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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

June 23, 2010
June 25, 2010
November 25, 2014
July 2010
September 2011   (Final data collection date for primary outcome measure)
Cystoscopic examination [ Time Frame: Days 1 and 14 ]
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.
Complete list of historical versions of study NCT01150565 on ClinicalTrials.gov Archive Site
Bladder pain [ Time Frame: During and following treatment; study days 1 to 90 ]
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).
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Interstitial Cystitis
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 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
12
September 2011
September 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT01150565
TAR-100-103
No
Not Provided
Not Provided
Allergan
Allergan
TARIS Biomedical, Inc.
Principal Investigator: Curtis Nickel, MD Queen's University/Kingston General Hospital
Allergan
November 2014

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