Trial | NCT01150565  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    lidocaine ...

  • Study Participants

    18
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.
Study Started
Jul 31
2010
Primary Completion
Sep 30
2011
Study Completion
Sep 30
2011
Last Update
Nov 25
2014
Estimate

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.

LiRIS low dose Experimental

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

LiRIS high dose Experimental

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

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
No Results Posted