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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01824303
• Date of registration: 31/03/2013
• Prospective Registration: No
• Primary sponsor: Allergan
• Public title: Safety, Tolerability and Efficacy Study of LiRIS® 400 mg in Women With Interstitial Cystitis
• Scientific title: A Phase 2 Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study Evaluating Safety, Tolerability and Efficacy of LiRIS® 400 mg in Women With Interstitial Cystitis Followed by an Open Label Extension
• Date of first enrolment: March 2013
• Target sample size: 31
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01824303
• Study type: Interventional
• Phase: Phase 2

Countries of recruitment

Canada, United States

Contacts

• Name: Curtis Nickel, MD
• Affiliation: Queen's University/Kingston General Hospital/Ontario Canada

Key inclusion & exclusion criteria

Inclusion Criteria

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

Exclusion Criteria (Blinded and Open-Label Extension):

- 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Interstitial Cystitis

Intervention(s)

Drug: LiRIS 400 mg

Other: LiRIS Placebo

Primary Outcome(s)

Change From Baseline in Participant Reported Average Bladder Pain on a Numerical Rating Scale (NRS) [Time Frame: Baseline, Day 12]

Secondary Outcome(s)

Change From Baseline in Bladder Pain/Interstitial Cystitis Symptom Score (BPIC-SS) [Time Frame: Baseline, Day 27]

Change From Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score [Time Frame: Baseline, Day 27]

Change From Baseline in Night-Time Daily Voids [Time Frame: Baseline, Day 27]

Change From Baseline in Total Daily Voids [Time Frame: Baseline, Day 27]

Change From Baseline in Average Void Volume Per Micturition [Time Frame: Baseline, Day 27]

Change From Baseline in Brief Pain Inventory (BPI) [Time Frame: Baseline, Day 27]

Change From Baseline in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) Score [Time Frame: Baseline, Day 27]

Change From Baseline in Post-Void Bladder Pain [Time Frame: Baseline, Day 27]

Secondary ID(s)

TAR-100-202

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

TARIS Biomedical, Inc.

Results

• Results available: Yes
• Date Posted: 26/11/2015
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01824303