Interstitial CystitisPhase 2NCT01475253
Double-Blind Placebo Controlled Study of Safety,Tolerability, and Efficacy of LiRIS® in Women With Interstitial Cystitis
A Phase 2 study testing Lidocaine Releasing Intravesical System - LiRIS® in people with Interstitial Cystitis, run by Allergan at 29 sites in 2 countries.
Trial summary
The purpose of this study is to determine if LiRIS®, an investigational drug-delivery system, is safe, tolerable and effective in women with Interstitial Cystitis. LiRIS® is inserted into the bladder via cystoscopy , remains in the bladder for 14 days, and is removed via cystoscopy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Interstitial Cystitis
- What is being tested?
- Lidocaine Releasing Intravesical System - LiRIS®
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 29 sitesin 2 countries
- Study dates
- Nov 2011to Dec 2012
- 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
- Women age 18 and over
- Diagnosed with Interstitial Cystitis as defined by protocol
- Able and willing to complete questionnaires and diary
- Able to comply with visit schedule including Day 14 Removal visit
- Completion of blinded study prior to enrolling in unblinded part of study
Who cannot join
- Pregnant or lactating women
- Bladder or urethra anatomical feature that would prevent the safe indwelling or insertion of the investigational product
- History or presence of any condition that would make it difficult to evaluate symptoms
- Did not complete blinded study (unblinded part of study only)
Trial locations and contacts
29 sites in 2 countries.
29 sites in 2 countries
United States27 sites
Manatee Medical Research Institute, LLC
Bradenton, Florida, 34205
Lahey Clinic Medical Center
Burlington, Massachusetts, 01805
Medical University of South Carolina Urology Ambulatory Care
Charleston, South Carolina, 29425
MetroHealth Medical Center
Cleveland, Ohio, 44109
North Idaho Urology
Coeur d'Alene, Idaho, 83814
Genitourinary Surgical Consultants
Denver, Colorado, 80220
Women's Health Specialty Care
Farmington, Connecticut, 06032
Clinical Trials of Arizona
Glendale, Arizona, 85306
Citrus Valley Medical Research, Inc
Glendora, California, 91741
Female Pelvic Medicine & Urogynecology
Grand Rapids, Michigan, 49503
Alliance Urology Specialists
Greensboro, North Carolina, 27403
CRC of Jackson and Southeast Urogynecology
Jackson, Mississippi, 39202
First Urology
Jeffersonville, Indiana, 47130
Sheldon Freedman, MD Ltd
Las Vegas, Nevada, 89148
Idaho Urologic Center
Meridian, Idaho, 83642
Integrity Medical Research
Mountlake Terrace, Washington, 98043
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Grove Hill Clinical Research
New Britain, Connecticut, 06052
Arthur Smith Institute for Urology
New Hyde Park, New York, 11040
Penn. Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
University of Rochester, Department of Urology
Rochester, New York, 14642
William Beaumont Hospital
Royal Oak, Michigan, 48073
Regional Urology LLC
Shreveport, Louisiana, 71106
Stanford University Department of Urology
Stanford, California, 94306
Bay State Clinical Trials, Inc
Watertown, Massachusetts, 02472
Wake Forest University Health Sciences Medical Center
Winston-Salem, North Carolina, 27103
Canada2 sites
Centre for Applied Urologic Research/Kingston General Hospital
Kingston, Ontario, K7L 3J7
Pacific Urological Research
Victoria, British Columbia, V8V 3N1
About this study
Official title: A Phase 2a Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study Evaluating Safety, Tolerability and Efficacy of LiRIS® in Women With Interstitial Cystitis Followed by an Open Label Extension
The purpose of this study is to determine if LiRIS®, an investigational drug-delivery system, is safe, tolerable and effective in women with Interstitial Cystitis. LiRIS® is inserted into the bladder via cystoscopy , remains in the bladder for 14 days, and is removed via cystoscopy.
Read the detailed description
The study is conducted in 2 parts - a randomized, blinded part in which patients are randomly assigned to one of 3 possible arms (LiRIS® - contains lidocaine), LiRIS Placebo (LiRIS with inactive substance) or Sham(Insertion procedure only with neither LiRIS nor LiRIS Placebo), followed by an open extension part in which all patients are assigned to receive LiRIS® (with lidocaine). In part 1 of the study, treatment is managed in a double-blind manner for LiRIS® and LiRIS Placebo arms; and in a single-blind manner for the Sham arm (e.g.,the study doctor will know the treatment assignment for patients assigned to Sham).
All patients who complete part 1 of the study have the option to enter the extension.
- Conditions
- Interstitial Cystitis
- Being tested
- Lidocaine Releasing Intravesical System - LiRIS®, LiRIS Placebo, Sham Cystoscopy Procedure
- Medical subject headings
- Cystitis, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine Releasing Intravesical System - LiRIS®Drug
Also called LiRIS® 400 mg, LiRIS® 400 mg (Active)
Lidocaine Releasing Intravesical System (LiRIS®) is inserted into the bladder via cystoscopy on Study Day 0 and removed on Study Day 14. LiRIS releases lidocaine gradually during the 14 day indwelling period.
LiRIS PlaceboOther
Also called LiRIS® 400 mg Placebo
LiRIS Placebo contains inactive substance only; LiRIS Placebo is inserted into the bladder via cystoscopy on study Day 0 and removed via cystoscopy on study Day 14.
Sham Cystoscopy ProcedureProcedure or surgery
Also called Sham Comparator, Sham arm
Cystoscopy procedure only; no investigational product is inserted/removed from the bladder.
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine Releasing Intravesical System | Experimental | Lidocaine Releasing Intravesical System (LiRIS®) is inserted into the bladder via cystoscopy on Study Day 0 and removed on Study Day 14. LiRIS releases lidocaine gradually during the 14 day indwelling period. Receives: Drug: Lidocaine Releasing Intravesical System - LiRIS® |
| LiRIS containing inactive substance only | Placebo comparator | LiRIS Placebo is inserted into the bladder via cystoscopy on study Day 0 and removed via cystoscopy on study Day 14. Receives: Other: LiRIS Placebo |
| Cystoscopy Procedure | Sham comparator | No intervention. Cystoscopy procedure is performed on study Day 0 and study Day 14 to mimick active and placebo study arms without insertion of Investigational Product into the bladder. Receives: Procedure: Sham Cystoscopy Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) at Day 7
Participant reported symptom of bladder pain in the prior 24 hours using a 10 centimeter (cm) horizontal line Pain Visual Analog Scale recorded in a diary. Participants were instructed to to put a mark on the line at the point that best described their bladder pain with 0 (far left on the line) reflecting no pain and 10 (far right on the line) reflecting worse possible pain. A negative change from Baseline indicates improvement.
Measured: Baseline, Day 7
Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) at Day 14
Participant reported symptom of bladder pain in the prior 24 hours using a 10 centimeter horizontal line Pain Visual Analog Scale recorded in a diary. Participants were instructed to to put a mark on the line at the point that best described their bladder pain with 0 (far left on the line) reflecting no pain and 10 (far right on the line) reflecting worse possible pain. A negative change from Baseline indicates improvement.
Measured: Baseline, Day 14
Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) ay Day 28
Participant reported symptom of bladder pain in the prior 24 hours using a 10 centimeter horizontal line Pain Visual Analog Scale recorded in a diary. Participants were instructed to to put a mark on the line at the point that best described their bladder pain with 0 (far left on the line) reflecting no pain and 10 (far right on the line) reflecting worse possible pain. A negative change from Baseline indicates improvement.
Measured: Baseline, Day 28
Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) at Day 42
Participant reported symptom of bladder pain in the prior 24 hours using a 10 centimeter horizontal line Pain Visual Analog Scale recorded in a diary. Participants were instructed to to put a mark on the line at the point that best described their bladder pain with 0 (far left on the line) reflecting no pain and 10 (far right on the line) reflecting worse possible pain. A negative change from Baseline indicates improvement.
Measured: Baseline, Day 42
Secondary outcomes (6)
Percentage of Responders Using the Global Response Assessment (GRA)
Participants assessed their response to treatment using a seven item scale from Markedly improved to Markedly worse. A responder was defined as a participant who rated their symptoms as either Moderately or Markedly improved.
Measured: Baseline, Days 7, 14, 28 and 42
Change From Baseline in Urinary Urgency as Assessed by VAS
Urinary urgency was defined as an immediate unstoppable urge to urinate which may be due to a sudden involuntary contraction of the muscular wall of the bladder and may be accompanied by discomfort in the bladder. Participants reported symptom of urinary urgency in the last 24 hours using a Urgency Visual Analogue Scale (VAS). The Urgency VAS consists of a 10 centimeter (cm) horizontal line with the words "No Urgency" (best) at the left end (0 cm) and the words "Urgency as bad as you can imagine" (worst) at the right end (10 cm). Participants were instructed to complete the Pain VAS by marking the spot on the line that corresponded to their urinary urgency. A negative change from Baseline indicates improvement.
Measured: Baseline, Days 7, 14, 28 and 42
Change From Baseline in Voiding Frequency
Participants recorded Voiding Frequency in a 72 hour voiding log at Day 7, 14, 28 and 42. Lower numbers of voiding frequency is the best. A negative change from Baseline indicates improvement.
Measured: Baseline, Days 7, 14, 28 and 42
Change Form Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score
Participants answered four questions about bladder/voiding symptoms over the past month. 2 questions were on a scale of 0=Not at all to 5=Almost always, 1 question on a scale of 0=Not at all to 5=5 or more times per night and 1 questions from 0=Not at all to 4=Almost always for a total possible score of 0 (best) to19 (worst). A negative change from Baseline indicates improvement
Measured: Baseline, Days 7, 14, 28 and 42
Change From Baseline in Interstitial Cystitis Problem Index (ICPI) Score
Participants answered four questions about how bothersome their symptoms were over the past month using a 5 point scale: 1=No problem to 4=Big problem for a total possible score of 0 (best) to 16 worst). A negative change from Baseline indicates improvement.
Measured: Baseline, Days 7, 14, 28 and 42
Percentage of Participants With Change From Baseline in Cystoscopic Examination Findings
Cystoscopic examinations were performed at Baseline and Day 14. The investigator assessed the urethra and bladder for the following: visibility of ureters, stricture, erythema, presence and number of Hunner's lesion(s) and the extent of erythema. For sites with the capability, videography or high resolution digital photographs of the bladder were taken. The findings at Day 14 were compared to the findings at Baseline and were reported as Improvement, Worsening or No Change.
Measured: Baseline, Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionDec 2012
- Study completionDec 2012
Why it stopped: This study was not enrolled completely and was terminated.
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.
- Other trials for Interstitial CystitisStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- TARIS Biomedical, Inc.
- Responsible party
- Sponsor
- Investigators
- Curtis Nickel, MD, Principal investigator, Queen's University/Kingston General Hospital/Ontario Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01475253
- Sponsor's protocol ID
- TAR-100-201
- Status last verified
- Aug 2015
- First submitted
- 3 Nov 2011
- Last updated
- 21 Sep 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study Evaluating Safety, Tolerability and Efficacy of LiRIS® in Women With Interstitial Cystitis Followed by an Open Label Extension
- ClinicalTrials.gov ID
- NCT01475253
- Acronym / sponsor ID
- TAR-100-201
- Conditions
- Interstitial Cystitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was not enrolled completely and was terminated.
- Enrolment
- 104 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Collaborators
- TARIS Biomedical, Inc.
- Study start
- Nov 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 21 Nov 2011 (estimated)
- Results
- Posted 21 Sep 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if LiRIS®, an investigational drug-delivery system, is safe, tolerable and effective in women with Interstitial Cystitis. LiRIS® is inserted into the bladder via cystoscopy , remains in the bladder for 14 days, and is removed via cystoscopy.
Detailed description
The study is conducted in 2 parts - a randomized, blinded part in which patients are randomly assigned to one of 3 possible arms (LiRIS® - contains lidocaine), LiRIS Placebo (LiRIS with inactive substance) or Sham(Insertion procedure only with neither LiRIS nor LiRIS Placebo), followed by an open extension part in which all patients are assigned to receive LiRIS® (with lidocaine). In part 1 of the study, treatment is managed in a double-blind manner for LiRIS® and LiRIS Placebo arms; and in a single-blind manner for the Sham arm (e.g.,the study doctor will know the treatment assignment for patients assigned to Sham).
All patients who complete part 1 of the study have the option to enter the extension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lidocaine Releasing Intravesical System | Experimental | Drug: Lidocaine Releasing Intravesical System - LiRIS®Lidocaine Releasing Intravesical System (LiRIS®) is inserted into the bladder via cystoscopy on Study Day 0 and removed on Study Day 14. LiRIS releases lidocaine gradually during the 14 day indwelling period. |
| LiRIS containing inactive substance only | Placebo comparator | Other: LiRIS PlaceboLiRIS Placebo is inserted into the bladder via cystoscopy on study Day 0 and removed via cystoscopy on study Day 14. |
| Cystoscopy Procedure | Sham comparator | Procedure: Sham Cystoscopy ProcedureNo intervention. Cystoscopy procedure is performed on study Day 0 and study Day 14 to mimick active and placebo study arms without insertion of Investigational Product into the bladder. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women age 18 and over
- Diagnosed with Interstitial Cystitis as defined by protocol
- Able and willing to complete questionnaires and diary
- Able to comply with visit schedule including Day 14 Removal visit
- Completion of blinded study prior to enrolling in unblinded part of study
Key exclusion criteria (4 listed)
- Pregnant or lactating women
- Bladder or urethra anatomical feature that would prevent the safe indwelling or insertion of the investigational product
- History or presence of any condition that would make it difficult to evaluate symptoms
- Did not complete blinded study (unblinded part of study only)
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 |
|---|---|---|
| Lidocaine Releasing Intravesical System - LiRIS®Also: LiRIS® 400 mg, LiRIS® 400 mg (Active)Lidocaine Releasing Intravesical System (LiRIS®) is inserted into the bladder via cystoscopy on Study Day 0 and removed on Study Day 14. LiRIS releases lidocaine gradually during the 14 day indwelling period. | Drug | Lidocaine Releasing Intravesical System |
| LiRIS PlaceboAlso: LiRIS® 400 mg PlaceboLiRIS Placebo contains inactive substance only; LiRIS Placebo is inserted into the bladder via cystoscopy on study Day 0 and removed via cystoscopy on study Day 14. | Other | LiRIS containing inactive substance only |
| Sham Cystoscopy ProcedureAlso: Sham Comparator, Sham armCystoscopy procedure only; no investigational product is inserted/removed from the bladder. | Procedure or surgery | Cystoscopy Procedure |
Primary outcome
Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) at Day 7
Time frame: Baseline, Day 7
Participant reported symptom of bladder pain in the prior 24 hours using a 10 centimeter (cm) horizontal line Pain Visual Analog Scale recorded in a diary. Participants were instructed to to put a mark on the line at the point that best described their bladder pain with 0 (far left on the line) reflecting no pain and 10 (far right on the line) reflecting worse possible pain. A negative change from Baseline indicates improvement.
Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) at Day 14
Time frame: Baseline, Day 14
Participant reported symptom of bladder pain in the prior 24 hours using a 10 centimeter horizontal line Pain Visual Analog Scale recorded in a diary. Participants were instructed to to put a mark on the line at the point that best described their bladder pain with 0 (far left on the line) reflecting no pain and 10 (far right on the line) reflecting worse possible pain. A negative change from Baseline indicates improvement.
Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) ay Day 28
Time frame: Baseline, Day 28
Participant reported symptom of bladder pain in the prior 24 hours using a 10 centimeter horizontal line Pain Visual Analog Scale recorded in a diary. Participants were instructed to to put a mark on the line at the point that best described their bladder pain with 0 (far left on the line) reflecting no pain and 10 (far right on the line) reflecting worse possible pain. A negative change from Baseline indicates improvement.
Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) at Day 42
Time frame: Baseline, Day 42
Participant reported symptom of bladder pain in the prior 24 hours using a 10 centimeter horizontal line Pain Visual Analog Scale recorded in a diary. Participants were instructed to to put a mark on the line at the point that best described their bladder pain with 0 (far left on the line) reflecting no pain and 10 (far right on the line) reflecting worse possible pain. A negative change from Baseline indicates improvement.
6 secondary outcomes
Percentage of Responders Using the Global Response Assessment (GRA)
Time frame: Baseline, Days 7, 14, 28 and 42
Change From Baseline in Urinary Urgency as Assessed by VAS
Time frame: Baseline, Days 7, 14, 28 and 42
Change From Baseline in Voiding Frequency
Time frame: Baseline, Days 7, 14, 28 and 42
Change Form Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score
Time frame: Baseline, Days 7, 14, 28 and 42
Change From Baseline in Interstitial Cystitis Problem Index (ICPI) Score
Time frame: Baseline, Days 7, 14, 28 and 42
Percentage of Participants With Change From Baseline in Cystoscopic Examination Findings
Time frame: Baseline, Day 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Curtis Nickel, MD principal investigator
Queen's University/Kingston General Hospital/Ontario Canada
29 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 Lidocaine Releasing Intravesical System - LiRIS® in people with Interstitial Cystitis, run by Allergan at 29 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 5 inclusion and 4 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: stopped early, as of the sponsor's last update on 21 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 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 21 Sep 2015). 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 Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) at Day 7 (time frame: Baseline, Day 7). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Sep 2015.