Phase 2
Completed N=31
PK/PD, Long-term Safety and Efficacy of Tamsulosin Treatment in Children With Neurogenic Bladder
Bladder, Neurogenic
Source: ClinicalTrials.gov NCT00340704 ↗
Enrolled (actual)
31
Serious AEs
3.5%
Results posted
Feb 2016
Primary outcomePrimary: Percentage of LPP Responders for Group D-Denovo and Group D-527.51 Rollover — 73.1; 35.7; 26.7; 67.9 percentage of responders
Summary
Aims of this study is to characterize the pharmacokinetic/pharmacodynamic profile and evaluate the safety, efficacy and tolerability, of tamsulosin hydrochloride as treatment in children with a neuropathic bladder, over the course of 12 months of active treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of LPP Responders for Group D-Denovo and Group D-527.51 Rollover |
73.1; 35.7; 26.7; 67.9; 58.3; 20.7 | — |
| PRIMARY Number of LPP Responders at Each Visit Over Time (Classified by Last Value on Treatment) for Group D-527.51 Rollover. |
38; 1; 0; 2; 7; 2 | — |
| SECONDARY Early Responders Who Maintained Their LPP Below 40 cm H2O During the Study for Group D-Denovo and Group D-527.51 Rollover |
17; 5; 3 | — |
| SECONDARY Change From Baseline in LPP for Group D-527.51 Rollover |
48.50; 48.5; 55.50; 29.00; 49.50; 64.75 | — |
| SECONDARY Percent Change From Baseline in LPP for Group D-527.51 Rollover |
48.50; 48.50; 55.50; 29.00; 49.50; 64.75 | — |
| SECONDARY Response Defined as Stabilization or Improvement of Hydroureter Measured by Renal Ultrasound Compared to Baseline for Group D-Denovo and Group D-527.51 Rollover |
26; 15; 28; 43; 8; 19 | — |
| SECONDARY Response Defined as Stabilization or Improvement of Hydronephrosis Measured by Renal Ultrasound Compared to Baseline for Group D-Denovo and Group D-527.51 Rollover |
26; 15; 28; 39; 8; 17 | — |
| SECONDARY LPP Response at Any Time During the Trial for Group D-Denovo and Group D-527.51 Rollover |
26; 16; 16; 42; 8; 12 | — |
| SECONDARY Number of Participants With Clinically Relevant Abnormalities for Physical Examination, Vital Signs/Orthostatic Testing, Electrocardiogram (ECG), Laboratory Values,Urinalysis,Occurence of Adverse Events & Cognitive Testing for Group D-527.51 Rollover |
1; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Relevant Abnormalities for Physical Examination, Vital Signs/Orthostatic Testing, Electrocardiogram (ECG), Laboratory Values, Urinalysis, Occurence of Adverse Events and Cognitive Testing for Group D-Denovo |
0; 0; 1; 0; 0; 1 | — |
| SECONDARY Vision Testing for Group D-Denovo |
11; 7; 12; 8; 1; 8 | — |
| SECONDARY Vision Testing for Group D-527.51 Rollover |
32; 10; 12; 5; 2; 4 | — |
| SECONDARY Cmax,1 |
1.67 | — |
| SECONDARY Tmax, 1 |
6 | — |
| SECONDARY Cmax, 1 ,DW ,Norm |
1120 | — |
| SECONDARY Cpre,ss |
0.914; 1.83; 4.03 | — |
| SECONDARY Cmax,ss |
2.79; 5.02; 14.10 | — |
| SECONDARY Cmax,ss, DW, Norm |
2040; 1850; 2240 | — |
| SECONDARY Cmin,ss |
0.747; 1.52; 4.01 | — |
| SECONDARY Tmax,ss |
5.00; 5.92; 5.01 | — |
| SECONDARY AUCτ,ss |
35.80; 68.20; 175.00 | — |
| SECONDARY AUCτ ,ss ,DW ,Norm |
26100; 25200; 27700 | — |
| SECONDARY λz,ss |
0.0589; 0.0671; 0.0496 | — |
| SECONDARY t1/2,ss |
11.80; 10.30; 14.00 | — |
| SECONDARY MRTpo,ss |
18.70; 17.60; 20.90 | — |
| SECONDARY CL/F,ss,W,Norm |
0.0383; 0.0397; 0.0361 | — |
| SECONDARY Vz/F,ss,W,Norm |
0.65; 0.591; 0.729 | — |
| SECONDARY RA,Cmax |
1.58 | — |
Eligibility Criteria
Inclusion Criteria
- Neuropathic bladder secondary to known neurological disorder
- Elevated detrusor leak point pressures (LPP) ≥40 cm H2O confirmed by two measurements at baseline
Exclusion Criteria
- Clinically significant abnormalities as determined by the investigator
- A history of relevant orthostatic hypotension, fainting spells or blackouts
Data sourced from ClinicalTrials.gov (NCT00340704). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.