Phase 1B Pilot Safety Study of LiRIS-TM, A Novel Bladder Drug Delivery Platform in Patients With Interstitial Cystitis
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Allergan
- Enrollment
- 18
- Locations
- 3
- Primary Endpoint
- Cystoscopic examination
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
LiRIS low dose
The first dose group of approximately 10 patients receive low dose LiRIS on Day 1 to Day 14.
Intervention: LiRIS low dose and LiRIS high dose (Drug)
LiRIS high dose
The second dose group of approximately 10 patients receive high dose LiRIS on Day 1 to Day 14.
Intervention: LiRIS low dose and LiRIS high dose (Drug)
Outcomes
Primary Outcomes
Cystoscopic examination
Time Frame: Days 1 and 14
Secondary Outcomes
- Bladder pain(During and following treatment; study days 1 to 90)