NCT03038321

Brief 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)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2017

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2017

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 31, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

February 1, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

May 23, 2017

Status Verified

March 1, 2017

Enrollment Period

10 months

First QC Date

January 15, 2017

Last Update Submit

May 19, 2017

Conditions

Non-Muscle-invasive Bladder Cancer (NMIBC)Bacillus Calmette-Guerin (BCG) CystitisIntra-vesical Instillation

Keywords

BCG CystitisBladder CancerLevofloxacinSolifenacinLornoxicam

Outcome Measures

Primary Outcomes (1)

  • Comparing the drugs efficacy on decreasing systemic and local side effects of BCG

    \_\_ Outcome Measure by Four-class classification grid of BCG adverse events

    6 weeks

Secondary Outcomes (3)

  • Comparing the drugs effect on decreasing voiding and storage urinary symptoms of BCG

    6 weeks

  • Prostatic specific antigen (PSA) change

    1 month and 3 months

  • recurrence free survival

    1 year

Study Arms (3)

solifenacin

ACTIVE COMPARATOR

(Sofenacin ''solifenacin 10 m'') \[Marcyrl Pharmaceutical Industries - Egypt\]

Drug: sofenacin

levofloxacin

ACTIVE COMPARATOR

(Tavanic ''levofloxacin 500 mg'') \[Sanofi-Aventis - Egypt\]

Drug: Tavanic

lornoxicam

ACTIVE COMPARATOR

(Xefo ''lornoxicam 8 mg'') \[Multi-Apex - Egypt, under license of: NYCOMED, Austria\]

Drug: Xefo

Interventions

sofenacinDRUG

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

Also known as: Solfenacin 10 mg
solifenacin
TavanicDRUG

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

Also known as: levofloxacin 500
levofloxacin
XefoDRUG

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

Also known as: lornoxicam
lornoxicam

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients classified as intermediate or high risk of the bladder tumour

You may not qualify if:

  • Patient over 80 years (natural decline in immune system function)
  • Refuse to complete study requirements
  • Contraindication to BCG therapy
  • High post-void residual (PVR) above 85 ml
  • American Urological Association (AUA) Symptoms score above 20
  • Sensitivity to previously mentioned 3 drugs
  • High serum creatinine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urology and Nephrology Center

Al Mansurah, Aldakahlia, 35516, Egypt

Location

MeSH Terms

Conditions

Non-Muscle Invasive Bladder NeoplasmsCystitisUrinary Bladder Neoplasms

Interventions

Ofloxacinlornoxicam

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Hassan Abol-Enein, MD, Phd

    Urology and Nephrology Center

    STUDY CHAIR

  • Ahmed Mosbah, MD

    Urology and Nephrology Center

    STUDY DIRECTOR

  • Ahmed Elhussein, MBBCH

    Urology and Nephrology Center

    PRINCIPAL INVESTIGATOR

  • Ahmed Elkarta, MBBCH

    Urology and Nephrology Center

    PRINCIPAL INVESTIGATOR

  • Mohamed Soltan

    Urology and Nephrology Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Urology Msc, Oncology fellow at Urology and Nephrology Center, Principal Investigator

Study Record Dates

First Submitted

January 15, 2017

First Posted

January 31, 2017

Study Start

February 1, 2017

Primary Completion

December 1, 2017

Study Completion

December 1, 2019

Last Updated

May 23, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will share

meta-analyses by contact the Prof. Hassan Abol-Enein, MD, Phd (Study Chair)

Locations

EG(1)