Non-Muscle-invasive Bladder Cancer (NMIBC)Phase 4NCT03038321
Solifenacin, Levofloxacin or Lornoxicam, Which Is Ideal for Management of Intravesical Instillation BCG Side Effects?
A Phase 4 study testing sofenacin, Tavanic and Xefo in people with Non-Muscle-invasive Bladder Cancer (NMIBC) and Bacillus Calmette-Guerin (BCG) Cystitis, run by Mansoura University at 1 site in Egypt.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non-Muscle-invasive Bladder Cancer (NMIBC), Bacillus Calmette-Guerin (BCG) Cystitis, Intra-vesical Instillation
- What is being tested?
- sofenacin, Tavanic and Xefo
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2017to Dec 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients classified as intermediate or high risk of the bladder tumour
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Solifenacin vs Levofloxacin vs Lornoxicam for Management of Intravesical Instillation of Bacillus Calmette-Guerin (BCG) Side Effects A Single Blinded Randomised Controlled Study
Compare the different supposed clinical treatment of side effects associated with intravesical BCG by levofloxacin (quinolones) vs solifenacin (selective anti-muscarinic) vs lornoxicam (NSAID)
Read the detailed description
For urothelial carcinoma (UC), which accounts for over 90% of bladder cancers, more than 70% of bladder cancer patients present with non-muscle-invasive disease. Approximately 40-80% of these tumors will recur within the first year, of which 10-25% will progress to muscle-invasive disease.
Intravesical treatments with cytotoxic chemotherapy and immunotherapy have become the mainstay following transurethral resection (TUR). Increasing knowledge of BCG use allows for effective management of these once debilitating side effects. The majority of patients will still experience cystitis-like symptoms to some degree, including urinary frequency (71%), cystitis (67%), fever (25%), and hematuria (23%).
Oxybutynin increases in fever, flu-like symptoms, dry mouth and constipation. However, in this study oxybutynin started the night before treatment causing an element of incomplete bladder emptying and allowing an increased BCG dwell time. We think that these effect can be reversed by use anticholinergic 6 hours post BCG instillation Anti-inflammatory drugs significantly reduced BCG-induced granulocyte activation and did not impair BCG-induced lymphocyte cytotoxicity against bladder tumor cells in mice. The committee of International Bladder Cancer Group (IBCG) recommend use of anti-inflammatory agents (NSAIDs) for treatment of non-bacterial or chemical cystitis and other systemic BCG side effect.
Fluoroquinolone with tuberculostatic properties, has been shown to significantly prolong survival in mice with BCG systemic infection and did not affect the antitumor efficacy of BCG. ofloxacin significantly decreased by 18.5% the incidence of class II or higher moderate and severe adverse events of BCG.
Because of sparse published studies on BCG side effect management, the 2016 European Association of Urology (EAU) guidelines management options for side effects associated with intravesical BCG modify the IBCG committee clinical practice without any degree of recommendation. So, in this study the investigators will try to fill the gap in the literature.
- Conditions
- Non-Muscle-invasive Bladder Cancer (NMIBC), Bacillus Calmette-Guerin (BCG) Cystitis, Intra-vesical Instillation
- Being tested
- sofenacin, Tavanic, Xefo
- Keywords
- BCG Cystitis, Bladder Cancer, Levofloxacin, Solifenacin, Lornoxicam
- Medical subject headings
- Non-Muscle Invasive Bladder Neoplasms, Cystitis, Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sofenacinDrug
Also called Solfenacin 10 mg
solifenacin 10 mg, 6 hours after IVI of BCG and continue for another 2 days post instillation
TavanicDrug
Also called levofloxacin 500
levofloxacin 500 mg, 6 hours after IVI of BCG and continue for another 2 days post instillation.
XefoDrug
Also called lornoxicam
lornoxicam 8 mg, 6 hours after IVI of BCG and continue for another 2 days post instillation.
| Study group | Role | What they receive |
|---|---|---|
| solifenacin | Active comparator | (Sofenacin ''solifenacin 10 m'') [Marcyrl Pharmaceutical Industries - Egypt] Receives: Drug: sofenacin |
| levofloxacin | Active comparator | (Tavanic ''levofloxacin 500 mg'') [Sanofi-Aventis - Egypt] Receives: Drug: Tavanic |
| lornoxicam | Active comparator | (Xefo ''lornoxicam 8 mg'') [Multi-Apex - Egypt, under license of: NYCOMED, Austria] Receives: Drug: Xefo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing the drugs efficacy on decreasing systemic and local side effects of BCG
__ Outcome Measure by Four-class classification grid of BCG adverse events
Measured: 6 weeks
Secondary outcomes (3)
Comparing the drugs effect on decreasing voiding and storage urinary symptoms of BCG
__ Outcome Measure by overactive bladder symptoms scores and American Urological Association Symptom Index
Measured: 6 weeks
Prostatic specific antigen (PSA) change
__ Outcome Measure by PSA measure 1 and 3 months post instillation
Measured: 1 month and 3 months
recurrence free survival
__ Outcome Measure by Number of patients surviving for one year without tumor recurrence will be counted and compared
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2017 (estimated)
- Study start1 Feb 2017
- Primary completionDec 2017 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Muscle-invasive Bladder Cancer (NMIBC)Studies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelwahab Hashem, Mansoura University
- Investigators
- Hassan Abol-Enein, MD, Phd, Study chair, Urology and Nephrology CenterAhmed Mosbah, MD, Study director, Urology and Nephrology CenterAhmed Elhussein, MBBCH, Principal investigator, Urology and Nephrology CenterAhmed Elkarta, MBBCH, Principal investigator, Urology and Nephrology CenterMohamed Soltan, Principal investigator, Urology and Nephrology Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03038321
- Sponsor's protocol ID
- R/17.01.02
- Status last verified
- Mar 2017
- First submitted
- 15 Jan 2017
- Last updated
- 23 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: meta-analyses by contact the Prof. Hassan Abol-Enein, MD, Phd (Study Chair)
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Solifenacin vs Levofloxacin vs Lornoxicam for Management of Intravesical Instillation of Bacillus Calmette-Guerin (BCG) Side Effects A Single Blinded Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT03038321
- Acronym / sponsor ID
- R/17.01.02
- Conditions
- Non-Muscle-invasive Bladder Cancer (NMIBC), Bacillus Calmette-Guerin (BCG) Cystitis, Intra-vesical Instillation
- Keywords
- BCG Cystitis, Bladder Cancer, Levofloxacin, Solifenacin, Lornoxicam
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 31 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Compare the different supposed clinical treatment of side effects associated with intravesical BCG by levofloxacin (quinolones) vs solifenacin (selective anti-muscarinic) vs lornoxicam (NSAID)
Detailed description
For urothelial carcinoma (UC), which accounts for over 90% of bladder cancers, more than 70% of bladder cancer patients present with non-muscle-invasive disease. Approximately 40-80% of these tumors will recur within the first year, of which 10-25% will progress to muscle-invasive disease.
Intravesical treatments with cytotoxic chemotherapy and immunotherapy have become the mainstay following transurethral resection (TUR). Increasing knowledge of BCG use allows for effective management of these once debilitating side effects. The majority of patients will still experience cystitis-like symptoms to some degree, including urinary frequency (71%), cystitis (67%), fever (25%), and hematuria (23%).
Oxybutynin increases in fever, flu-like symptoms, dry mouth and constipation. However, in this study oxybutynin started the night before treatment causing an element of incomplete bladder emptying and allowing an increased BCG dwell time. We think that these effect can be reversed by use anticholinergic 6 hours post BCG instillation Anti-inflammatory drugs significantly reduced BCG-induced granulocyte activation and did not impair BCG-induced lymphocyte cytotoxicity against bladder tumor cells in mice. The committee of International Bladder Cancer Group (IBCG) recommend use of anti-inflammatory agents (NSAIDs) for treatment of non-bacterial or chemical cystitis and other systemic BCG side effect.
Fluoroquinolone with tuberculostatic properties, has been shown to significantly prolong survival in mice with BCG systemic infection and did not affect the antitumor efficacy of BCG. ofloxacin significantly decreased by 18.5% the incidence of class II or higher moderate and severe adverse events of BCG.
Because of sparse published studies on BCG side effect management, the 2016 European Association of Urology (EAU) guidelines management options for side effects associated with intravesical BCG modify the IBCG committee clinical practice without any degree of recommendation. So, in this study the investigators will try to fill the gap in the literature.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| solifenacin | Active comparator | Drug: sofenacin(Sofenacin ''solifenacin 10 m'') [Marcyrl Pharmaceutical Industries - Egypt] |
| levofloxacin | Active comparator | Drug: Tavanic(Tavanic ''levofloxacin 500 mg'') [Sanofi-Aventis - Egypt] |
| lornoxicam | Active comparator | Drug: Xefo(Xefo ''lornoxicam 8 mg'') [Multi-Apex - Egypt, under license of: NYCOMED, Austria] |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients classified as intermediate or high risk of the bladder tumour
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sofenacinAlso: Solfenacin 10 mgsolifenacin 10 mg, 6 hours after IVI of BCG and continue for another 2 days post instillation | Drug | solifenacin |
| TavanicAlso: levofloxacin 500levofloxacin 500 mg, 6 hours after IVI of BCG and continue for another 2 days post instillation. | Drug | levofloxacin |
| XefoAlso: lornoxicamlornoxicam 8 mg, 6 hours after IVI of BCG and continue for another 2 days post instillation. | Drug | lornoxicam |
Primary outcome
Comparing the drugs efficacy on decreasing systemic and local side effects of BCG
Time frame: 6 weeks
__ Outcome Measure by Four-class classification grid of BCG adverse events
3 secondary outcomes
Comparing the drugs effect on decreasing voiding and storage urinary symptoms of BCG
Time frame: 6 weeks
Prostatic specific antigen (PSA) change
Time frame: 1 month and 3 months
recurrence free survival
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2017.
- Individual participant dataSharing planned: Yes. meta-analyses by contact the Prof. Hassan Abol-Enein, MD, Phd (Study Chair)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hassan Abol-Enein, MD, Phd study chair
Urology and Nephrology Center
Ahmed Mosbah, MD study director
Urology and Nephrology Center
Ahmed Elhussein, MBBCH principal investigator
Urology and Nephrology Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing sofenacin, Tavanic and Xefo in people with Non-Muscle-invasive Bladder Cancer (NMIBC) and Bacillus Calmette-Guerin (BCG) Cystitis, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparing the drugs efficacy on decreasing systemic and local side effects of BCG (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2017.