Trial · NCT02411110
A Safety and Efficacy Study of LiRIS® in Females With Interstitial Cystitis/Bladder Pain Syndrome
NCT02411110, Phase 2, Completed, Allergan; results first posted 2018-01-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Safety and Efficacy Study of LiRIS® in Females With Interstitial Cystitis/Bladder Pain Syndrome. Trials, record NCT02411110. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02411110
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Safety and Efficacy Study of LiRIS® in Females With Interstitial Cystitis/Bladder Pain Syndrome
- NCT number
- NCT02411110
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 131 participants, actual
- Lead sponsor
- Allergan
- Conditions
- Cystitis, Interstitial, Painful Bladder Syndrome
- Interventions
- LiRIS®, LiRIS Placebo
- First posted
- 2015-04-08
- Last updated
- 2018-01-04
- Results first posted
- 2018-01-04
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Daily Average Bladder Pain to Treatment 1 Week 4 Follow-up | 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. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Daily Average Bladder Pain to Treatment 1 Week 4 Follow-up | Baseline (Days -7 to 0) to Treatment 1 Week 4 | Modified Intent-to-Treat (mITT) Analysis Population included all participants who were randomized and received Treatment 1. | score on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Daily Average Bladder Pain to Treatment 1 Week 4 Follow-up | LiRIS® (Treatment Period 1) | -1.2 | 90% Confidence Interval -1.77 to -0.58 | score on a scale | |
| Change From Baseline in Daily Average Bladder Pain to Treatment 1 Week 4 Follow-up | LiRIS Placebo (Treatment Period 1) | -1.5 | 90% Confidence Interval -2.14 to -0.87 | score on a scale |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period 1 | STARTED | LiRIS® (Treatment Period 1)/LiRIS® (Treatment Period 2) | 65 | |
| Treatment Period 1 | STARTED | LiRIS Placebo (Treatment Period 1)/LiRIS® (Treatment Period 2) | 66 | |
| Treatment Period 1 | COMPLETED | LiRIS® (Treatment Period 1)/LiRIS® (Treatment Period 2) | 56 | |
| Treatment Period 1 | COMPLETED | LiRIS Placebo (Treatment Period 1)/LiRIS® (Treatment Period 2) | 59 | |
| Treatment Period 1 | NOT COMPLETED | LiRIS® (Treatment Period 1)/LiRIS® (Treatment Period 2) | 9 | |
| Treatment Period 1 | NOT COMPLETED | LiRIS Placebo (Treatment Period 1)/LiRIS® (Treatment Period 2) | 7 | |
| Treatment Period 2 | STARTED | LiRIS® (Treatment Period 1)/LiRIS® (Treatment Period 2) | 50 | |
| Treatment Period 2 | STARTED | LiRIS Placebo (Treatment Period 1)/LiRIS® (Treatment Period 2) | 48 | |
| Treatment Period 2 | COMPLETED | LiRIS® (Treatment Period 1)/LiRIS® (Treatment Period 2) | 49 | |
| Treatment Period 2 | COMPLETED | LiRIS Placebo (Treatment Period 1)/LiRIS® (Treatment Period 2) | 44 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events76
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 | Nausea | Gastrointestinal disorders | LiRIS Placebo (Treatment Period 1) | 1 | 66 | |
| other | Nausea | Gastrointestinal disorders | LiRIS® (Treatment Period 1) | 4 | 65 | |
| other | Nausea | Gastrointestinal disorders | LiRIS Placebo (Treatment Period 1)/LiRIS® (Treatment Period 2) | 2 | 48 | |
| other | Nausea | Gastrointestinal disorders | LiRIS® (Treatment Period 1)/LiRIS® (Treatment Period 2) | 2 | 50 | |
| other | Urinary tract infection | Infections and infestations | LiRIS Placebo (Treatment Period 1) | 16 | 66 | |
| other | Urinary tract infection | Infections and infestations | LiRIS® (Treatment Period 1) | 10 | 65 | |
| other | Urinary tract infection | Infections and infestations | LiRIS Placebo (Treatment Period 1)/LiRIS® (Treatment Period 2) | 4 | 48 | |
| other | Urinary tract infection | Infections and infestations | LiRIS® (Treatment Period 1)/LiRIS® (Treatment Period 2) | 4 | 50 | |
| other | Vulvovaginal mycotic infection | Infections and infestations | LiRIS Placebo (Treatment Period 1) | 4 | 66 | |
| other | Vulvovaginal mycotic infection | Infections and infestations | LiRIS® (Treatment Period 1) | 3 | 65 |
1 to 10 of 76Source ClinicalTrials.gov
See all 76 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | LiRIS Placebo (Treatment Period 1) | ||
| Total, all-cause mortality | LiRIS® (Treatment Period 1) | ||
| Total, all-cause mortality | LiRIS Placebo (Treatment Period 1)/LiRIS® (Treatment Period 2) | ||
| Total, all-cause mortality | LiRIS® (Treatment Period 1)/LiRIS® (Treatment Period 2) | ||
| Total, other adverse events | LiRIS Placebo (Treatment Period 1) | 22 | 66 |
| Total, other adverse events | LiRIS® (Treatment Period 1) | 22 | 65 |
| Total, other adverse events | LiRIS Placebo (Treatment Period 1)/LiRIS® (Treatment Period 2) | 4 | 48 |
| Total, other adverse events | LiRIS® (Treatment Period 1)/LiRIS® (Treatment Period 2) | 7 | 50 |
| Total, serious adverse events | LiRIS Placebo (Treatment Period 1) | 1 | 66 |
| Total, serious adverse events | LiRIS® (Treatment Period 1) | 2 | 65 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34288094 | DERIVED |
Source PubMed
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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02411110
GET https://conductscience.org/api/trials/v1/NCT02411110/events?page=2