Safety Study of LiRIS in Interstitial Cystitis (IC) Patients

• ClinicalTrials.gov Identifier: NCT01150565
• Recruitment Status: Completed
• First Posted: June 25, 2010
• Last Update Posted: November 25, 2014
• Sponsor: Allergan
• Collaborator: TARIS Biomedical, Inc.
• Information provided by (Responsible Party): Allergan

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Interstitial Cystitis	Drug: LiRIS low dose and LiRIS high dose	Phase 1

Detailed 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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 18 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Official Title: Phase 1B Pilot Safety Study of LiRIS-TM, A Novel Bladder Drug Delivery Platform in Patients With Interstitial Cystitis
• Study Start Date: July 2010
• Actual Primary Completion Date: September 2011
• Actual Study Completion Date: September 2011

Arms and Interventions

Arm	Intervention/treatment
Experimental: LiRIS low dose; The first dose group of approximately 10 patients receive low dose LiRIS on Day 1 to Day 14.	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.
Experimental: LiRIS high dose; The second dose group of approximately 10 patients receive high dose LiRIS on Day 1 to Day 14.	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.

Outcome Measures

Primary Outcome Measures :

1. Cystoscopic examination [ Time Frame: Days 1 and 14 ]

Secondary Outcome Measures :

1. Bladder pain [ Time Frame: During and following treatment; study days 1 to 90 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Canada, British Columbia

Dr. Steinhoff Clinical Research

Victoria, British Columbia, Canada, V8V 3N1

Canada, Nova Scotia

Queen Elizabeth II Health Sciences Centre, Halifax Infirmary

Halifax, Nova Scotia, Canada, B3H 3A7

Canada, Ontario

Centre for Applied Urological Research

Kingston, Ontario, Canada, K7L 3J7

Sponsors and Collaborators

Allergan

TARIS Biomedical, Inc.

Investigators

• Principal Investigator: Curtis Nickel, MD; Queen's University/Kingston General Hospital

More Information

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT01150565
• Other Study ID Numbers: TAR-100-103
• First Posted: June 25, 2010
• Last Update Posted: November 25, 2014
• Last Verified: November 2014

Additional relevant MeSH terms:

Cystitis; Cystitis, Interstitial; Urinary Bladder Diseases; Urologic Diseases