Cystitis, InterstitialPhase 2NCT02395042
A Safety and Efficacy Study of LiRIS® in Females With Interstitial Cystitis With Hunner's Lesions
A Phase 2 study testing LiRIS® in people with Cystitis, Interstitial and Ulcer, run by Allergan at 19 sites in 2 countries.
Trial summary
This is a safety and efficacy study of LiRIS® in females with interstitial cystitis with Hunner's lesions. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cystitis, Interstitial, Ulcer
- What is being tested?
- LiRIS®
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 19 sitesin 2 countries
- Study dates
- 15 Apr 2015to 20 Nov 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 with Hunner's lesions/ulcers
Who cannot join
- Previous treatment with LiRIS®
- Interstitial cystitis/bladder pain syndrome, without Hunner's lesions/ulcers
Trial locations and contacts
19 sites in 2 countries.
19 sites in 2 countries
United States17 sites
Atlanta Medical Research Institute
Alpharetta, Georgia, 30005
Anne Arundel Urology, P.A.
Annapolis, Maryland, 21401
Chesapeake Urology Research Associates
Baltimore, Maryland, 21237
McKay Urology
Charlotte, North Carolina, 28207
Western New York Urology Associates, LLC
Cheektowaga, New York, 14214
MetroHealth System/Center for Advanced Gynecology
Cleveland, Ohio, 44109
Women's Health Specialty Care
Farmington, Connecticut, 06032
Eastern Urological Associates, PA
Greenville, North Carolina, 27834
Beyer Research
Kalamazoo, Michigan, 49009
Tri Valley Urology Medical Group
Murrieta, California, 92562
Philadelphia Urosurgical Associates
Philadelphia, Pennsylvania, 19107
Beaumont Health System
Royal Oak, Michigan, 48073
University of Washington
Seattle, Washington, 98195
Washington University School of Medicine Department of Surgery
St Louis, Missouri, 63110
Sutter Institute for Medical Research
Vacaville, California, 95688
Aurora Health Care
West Allis, Wisconsin, 53227
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27103
Canada2 sites
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 With Hunner's Lesions
This is a safety and efficacy study of LiRIS® in females with interstitial cystitis with Hunner's lesions.
- Conditions
- Cystitis, Interstitial, Ulcer
- Being tested
- LiRIS®, LiRIS Placebo
- Medical subject headings
- Cystitis, Interstitial, Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiRIS®Drug
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 PlaceboDrug
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 Placebo, LiRIS Placebo (Tx 1)/LiRIS® (Tx 2) | Placebo comparator | Treatment 1 Period (Tx 1): Matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 10 and then removed and a second matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 14 and removed on Day 28. Treatment 2 Period (Tx 2): optional LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 and removed on Day 14. Receives: Drug: LiRIS® |
| LiRIS®, LiRIS® (Tx 1)/LiRIS® (Tx 2) | Experimental | Treatment 1 Period: LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 then removed and a second LiRIS® 400 mg inserted into the bladder on Day 14 and removed on Day 28. Treatment 2 Period: optional LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 and then removed on Day 14. Receives: Drug: LiRIS®; Drug: LiRIS Placebo |
| LiRIS Placebo, LiRIS® (Tx 1)/ LiRIS® (Tx 2) | Experimental | Treatment 1 Period: Matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 0 and then removed and LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 14 then removed on Day 28. Treatment 2 Period: optional LiRIS® 400 mg inserted into the bladder by cystoscopy on Day 0 then removed on Day 14. Receives: Drug: LiRIS®; Drug: LiRIS Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in the Daily Average Bladder Pain Numeric Rating Scale (NRS)
The participant recorded their daily bladder pain score over the previous 24-hour period on a 7-day pain assessment tool as measured by an NRS on an 11-point scale where 0=no pain to 10=worst pain imaginable. The daily pain scores 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 (baseline bladder pain NRS: ≤ 5 or > 5) as factors was used for analysis.
Measured: Baseline (Day -7 to Day 0) to Week 4
Secondary outcomes (2)
Change From Baseline in the Number of Hunner's Lesions
During each cystoscopy, the investigator counted the number of lesions visible while performing the bladder scan. A negative change from Baseline indicates improvement (less lesions). An ANCOVA model with Baseline value as a covariate and treatment group and stratification (baseline bladder pain NRS: ≤ 5 or > 5) as factors was used for analysis.
Measured: Baseline (Day 0) to Week 4
Change From Baseline in Composite Score of Hunner's Lesions Calculated Based on Number, Size, and Severity of Lesions
A standardized video capture protocol for bladder mapping was followed to assess any changes in the number, the size and the severity, of lesions during the study as a result of treatment. A negative change from Baseline indicates improvement.
Measured: Baseline (Day 1) to Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2015 (estimated)
- Study start15 Apr 2015
- Primary completion29 Jun 2017
- Study completion20 Nov 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
- 59 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
- NCT02395042
- Sponsor's protocol ID
- 201025-001
- Status last verified
- Aug 2018
- First submitted
- 17 Mar 2015
- Last updated
- 5 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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 5 Oct 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 With Hunner's Lesions
- ClinicalTrials.gov ID
- NCT02395042
- Acronym / sponsor ID
- 201025-001
- Conditions
- Cystitis, Interstitial, Ulcer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 15 Apr 2015 (actual)
- Primary completion
- 29 Jun 2017 (actual)
- Study completion
- 20 Nov 2017 (actual)
- First posted
- 20 Mar 2015 (estimated)
- Results
- Posted 5 Oct 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 with Hunner's lesions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LiRIS Placebo, LiRIS Placebo (Tx 1)/LiRIS® (Tx 2) | Placebo comparator | Drug: LiRIS®Treatment 1 Period (Tx 1): Matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 10 and then removed and a second matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 14 and removed on Day 28. Treatment 2 Period (Tx 2): optional LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 and removed on Day 14. |
| LiRIS®, LiRIS® (Tx 1)/LiRIS® (Tx 2) | Experimental | Drug: LiRIS®, Drug: LiRIS PlaceboTreatment 1 Period: LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 then removed and a second LiRIS® 400 mg inserted into the bladder on Day 14 and removed on Day 28. Treatment 2 Period: optional LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 and then removed on Day 14. |
| LiRIS Placebo, LiRIS® (Tx 1)/ LiRIS® (Tx 2) | Experimental | Drug: LiRIS®, Drug: LiRIS PlaceboTreatment 1 Period: Matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 0 and then removed and LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 14 then removed on Day 28. Treatment 2 Period: optional LiRIS® 400 mg inserted into the bladder by cystoscopy on Day 0 then removed on Day 14. |
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 with Hunner's lesions/ulcers
Key exclusion criteria (2 listed)
- Previous treatment with LiRIS®
- Interstitial cystitis/bladder pain syndrome, without Hunner's lesions/ulcers
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. | Drug | LiRIS Placebo, LiRIS Placebo (Tx 1)/LiRIS® (Tx 2), LiRIS Placebo, LiRIS® (Tx 1)/ LiRIS® (Tx 2), LiRIS®, LiRIS® (Tx 1)/LiRIS® (Tx 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 | Drug | LiRIS Placebo, LiRIS® (Tx 1)/ LiRIS® (Tx 2), LiRIS®, LiRIS® (Tx 1)/LiRIS® (Tx 2) |
Primary outcome
Change From Baseline in the Daily Average Bladder Pain Numeric Rating Scale (NRS)
Time frame: Baseline (Day -7 to Day 0) to Week 4
The participant recorded their daily bladder pain score over the previous 24-hour period on a 7-day pain assessment tool as measured by an NRS on an 11-point scale where 0=no pain to 10=worst pain imaginable. The daily pain scores 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 (baseline bladder pain NRS: ≤ 5 or > 5) as factors was used for analysis.
2 secondary outcomes
Change From Baseline in the Number of Hunner's Lesions
Time frame: Baseline (Day 0) to Week 4
Change From Baseline in Composite Score of Hunner's Lesions Calculated Based on Number, Size, and Severity of Lesions
Time frame: Baseline (Day 1) to Week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 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.
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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
19 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 Ulcer, run by Allergan at 19 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 5 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 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. Some participants in this study may receive a placebo. 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 5 Oct 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 the Daily Average Bladder Pain Numeric Rating Scale (NRS) (time frame: Baseline (Day -7 to Day 0) to 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 NCT02395042, 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 5 Oct 2018.