Cystitis, InterstitialPhase 2NCT02411110
A Safety and Efficacy Study of LiRIS® in Females With Interstitial Cystitis/Bladder Pain Syndrome
A Phase 2 study testing LiRIS® in people with Cystitis, Interstitial and Painful Bladder Syndrome, run by Allergan at 34 sites in 2 countries.
Trial summary
This is a safety and efficacy study of LiRIS® in females with interstitial cystitis/bladder pain syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cystitis, Interstitial, Painful Bladder Syndrome
- What is being tested?
- LiRIS®
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 131 participants
- Where
- 34 sitesin 2 countries
- Study dates
- 21 May 2015to 9 Jan 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of interstitial cystitis or bladder pain syndrome
Who cannot join
- Diagnosis of interstitial cystitis with Hunner's lesions/ulcers
- Previous treatment with LiRIS®
Trial locations and contacts
34 sites in 2 countries.
34 sites in 2 countries
United States31 sites
Atlanta Medical Research Instititute
Alpharetta, Georgia, 30005
Anne Arundel Urology, P.A.
Annapolis, Maryland, 21401
Chesapeake Urology Research Associates
Baltimore, Maryland, 21237
Manatee Medical Research Institute
Bradenton, Florida, 34205
McKay Urology
Charlotte, North Carolina, 28207
Western New York Urology Associates
Cheektowaga, New York, 14225
MetroHealth System
Cleveland, Ohio, 44109
IC Study LLC
Escondido, California, 92025
Women's Health Specialty Care
Farmington, Connecticut, 06032
Associated Surgeons and Physicians LLC DBA Women's Health Advantage
Fort Wayne, Indiana, 46825
Alliance Urology Specialist, P.A.
Greensboro, North Carolina, 27403
Eastern Urological Associates, PA
Greenville, North Carolina, 27834
Beyer Research
Kalamazoo, Michigan, 49009
BRANY, as agent The Arthur Smith Institute for North Shore Long Island Jewish Health System
Lake Success, New York, 11042
Tower Urology
Los Angeles, California, 90048
Idaho Urologic Institute
Meridian, Idaho, 83642
Coastal Clinical Research, Inc.
Mobile, Alabama, 36608
Integrity Medical Research (Urology Northwest)
Mountlake Terrace, Washington, 98043
Tri Valley Urology Medical Group
Murrieta, California, 92562
Yale University
New Haven, Connecticut, 06519
Female Sexual and Pelvic Health Institute
Philadelphia, Pennsylvania, 19107
Urology Institute of Long Island
Plainview, New York, 11803
William Beaumont Hospital
Royal Oak, Michigan, 48073
Genesis Research LLC
San Diego, California, 92123
University of Washington
Seattle, Washington, 98195
Regional Urology, LLC
Shreveport, Louisiana, 71106
Washington University
St Louis, Missouri, 63110
Saint Louis University School of Medicine Department of Obstetrics, Gynecology, and Women's Health Division of Research
St Louis, Missouri, 63117
Sutter Health
Vacaville, California, 95688
Cooper University Hospita/ Univeristy Urogynecology Associates
Voorhees Township, New Jersey, 08043
Wake Forest University
Winston-Salem, North Carolina, 27103
Canada3 sites
Urology Associates/Urologic Medical Research
Kitchener, Ontario, N2N 2B9
Sunnybrook Health Science Centre
Toronto, Ontario, M4N 3M5
Silverado Research Inc
Victoria, British Columbia, V8T 2C1
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating Safety and Efficacy of LiRIS® 400 mg in Females With Interstitial Cystitis/Bladder Pain Syndrome
This is a safety and efficacy study of LiRIS® in females with interstitial cystitis/bladder pain syndrome.
- Conditions
- Cystitis, Interstitial, Painful Bladder Syndrome
- Being tested
- LiRIS®, LiRIS Placebo
- Medical subject headings
- Cystitis, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiRIS®Combination product
LiRIS® is a drug-device combination product which is placed in the bladder during cystoscopy and remains in the bladder, gradually releasing lidocaine until removed from the bladder via cystoscopy.
LiRIS PlaceboCombination product
LiRIS placebo is a drug-device combination product, matching the LiRIS® which is placed in the bladder during cystoscopy, remains in the bladder until removed from the bladder via cystoscopy.
| Study group | Role | What they receive |
|---|---|---|
| LiRIS® (Treatment Period 1)/LiRIS® (Treatment Period 2) | Experimental | Treatment Period 1: continuous release of lidocaine inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 1. Treatment Period 2: optional continuous release of lidocaine inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 2. Receives: Combination Product: LiRIS® |
| LiRIS Placebo (Treatment Period 1)/LiRIS® (Treatment Period 2) | Other | Treatment period 1: Matching placebo device to LiRIS inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 1. Treatment Period 2: optional continuous release of lidocaine inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 2. Receives: Combination Product: LiRIS®; Combination Product: LiRIS Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Daily Average Bladder Pain to Treatment 1 Week 4 Follow-up
The participant recorded their bladder pain over the previous 24-hour period in a 7-day pain assessment tool using an 11-point Numeric Rating Scale (NRS) (0 to 10) where 0=no pain to 10= worst pain. Pain data recorded over the 7-day period were averaged. A negative change from Baseline indicates improvement. An Analysis of Covariance (ANCOVA) model with baseline value as a covariate and treatment group and stratification factors (age group: < 40 years or ≥ 40 years and baseline bladder pain NRS: ≤ 6 or > 6) as factors was used for analysis.
Measured: Baseline (Days -7 to 0) to Treatment 1 Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2015 (estimated)
- Study start21 May 2015
- Primary completion12 Oct 2016
- Study completion9 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cystitis, InterstitialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Till Geib, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02411110
- Sponsor's protocol ID
- 201025-002
- Status last verified
- Dec 2017
- First submitted
- 3 Apr 2015
- Last updated
- 4 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Publications
Evans R, Kohan A, Moldwin R, Radecki D, Geib T, Peters KM. Safety, tolerability, and efficacy of LiRIS 400 mg in women with interstitial cystitis/bladder pain syndrome with or without Hunner lesions. Neurourol Urodyn. 2021 Sep;40(7):1730-1739. doi: 10.1002/nau.24702. Epub 2021 Jul 20.
PubMed 34288094
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating Safety and Efficacy of LiRIS® 400 mg in Females With Interstitial Cystitis/Bladder Pain Syndrome
- ClinicalTrials.gov ID
- NCT02411110
- Acronym / sponsor ID
- 201025-002
- Conditions
- Cystitis, Interstitial, Painful Bladder Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 21 May 2015 (actual)
- Primary completion
- 12 Oct 2016 (actual)
- Study completion
- 9 Jan 2017 (actual)
- First posted
- 8 Apr 2015 (estimated)
- Results
- Posted 4 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a safety and efficacy study of LiRIS® in females with interstitial cystitis/bladder pain syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LiRIS® (Treatment Period 1)/LiRIS® (Treatment Period 2) | Experimental | Combination Product: LiRIS®Treatment Period 1: continuous release of lidocaine inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 1. Treatment Period 2: optional continuous release of lidocaine inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 2. |
| LiRIS Placebo (Treatment Period 1)/LiRIS® (Treatment Period 2) | Other | Combination Product: LiRIS®, Combination Product: LiRIS PlaceboTreatment period 1: Matching placebo device to LiRIS inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 1. Treatment Period 2: optional continuous release of lidocaine inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of interstitial cystitis or bladder pain syndrome
Key exclusion criteria (2 listed)
- Diagnosis of interstitial cystitis with Hunner's lesions/ulcers
- Previous treatment with LiRIS®
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LiRIS®LiRIS® is a drug-device combination product which is placed in the bladder during cystoscopy and remains in the bladder, gradually releasing lidocaine until removed from the bladder via cystoscopy. | Combination product | LiRIS Placebo (Treatment Period 1)/LiRIS® (Treatment Period 2), LiRIS® (Treatment Period 1)/LiRIS® (Treatment Period 2) |
| LiRIS PlaceboLiRIS placebo is a drug-device combination product, matching the LiRIS® which is placed in the bladder during cystoscopy, remains in the bladder until removed from the bladder via cystoscopy. | Combination product | LiRIS Placebo (Treatment Period 1)/LiRIS® (Treatment Period 2) |
Primary outcome
Change From Baseline in Daily Average Bladder Pain to Treatment 1 Week 4 Follow-up
Time frame: Baseline (Days -7 to 0) to Treatment 1 Week 4
The participant recorded their bladder pain over the previous 24-hour period in a 7-day pain assessment tool using an 11-point Numeric Rating Scale (NRS) (0 to 10) where 0=no pain to 10= worst pain. Pain data recorded over the 7-day period were averaged. A negative change from Baseline indicates improvement. An Analysis of Covariance (ANCOVA) model with baseline value as a covariate and treatment group and stratification factors (age group: < 40 years or ≥ 40 years and baseline bladder pain NRS: ≤ 6 or > 6) as factors was used for analysis.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34288094Evans R, Kohan A, Moldwin R, Radecki D, Geib T, Peters KM. Safety, tolerability, and efficacy of LiRIS 400 mg in women with interstitial cystitis/bladder pain syndrome with or without Hunner lesions. Neurourol Urodyn. 2021 Sep;40(7):1730-1739. doi: 10.1002/nau.24702. Epub 2021 Jul 20.
- Additional InformationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Till Geib study director
Allergan
34 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LiRIS® in people with Cystitis, Interstitial and Painful Bladder Syndrome, run by Allergan at 34 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Daily Average Bladder Pain to Treatment 1 Week 4 Follow-up (time frame: Baseline (Days -7 to 0) to Treatment 1 Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02411110, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2018.