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A Safety and Efficacy Study of LiRIS® in Females With Interstitial Cystitis/Bladder Pain Syndrome

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ClinicalTrials.gov Identifier: NCT02411110
Recruitment Status : Completed
First Posted : April 8, 2015
Results First Posted : January 4, 2018
Last Update Posted : January 4, 2018
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief Summary:
This is a safety and efficacy study of LiRIS® in females with interstitial cystitis/bladder pain syndrome.

Condition or disease Intervention/treatment Phase
Cystitis, Interstitial Painful Bladder Syndrome Combination Product: LiRIS® Combination Product: LiRIS Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 131 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating Safety and Efficacy of LiRIS® 400 mg in Females With Interstitial Cystitis/Bladder Pain Syndrome
Actual Study Start Date : May 21, 2015
Actual Primary Completion Date : October 12, 2016
Actual Study Completion Date : January 9, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LiRIS® (Treatment Period 1)/LiRIS® (Treatment Period 2)
Treatment Period 1: continuous release of lidocaine inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 1. Treatment Period 2: optional continuous release of lidocaine inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 2.
Combination Product: 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.

LiRIS Placebo (Treatment Period 1)/LiRIS® (Treatment Period 2)
Treatment period 1: Matching placebo device to LiRIS inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 1. Treatment Period 2: optional continuous release of lidocaine inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 2.
Combination Product: 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.

Combination Product: LiRIS Placebo
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.




Primary Outcome Measures :
  1. Change From Baseline in Daily Average Bladder Pain to Treatment 1 Week 4 Follow-up [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of interstitial cystitis or bladder pain syndrome

Exclusion Criteria:

  • Diagnosis of interstitial cystitis with Hunner's lesions/ulcers
  • Previous treatment with LiRIS®

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02411110


  Show 34 Study Locations
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Till Geib Allergan

Additional Information:
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02411110     History of Changes
Other Study ID Numbers: 201025-002
First Posted: April 8, 2015    Key Record Dates
Results First Posted: January 4, 2018
Last Update Posted: January 4, 2018
Last Verified: December 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Additional relevant MeSH terms:
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Cystitis
Cystitis, Interstitial
Syndrome
Disease
Pathologic Processes
Urinary Bladder Diseases
Urologic Diseases
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action