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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by Lipella Pharmaceuticals, Inc.
Sponsor:
Collaborator:
Pending
Information provided by (Responsible Party):
Lipella Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01393223
First received: July 7, 2011
Last updated: March 31, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention Phase
Interstitial Cystitis
Drug: LP-08 80mg
Drug: Normal Saline Placebo
Drug: LP-08 20mg
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, 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)

Resource links provided by NLM:


Further study details as provided by Lipella Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Safety [ Time Frame: Up to 31 weeks following treatment ] [ Designated as safety issue: Yes ]
    The number/severity of adverse events throughout the study


Secondary Outcome Measures:
  • Efficacy Voids Per Day (VPD) [ Time Frame: 2, 4, 8, 16, 24 weeks following treatment ] [ Designated as safety issue: No ]
    The change in voids per day (urinary frequency) as measured on a 3 day voiding diary

  • Efficacy Global Response Assessment (GRA) [ Time Frame: 4, 8, 16, 24 weeks following treatment ] [ Designated as safety issue: No ]
    Reporting a "moderate" or "marked" improvement on the GRA

  • Efficacy Symptom [ Time Frame: 2, 4, 8, 16, 24 weeks following treatment ] [ Designated as safety issue: No ]
    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) [ Time Frame: 2, 4, 8, 16, 24 weeks following treatment ] [ Designated as safety issue: No ]
    The change in pain as recorded on the VAS

  • Efficacy Diary [ Time Frame: 2, 4, 8, 16, 24 weeks following treatment ] [ Designated as safety issue: No ]
    The change from baseline in average voided volume, urgency and nocturia episodes per day as measured on a 3 day voiding diary


Estimated Enrollment: 36
Study Start Date: January 2015
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: LP-08 80mg
4 weekly intravesical administration of LP-08 80mg
Drug: LP-08 80mg
Active Comparator: LP-08 20mg
4 weekly intravesical administration of LP-08 20mg
Drug: LP-08 20mg
Placebo Comparator: Normal Saline
Four weekly normal saline intravesical administration
Drug: Normal Saline Placebo

Detailed Description:

This is a multicenter, 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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 (see Appendix C) 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. Have at least one voided volume > 75 mL in a 24-hour period, confirmed by voiding diary at Visit 2
  5. 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
  6. Provide signed informed consent
  7. 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 had symptoms of IC/BPS for more than 10 years
  4. 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.
  5. 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
  6. 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

  7. 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
  8. Previous augmentation cystoplasty, cystectomy, neurectomy (i.e., hypogastric nerve plexus ablation) or bladder botulinum toxin injections
  9. 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
  10. Percutaneous Tibial Nerve Stimulation (PTNS) treatment within the past 90 days
  11. 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
  12. Post-void residual (PVR) urine volume of > 150 mL at screening
  13. 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
  14. Previously received intravesical liposomes
  15. Urinary tract or prostatic infection in the past 90 days before study entry
  16. Active genital herpes or vaginitis
  17. Urethral diverticulum
  18. Pelvic malignancy within the past five years
  19. History of cyclophosphamide or chemical cystitis, or tuberculosis or pelvic radiation
  20. History of bladder or prostate tumors (benign or malignant)
  21. Uncontrolled diabetes
  22. Has any condition that would preclude treatment due to contraindications and/or warnings in the product labeling
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01393223

Contacts
Contact: Jonathan Kafuman, PhD 412-894-1853 jhk@lipella.com
Contact: Michele Anthony, BS 412-894-1853 michele.anthony@lipella.com

Locations
United States, Pennsylvania
Pending Not yet recruiting
Pittsburgh, Pennsylvania, United States
Contact: Jonathan Kaufman, PhD    412-894-1853    jhk@lipella.com   
Contact: Michele Anthony, BS    412-894-1853    michele.anthony@lipella.com   
Sponsors and Collaborators
Lipella Pharmaceuticals, Inc.
Pending
  More Information

No publications provided

Responsible Party: Lipella Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01393223     History of Changes
Other Study ID Numbers: PhaseIIb LP-08 IC/BPS
Study First Received: July 7, 2011
Last Updated: March 31, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration
United States: Data and Safety Monitoring Board

Keywords provided by Lipella Pharmaceuticals, Inc.:
Interstitial Cystitis
Painful Bladder Syndrome
Bladder Pain Syndrome
Liposome
LP-08

Additional relevant MeSH terms:
Cystitis
Cystitis, Interstitial
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on August 27, 2014