOther
Who is being recruted

Urogenital Diseases+5

+ Urinary Bladder Diseases

+ Cystitis

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: March 2013
See protocol details

Summary

Principal SponsorAllergan
Last updated: January 26, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2013

Actual date on which the first participant was enrolled.

The study is conducted in 2 parts: a randomized, blinded part in which subjects are assigned randomly (by chance) to LiRIS 400 mg or LiRIS placebo; subjects who complete this part and are eligible to continue, may participate in the open-label part in which all subjects receive LiRIS 400 mg. In both parts of the study (blinded and open-label), LiRIS is inserted into the bladder during cystoscopy, remains in the bladder for 14 days, and is removed during cystoscopy. In addition to the 14 day period with the LiRIS/LiRIS Placebo, there is a screening period of up to 2 weeks and a follow up period of 4 weeks.

NCT01824303
Principal SponsorAllergan
Last updated: January 26, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

31 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesUrinary Bladder DiseasesCystitisFemale Urogenital Diseases and Pregnancy ComplicationsUrologic DiseasesFemale Urogenital DiseasesMale Urogenital DiseasesCystitis, Interstitial

Criteria

Inclusion Criteria Blinded study: Women age 18 and over Diagnosed with Interstitial Cystitis as defined by protocol Able to report IC symptoms of bladder pain, voiding habits, as required by protocol, and record in diary Able to comply with visit schedule and diary completion at home Open-label Extension: Must have completed the blinded study prior to screening for the Open-label extension Exclusion Criteria (Blinded and Open-Label Extension): Pregnant or lactating women History or presence of any condition that would make it difficult to accurately evaluate bladder symptoms Bladder or urethral abnormality that would prevent safe insertion of investigational product Requiring medication not allowed per study protocol

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days. If eligible, participants could participate in the Open Label Extension where all participants were treated with LiRIS 400 mg.

Group II

Placebo
LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days. If eligible, participants could participate in the Open Label Extension where all participants were treated with LiRIS 400 mg.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 17 locations

Citrus Valley Medical Research , Inc.

Glendora, United StatesOpen Citrus Valley Medical Research , Inc. in Google Maps

Atlantic Urological Associates

Daytona Beach, United States

University of Kansas Medical Center

Kansas City, United States

The UrogynecologyCenter, LLC

Overland Park, United States
Suspended17 Study Centers