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

NCT01393223 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2018-11-01

No results posted yet for this study

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

Interventions

DRUG

LP-08 80mg

Intravesical instillation of 80mg LP08

DRUG

Normal saline

Intravesical instillation of normal saline

DRUG

LP-08 20mg

Intravesical instillation of 20mg LP08

Sponsors & Collaborators

  • William Beaumont Hospitals

    collaborator OTHER

  • Lipella Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-21
Primary Completion
2018-06-14
Completion
2018-06-14

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01393223 on ClinicalTrials.gov