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Safety Study of LiRIS in Interstitial Cystitis (IC) Patients

NCT ID: NCT01150565

Last Updated: 2014-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2011-09-30

Brief Summary

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The purpose of this study is primarily to evaluate the safety and tolerability of two dose levels of an investigational drug-delivery system (LiRIS) in patients who have moderate to severe symptoms of interstitial cystitis.

Detailed Description

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Approximately 20 female patients with interstitial cystitis will be enrolled in this study at multiple centers in Canada. LiRIS is being developed to provide drug therapy directly into the urinary bladder. LiRIS contains Lidocaine, a marketed drug (approved by Health Canada) which is commonly used for local (skin or oral)anaesthesia. LiRIS is designed to release a controlled amount of lidocaine while in the bladder over a 2 week period.

Two dose groups of approximately 10 patients per group will be enrolled into the study; the first group of patients will receive low dose LiRIS, and the second group will receive high dose LiRIS. All patients receive LiRIS treatment for 14 days, and clinic follow-up at 7 and 14 days after treatment. Additional telephone follow-up occurs at approximately 6 and 10 weeks after LiRIS treatment. The maximum duration of participation, including a screening period of up to 14 days, will be 104 days.

Conditions

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Interstitial Cystitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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LiRIS low dose

The first dose group of approximately 10 patients receive low dose LiRIS on Day 1 to Day 14.

Group Type EXPERIMENTAL

LiRIS low dose and LiRIS high dose

Intervention Type DRUG

Drug delivery system containing lidocaine; LiRIS (low or high dose) is inserted into bladder via cystoscopy on Day 1 and removed via cystoscopy on Day 14. Designed to release lidocaine over a 14 day period.

LiRIS high dose

The second dose group of approximately 10 patients receive high dose LiRIS on Day 1 to Day 14.

Group Type EXPERIMENTAL

LiRIS low dose and LiRIS high dose

Intervention Type DRUG

Drug delivery system containing lidocaine; LiRIS (low or high dose) is inserted into bladder via cystoscopy on Day 1 and removed via cystoscopy on Day 14. Designed to release lidocaine over a 14 day period.

Interventions

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LiRIS low dose and LiRIS high dose

Drug delivery system containing lidocaine; LiRIS (low or high dose) is inserted into bladder via cystoscopy on Day 1 and removed via cystoscopy on Day 14. Designed to release lidocaine over a 14 day period.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Female patients ≥ 18 years of age
* If of child-bearing potential, agrees to use effective contraception defined by protocol
* Capable of understanding and completing symptom diaries and questionnaires as required in the study
* Diagnosed with IC, as defined by protocol criteria

Exclusion Criteria

* Bladder or urethra anatomical feature that, in the opinion of the investigator, might prevent the safe placement, indwelling use, or removal of LiRIS
* History or presence of any medical condition that would interfere with ability to assess symptoms
* Pregnant or lactating patients
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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TARIS Biomedical, Inc.

INDUSTRY

Sponsor Role collaborator

Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Curtis Nickel, MD

Role: PRINCIPAL_INVESTIGATOR

Queen's University/Kingston General Hospital

Locations

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Dr. Steinhoff Clinical Research

Victoria, British Columbia, Canada

Site Status

Queen Elizabeth II Health Sciences Centre, Halifax Infirmary

Halifax, Nova Scotia, Canada

Site Status

Centre for Applied Urological Research

Kingston, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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TAR-100-103

Identifier Type: -

Identifier Source: org_study_id