NCT01393223 is a Phase 2 clinical trial of LP-08 80mg in Interstitial Cystitis, sponsored by Lipella Pharmaceuticals, Inc..

Who is sponsoring NCT01393223?

NCT01393223 is sponsored by Lipella Pharmaceuticals, Inc..

What drugs are being tested in NCT01393223?

Interventions in NCT01393223: LP-08 80mg, Normal saline, LP-08 20mg.

What condition does NCT01393223 study?

NCT01393223 studies Interstitial Cystitis.

Is NCT01393223 still recruiting?

NCT01393223 is currently completed. Last updated 1 November 2018.

Last reviewed 2018-11-01 · How we verify

NCT01393223

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 2 Last updated 1 November 2018

What this trial tests

Phase 2 trial testing LP-08 80mg in Interstitial Cystitis in 21 participants. Completed in 14 June 2018.

Timeline

21 July 2015

Primary endpoint
14 June 2018

14 June 2018

Quick facts

Lead sponsor	Lipella Pharmaceuticals, Inc.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	21
Start date	21 July 2015
Primary completion	14 June 2018
Estimated completion	14 June 2018
Sites	1 location across United States

Drugs / interventions tested

LP-08 80mg — full drug profile →
Normal saline
LP-08 20mg — full drug profile →

Conditions studied

Interstitial Cystitis — all drugs for Interstitial Cystitis →

Sponsor

Lipella Pharmaceuticals, Inc. — full company profile →

Who can join

Adults 18 to 70, any sex, with Interstitial Cystitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Broaden Horizons: The Advancement of Interstitial Cystitis/Bladder Pain Syndrome.
Li J, Yi X, Ai J. · · 2022 · cited 27× · PMID 36498919 · DOI 10.3390/ijms232314594
Review of intravesical therapies for bladder pain syndrome/interstitial cystitis.
Cvach K, Rosamilia A. · · 2015 · cited 14× · PMID 26816864 · DOI 10.3978/j.issn.2223-4683.2015.10.07

Verify or expand the search:

Other recruiting trials for Interstitial Cystitis

Currently open trials in the same condition.

NCT06299683 — Pain Type and Interstitial Cystitis/Bladder Pain Syndrome Treatment · NA · recruiting
NCT05696444 — Medtronic Hugo™ Robotic Assisted Surgery (RAS) System in Urologic Surgery (Expand URO) · NA · active not recruiting
NCT05485207 — Transvaginal Botulinum Toxin A for Interstitial Cystitis / Bladder Pain Syndrome · EARLY_PHASE1 · active not recruiting
NCT04734847 — Motor Cortical Neuromodulation in Women With Interstitial Cystitis/Bladder Pain Syndrome · NA · recruiting
NCT00499317 — Genetic Study of Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS) · recruiting

Other Lipella Pharmaceuticals, Inc. trials

Trials by the same sponsor.

NCT06233591 — Evaluating LP-10 in Subjects With OLP · Phase 2 · active not recruiting
NCT03129126 — The Safety, Tolerability and Efficacy of LP-10 in Subjects With Refractory Moderate to Severe Hemorrhagic Cystitis · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01393223 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Lipella Pharmaceuticals, Inc.
Last refreshed: 1 November 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01393223.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing