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Safety Study of LiRIS in Interstitial Cystitis (IC) Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01150565
Recruitment Status : Completed
First Posted : June 25, 2010
Last Update Posted : November 25, 2014
Sponsor:
Collaborator:
TARIS Biomedical, Inc.
Information provided by (Responsible Party):
Allergan

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Interstitial Cystitis Drug: LiRIS low dose and LiRIS high dose Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Phase 1B Pilot Safety Study of LiRIS-TM, A Novel Bladder Drug Delivery Platform in Patients With Interstitial Cystitis
Study Start Date : July 2010
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

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Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Cystoscopic examination [ Time Frame: Days 1 and 14 ]

Secondary Outcome Measures :
  1. Bladder pain [ Time Frame: During and following treatment; study days 1 to 90 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01150565


Locations
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Canada, British Columbia
Dr. Steinhoff Clinical Research
Victoria, British Columbia, Canada, V8V 3N1
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Centre, Halifax Infirmary
Halifax, Nova Scotia, Canada, B3H 3A7
Canada, Ontario
Centre for Applied Urological Research
Kingston, Ontario, Canada, K7L 3J7
Sponsors and Collaborators
Allergan
TARIS Biomedical, Inc.
Investigators
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Principal Investigator: Curtis Nickel, MD Queen's University/Kingston General Hospital
More Information
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01150565    
Other Study ID Numbers: TAR-100-103
First Posted: June 25, 2010    Key Record Dates
Last Update Posted: November 25, 2014
Last Verified: November 2014
Additional relevant MeSH terms:
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Cystitis
Cystitis, Interstitial
Urinary Bladder Diseases
Urologic Diseases