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

NCT01393223 | Completed Phase 2 DMC

• 1 other identifier: PhaseII LP-08 IC/BPS
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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

Conditions

Interstitial Cystitis

Keywords

Interstitial Cystitis; Painful Bladder Syndrome; Bladder Pain Syndrome; Liposome; LP-08

Outcome Measures

Primary Outcomes (1)

• Safety of Intravesical LP08: number/severity of adverse events

  The number/severity of adverse events throughout the study

  Up to 31 weeks following treatment

Secondary Outcomes (5)

• Efficacy Voids Per Day (VPD)

  2, 4, 8, 16, 24 weeks following treatment

• Efficacy Global Response Assessment (GRA)

  4, 8, 16, 24 weeks following treatment

• Efficacy Symptom

  2, 4, 8, 16, 24 weeks following treatment

• Efficacy Visual Analog Scale (VAS)

  2, 4, 8, 16, 24 weeks following treatment

• Efficacy Diary

  2, 4, 8, 16, 24 weeks following treatment

Study Arms (3)

LP-08 80mg

ACTIVE COMPARATOR

4 weekly intravesical administration of LP-08 80mg

Drug: LP-08 80mg

LP-08 20mg

ACTIVE COMPARATOR

4 weekly intravesical administration of LP-08 20mg

Drug: LP-08 20mg

Normal Saline

PLACEBO COMPARATOR

Four weekly normal saline intravesical administration

Drug: Normal saline

Interventions

LP-08 80mg DRUG

Intravesical instillation of 80mg LP08

LP-08 80mg

Normal saline DRUG

Intravesical instillation of normal saline

Normal Saline

LP-08 20mg DRUG

Intravesical instillation of 20mg LP08

LP-08 20mg

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lipella Pharmaceuticals, Inc.: lead
• Corewell Health East: collaborator

Study Sites (1)

William Beaumont Hospitals

Royal Oak, Michigan, United States

Location

MeSH Terms

Conditions

Cystitis, Interstitial

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2011
• First Posted: July 13, 2011
• Study Start: July 21, 2015
• Primary Completion: June 14, 2018
• Study Completion: June 14, 2018
• Last Updated: November 1, 2018

Record last verified: 2018-10

Locations

US (1)