|drug1919||IncobotulinumtoxinA 100 UNT Injection [Xeomin] Wiki||0.71|
|drug2690||OnabotulinumtoxinA 100 UNT [Botox] Wiki||0.71|
There are 2 clinical trials
The aim of the original study was to compare Incobot/A versus Onabot/A in order to evaluate if the differences in the pharmacologic formulations between the two drugs could affect their efficacy and safety in the treatment of neurogenic overactive bladder (OAB). In the original study protocol two different dosages for either Incobot/A and Onabot/A (200 U and 100 U) were considered, to treat patients with neurogenic detrusor overactivity incontinence performing intermittent catheterization (IC) with higher dosages and those able to void spontaneously with lower dosage, with the resulting four treatment groups. For such a study, a very large sample of participants should have been treated and followed up, to have adequate power to demonstrate the hypothesis. At the end of last February 2020, we had to temporarily stop all the clinical activities related to the study and patients' recruitment, due to the occurrence of Sars-Cov-2 pandemic in our Country. At that point, a non-inferiority study seemed to be possible and adequate, and we adapted the protocol accordingly. In addition, on the basis of previously published information, we could hypothesize that the new drug (Incobot/A) would have had at least a roughly similar effect to the control drug (Onabot/A). In order to perform a non-inferiority study, the power and sample size analysis have been re-planned. Thus, we perform a not planned interim analysis to show the preliminary results of an ongoing, non-inferiority trial in which patients' recruitment temporarily stopped due to incontrollable external factors. The present study will be aimed to assess the non-inferiority of Incobot/A compared to Onabot/A on the efficacy and safety parameters, in the treatment of patients with refractory NDOI performing IC, who are randomized to receive 200 U of Incobot/A or Onabot/A intradetrusor injections and who are followed up to 12 wks after treatment
Description: change from baseline in the daily frequency of urinary incontinence episodes, as assessed by the 3-day voiding diary.Measure: Change from baseline in the frequency of urinary incontinence episodes. Time: 24 weeks
Description: Measurement of eventual differencies between the two arms of treatment in the frequency of urinary tract infections at 2, 12 and 24 weeks after treatmentMeasure: Evaluation of frequency of urinary tract infections in both arms of treatment. Time: 2, 12, 24 weeks
Description: Significant improvements in urodynamic parameters (maximum cystometric capacity, maximum detrusor pressure during first involuntary detrusor contraction) at 12 and 24 weeks as compared to baseline.Measure: Change from baseline in urodynamic parameters. Time: 24 weeks
Description: Significant improvement in I-QoL total score at 2, 12 and 24 weeks as compared to baseline.Measure: Change from baseline in Incontinence Quality of Life (I-QoL) questionnaire total score. Time: 2, 12, 24 weeks
Description: Assessment of possible adverse events-AE (systemic AEs: fatigue, weakness, dyspnoea, gastrointestinal irritation, Flu-like symptoms, dizziness; local AEs: haematuria, dysuria, urinary retention, post-void residual volume > 150 ml) at 2, 12 and 24 weeks after treatment.Measure: Recording of the adverse events. Time: 2, 12, 24 weeks
In this study, researchers want to find whether the study drug BAY1817080 has an effect on the electrocardiogram (ECG). 40 healthy male or female participants with the age of 18 to 65 years will be enrolled into this study. The ECG of the participants will be monitored closely by the researchers to detect any change after intake of the study medication.
Description: Area under the concentration vs. time curve from zero to 24 hours after multiple dosesMeasure: AUC(0-24)md after multiple oral doses of BAY1817080 therapeutic or supra-therapeutic dose Time: Predose and up to 24 hours after last dose of BAY1817080 at Day 3
Description: Area under the concentration vs. time curve from zero to infinity after single doseMeasure: AUC after a single oral dose of moxifloxacin Time: Predose and up to 24 hours after single dose of moxifloxacin at Day 3
Description: Maximum observed drug concentration in measured matrix after multiple dosesMeasure: Cmax,md after multiple oral doses of BAY1817080 therapeutic or supra-therapeutic dose Time: Up to 24 hours after last dose of BAY1817080 at Day 3
Description: Maximum observed drug concentration in measured matrix after single doseMeasure: Cmax after a single oral dose of moxifloxacin Time: Up to 24 hours after single dose of moxifloxacin at Day 3
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.Drug Reports MeSH Reports HPO Reports