Safety Study of LiRIS in Interstitial Cystitis (IC) Patients

Phase 1B Pilot Safety Study of LiRIS-TM, A Novel Bladder Drug Delivery Platform in Patients With Interstitial Cystitis

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.

Study Overview

• Status: Completed
• Conditions: Interstitial Cystitis
• Intervention / Treatment: Drug: LiRIS low dose and LiRIS high dose

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Victoria, British Columbia, Canada, V8V 3N1
      • Dr. Steinhoff Clinical Research
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 3A7
      • Queen Elizabeth II Health Sciences Centre, Halifax Infirmary
  • Ontario
    • Kingston, Ontario, Canada, K7L 3J7
      • Centre for Applied Urological Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LiRIS low dose; The first dose group of approximately 10 patients receive low dose LiRIS on Day 1 to Day 14.	Drug: 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.
Experimental: LiRIS high dose; The second dose group of approximately 10 patients receive high dose LiRIS on Day 1 to Day 14.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cystoscopic examination	Days 1 and 14

Secondary Outcome Measures

Outcome Measure	Time Frame
Bladder pain	During and following treatment; study days 1 to 90

Collaborators and Investigators

• Sponsor: Allergan
• Collaborators: TARIS Biomedical, Inc.
• Investigators: Principal Investigator: Curtis Nickel, MD, Queen's University/Kingston General Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: June 23, 2010
• First Submitted That Met QC Criteria: June 24, 2010
• First Posted (Estimate): June 25, 2010

Study Record Updates

• Last Update Posted (Estimate): November 25, 2014
• Last Update Submitted That Met QC Criteria: November 24, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Cystitis; Cystitis, Interstitial
• Other Study ID Numbers: TAR-100-103