Safety Study of LiRIS in Interstitial Cystitis (IC) Patients

Allergan

Status and phase: Completed; Phase 1

Conditions: Interstitial Cystitis

Treatments: Drug: LiRIS low dose and LiRIS high dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT01150565

TAR-100-103

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

18 participants in 2 patient groups

LiRIS low dose

Experimental group

Description:

The first dose group of approximately 10 patients receive low dose LiRIS on Day 1 to Day 14.

Treatment:

Drug: LiRIS low dose and LiRIS high dose

LiRIS high dose

Experimental group

Description:

The second dose group of approximately 10 patients receive high dose LiRIS on Day 1 to Day 14.

Treatment:

Drug: LiRIS low dose and LiRIS high dose