Safety Study of LiRIS in Interstitial Cystitis (IC) Patients

Interstitial Cystitis Clinical Trial

Official title:

Phase 1B Pilot Safety Study of LiRIS-TM, A Novel Bladder Drug Delivery Platform in Patients With Interstitial Cystitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01150565
• Other study ID #: TAR-100-103
• Status: Completed
• Phase: Phase 1
• First received: June 23, 2010
• Last updated: November 24, 2014
• Start date: July 2010
• Est. completion date: September 2011

Study information

• Verified date: November 2014
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Cystitis
• Cystitis, Interstitial
• Interstitial Cystitis

Intervention

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.

Locations

Country	Name	City	State
Canada	Queen Elizabeth II Health Sciences Centre, Halifax Infirmary	Halifax	Nova Scotia
Canada	Centre for Applied Urological Research	Kingston	Ontario
Canada	Dr. Steinhoff Clinical Research	Victoria	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Allergan	TARIS Biomedical, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cystoscopic examination		Days 1 and 14	Yes
Secondary	Bladder pain		During and following treatment; study days 1 to 90	Yes