Clinical trial · Interventional
Solifenacin, Levofloxacin or Lornoxicam, Which Is Ideal for Management of Intravesical Instillation BCG Side Effects?
Solifenacin vs Levofloxacin vs Lornoxicam for Management of Intravesical Instillation of Bacillus Calmette-Guerin (BCG) Side Effects A Single Blinded Randomised Controlled Study
NCT03038321CI-TRIAL-00027755unknownPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bacillus Calmette-Guerin (BCG) Cystitis | — | UNRESOLVED | — |
| Intra-vesical Instillation | — | UNRESOLVED | — |
| Non-Muscle-invasive Bladder Cancer (NMIBC) | Non-Muscle Invasive Bladder Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| sofenacin | Drug | — | UNRESOLVED |
| Tavanic | Drug | — | UNRESOLVED |
| Xefo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- solifenacin
- description
- (Sofenacin ''solifenacin 10 m'') \[Marcyrl Pharmaceutical Industries - Egypt\]
- interventionNames
- Drug: sofenacin
- type
- ACTIVE_COMPARATOR
- label
- levofloxacin
- description
- (Tavanic ''levofloxacin 500 mg'') \[Sanofi-Aventis - Egypt\]
- interventionNames
- Drug: Tavanic
- type
- ACTIVE_COMPARATOR
- label
- lornoxicam
- description
- (Xefo ''lornoxicam 8 mg'') \[Multi-Apex - Egypt, under license of: NYCOMED, Austria\]
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: • Patients classified as intermediate or high risk of the bladder tumour Exclusion Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.