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

Status Completed

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.

Clinical Trial 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

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

Related Conditions & MeSH terms

• Cystitis
• Cystitis, Interstitial
• Interstitial Cystitis

• NCT number: NCT01150565
• Study type: Interventional
• Source: Allergan
• Status: Completed
• Phase: Phase 1
• Start date: July 2010
• Completion date: September 2011