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Evaluation of Intravesical LP08 in Patients With Interstitial Cystitis/Painful Bladder Syndrome

Primary Purpose

Interstitial Cystitis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
LP-08 80mg
Normal saline
LP-08 20mg
Sponsored by
Lipella Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Interstitial Cystitis focused on measuring Interstitial Cystitis, Painful Bladder Syndrome, Bladder Pain Syndrome, Liposome, LP-08

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

A patient is deemed suitable for inclusion in the study if the patient meets the following criteria:

  1. Male or female at least 18 years of age
  2. IC/BPS diagnosed by a health care provider based the following criteria:

    Complaint of suprapubic pain related to bladder filling, accompanied by other symptoms such as increased daytime and night time frequency, in the absence of proven urinary infection or other obvious pathology Have had IC/BPS symptoms for at least six months Score of ≥ 12 on the ICSI/PI at baseline Urinary frequency > 10 times a day by self-report and confirmed on baseline three-day voiding diary Have IC/BPS that in the judgment of the investigator has been stable in the previous 30 days IC/BPS-related pain defined as a score of > 3 cm and < 9 cm on the pain VAS where 0 is no pain and 10 is maximum pain

  3. Have had inadequate clinical responses with conservative treatments, which may include one or more of the following: 1) timed voiding and behavioral modification therapy, 2) dietary restrictions, 3) stress reduction and/or 5) oral therapy with any of the following medications:

    Antidepressants Antihistamines Antimuscarinic and anticholinergic agents Alpha adrenergic blockers Analgesics Pentosan polysulfate

  4. Women of childbearing potential: have a negative urine pregnancy test at screening, and must agree to use an acceptable from of contraception (oral contraceptives, intrauterine or double barrier methods), as agreed to by the investigator, during the study period
  5. Provide signed informed consent
  6. Subject agrees to be available for the follow-up evaluations as required by the protocol

Exclusion Criteria:

Patients are excluded from enrollment in the study if any of the following are true:

  1. Currently pregnant or breastfeeding, or plan to become pregnant during the course of the study
  2. Have received investigational products or devices within 30 days prior to screening visit
  3. Have received intravesical therapy or bladder hydrodistention within 30 days prior to screening visit. Intravesical instillations may include liquid or drug delivery devices, pentosan polysulfate sodium, lidocaine, steroid, heparin, chondroitin and any combination or additional formulation.
  4. Have participated in IC/BPS research trial within 90 days prior to screening visit or has not returned to baseline if participated in IC/BPS research trial greater than 90 days prior to screening visit
  5. Have received any of the following medication within 30 days of screening visit, unless such medications have been administered at a stable dose during this month and are expected to remain at a stable dose throughout the study:

    Antidepressants Antihistamines (use of antihistamines as needed for allergies is allowed) Anticonvulsants Antimuscarinic and anticholinergic agents Alpha adrenergic blockers Pentosan polysulfate sodium Oral chondroitin

  6. Have indicated use of > 70 mg of morphine equivalents of opioids per week to control their IC/BPS pain within 30 days prior to screening, or are expected to require this level of IC/BPS pain control during the study period
  7. Previous augmentation cystoplasty, cystectomy, neurectomy (i.e., hypogastric nerve plexus ablation). Bladder botulinum toxin injections within nine months prior to screening.
  8. Sacral and/or pudendal nerve neuromodulation device (Interstim) within the last 6 months. Subjects would not be excluded if they had Interstim greater than 6 months ago and is on a stable setting within the past 90 days
  9. Percutaneous Tibial Nerve Stimulation (PTNS) treatment within the past 90 days
  10. Evidence of renal impairment (creatinine > two times the upper limit of normal at Visit 1), hepatic impairment (AST or ALT > three times the upper limit of normal at Visit 1), clinically significant cardiovascular, respiratory, or psychiatric diseases per investigator's judgment
  11. Post-void residual (PVR) urine volume of > 150 mL at screening
  12. Any condition that in the judgment of the investigator would interfere with the patient's ability to provide informed consent, comply with study instructions, place the patient at increased risk, or which might confound the interpretation of the study results
  13. Previously received intravesical liposomes
  14. Urinary tract or prostatic infection in the past 90 days before study entry
  15. Active genital herpes or vaginitis
  16. Urethral diverticulum
  17. Pelvic malignancy within the past five years
  18. History of cyclophosphamide or chemical cystitis, or tuberculosis or pelvic radiation
  19. History of bladder or prostate tumors (benign or malignant)
  20. Uncontrolled diabetes
  21. Has any condition that would preclude treatment due to contraindications and/or warnings in the product labeling

Sites / Locations

  • William Beaumont Hospitals

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

LP-08 80mg

LP-08 20mg

Normal Saline

Arm Description

4 weekly intravesical administration of LP-08 80mg

4 weekly intravesical administration of LP-08 20mg

Four weekly normal saline intravesical administration

Outcomes

Primary Outcome Measures

Safety of Intravesical LP08: number/severity of adverse events
The number/severity of adverse events throughout the study

Secondary Outcome Measures

Efficacy Voids Per Day (VPD)
The change in voids per day (urinary frequency) as measured on a 3 day voiding diary
Efficacy Global Response Assessment (GRA)
Reporting a "moderate" or "marked" improvement on the GRA
Efficacy Symptom
The change in the symptoms and problems of interstitial cystitis from the baseline as measured by the O'Leary-Sant Interstitial Cystitis Symptom Index
Efficacy Visual Analog Scale (VAS)
The change in pain as recorded on the VAS
Efficacy Diary
The change from baseline in average voided volume, urgency and nocturia episodes per day as measured on a 3 day voiding diary

Full Information

First Posted
July 7, 2011
Last Updated
October 31, 2018
Sponsor
Lipella Pharmaceuticals, Inc.
Collaborators
William Beaumont Hospitals
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1. Study Identification

Unique Protocol Identification Number
NCT01393223
Brief Title
Evaluation of Intravesical LP08 in Patients With Interstitial Cystitis/Painful Bladder Syndrome
Official Title
A Single-Center, Double-Blind, Randomized, Dose-Ranging, Placebo Controlled Trial Comparing the Safety, Tolerability and Efficacy of LP-08 With Placebo in Subjects With Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
July 21, 2015 (Actual)
Primary Completion Date
June 14, 2018 (Actual)
Study Completion Date
June 14, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lipella Pharmaceuticals, Inc.
Collaborators
William Beaumont Hospitals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to assess the safety and tolerability of two doses of LP08 compared to placebo. Hypothesis: Safety of the LP-08 therapy will not be significantly different from the placebo group. Secondary Efficacy Endpoints: A matched-pair data analysis design will be employed, i.e. the measured outcomes will be subjects' improvements in quantitative and qualitative measures of the disease condition being assessed prior to and after LP-08 instillations at four and eight weeks follow-up visits
Detailed Description
This is a single-center, dose-ranging, placebo-controlled, double-blind, randomized study including male and female subjects with interstitial cystitis/bladder pain syndrome (IC/BPS) as determined by a physician using the current diagnostic criteria for IC/BPS. A total of 36 subjects will be enrolled at up to five (5) study sites in the U.S. Enrollment is expected to be completed within one year of initiating the study. The study is comprised of two parts. The first part of the study is a dose-ranging, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability and efficacy of LP-08 at 20 mg and 80 mg doses as compared with placebo. The second part of the study is an Open Label Extension study of the safety, tolerability and efficacy of LP-08 80 mg. Subjects randomized to the placebo control group must have completed the randomized portion study, including the eight week follow-up period, to be eligible for the Open Label Extension.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interstitial Cystitis
Keywords
Interstitial Cystitis, Painful Bladder Syndrome, Bladder Pain Syndrome, Liposome, LP-08

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LP-08 80mg
Arm Type
Active Comparator
Arm Description
4 weekly intravesical administration of LP-08 80mg
Arm Title
LP-08 20mg
Arm Type
Active Comparator
Arm Description
4 weekly intravesical administration of LP-08 20mg
Arm Title
Normal Saline
Arm Type
Placebo Comparator
Arm Description
Four weekly normal saline intravesical administration
Intervention Type
Drug
Intervention Name(s)
LP-08 80mg
Intervention Description
Intravesical instillation of 80mg LP08
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
Intravesical instillation of normal saline
Intervention Type
Drug
Intervention Name(s)
LP-08 20mg
Intervention Description
Intravesical instillation of 20mg LP08
Primary Outcome Measure Information:
Title
Safety of Intravesical LP08: number/severity of adverse events
Description
The number/severity of adverse events throughout the study
Time Frame
Up to 31 weeks following treatment
Secondary Outcome Measure Information:
Title
Efficacy Voids Per Day (VPD)
Description
The change in voids per day (urinary frequency) as measured on a 3 day voiding diary
Time Frame
2, 4, 8, 16, 24 weeks following treatment
Title
Efficacy Global Response Assessment (GRA)
Description
Reporting a "moderate" or "marked" improvement on the GRA
Time Frame
4, 8, 16, 24 weeks following treatment
Title
Efficacy Symptom
Description
The change in the symptoms and problems of interstitial cystitis from the baseline as measured by the O'Leary-Sant Interstitial Cystitis Symptom Index
Time Frame
2, 4, 8, 16, 24 weeks following treatment
Title
Efficacy Visual Analog Scale (VAS)
Description
The change in pain as recorded on the VAS
Time Frame
2, 4, 8, 16, 24 weeks following treatment
Title
Efficacy Diary
Description
The change from baseline in average voided volume, urgency and nocturia episodes per day as measured on a 3 day voiding diary
Time Frame
2, 4, 8, 16, 24 weeks following treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: A patient is deemed suitable for inclusion in the study if the patient meets the following criteria: Male or female at least 18 years of age IC/BPS diagnosed by a health care provider based the following criteria: Complaint of suprapubic pain related to bladder filling, accompanied by other symptoms such as increased daytime and night time frequency, in the absence of proven urinary infection or other obvious pathology Have had IC/BPS symptoms for at least six months Score of ≥ 12 on the ICSI/PI at baseline Urinary frequency > 10 times a day by self-report and confirmed on baseline three-day voiding diary Have IC/BPS that in the judgment of the investigator has been stable in the previous 30 days IC/BPS-related pain defined as a score of > 3 cm and < 9 cm on the pain VAS where 0 is no pain and 10 is maximum pain Have had inadequate clinical responses with conservative treatments, which may include one or more of the following: 1) timed voiding and behavioral modification therapy, 2) dietary restrictions, 3) stress reduction and/or 5) oral therapy with any of the following medications: Antidepressants Antihistamines Antimuscarinic and anticholinergic agents Alpha adrenergic blockers Analgesics Pentosan polysulfate Women of childbearing potential: have a negative urine pregnancy test at screening, and must agree to use an acceptable from of contraception (oral contraceptives, intrauterine or double barrier methods), as agreed to by the investigator, during the study period Provide signed informed consent Subject agrees to be available for the follow-up evaluations as required by the protocol Exclusion Criteria: Patients are excluded from enrollment in the study if any of the following are true: Currently pregnant or breastfeeding, or plan to become pregnant during the course of the study Have received investigational products or devices within 30 days prior to screening visit Have received intravesical therapy or bladder hydrodistention within 30 days prior to screening visit. Intravesical instillations may include liquid or drug delivery devices, pentosan polysulfate sodium, lidocaine, steroid, heparin, chondroitin and any combination or additional formulation. Have participated in IC/BPS research trial within 90 days prior to screening visit or has not returned to baseline if participated in IC/BPS research trial greater than 90 days prior to screening visit Have received any of the following medication within 30 days of screening visit, unless such medications have been administered at a stable dose during this month and are expected to remain at a stable dose throughout the study: Antidepressants Antihistamines (use of antihistamines as needed for allergies is allowed) Anticonvulsants Antimuscarinic and anticholinergic agents Alpha adrenergic blockers Pentosan polysulfate sodium Oral chondroitin Have indicated use of > 70 mg of morphine equivalents of opioids per week to control their IC/BPS pain within 30 days prior to screening, or are expected to require this level of IC/BPS pain control during the study period Previous augmentation cystoplasty, cystectomy, neurectomy (i.e., hypogastric nerve plexus ablation). Bladder botulinum toxin injections within nine months prior to screening. Sacral and/or pudendal nerve neuromodulation device (Interstim) within the last 6 months. Subjects would not be excluded if they had Interstim greater than 6 months ago and is on a stable setting within the past 90 days Percutaneous Tibial Nerve Stimulation (PTNS) treatment within the past 90 days Evidence of renal impairment (creatinine > two times the upper limit of normal at Visit 1), hepatic impairment (AST or ALT > three times the upper limit of normal at Visit 1), clinically significant cardiovascular, respiratory, or psychiatric diseases per investigator's judgment Post-void residual (PVR) urine volume of > 150 mL at screening Any condition that in the judgment of the investigator would interfere with the patient's ability to provide informed consent, comply with study instructions, place the patient at increased risk, or which might confound the interpretation of the study results Previously received intravesical liposomes Urinary tract or prostatic infection in the past 90 days before study entry Active genital herpes or vaginitis Urethral diverticulum Pelvic malignancy within the past five years History of cyclophosphamide or chemical cystitis, or tuberculosis or pelvic radiation History of bladder or prostate tumors (benign or malignant) Uncontrolled diabetes Has any condition that would preclude treatment due to contraindications and/or warnings in the product labeling
Facility Information:
Facility Name
William Beaumont Hospitals
City
Royal Oak
State/Province
Michigan
Country
United States

12. IPD Sharing Statement

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Evaluation of Intravesical LP08 in Patients With Interstitial Cystitis/Painful Bladder Syndrome

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