A Safety and Efficacy Study of LiRIS® in Females With Interstitial Cystitis With Hunner's Lesions

Allergan

Status and phase: Completed; Phase 2

Conditions: Ulcer; Cystitis, Interstitial

Treatments: Drug: LiRIS Placebo; Drug: LiRIS®

Study type: Interventional

Funder types: Industry

Identifiers

NCT02395042

201025-001

Details and patient eligibility

About

This is a safety and efficacy study of LiRIS® in females with interstitial cystitis with Hunner's lesions.

Enrollment: 59 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of interstitial cystitis with Hunner's lesions/ulcers

Exclusion criteria

• Previous treatment with LiRIS®
• Interstitial cystitis/bladder pain syndrome, without Hunner's lesions/ulcers

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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59 participants in 3 patient groups, including a placebo group

LiRIS Placebo, LiRIS Placebo (Tx 1)/LiRIS® (Tx 2)

Placebo Comparator group

Description:

Treatment 1 Period (Tx 1): Matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 10 and then removed and a second matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 14 and removed on Day 28. Treatment 2 Period (Tx 2): optional LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 and removed on Day 14.

Treatment:

Drug: LiRIS®

LiRIS®, LiRIS® (Tx 1)/LiRIS® (Tx 2)

Experimental group

Description:

Treatment 1 Period: LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 then removed and a second LiRIS® 400 mg inserted into the bladder on Day 14 and removed on Day 28. Treatment 2 Period: optional LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 and then removed on Day 14.

Treatment:

Drug: LiRIS®

Drug: LiRIS Placebo

LiRIS Placebo, LiRIS® (Tx 1)/ LiRIS® (Tx 2)

Experimental group

Description:

Treatment 1 Period: Matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 0 and then removed and LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 14 then removed on Day 28. Treatment 2 Period: optional LiRIS® 400 mg inserted into the bladder by cystoscopy on Day 0 then removed on Day 14.

Treatment:

Drug: LiRIS®

Drug: LiRIS Placebo