Trial · NCT01475253
Double-Blind Placebo Controlled Study of Safety,Tolerability, and Efficacy of LiRIS® in Women With Interstitial Cystitis
NCT01475253, Phase 2, Terminated, Allergan; results first posted 2015-09-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Double-Blind Placebo Controlled Study of Safety,Tolerability, and Efficacy of LiRIS® in Women With Interstitial Cystitis. Trials, record NCT01475253. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01475253
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Double-Blind Placebo Controlled Study of Safety,Tolerability, and Efficacy of LiRIS® in Women With Interstitial Cystitis
- NCT number
- NCT01475253
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 104 participants, actual
- Lead sponsor
- Allergan
- Conditions
- Interstitial Cystitis
- Interventions
- Lidocaine Releasing Intravesical System - LiRIS®, LiRIS Placebo, Sham Cystoscopy Procedure
- First posted
- 2011-11-21
- Last updated
- 2015-09-21
- Results first posted
- 2015-09-21
- Limitations and caveats
- As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group. Only safety analyses were completed.
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) at Day 7 | 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. |
| Primary | Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) at Day 14 | 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. |
| Primary | Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) ay Day 28 | 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. |
| Primary | Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) at Day 42 | 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. |
| Secondary | Percentage of Responders Using the Global Response Assessment (GRA) | Baseline, Days 7, 14, 28 and 42 | 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. |
| Secondary | Change From Baseline in Urinary Urgency as Assessed by VAS | Baseline, Days 7, 14, 28 and 42 | 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. |
| Secondary | Change From Baseline in Voiding Frequency | Baseline, Days 7, 14, 28 and 42 | 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. |
| Secondary | Change Form Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score | Baseline, Days 7, 14, 28 and 42 | 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 |
| Secondary | Change From Baseline in Interstitial Cystitis Problem Index (ICPI) Score | Baseline, Days 7, 14, 28 and 42 | 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. |
| Secondary | Percentage of Participants With Change From Baseline in Cystoscopic Examination Findings | Baseline, Day 14 | 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. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Percentage of Responders Using the Global Response Assessment (GRA) | Baseline, Days 7, 14, 28 and 42 | Complete IDMC Population included all participants with available IDMC data. As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group. | Percentage of Responders | NUMBER |
| PRIMARY | Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) at Day 7 | Baseline, Day 7 | Independent Data Monitoring Committee (IDMC) Population included data reviewed by the IDMC prior to study suspension. As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group. | centimeters | MEAN |
| PRIMARY | Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) at Day 14 | Baseline, Day 14 | Independent Data Monitoring Committee (IDMC) Population included data reviewed by the IDMC prior to study suspension. As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group. | centimeters | MEAN |
| PRIMARY | Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) ay Day 28 | Baseline, Day 28 | Independent Data Monitoring Committee (IDMC) Population included data reviewed by the IDMC prior to study suspension. As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group. | centimeters | MEAN |
| PRIMARY | Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) at Day 42 | Baseline, Day 42 | Independent Data Monitoring Committee (IDMC) Population included data reviewed by the IDMC prior to study suspension. As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group. | centimeters | MEAN |
| SECONDARY | Change From Baseline in Urinary Urgency as Assessed by VAS | Baseline, Days 7, 14, 28 and 42 | Complete IDMC Population included all participants with available IDMC data. As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group. | centimeters | MEAN |
| SECONDARY | Change From Baseline in Voiding Frequency | Baseline, Days 7, 14, 28 and 42 | Complete IDMC Population included all participants with available IDMC data. As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group. | Voids | MEAN |
| SECONDARY | Change Form Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score | Baseline, Days 7, 14, 28 and 42 | Complete IDMC Population included all participants with available IDMC data. As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Interstitial Cystitis Problem Index (ICPI) Score | Baseline, Days 7, 14, 28 and 42 | Complete IDMC Population included all participants with available IDMC data. As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group. | score on a scale | MEAN |
| SECONDARY | Percentage of Participants With Change From Baseline in Cystoscopic Examination Findings | Baseline, Day 14 | Intent-to-treat population included all enrolled participants for whom the study insertion procedure on Baseline Randomized was initiated. As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group68
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Responders Using the Global Response Assessment (GRA) | LiRIS® 400 Mg-Randomized Study | Day 7 | 24 | Percentage of Responders | |
| Percentage of Responders Using the Global Response Assessment (GRA) | LiRIS® Placebo-Randomized Study | Day 7 | 18 | Percentage of Responders | |
| Percentage of Responders Using the Global Response Assessment (GRA) | LiRIS® 400 Mg-Randomized Study | Day 14 | 17 | Percentage of Responders | |
| Percentage of Responders Using the Global Response Assessment (GRA) | LiRIS® Placebo-Randomized Study | Day 14 | 20 | Percentage of Responders | |
| Percentage of Responders Using the Global Response Assessment (GRA) | LiRIS® 400 Mg-Randomized Study | Day 28 | 7 | Percentage of Responders | |
| Percentage of Responders Using the Global Response Assessment (GRA) | LiRIS® Placebo-Randomized Study | Day 28 | 25 | Percentage of Responders | |
| Percentage of Responders Using the Global Response Assessment (GRA) | LiRIS® 400 Mg-Randomized Study | Day 42 | 12 | Percentage of Responders | |
| Percentage of Responders Using the Global Response Assessment (GRA) | LiRIS® Placebo-Randomized Study | Day 42 | 21 | Percentage of Responders | |
| Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) at Day 7 | LiRIS® 400 Mg-Randomized Study | -1.25 | Standard Deviation 2.45 | centimeters | |
| Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) at Day 7 | LiRIS® Placebo-Randomized Study | -0.84 | Standard Deviation 1.92 | centimeters |
1 to 10 of 68Source ClinicalTrials.gov
See all 68 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Randomized, Blinded Study | STARTED | LiRIS® 400 mg - Randomized Study | 47 | |
| Randomized, Blinded Study | STARTED | LiRIS® Placebo-Randomized Study | 46 | |
| Randomized, Blinded Study | STARTED | Sham Cystoscopic Procedure-Randomized Study | 11 | |
| Randomized, Blinded Study | STARTED | LiRIS® 400 mg - Open Label Extension | 0 | |
| Randomized, Blinded Study | COMPLETED | LiRIS® 400 mg - Randomized Study | 45 | |
| Randomized, Blinded Study | COMPLETED | LiRIS® Placebo-Randomized Study | 45 | |
| Randomized, Blinded Study | COMPLETED | Sham Cystoscopic Procedure-Randomized Study | 11 | |
| Randomized, Blinded Study | COMPLETED | LiRIS® 400 mg - Open Label Extension | 0 | |
| Randomized, Blinded Study | NOT COMPLETED | LiRIS® 400 mg - Randomized Study | 2 | |
| Randomized, Blinded Study | NOT COMPLETED | LiRIS® Placebo-Randomized Study | 1 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events132
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Dysuria | Renal and urinary disorders | LiRIS® 400 mg - Randomized Study | 11 | 46 | 13 |
| other | Dysuria | Renal and urinary disorders | LiRIS® Placebo - Randomized Study | 7 | 46 | 8 |
| other | Dysuria | Renal and urinary disorders | Sham Cystoscopic Procedure - Randomized Study | 0 | 11 | 0 |
| other | Dysuria | Renal and urinary disorders | LiRIS 400 mg - Open Label Extension | 9 | 56 | 12 |
| other | Bladder Pain | Renal and urinary disorders | LiRIS® 400 mg - Randomized Study | 8 | 46 | 9 |
| other | Bladder Pain | Renal and urinary disorders | LiRIS® Placebo - Randomized Study | 11 | 46 | 12 |
| other | Bladder Pain | Renal and urinary disorders | Sham Cystoscopic Procedure - Randomized Study | 1 | 11 | 1 |
| other | Bladder Pain | Renal and urinary disorders | LiRIS 400 mg - Open Label Extension | 9 | 56 | 10 |
| other | Bladder Discomfort | Renal and urinary disorders | LiRIS® 400 mg - Randomized Study | 5 | 46 | 5 |
| other | Bladder Discomfort | Renal and urinary disorders | LiRIS® Placebo - Randomized Study | 2 | 46 | 2 |
1 to 10 of 132Source ClinicalTrials.gov
See all 132 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | LiRIS® 400 mg - Randomized Study | ||
| Total, all-cause mortality | LiRIS® Placebo - Randomized Study | ||
| Total, all-cause mortality | Sham Cystoscopic Procedure - Randomized Study | ||
| Total, all-cause mortality | LiRIS 400 mg - Open Label Extension | ||
| Total, other adverse events | LiRIS® 400 mg - Randomized Study | 23 | 46 |
| Total, other adverse events | LiRIS® Placebo - Randomized Study | 23 | 46 |
| Total, other adverse events | Sham Cystoscopic Procedure - Randomized Study | 7 | 11 |
| Total, other adverse events | LiRIS 400 mg - Open Label Extension | 29 | 56 |
| Total, serious adverse events | LiRIS® 400 mg - Randomized Study | 1 | 46 |
| Total, serious adverse events | LiRIS® Placebo - Randomized Study | 2 | 46 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT01475253
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