Double-Blind Placebo Controlled Study of Safety,Tolerability, and Efficacy of LiRIS® in Women With Interstitial Cystitis

Allergan

Status and phase: Terminated; Phase 2

Conditions: Interstitial Cystitis

Treatments: Drug: Lidocaine Releasing Intravesical System - LiRIS®; Other: LiRIS Placebo; Procedure: Sham Cystoscopy Procedure

Study type: Interventional

Funder types: Industry

Identifiers

NCT01475253

TAR-100-201

Details and patient eligibility

About

The purpose of this study is to determine if LiRIS®, an investigational drug-delivery system, is safe, tolerable and effective in women with Interstitial Cystitis. LiRIS® is inserted into the bladder via cystoscopy , remains in the bladder for 14 days, and is removed via cystoscopy.

Full description

The study is conducted in 2 parts - a randomized, blinded part in which patients are randomly assigned to one of 3 possible arms (LiRIS® - contains lidocaine), LiRIS Placebo (LiRIS with inactive substance) or Sham(Insertion procedure only with neither LiRIS nor LiRIS Placebo), followed by an open extension part in which all patients are assigned to receive LiRIS® (with lidocaine). In part 1 of the study, treatment is managed in a double-blind manner for LiRIS® and LiRIS Placebo arms; and in a single-blind manner for the Sham arm (e.g.,the study doctor will know the treatment assignment for patients assigned to Sham).

All patients who complete part 1 of the study have the option to enter the extension.

Enrollment: 104 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women age 18 and over
• Diagnosed with Interstitial Cystitis as defined by protocol
• Able and willing to complete questionnaires and diary
• Able to comply with visit schedule including Day 14 Removal visit
• Completion of blinded study prior to enrolling in unblinded part of study

Exclusion criteria

• Pregnant or lactating women
• Bladder or urethra anatomical feature that would prevent the safe indwelling or insertion of the investigational product
• History or presence of any condition that would make it difficult to evaluate symptoms
• Did not complete blinded study (unblinded part of study only)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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104 participants in 3 patient groups, including a placebo group

Lidocaine Releasing Intravesical System

Experimental group

Description:

Lidocaine Releasing Intravesical System (LiRIS®) is inserted into the bladder via cystoscopy on Study Day 0 and removed on Study Day 14. LiRIS releases lidocaine gradually during the 14 day indwelling period.

Treatment:

Drug: Lidocaine Releasing Intravesical System - LiRIS®

LiRIS containing inactive substance only

Placebo Comparator group

Description:

LiRIS Placebo is inserted into the bladder via cystoscopy on study Day 0 and removed via cystoscopy on study Day 14.

Treatment:

Other: LiRIS Placebo

Cystoscopy Procedure

Sham Comparator group

Description:

No intervention. Cystoscopy procedure is performed on study Day 0 and study Day 14 to mimick active and placebo study arms without insertion of Investigational Product into the bladder.

Treatment:

Procedure: Sham Cystoscopy Procedure