LP-10 for Cystitis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Cystitis+1 More
LP-10 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will assess the safety and tolerability of three doses of LP-10 (intravesical tacrolimus). 12 subjects will be enrolled and treated in a prospective and multi-center trial. 4 subjects will be allocated into each one of three groups.

Eligible Conditions
  • Cystitis

Treatment Effectiveness

Study Objectives

1 Primary · 12 Secondary · Reporting Duration: At every patient visit, up to 2 weeks following initial treatment

Week 2
Blood chemistry and liver function test
Incidence of Treatment-Emergent Adverse Events
Mean urine hemoglobin concentration
Patient Reported Global Response Assessment Survey Score
Patient Reported Health Related Quality of Life Survey Score
Patient Reported Mean episodes of visible blood
Patient Reported Pain and Urgency
Patient Reported Urinary frequency
Post void residual urine volume
Urine Dipstick Mean episodes of Visible Blood
Urine analysis with microscopy
Whole blood Add to dictionary levels
Week 2
Bladder Cystoscopy

Trial Safety

Trial Design

3 Treatment Groups

LP-10 4mg
1 of 3
LP-10 2mg
1 of 3
LP-10 8mg
1 of 3
Experimental Treatment

12 Total Participants · 3 Treatment Groups

Primary Treatment: LP-10 · No Placebo Group · Phase 2

LP-10 4mg
Drug
Experimental Group · 1 Intervention: LP-10 · Intervention Types: Drug
LP-10 2mg
Drug
Experimental Group · 1 Intervention: LP-10 · Intervention Types: Drug
LP-10 8mg
Drug
Experimental Group · 1 Intervention: LP-10 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at every patient visit, up to 2 weeks following initial treatment

Who is running the clinical trial?

Lipella Pharmaceuticals, Inc.Lead Sponsor
1 Previous Clinical Trials
21 Total Patients Enrolled
1 Trials studying Cystitis
21 Patients Enrolled for Cystitis

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
The subject is willing and capable of understanding and complying with all requirements of the protocol, including proper completion of the 3 day Hemorrhagic Cystitis Diary (HC Diary) and self-administered questionnaires.
You are at least 18 years old.
The history of sterile moderate to severe HC for at least 3 months documented in the medical record with at least 1 episode of macroscopic hematuria with or without clot.
There have been previous attempts to treat HC with medication or other therapies without success.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 23rd, 2021

Last Reviewed: October 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Tennessee100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Emory University100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%