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Solifenacin, Levofloxacin or Lornoxicam, Which Is Ideal for Management of Intravesical Instillation BCG Side Effects?

NCT03038321 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2017-05-23

No results posted yet for this study

Summary

Compare the different supposed clinical treatment of side effects associated with intravesical BCG by levofloxacin (quinolones) vs solifenacin (selective anti-muscarinic) vs lornoxicam (NSAID)

Conditions

  • Non-Muscle-invasive Bladder Cancer (NMIBC)
  • Bacillus Calmette-Guerin (BCG) Cystitis
  • Intra-vesical Instillation

Interventions

DRUG

sofenacin

solifenacin 10 mg, 6 hours after IVI of BCG and continue for another 2 days post instillation

DRUG

Tavanic

levofloxacin 500 mg, 6 hours after IVI of BCG and continue for another 2 days post instillation.

DRUG

Xefo

lornoxicam 8 mg, 6 hours after IVI of BCG and continue for another 2 days post instillation.

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Principal Investigators

  • Hassan Abol-Enein, MD, Phd · Urology and Nephrology Center

  • Ahmed Mosbah, MD · Urology and Nephrology Center

  • Ahmed Elhussein, MBBCH · Urology and Nephrology Center

  • Ahmed Elkarta, MBBCH · Urology and Nephrology Center

  • Mohamed Soltan · Urology and Nephrology Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-02-01
Primary Completion
2017-12-31
Completion
2019-12-31

Countries

  • Egypt

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 NCT03038321 on ClinicalTrials.gov