NCT01578304 is a Phase 4 clinical trial of Imidafenacin in Overactive Bladder, sponsored by LG Life Sciences.

Who is sponsoring NCT01578304?

NCT01578304 is sponsored by LG Life Sciences.

What drugs are being tested in NCT01578304?

Interventions in NCT01578304: Imidafenacin, Fesoterodine.

What condition does NCT01578304 study?

NCT01578304 studies Overactive Bladder.

Is NCT01578304 still recruiting?

NCT01578304 is currently completed. Last updated 13 April 2012.

Last reviewed 2012-04-13 · How we verify

NCT01578304

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

Phase IV Study to Evaluate the Efficacy and Safety Imidafenacin Versus Fesoterodine in Patients With Overactive Bladder

Completed Phase 4 Last updated 13 April 2012

What this trial tests

Phase 4 trial testing Imidafenacin in Overactive Bladder in 207 participants. Completed in 1 October 2011.

Timeline

1 December 2010

Primary endpoint
1 October 2011

1 October 2011

Quick facts

Lead sponsor	LG Life Sciences
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	207
Start date	1 December 2010
Primary completion	1 October 2011
Estimated completion	1 October 2011
Sites	1 location across South Korea

Drugs / interventions tested

Imidafenacin (IMIDAFENACIN) — full drug profile →
Fesoterodine (FESOTERODINE) — full drug profile →

Conditions studied

Overactive Bladder — all drugs for Overactive Bladder →

Sponsor

LG Life Sciences — full company profile →

Who can join

20 and older, any sex, with Overactive Bladder. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Difference in daily mean urination frequency between the end of treatment period(Week 12) and the end of observation period(Baseline, Week 0)
Time frame: up to 12 weeks

Sponsor's own description

To evaluate the efficacy and safety after 12 weeks oral administration of Imidafenacin 0.1mg b.i.d versus Fesoterodine 4mg once daily for the urge incontinence and/or increased urinary frequency associated with urgency as may occur in patients with overactive bladder.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Comparative assessment of efficacy and safety of approved oral therapies for overactive bladder: a systematic review and network meta-analysis.
He W, Huang G, Cui W, Tian Y, et al · · 2023 · cited 10× · PMID 37506033 · DOI 10.1590/s1677-5538.ibju.2023.0158

Verify or expand the search:

Other recruiting trials for Overactive Bladder

Currently open trials in the same condition.

NCT06201013 — Vitamin D Treat-to-Target Strategy for Children With Overactive Bladder-Wet · NA · recruiting
NCT05895045 — Yoga for Treatment of Overactive Bladder in Pediatric Patients · NA · recruiting
NCT07209397 — Detrusor Nerve Radiofrequency Ablation for Overactive Bladder in Women · NA · recruiting
NCT06921746 — Changes in the Urinary Microbiome and Metabolome During Treatment of the Overactive Bladder in Female Patients · recruiting
NCT06935240 — Investigation of Effects of Electrical Stimulation in Women With Vaginal Laxity · NA · recruiting

Other LG Life Sciences trials

Trials by the same sponsor.

NCT02831361 — Trial to Evaluate the Efficacy and Safety of Gemigliptin Compared With Placebo Added on Insulin Alone or on Insulin in C · Phase 3 · completed
NCT03015909 — Evaluation of the Ease of Use, Preference, and Safety of EutropinPen Inj. · Phase 4 · completed
NCT02746380 — A Study Comparing LBAL to Humira® in Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy · Phase 3 · completed
NCT02290301 — An Observational Study to Evaluate Cardiovascular Outcomes of T2DM PatientsTreated With Gemigliptin · 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 NCT01578304 (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 LG Life Sciences
Last refreshed: 13 April 2012

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/NCT01578304.

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