Trial Outcomes & Findings for Study to Evaluate the Efficacy and Safety of Tamsulosin in Children With Neurogenic Bladder (NCT NCT00796614)
NCT ID: NCT00796614
Last Updated: 2015-10-29
Results Overview
The primary endpoint was response to treatment defined as patients who decreased their detrusor leak point pressure (LPP) based upon two evaluations on the same day to less than 40 cm H2O at Week 14 (end of treatment). Detrusor leak point pressure (LPP) recorded in cm H2O was obtained using a standard urodynamic technique, a cystometrogram. On treatment (OT): Consist of all on treatment data. Observations measured ≤3 days of stopping treatment was considered as on treatment. Missing data in these analyses was not replaced or imputed.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
231 participants
Primary outcome timeframe
Week 14
Results posted on
2015-10-29
Participant Flow
The trial included children from 2-16 years of age, with elevated detrusor leak point pressure associated with a known neurologic defect (e.g., spina bifida). The three age strata were 2-\<5 years, 5-\<10 years and 10-16 years of age. In this study, 231 subjects were enrolled, 162 subjects were randomised and 161 subjects were treated.
Participant milestones
| Measure |
Placebo
Subjects were orally administered to matching placebo to tamsulosin hydrochloride, with once daily by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of apple sauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
|
Tamsulosin - Low Dose Level
Subjects were orally administered to low dose level (0.001 - 0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
|
Tamsulosin - Medium Dose Level
Subjects were orally administered to medium dose level (0.002 - 0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
|
Tamsulosin - High Dose Level
Subjects were orally administered to high dose level (0.004 - 0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
41
|
40
|
39
|
41
|
|
Overall Study
Not Treated
|
0
|
0
|
1
|
0
|
|
Overall Study
COMPLETED
|
36
|
36
|
36
|
40
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
3
|
1
|
Reasons for withdrawal
| Measure |
Placebo
Subjects were orally administered to matching placebo to tamsulosin hydrochloride, with once daily by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of apple sauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
|
Tamsulosin - Low Dose Level
Subjects were orally administered to low dose level (0.001 - 0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
|
Tamsulosin - Medium Dose Level
Subjects were orally administered to medium dose level (0.002 - 0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
|
Tamsulosin - High Dose Level
Subjects were orally administered to high dose level (0.004 - 0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
1
|
|
Overall Study
Other than stated
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Study to Evaluate the Efficacy and Safety of Tamsulosin in Children With Neurogenic Bladder
Baseline characteristics by cohort
| Measure |
Placebo
n=41 Participants
Subjects were orally administered to matching placebo to tamsulosin hydrochloride, with once daily by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of apple sauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
|
Tamsulosin - Low Dose Level
n=40 Participants
Subjects were orally administered to low dose level (0.001 - 0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
|
Tamsulosin - Medium Dose Level
n=39 Participants
Subjects were orally administered to medium dose level (0.002 - 0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
|
Tamsulosin - High Dose Level
n=41 Participants
Subjects were orally administered to high dose level (0.004 - 0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
|
Total
n=161 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
8.4 Years
STANDARD_DEVIATION 3.7 • n=5 Participants
|
8.1 Years
STANDARD_DEVIATION 4.2 • n=7 Participants
|
8.1 Years
STANDARD_DEVIATION 3.8 • n=5 Participants
|
8.2 Years
STANDARD_DEVIATION 4.3 • n=4 Participants
|
8.2 Years
STANDARD_DEVIATION 4.0 • n=21 Participants
|
|
Age, Customized
2 to < 5 years
|
7 participants
n=5 Participants
|
8 participants
n=7 Participants
|
7 participants
n=5 Participants
|
8 participants
n=4 Participants
|
30 participants
n=21 Participants
|
|
Age, Customized
5 to < 10 years
|
18 participants
n=5 Participants
|
17 participants
n=7 Participants
|
17 participants
n=5 Participants
|
18 participants
n=4 Participants
|
70 participants
n=21 Participants
|
|
Age, Customized
10 to 16 years
|
16 participants
n=5 Participants
|
15 participants
n=7 Participants
|
15 participants
n=5 Participants
|
15 participants
n=4 Participants
|
61 participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
64 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
97 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Week 14Population: Full analysis set-LPP (FAS-LPP): Includes all patients in the treated set who received at least one dose of randomised. FAS-LPP contains same patients as TS.
The primary endpoint was response to treatment defined as patients who decreased their detrusor leak point pressure (LPP) based upon two evaluations on the same day to less than 40 cm H2O at Week 14 (end of treatment). Detrusor leak point pressure (LPP) recorded in cm H2O was obtained using a standard urodynamic technique, a cystometrogram. On treatment (OT): Consist of all on treatment data. Observations measured ≤3 days of stopping treatment was considered as on treatment. Missing data in these analyses was not replaced or imputed.
Outcome measures
| Measure |
Placebo
n=34 Participants
Subjects were orally administered to matching placebo to tamsulosin hydrochloride, with once daily by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of apple sauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
|
Tamsulosin - Low Dose Level
n=35 Participants
Subjects were orally administered to low dose level (0.001 - 0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
|
Tamsulosin - Medium Dose Level
n=33 Participants
Subjects were orally administered to medium dose level (0.002 - 0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
|
Tamsulosin - High Dose Level
n=33 Participants
Subjects were orally administered to high dose level (0.004 - 0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
|
|---|---|---|---|---|
|
Response to Treatment Defined as Patients Who Decrease Their Detrusor Leak Point Pressure (LPP) to <40 cm H2O Based Upon Two Evaluations on the Same Day.
|
35.3 Percentage of participants
|
45.7 Percentage of participants
|
27.3 Percentage of participants
|
42.4 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 14Population: Full analysis set-LPP (FAS-LPP), OT
Change from baseline in detrusor leak point pressure (LPP) at Week 14 (end of treatment) between each dose group and the placebo group was compared for the FAS-LPP.
Outcome measures
| Measure |
Placebo
n=30 Participants
Subjects were orally administered to matching placebo to tamsulosin hydrochloride, with once daily by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of apple sauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
|
Tamsulosin - Low Dose Level
n=32 Participants
Subjects were orally administered to low dose level (0.001 - 0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
|
Tamsulosin - Medium Dose Level
n=31 Participants
Subjects were orally administered to medium dose level (0.002 - 0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
|
Tamsulosin - High Dose Level
n=33 Participants
Subjects were orally administered to high dose level (0.004 - 0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
|
|---|---|---|---|---|
|
Change From Baseline in LPP at Week 14 (End of Treatment)
|
-11.4 cm H2O
Standard Error 4.6
|
-17.6 cm H2O
Standard Error 4.5
|
-4.6 cm H2O
Standard Error 4.4
|
-14.3 cm H2O
Standard Error 4.3
|
SECONDARY outcome
Timeframe: Baseline and Week 14.Population: Full analysis set-LPP (FAS-LPP), OT
Percent changes in detrusor leak point pressure (LPP) from baseline to the end of treatment at Week 14 between each dose group and the placebo group were compared for the FAS-LPP.
Outcome measures
| Measure |
Placebo
n=30 Participants
Subjects were orally administered to matching placebo to tamsulosin hydrochloride, with once daily by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of apple sauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
|
Tamsulosin - Low Dose Level
n=32 Participants
Subjects were orally administered to low dose level (0.001 - 0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
|
Tamsulosin - Medium Dose Level
n=31 Participants
Subjects were orally administered to medium dose level (0.002 - 0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
|
Tamsulosin - High Dose Level
n=33 Participants
Subjects were orally administered to high dose level (0.004 - 0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
|
|---|---|---|---|---|
|
Percentage Change From Baseline in LPP at Week 14 (End of Treatment)
|
-19.9 Percentage change
Standard Error 7.3
|
-27.4 Percentage change
Standard Error 7.1
|
-1.9 Percentage change
Standard Error 7
|
-23.9 Percentage change
Standard Error 6.9
|
SECONDARY outcome
Timeframe: Baseline and Week 14Population: Full analysis set-renal (FAS-RENAL): This analysis set includes all patients in the treated set who received at least one dose of randomised treatment and had at least one on-treatment renal ultrasound measurement.
Hydronephrosis response was defined as stabilisation or improvement of hydronephrosis measured by renal ultrasound at the end of treatment when compared to baseline, based on ultrasound grading. The lower or same grade at end of treatment compared to baseline is considered an improvement or stabilization
Outcome measures
| Measure |
Placebo
n=40 Participants
Subjects were orally administered to matching placebo to tamsulosin hydrochloride, with once daily by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of apple sauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
|
Tamsulosin - Low Dose Level
n=38 Participants
Subjects were orally administered to low dose level (0.001 - 0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
|
Tamsulosin - Medium Dose Level
n=38 Participants
Subjects were orally administered to medium dose level (0.002 - 0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
|
Tamsulosin - High Dose Level
n=40 Participants
Subjects were orally administered to high dose level (0.004 - 0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
|
|---|---|---|---|---|
|
Response With Regard to Hydronephrosis Was Defined as Improvement or Stabilisation Based Upon the Renal Ultrasound Grading at Week 14 (End of Treatment) Compared to Baseline
Left Kidney [N= 34; 34; 33; 40]
|
32 Participants
|
31 Participants
|
31 Participants
|
37 Participants
|
|
Response With Regard to Hydronephrosis Was Defined as Improvement or Stabilisation Based Upon the Renal Ultrasound Grading at Week 14 (End of Treatment) Compared to Baseline
Right Kidney [N= 33; 34; 34; 40]
|
31 Participants
|
33 Participants
|
30 Participants
|
38 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 14Population: Full analysis set-renal (FAS-RENAL)
Hydroureter response was defined as stabilisation or improvement based on change from baseline in the presence or absence of hydroureter at the end of treatment (Week 14). Response defined as stabilization or improvement of hydroureter measured by renal ultrasound compared to baseline by treatment group (Patients are classified according to the treatment they were taking at Week 14 or end of treatment) at Week 14.
Outcome measures
| Measure |
Placebo
n=40 Participants
Subjects were orally administered to matching placebo to tamsulosin hydrochloride, with once daily by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of apple sauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
|
Tamsulosin - Low Dose Level
n=38 Participants
Subjects were orally administered to low dose level (0.001 - 0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
|
Tamsulosin - Medium Dose Level
n=38 Participants
Subjects were orally administered to medium dose level (0.002 - 0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
|
Tamsulosin - High Dose Level
n=40 Participants
Subjects were orally administered to high dose level (0.004 - 0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
|
|---|---|---|---|---|
|
Response With Regard to Hydroureter Was Defined as Improvement or Stabilisation Based Upon the Renal Ultrasound at Week 14 (End of Treatment) Compared to Baseline
Left Kidney (N= 34, 34, 33, 40)
|
33 Participants
|
33 Participants
|
32 Participants
|
38 Participants
|
|
Response With Regard to Hydroureter Was Defined as Improvement or Stabilisation Based Upon the Renal Ultrasound at Week 14 (End of Treatment) Compared to Baseline
Right Kidney (N= 33, 34, 34, 40)
|
33 Participants
|
33 Participants
|
32 Participants
|
38 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 14Population: Full analysis set-catheter (FAS-CATH): This analysis set includes all patients in the treated set who received at least one dose of randomised treatment, were on a catheterisation regimen, and had at least one on-treatment catheterisation assessment.
Change in baseline urine volumes obtained by catheterisation as recorded in catheterisation diary at Week 14.
Outcome measures
| Measure |
Placebo
n=24 Participants
Subjects were orally administered to matching placebo to tamsulosin hydrochloride, with once daily by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of apple sauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
|
Tamsulosin - Low Dose Level
n=18 Participants
Subjects were orally administered to low dose level (0.001 - 0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
|
Tamsulosin - Medium Dose Level
n=16 Participants
Subjects were orally administered to medium dose level (0.002 - 0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
|
Tamsulosin - High Dose Level
n=21 Participants
Subjects were orally administered to high dose level (0.004 - 0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
|
|---|---|---|---|---|
|
Change From Baseline in Urine Volume at Week 14
|
-2.3 mL
Standard Error 14.0
|
-32.2 mL
Standard Error 15.5
|
4.4 mL
Standard Error 16.3
|
3.3 mL
Standard Error 14.2
|
SECONDARY outcome
Timeframe: Baseline and Week 14Population: Full analysis set-catheter (FAS-CATH)
Change from baseline in number of times patient was wet at time of catheterisation as recorded in catheterisation diary.
Outcome measures
| Measure |
Placebo
n=24 Participants
Subjects were orally administered to matching placebo to tamsulosin hydrochloride, with once daily by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of apple sauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
|
Tamsulosin - Low Dose Level
n=18 Participants
Subjects were orally administered to low dose level (0.001 - 0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
|
Tamsulosin - Medium Dose Level
n=16 Participants
Subjects were orally administered to medium dose level (0.002 - 0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
|
Tamsulosin - High Dose Level
n=21 Participants
Subjects were orally administered to high dose level (0.004 - 0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
|
|---|---|---|---|---|
|
Change From Baseline in Number of Times Patient Was Wet at Catheterisation
|
0.3 Times patient wet at catheterization
Standard Error 0.8
|
-1.7 Times patient wet at catheterization
Standard Error 0.9
|
0.0 Times patient wet at catheterization
Standard Error 0.9
|
-0.4 Times patient wet at catheterization
Standard Error 0.8
|
SECONDARY outcome
Timeframe: From first drug administration until 28 days after last study drug administration, upto 160 daysPopulation: Treated Set (TS). All subjects began treatment with their low dose and then they were titrated to their randomised medium or high dose. Therefore some of the subjects were counted more than once for having reported adverse events with different doses of the study.
Number of participants with Clinically Relevant Abnormalities for Physical Examination, Vital Signs/Orthostatic testing (blood pressure, pulse and respiratory rate), Electrocardiogram (ECG), Laboratory Values inclusive of hormonal assays, vision testing, Cognitive Testing, Occurrence of treatment emergent adverse events, Premature discontinuation of study drug due to AE and Urinalysis. Relevant findings or worsening of baseline conditions were reported as adverse events.
Outcome measures
| Measure |
Placebo
n=41 Participants
Subjects were orally administered to matching placebo to tamsulosin hydrochloride, with once daily by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of apple sauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
|
Tamsulosin - Low Dose Level
n=120 Participants
Subjects were orally administered to low dose level (0.001 - 0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
|
Tamsulosin - Medium Dose Level
n=80 Participants
Subjects were orally administered to medium dose level (0.002 - 0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
|
Tamsulosin - High Dose Level
n=40 Participants
Subjects were orally administered to high dose level (0.004 - 0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
|
|---|---|---|---|---|
|
Number of Participants With Clinically Relevant Abnormalities for Physical Examination, Vital Signs/Orthostatic Testing, Electorocardiogram (ECG), Laboratory Values, Urinalysis, Treatment Emergent AE's and Cognitive Testing.
Occurrence of treatment emergent adverse events
|
18 Participants
|
39 Participants
|
24 Participants
|
15 Participants
|
|
Number of Participants With Clinically Relevant Abnormalities for Physical Examination, Vital Signs/Orthostatic Testing, Electorocardiogram (ECG), Laboratory Values, Urinalysis, Treatment Emergent AE's and Cognitive Testing.
Premature discontinuation of study drug due to AE
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Relevant Abnormalities for Physical Examination, Vital Signs/Orthostatic Testing, Electorocardiogram (ECG), Laboratory Values, Urinalysis, Treatment Emergent AE's and Cognitive Testing.
Sinus tachycardia
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 14.Population: Treated Set (TS). Number of particiapants Analysed are the number of participants whose data were available for this endpoint.
Median change from baseline to Week 14 in post void residual (mL) by study treatment.
Outcome measures
| Measure |
Placebo
n=31 Participants
Subjects were orally administered to matching placebo to tamsulosin hydrochloride, with once daily by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of apple sauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
|
Tamsulosin - Low Dose Level
n=36 Participants
Subjects were orally administered to low dose level (0.001 - 0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
|
Tamsulosin - Medium Dose Level
n=34 Participants
Subjects were orally administered to medium dose level (0.002 - 0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
|
Tamsulosin - High Dose Level
n=38 Participants
Subjects were orally administered to high dose level (0.004 - 0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
|
|---|---|---|---|---|
|
Post Void Residual Volume at Week 14
|
3 mL
Standard Deviation 80.28
|
-19 mL
Standard Deviation 66.4
|
-1.5 mL
Standard Deviation 92.33
|
0.00 mL
Standard Deviation 58.67
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Tamsulosin - Low Dose Level
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Tamsulosin - Medium Dose Level
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Tamsulosin - High Dose Level
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=41 participants at risk
Subjects were orally administered to matching placebo to tamsulosin hydrochloride, with once daily by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of apple sauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
|
Tamsulosin - Low Dose Level
n=120 participants at risk
Subjects were orally administered to low dose level (0.001 - 0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
|
Tamsulosin - Medium Dose Level
n=80 participants at risk
Subjects were orally administered to medium dose level (0.002 - 0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
|
Tamsulosin - High Dose Level
n=40 participants at risk
Subjects were orally administered to high dose level (0.004 - 0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
|
|---|---|---|---|---|
|
General disorders
Death
|
0.00%
0/41 • From first drug administration until 28 days after last study drug administration, upto 160 days.
All subjects began treatment with their low dose and then they were titrated to their randomised medium or high dose. Therefore some of the subjects were counted more than once for having reported adverse events with different doses of the study.
|
0.83%
1/120 • From first drug administration until 28 days after last study drug administration, upto 160 days.
All subjects began treatment with their low dose and then they were titrated to their randomised medium or high dose. Therefore some of the subjects were counted more than once for having reported adverse events with different doses of the study.
|
0.00%
0/80 • From first drug administration until 28 days after last study drug administration, upto 160 days.
All subjects began treatment with their low dose and then they were titrated to their randomised medium or high dose. Therefore some of the subjects were counted more than once for having reported adverse events with different doses of the study.
|
0.00%
0/40 • From first drug administration until 28 days after last study drug administration, upto 160 days.
All subjects began treatment with their low dose and then they were titrated to their randomised medium or high dose. Therefore some of the subjects were counted more than once for having reported adverse events with different doses of the study.
|
|
Injury, poisoning and procedural complications
Shunt malfunction
|
2.4%
1/41 • From first drug administration until 28 days after last study drug administration, upto 160 days.
All subjects began treatment with their low dose and then they were titrated to their randomised medium or high dose. Therefore some of the subjects were counted more than once for having reported adverse events with different doses of the study.
|
0.00%
0/120 • From first drug administration until 28 days after last study drug administration, upto 160 days.
All subjects began treatment with their low dose and then they were titrated to their randomised medium or high dose. Therefore some of the subjects were counted more than once for having reported adverse events with different doses of the study.
|
0.00%
0/80 • From first drug administration until 28 days after last study drug administration, upto 160 days.
All subjects began treatment with their low dose and then they were titrated to their randomised medium or high dose. Therefore some of the subjects were counted more than once for having reported adverse events with different doses of the study.
|
0.00%
0/40 • From first drug administration until 28 days after last study drug administration, upto 160 days.
All subjects began treatment with their low dose and then they were titrated to their randomised medium or high dose. Therefore some of the subjects were counted more than once for having reported adverse events with different doses of the study.
|
|
Vascular disorders
Haematoma
|
2.4%
1/41 • From first drug administration until 28 days after last study drug administration, upto 160 days.
All subjects began treatment with their low dose and then they were titrated to their randomised medium or high dose. Therefore some of the subjects were counted more than once for having reported adverse events with different doses of the study.
|
0.00%
0/120 • From first drug administration until 28 days after last study drug administration, upto 160 days.
All subjects began treatment with their low dose and then they were titrated to their randomised medium or high dose. Therefore some of the subjects were counted more than once for having reported adverse events with different doses of the study.
|
0.00%
0/80 • From first drug administration until 28 days after last study drug administration, upto 160 days.
All subjects began treatment with their low dose and then they were titrated to their randomised medium or high dose. Therefore some of the subjects were counted more than once for having reported adverse events with different doses of the study.
|
0.00%
0/40 • From first drug administration until 28 days after last study drug administration, upto 160 days.
All subjects began treatment with their low dose and then they were titrated to their randomised medium or high dose. Therefore some of the subjects were counted more than once for having reported adverse events with different doses of the study.
|
Other adverse events
| Measure |
Placebo
n=41 participants at risk
Subjects were orally administered to matching placebo to tamsulosin hydrochloride, with once daily by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of apple sauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
|
Tamsulosin - Low Dose Level
n=120 participants at risk
Subjects were orally administered to low dose level (0.001 - 0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
|
Tamsulosin - Medium Dose Level
n=80 participants at risk
Subjects were orally administered to medium dose level (0.002 - 0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
|
Tamsulosin - High Dose Level
n=40 participants at risk
Subjects were orally administered to high dose level (0.004 - 0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
14.6%
6/41 • From first drug administration until 28 days after last study drug administration, upto 160 days.
All subjects began treatment with their low dose and then they were titrated to their randomised medium or high dose. Therefore some of the subjects were counted more than once for having reported adverse events with different doses of the study.
|
0.83%
1/120 • From first drug administration until 28 days after last study drug administration, upto 160 days.
All subjects began treatment with their low dose and then they were titrated to their randomised medium or high dose. Therefore some of the subjects were counted more than once for having reported adverse events with different doses of the study.
|
1.2%
1/80 • From first drug administration until 28 days after last study drug administration, upto 160 days.
All subjects began treatment with their low dose and then they were titrated to their randomised medium or high dose. Therefore some of the subjects were counted more than once for having reported adverse events with different doses of the study.
|
0.00%
0/40 • From first drug administration until 28 days after last study drug administration, upto 160 days.
All subjects began treatment with their low dose and then they were titrated to their randomised medium or high dose. Therefore some of the subjects were counted more than once for having reported adverse events with different doses of the study.
|
|
Gastrointestinal disorders
Constipation
|
7.3%
3/41 • From first drug administration until 28 days after last study drug administration, upto 160 days.
All subjects began treatment with their low dose and then they were titrated to their randomised medium or high dose. Therefore some of the subjects were counted more than once for having reported adverse events with different doses of the study.
|
0.00%
0/120 • From first drug administration until 28 days after last study drug administration, upto 160 days.
All subjects began treatment with their low dose and then they were titrated to their randomised medium or high dose. Therefore some of the subjects were counted more than once for having reported adverse events with different doses of the study.
|
0.00%
0/80 • From first drug administration until 28 days after last study drug administration, upto 160 days.
All subjects began treatment with their low dose and then they were titrated to their randomised medium or high dose. Therefore some of the subjects were counted more than once for having reported adverse events with different doses of the study.
|
0.00%
0/40 • From first drug administration until 28 days after last study drug administration, upto 160 days.
All subjects began treatment with their low dose and then they were titrated to their randomised medium or high dose. Therefore some of the subjects were counted more than once for having reported adverse events with different doses of the study.
|
|
Gastrointestinal disorders
Vomiting
|
12.2%
5/41 • From first drug administration until 28 days after last study drug administration, upto 160 days.
All subjects began treatment with their low dose and then they were titrated to their randomised medium or high dose. Therefore some of the subjects were counted more than once for having reported adverse events with different doses of the study.
|
1.7%
2/120 • From first drug administration until 28 days after last study drug administration, upto 160 days.
All subjects began treatment with their low dose and then they were titrated to their randomised medium or high dose. Therefore some of the subjects were counted more than once for having reported adverse events with different doses of the study.
|
5.0%
4/80 • From first drug administration until 28 days after last study drug administration, upto 160 days.
All subjects began treatment with their low dose and then they were titrated to their randomised medium or high dose. Therefore some of the subjects were counted more than once for having reported adverse events with different doses of the study.
|
7.5%
3/40 • From first drug administration until 28 days after last study drug administration, upto 160 days.
All subjects began treatment with their low dose and then they were titrated to their randomised medium or high dose. Therefore some of the subjects were counted more than once for having reported adverse events with different doses of the study.
|
|
Infections and infestations
Influenza
|
7.3%
3/41 • From first drug administration until 28 days after last study drug administration, upto 160 days.
All subjects began treatment with their low dose and then they were titrated to their randomised medium or high dose. Therefore some of the subjects were counted more than once for having reported adverse events with different doses of the study.
|
2.5%
3/120 • From first drug administration until 28 days after last study drug administration, upto 160 days.
All subjects began treatment with their low dose and then they were titrated to their randomised medium or high dose. Therefore some of the subjects were counted more than once for having reported adverse events with different doses of the study.
|
1.2%
1/80 • From first drug administration until 28 days after last study drug administration, upto 160 days.
All subjects began treatment with their low dose and then they were titrated to their randomised medium or high dose. Therefore some of the subjects were counted more than once for having reported adverse events with different doses of the study.
|
5.0%
2/40 • From first drug administration until 28 days after last study drug administration, upto 160 days.
All subjects began treatment with their low dose and then they were titrated to their randomised medium or high dose. Therefore some of the subjects were counted more than once for having reported adverse events with different doses of the study.
|
|
Infections and infestations
Nasopharyngitis
|
2.4%
1/41 • From first drug administration until 28 days after last study drug administration, upto 160 days.
All subjects began treatment with their low dose and then they were titrated to their randomised medium or high dose. Therefore some of the subjects were counted more than once for having reported adverse events with different doses of the study.
|
4.2%
5/120 • From first drug administration until 28 days after last study drug administration, upto 160 days.
All subjects began treatment with their low dose and then they were titrated to their randomised medium or high dose. Therefore some of the subjects were counted more than once for having reported adverse events with different doses of the study.
|
5.0%
4/80 • From first drug administration until 28 days after last study drug administration, upto 160 days.
All subjects began treatment with their low dose and then they were titrated to their randomised medium or high dose. Therefore some of the subjects were counted more than once for having reported adverse events with different doses of the study.
|
10.0%
4/40 • From first drug administration until 28 days after last study drug administration, upto 160 days.
All subjects began treatment with their low dose and then they were titrated to their randomised medium or high dose. Therefore some of the subjects were counted more than once for having reported adverse events with different doses of the study.
|
|
Infections and infestations
Urinary tract infection
|
9.8%
4/41 • From first drug administration until 28 days after last study drug administration, upto 160 days.
All subjects began treatment with their low dose and then they were titrated to their randomised medium or high dose. Therefore some of the subjects were counted more than once for having reported adverse events with different doses of the study.
|
6.7%
8/120 • From first drug administration until 28 days after last study drug administration, upto 160 days.
All subjects began treatment with their low dose and then they were titrated to their randomised medium or high dose. Therefore some of the subjects were counted more than once for having reported adverse events with different doses of the study.
|
2.5%
2/80 • From first drug administration until 28 days after last study drug administration, upto 160 days.
All subjects began treatment with their low dose and then they were titrated to their randomised medium or high dose. Therefore some of the subjects were counted more than once for having reported adverse events with different doses of the study.
|
12.5%
5/40 • From first drug administration until 28 days after last study drug administration, upto 160 days.
All subjects began treatment with their low dose and then they were titrated to their randomised medium or high dose. Therefore some of the subjects were counted more than once for having reported adverse events with different doses of the study.
|
|
Nervous system disorders
Headache
|
14.6%
6/41 • From first drug administration until 28 days after last study drug administration, upto 160 days.
All subjects began treatment with their low dose and then they were titrated to their randomised medium or high dose. Therefore some of the subjects were counted more than once for having reported adverse events with different doses of the study.
|
0.83%
1/120 • From first drug administration until 28 days after last study drug administration, upto 160 days.
All subjects began treatment with their low dose and then they were titrated to their randomised medium or high dose. Therefore some of the subjects were counted more than once for having reported adverse events with different doses of the study.
|
3.8%
3/80 • From first drug administration until 28 days after last study drug administration, upto 160 days.
All subjects began treatment with their low dose and then they were titrated to their randomised medium or high dose. Therefore some of the subjects were counted more than once for having reported adverse events with different doses of the study.
|
2.5%
1/40 • From first drug administration until 28 days after last study drug administration, upto 160 days.
All subjects began treatment with their low dose and then they were titrated to their randomised medium or high dose. Therefore some of the subjects were counted more than once for having reported adverse events with different doses of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/41 • From first drug administration until 28 days after last study drug administration, upto 160 days.
All subjects began treatment with their low dose and then they were titrated to their randomised medium or high dose. Therefore some of the subjects were counted more than once for having reported adverse events with different doses of the study.
|
0.83%
1/120 • From first drug administration until 28 days after last study drug administration, upto 160 days.
All subjects began treatment with their low dose and then they were titrated to their randomised medium or high dose. Therefore some of the subjects were counted more than once for having reported adverse events with different doses of the study.
|
6.2%
5/80 • From first drug administration until 28 days after last study drug administration, upto 160 days.
All subjects began treatment with their low dose and then they were titrated to their randomised medium or high dose. Therefore some of the subjects were counted more than once for having reported adverse events with different doses of the study.
|
0.00%
0/40 • From first drug administration until 28 days after last study drug administration, upto 160 days.
All subjects began treatment with their low dose and then they were titrated to their randomised medium or high dose. Therefore some of the subjects were counted more than once for having reported adverse events with different doses of the study.
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
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Restriction type: OTHER