Safety, Tolerability and Efficacy Study of LiRIS® 400 mg in Women With Interstitial Cystitis

NCT01824303 | Terminated Phase 2 Results DMC

• 1 other identifier: TAR-100-202
• Study Type: interventional
• Target: 31
• Locations: 2 countries
• Sites: 17

Brief Summary

The purposes of the study is to determine if LiRIS®, an investigational drug-delivery system, is safe and tolerable in women with Interstitial Cystitis (IC), and to evaluate any change in IC symptoms following LiRIS administration.

Conditions

Interstitial Cystitis

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Participant Reported Average Bladder Pain on a Numerical Rating Scale (NRS)

  Participants rated their bladder pain over the previous 24 hours in an electronic diary using a horizontal line NRS by putting a mark on the line where: 0 (the far left of the line)=no pain to 10 (far right of the line)=worst pain imaginable. Bladder pain was averaged over a period of 3 days. A negative change from Baseline indicates improvement.

  Baseline, Day 12

Secondary Outcomes (8)

• Change From Baseline in Total Daily Voids

  Baseline, Day 27

• Change From Baseline in Night-Time Daily Voids

  Baseline, Day 27

• Change From Baseline in Average Void Volume Per Micturition

  Baseline, Day 27

• Change From Baseline in Post-Void Bladder Pain

  Baseline, Day 27

• Change From Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score

  Baseline, Day 27

Study Arms (2)

LiRIS 400 mg

EXPERIMENTAL

LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days. If eligible, participants could participate in the Open Label Extension where all participants were treated with LiRIS 400 mg.

Drug: LiRIS 400 mg

LiRIS Placebo

PLACEBO COMPARATOR

LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days. If eligible, participants could participate in the Open Label Extension where all participants were treated with LiRIS 400 mg.

Other: LiRIS Placebo

Interventions

LiRIS 400 mg DRUG

LiRIS 400 mg contains lidocaine which is gradually released into the bladder over 14 days.

LiRIS 400 mg

LiRIS Placebo OTHER

LiRIS Placebo contains lactose, inactive substance.

LiRIS Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Blinded study:
• Women age 18 and over
• Diagnosed with Interstitial Cystitis as defined by protocol
• Able to report IC symptoms of bladder pain, voiding habits, as required by protocol, and record in diary
• Able to comply with visit schedule and diary completion at home
• Open-label Extension:
• Must have completed the blinded study prior to screening for the Open-label extension

You may not qualify if:

• Pregnant or lactating women
• History or presence of any condition that would make it difficult to accurately evaluate bladder symptoms
• Bladder or urethral abnormality that would prevent safe insertion of investigational product
• Requiring medication not allowed per study protocol

Sponsors & Collaborators

• Allergan: lead
• TARIS Biomedical, Inc.: collaborator

Study Sites (17)

Citrus Valley Medical Research , Inc.

Glendora, California, 91741, United States

Location

Atlantic Urological Associates

Daytona Beach, Florida, 32114, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

The UrogynecologyCenter, LLC

Overland Park, Kansas, 66209-2002, United States

Location

Female Pelvic Medicine & Urogynecology Institute of MI

Grand Rapids, Michigan, 49503, United States

Location

William Beaumont Hospitals

Royal Oak, Michigan, 48073, United States

Location

North Shore - Long Island Jewish Heath System - Monter Cancer Center

New Hyde Park, New York, 11040, United States

Location

Premier Medical Group of the Hudson Valley PC

Newburgh, New York, 12550, United States

Location

Premier Medical Group of the Hudson Valley PC

Poughkeepsie, New York, 12601, United States

Location

Alliance Urology Specialists, PA

Greensboro, North Carolina, 27403, United States

Location

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27103, United States

Location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572, United States

Location

Volunteer Research Group, University of Tennessee Medical Center

Knoxville, Tennessee, 37920, United States

Location

Exdeo Clinical Research Inc.

Abbotsford, British Columbia, V2S 3N6, Canada

Location

Centre for Applied Urological Research

Kingston, Ontario, K7L 3J7, Canada

Location

MeSH Terms

Conditions

Cystitis, Interstitial

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Limitations and Caveats

Due to technical issues with the patient electronic diary used for the collection of the outcome measures data, as well as the small evaluable sample size and large variability, the efficacy data should be interpreted with caution.

Results Point of Contact

• Title: Therapeutic Area Head,
• Organization: Allergan, Inc

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Curtis Nickel, MD

  Queen's University/Kingston General Hospital/Ontario Canada

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2013
• First Posted: April 4, 2013
• Study Start: March 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 26, 2016
• Results First Posted: November 26, 2015

Record last verified: 2015-12

Locations

CA (2); US (15)