Trial · NCT05621616
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to Week 24 in Maximum Cystometric Capacity (MCC) | Baseline and week 24 | MCC is maximum bladder capacity reached at end of filling cytometry. |
| Secondary | Change from baseline in bladder compliance | Baseline and weeks 4 and 24 | Bladder compliance is calculated by change in volume divided by change in pressure during filling of the bladder. |
| Secondary | Change from baseline in filling volume until first detrusor contraction (>15cm H2O) | Baseline and weeks 4 and 24 | Change in bladder volume calculated by urodynamic assessments. |
| Secondary | Change from baseline in number of uninhibited detrusor contractions until leakage or until maximum 135% of age-related bladder capacity | Baseline and weeks 4 and 24 | Change in number of of uninhibited detrusor contractions is calculated by urodynamic assessments. |
| Secondary | Change from baseline in maximum catheterized daytime volume | Baseline and up to week 52 | Based on participant e-diary. |
| Secondary | Change from baseline in average catheterized daytime volume | Baseline and up to week 52 | Based on participant e-diary. |
| Secondary | Change from baseline in average morning catheterized volume | Baseline and up to week 52 | E-diary measure based on first catheterization after participant wakes up. |
| Secondary | Change from baseline in number of leakage episodes per 24 hours | Baseline and up to week 52 | Based on participant e-diary. |
| Secondary | Change from baseline in number of dry days per 7 days | Baseline and up to week 52 | Based on participant e-diary, dry defined as leakage-free. |
| Secondary | Acceptability by pediatric oral medicine acceptability questionnaire for caregivers (P-OMAQ-C) | Baseline and weeks 4, 24 and 52 | The P-OMAQ-C uses a 5-point numerical rate scale to measure acceptability of use of the tablet formulation with questions related to taste, smell and administration of study medication. Acceptability questionnaires to be completed by caregivers on an electronic device. |
| Secondary | Frequency of adverse events (AE) | Up to week 54 | An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. This includes events related to the comparator and events related to the (study) procedures. |
| Secondary | Number of Participants With Vital Sign Abnormalities and/or AEs | Up to week 54 | Number of participants with potentially clinically significant vital sign values. |
| Secondary | Number of participants with laboratory value abnormalities and/or AEs | Up to week 52 | Number of participants with potentially clinically significant laboratory values. |
| Secondary | Number of participants with electrocardiogram (ECG) abnormalities and/or AEs | Up to week 54 | Number of participants with potentially clinically significant ECG values. |
| Secondary | Number of participants with upper urinary tract ultrasound abnormalities and/or AEs | Up to week 52 | Number of participants with potentially clinically significant upper urinary tract ultrasounds. |
| Secondary | PK of mirabegron in plasma: Area under the concentration-time curve per 24 hours (AUC24) | Up to week 52 | AUC24 will be recorded from the PK plasma samples collected. |
| Secondary | PK of mirabegron in plasma: Concentration immediately prior to dosing (Ctrough) | Up to week 52 | Ctrough will be recorded from the PK plasma samples collected. |
| Secondary | PK of mirabegron in plasma: Apparent clearance (CL/F) | Up to week 52 | CL/F will be recorded from the PK plasma samples collected. |
| Secondary | PK of mirabegron in plasma: Apparent volume of distribution (VzF) | Up to week 52 | VzF will be recorded from the PK plasma samples collected. |
| Secondary | PK of mirabegron in plasma: Maximum concentration (Cmax) | Up to week 52 | Cmax will be recorded from the PK plasma samples collected. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT05621616/registered