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Intravesical Instillation of Liposome Encapsulated Botulinum Toxin A (Lipotoxin) in Treatment of Interstitial Cystitis

NCT02247557 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2017-03-09

No results posted yet for this study

Summary

To evaluate the efficacy and safety of intravesical instillation of Lipotoxin for the treatment of IC/BPS

Conditions

  • Interstitial Cystitis

Interventions

DRUG

Liposome encapsulated BoNT-A

Liposome encapsulated BoNT-A ( mixed BOTOX 200U/10ml in Liposome 80mg/40ml) in single intravesical instillation

DRUG

BOTOX 200U in normal saline

BOTOX 200U in normal saline (BoNT-A/NS) 50ml in single intravesical instillation

DRUG

Normal saline

Normal saline (N/S) 50ml in single intravesical instillation

Sponsors & Collaborators

  • Buddhist Tzu Chi General Hospital

    lead OTHER

Principal Investigators

  • Hann-Chorng Kuo, M.D. · Department of Urology, Buddihisst Tzu Chi General Hospital and Tzu Chi University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2017-02-28
Completion
2017-02-28
FDA Drug
Yes

Countries

  • Taiwan

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 NCT02247557 on ClinicalTrials.gov