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Safety Study of LiRIS in Interstitial Cystitis (IC) Patients

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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

Tracking Information
First Submitted Date  ICMJE June 23, 2010
First Posted Date  ICMJE June 25, 2010
Last Update Posted Date November 25, 2014
Study Start Date  ICMJE July 2010
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2010)
Cystoscopic examination [ Time Frame: Days 1 and 14 ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 24, 2010)
Cystoscopic examination [ Time Frame: Screen, Days 1,14 ]
A cystoscopic examination will be performed on Study Day 1 (Baseline) for all patients, prior to insertion of LiRIS. The investigator will assess the urethra and bladder for any abnormalities prior to LiRIS insertion. A final cystoscopic examination will be performed on Study Day 14 prior to removal of LiRIS.
Change History Complete list of historical versions of study NCT01150565 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 10, 2011)
Bladder pain [ Time Frame: During and following treatment; study days 1 to 90 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2010)
Bladder pain [ Time Frame: during and following treatment; study days 1 to 28 ]
Patients are asked to report bladder pain symptom on a scale of 1 to 10, daily during treatment and periodically following treatment, using a visual analogue score (VAS scale).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Study of LiRIS in Interstitial Cystitis (IC) Patients
Official Title  ICMJE Phase 1B Pilot Safety Study of LiRIS-TM, A Novel Bladder Drug Delivery Platform in Patients With Interstitial Cystitis
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE Interstitial Cystitis
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: LiRIS low dose
    The first dose group of approximately 10 patients receive low dose LiRIS on Day 1 to Day 14.
    Intervention: Drug: LiRIS low dose and LiRIS high dose
  • Experimental: LiRIS high dose
    The second dose group of approximately 10 patients receive high dose LiRIS on Day 1 to Day 14.
    Intervention: Drug: LiRIS low dose and LiRIS high dose
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 24, 2014)
18
Original Estimated Enrollment  ICMJE
 (submitted: June 24, 2010)
12
Actual Study Completion Date  ICMJE September 2011
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01150565
Other Study ID Numbers  ICMJE TAR-100-103
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Allergan
Study Sponsor  ICMJE Allergan
Collaborators  ICMJE TARIS Biomedical, Inc.
Investigators  ICMJE
Principal Investigator: Curtis Nickel, MD Queen's University/Kingston General Hospital
PRS Account Allergan
Verification Date November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP