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LP-08

Phase 2

Interstitial Cystitis | Small molecule | Urology |Lipella Pharmaceuticals Inc.|Last Updated: Nov 1, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment21

FDA Designations

No designations recorded

Clinical trial landscape

LP-08 · 1 trial · 1 indication

Phase 2 1
NCT01393223Evaluation of Intravesical LP08 in Patients With Interstitial Cystitis/Painful Bladder SyndromeInterstitial Cystitis
COMPLETED21 Analytics
PHASE2COMPLETED
Evaluation of Intravesical LP08 in Patients With Interstitial Cystitis/Painful Bladder Syndrome
Interstitial CystitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety of Intravesical LP08: number/severity of adverse events
Up to 31 weeks following treatment

The number/severity of adverse events throughout the study

Secondary Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
LP-08 80mgACTIVE_COMPARATOR4 weekly intravesical administration of LP-08 80mg
LP-08 20mgACTIVE_COMPARATOR4 weekly intravesical administration of LP-08 20mg
Normal SalinePLACEBO_COMPARATORFour weekly normal saline intravesical administration

Interventions

NameTypeDescription
LP-08 80mgDRUGIntravesical instillation of 80mg LP08
Normal salineDRUGIntravesical instillation of normal saline
LP-08 20mgDRUGIntravesical instillation of 20mg LP08
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites1

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 fillin...

Countries:United States
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Frequently asked questions about LP-08

What is LP-08 used for?

LP-08 is an investigational small molecule being developed for the treatment of interstitial cystitis, also known as painful bladder syndrome. It is administered intravesically, meaning directly into the bladder. The drug is currently in clinical development and has not been approved by the FDA.

Who makes LP-08?

LP-08 is being developed by Lipella Pharmaceuticals Inc., a company traded on the stock exchange under the ticker symbol LIPO. The company is conducting clinical research to evaluate the safety and efficacy of LP-08 for interstitial cystitis.

What phase is LP-08 in?

LP-08 is in Phase 2 clinical development. A Phase 2 clinical trial has been completed to evaluate the drug in patients with interstitial cystitis. The drug is still investigational and has not received regulatory approval.

What clinical trials is LP-08 in?

LP-08 has been studied in one completed Phase 2 clinical trial with the identifier NCT01393223. This trial, titled 'Evaluation of Intravesical LP08 in Patients With Interstitial Cystitis/Painful Bladder Syndrome,' enrolled 21 participants in the United States. The trial was randomized, double-blind, and placebo-controlled.

Is LP-08 the same as LP08?

LP-08 and LP08 refer to the same investigational drug. The clinical trial NCT01393223 uses the name LP08 in its title, while the drug is also referred to as LP-08. Both names denote the same small molecule being developed for interstitial cystitis.