Trial Outcomes & Findings for A Safety, Tolerability and Preliminary Efficacy Study of LiRIS® 400 mg in Women With Interstitial Cystitis (IC) and Hunner's Lesions (NCT NCT01879683)

Last Updated: 2015-12-18

Results Overview

The appearance of the Hunner's lesions was assessed by the investigator using video capture of the bladder mucosa during the cystoscopic examinations. Complete responders (CR)=no lesions observed at day of last LiRIS removal; Partial responders (PR)=presence of residual lesions on day of last LiRIS removal however there is cystoscopic evidence of a decrease in either: i) the affected area as calculated by size and dimension of individual lesions summed together or ii) the lesion number or iii) the lesion(s) severity (mild, moderate, severe) as compared with Baseline assessment; Stable Disease=no change in the appearance of lesions and no new lesions on day of last LiRIS removal compared with Baseline assessment; Non-responders=worsening of mucosal appearance on day of last LiRIS removal.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

10 participants

Primary outcome timeframe

Baseline, Day 14

Results posted on

2015-12-18

Participant Flow

Participant milestones

Participant milestones
Measure	LiRIS® 400 mg LiRIS® 400 mg (Lidocaine Releasing Intravesical System 400 mg); a drug-device combination product, placed in the urinary bladder, and releases lidocaine into the bladder over a 14 day period.
Overall Study STARTED	10
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	LiRIS® 400 mg LiRIS® 400 mg (Lidocaine Releasing Intravesical System 400 mg); a drug-device combination product, placed in the urinary bladder, and releases lidocaine into the bladder over a 14 day period.
Overall Study Did not Complete 4-week Follow-up Visit	1

Baseline Characteristics

A Safety, Tolerability and Preliminary Efficacy Study of LiRIS® 400 mg in Women With Interstitial Cystitis (IC) and Hunner's Lesions

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LiRIS® 400 mg n=10 Participants LiRIS® 400 mg (Lidocaine Releasing Intravesical System 400 mg); a drug-device combination product, placed in the urinary bladder, and releases lidocaine into the bladder over a 14 day period.
Age, Continuous	57.2 years STANDARD_DEVIATION 9.16 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Day 14

Population: Per protocol population included all participants who retained each LiRIS for both 14-day treatment periods and then completed the 4-week follow-up visit without any major protocol deviations.

Outcome measures

Outcome measures
Measure	LiRIS® 400 mg n=7 Participants LiRIS® 400 mg (Lidocaine Releasing Intravesical System 400 mg); a drug-device combination product, placed in the urinary bladder, and releases lidocaine into the bladder over a 14 day period.
Percentage of Participants by Change From Baseline in Appearance of Hunner's Lesions at Day 14 Non-Responders	0.0 percentage of participants
Percentage of Participants by Change From Baseline in Appearance of Hunner's Lesions at Day 14 Complete Responders	0.0 percentage of participants
Percentage of Participants by Change From Baseline in Appearance of Hunner's Lesions at Day 14 Partial Responders	85.7 percentage of participants
Percentage of Participants by Change From Baseline in Appearance of Hunner's Lesions at Day 14 Stable Disease	14.3 percentage of participants

PRIMARY outcome

Timeframe: Baseline, Day 28

The appearance of the Hunner's lesions was assessed by the investigator using video capture of the bladder mucosa during the cystoscopic examinations. Complete responders (CR)=no lesions observed at day of last LiRIS removal; Partial responders (PR) = presence of residual lesions on day of last LiRIS removal however there is cystoscopic evidence of a decrease in either i) the affected area as calculated by size and dimension of individual lesions summed together or ii) the lesion number or iii) the lesion(s) severity (mild, moderate, severe) as compared with Baseline assessment; Stable Disease=no change in the appearance of lesions and no new lesions on day of last LiRIS removal compared with Baseline assessment; Non-responders=worsening of mucosal appearance on day of last LiRIS removal.

Outcome measures

Outcome measures
Measure	LiRIS® 400 mg n=7 Participants LiRIS® 400 mg (Lidocaine Releasing Intravesical System 400 mg); a drug-device combination product, placed in the urinary bladder, and releases lidocaine into the bladder over a 14 day period.
Percentage of Participants by Change From Baseline in Appearance of Hunner's Lesions at Day 28 Partial Responders	100.0 percentage of participants
Percentage of Participants by Change From Baseline in Appearance of Hunner's Lesions at Day 28 Complete Responders	0.0 percentage of participants
Percentage of Participants by Change From Baseline in Appearance of Hunner's Lesions at Day 28 Stable Disease	0.0 percentage of participants
Percentage of Participants by Change From Baseline in Appearance of Hunner's Lesions at Day 28 Non-Responders	0.0 percentage of participants

SECONDARY outcome

Timeframe: Baseline, during treatment (Days 7, 14, 20, 28) and during follow up (Weeks 1, 2, 4, 8, 12)

Participants rated symptom bladder pain averaged over the previous 3 days using an 11-point numeric rating scale where: 0=no pain to 10=worst pain imaginable. A negative change from Baseline indicates improvement.

Outcome measures

Outcome measures
Measure	LiRIS® 400 mg n=7 Participants LiRIS® 400 mg (Lidocaine Releasing Intravesical System 400 mg); a drug-device combination product, placed in the urinary bladder, and releases lidocaine into the bladder over a 14 day period.
Change From Baseline in Patient Reported Interstitial Cystitis (IC) Symptom: Average Bladder Pain Baseline	5.46 score on a scale Standard Deviation 1.955
Change From Baseline in Patient Reported Interstitial Cystitis (IC) Symptom: Average Bladder Pain Change from Baseline at Week 12 Follow-up (n=5)	-4.40 score on a scale Standard Deviation 2.939
Change From Baseline in Patient Reported Interstitial Cystitis (IC) Symptom: Average Bladder Pain Change from Baseline at Day 7	-1.71 score on a scale Standard Deviation 1.494
Change From Baseline in Patient Reported Interstitial Cystitis (IC) Symptom: Average Bladder Pain Change from Baseline at Day 14	-2.97 score on a scale Standard Deviation 1.739
Change From Baseline in Patient Reported Interstitial Cystitis (IC) Symptom: Average Bladder Pain Change from Baseline at Day 20	-4.00 score on a scale Standard Deviation 2.498
Change From Baseline in Patient Reported Interstitial Cystitis (IC) Symptom: Average Bladder Pain Change from Baseline at Day 28	-4.27 score on a scale Standard Deviation 2.411
Change From Baseline in Patient Reported Interstitial Cystitis (IC) Symptom: Average Bladder Pain Change from Baseline at Week 1 Follow-up	-4.11 score on a scale Standard Deviation 2.753
Change From Baseline in Patient Reported Interstitial Cystitis (IC) Symptom: Average Bladder Pain Change from Baseline at Week 2 Follow-up	-3.70 score on a scale Standard Deviation 2.922
Change From Baseline in Patient Reported Interstitial Cystitis (IC) Symptom: Average Bladder Pain Change from Baseline at Week 4 Follow-up	-3.69 score on a scale Standard Deviation 2.781
Change From Baseline in Patient Reported Interstitial Cystitis (IC) Symptom: Average Bladder Pain Change from Baseline at Week 8 Follow-up (n=5)	-3.72 score on a scale Standard Deviation 3.371

SECONDARY outcome

Timeframe: Baseline, during treatment (Days 7, 14, 20, 28) and during follow-up (Weeks 1, 2, 4, 8, 12)

The number of day-time voidings and the number of night-time voidings were averaged over a period of 3 full days and nights. A negative change from Baseline indicates improvement

Outcome measures

Outcome measures
Measure	LiRIS® 400 mg n=7 Participants LiRIS® 400 mg (Lidocaine Releasing Intravesical System 400 mg); a drug-device combination product, placed in the urinary bladder, and releases lidocaine into the bladder over a 14 day period.
Change From Baseline in Patient Reported IC Symptom: Daily Total Voids Change from Baseline at Week 4 Follow-up	-5.4 voids Standard Deviation 4.29
Change From Baseline in Patient Reported IC Symptom: Daily Total Voids Baseline	18.2 voids Standard Deviation 5.74
Change From Baseline in Patient Reported IC Symptom: Daily Total Voids Change from Baseline at Day 7	-3.3 voids Standard Deviation 2.27
Change From Baseline in Patient Reported IC Symptom: Daily Total Voids Change from Baseline at Day 14	-3.5 voids Standard Deviation 3.95
Change From Baseline in Patient Reported IC Symptom: Daily Total Voids Change from Baseline at Day 20	-5.7 voids Standard Deviation 2.18
Change From Baseline in Patient Reported IC Symptom: Daily Total Voids Change from Baseline at Day 28	-5.5 voids Standard Deviation 2.46
Change From Baseline in Patient Reported IC Symptom: Daily Total Voids Change from Baseline at Week 1 Follow-up	-5.3 voids Standard Deviation 3.67
Change From Baseline in Patient Reported IC Symptom: Daily Total Voids Change from Baseline at Week 2 Follow-up	-4.5 voids Standard Deviation 4.41
Change From Baseline in Patient Reported IC Symptom: Daily Total Voids Change from Baseline at Week 8 Follow-up (n=5)	-4.9 voids Standard Deviation 4.42
Change From Baseline in Patient Reported IC Symptom: Daily Total Voids Change from Baseline at Week 1 Follow-up (n=5)	-3.9 voids Standard Deviation 4.42

Adverse Events

LiRIS® 400 mg

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	LiRIS® 400 mg n=10 participants at risk LiRIS® 400 mg (Lidocaine Releasing Intravesical System 400 mg); a drug-device combination product, placed in the urinary bladder, and releases lidocaine into the bladder over a 14 day period.
Gastrointestinal disorders Constipation	10.0% 1/10
Gastrointestinal disorders Nausea	10.0% 1/10
Gastrointestinal disorders Proctalgia	10.0% 1/10
Infections and infestations Cystitis	10.0% 1/10
Infections and infestations Urinary tract infection	10.0% 1/10
Nervous system disorders Headache	10.0% 1/10
Nervous system disorders Paraesthesia	10.0% 1/10
Renal and urinary disorders Dysuria	10.0% 1/10
Renal and urinary disorders Pollakiuria	10.0% 1/10
Respiratory, thoracic and mediastinal disorders Cough	10.0% 1/10
Respiratory, thoracic and mediastinal disorders Dyspnoea	10.0% 1/10
General disorders Peripheral swelling	10.0% 1/10
Injury, poisoning and procedural complications Fall	10.0% 1/10
Investigations Blood urine present	10.0% 1/10
Investigations White blood cells urine positive	10.0% 1/10
Skin and subcutaneous tissue disorders Rash	10.0% 1/10

Additional Information

Therapeutic Area Head,

Allergan, Inc

Phone: 714-246-4500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Publication restrictions are in place

Restriction type: OTHER