Study to Evaluate the Efficacy and Safety of Tamsulosin i... | NCT00796614

NCT00796614

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Participants received matching placebo to tamsulosin hydrochloride via opened capsules every day for 14 weeks	Drug: Placebo
Low dose	Experimental	Participants received 0.001 - 0.002 mg/kg tamsulosin hydrochloride via opened capsules every day for 14 weeks	Drug: tamsulosin hydrochloride
Medium dose	Experimental	Participants received 0.002 - 0.004 mg/kg tamsulosin hydrochloride via opened capsules every day for 14 weeks	Drug: tamsulosin hydrochloride
High dose	Experimental	Participants received 0.004 - 0.008 mg/kg tamsulosin hydrochloride via opened capsules every day for 14 weeks	Drug: tamsulosin hydrochloride

Name	Type	Description	Arm Group Labels	Other Names
tamsulosin hydrochloride	Drug	Oral	High dose Low dose Medium dose

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	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.	Week 14

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in LPP at Week 14 (End of Treatment)	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.	Baseline and Week 14
Percentage Change From Baseline in LPP at Week 14 (End of Treatment)

Eligibility Module

Contacts/Locations Module

Facility	Status	City	State	ZIP	Country	Contacts
		Los Angeles	California	90027	United States

References Module

Label	URL
Link to Prescribing Information	View source

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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.
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

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No data is available for this block.

Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

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No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Treated Set (TS): Includes all patients who were documented to have taken at least one dose of randomised treatment.

Arm/Group Information

ID	Title	Description
BG000	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.
BG001	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.
BG002	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.
BG003	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.
BG004	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG0008.4± 3.7 BG0018.1± 4.2 BG0028.1± 3.8 BG003

Age, Customized

Number

participants

Title

Denominators

Categories

2 to < 5 years

Title	Measurements
	BG0007 BG0018 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00016 BG00118 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

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.

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.

Posted

Number

Percentage of participants

Week 14

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.
OG003	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.

Units	Counts
Participants	OG00034 OG00135 OG00233 OG003

Title

Denominators

Categories

Title	Measurements
	OG00035.3 OG00145.7 OG00227.3 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Logistic regression model was used with treatment variable and three covariates: age group, concomitant use of anti-cholinergic medication and geographic region. The first two covariates were used in the stratification of the randomisation. On treatment (OT) analyses approach was used.	Regression, Logistic		0.5388		Odds Ratio (OR)	1.38			2-Sided	95	0.50	3.80				No	Superiority or Other

Secondary

Change From Baseline in LPP at Week 14 (End of Treatment)

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.

Full analysis set-LPP (FAS-LPP), OT

Posted

Least Squares Mean

Standard Error

cm H2O

Baseline and Week 14

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

Secondary

Percentage Change From Baseline in LPP at Week 14 (End of Treatment)

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.

Full analysis set-LPP (FAS-LPP), OT

Posted

Least Squares Mean

Standard Error

Percentage change

Baseline and Week 14.

ID	Title	Description
OG000	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.
OG001	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.
OG002	Tamsulosin - Medium Dose Level

Secondary

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

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

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.

Posted

Number

Participants

Baseline and Week 14

ID	Title	Description
OG000	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.
OG001	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.

Secondary

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

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.

Full analysis set-renal (FAS-RENAL)

Posted

Number

Participants

Baseline and Week 14

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Change From Baseline in Urine Volume at Week 14

Change in baseline urine volumes obtained by catheterisation as recorded in catheterisation diary at Week 14.

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.

Posted

Least Squares Mean

Standard Error

Baseline and Week 14

ID	Title	Description
OG000	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.
OG001	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.
OG002	Tamsulosin - Medium Dose Level

Secondary

Change From Baseline in Number of Times Patient Was Wet at Catheterisation

Change from baseline in number of times patient was wet at time of catheterisation as recorded in catheterisation diary.

Full analysis set-catheter (FAS-CATH)

Posted

Least Squares Mean

Standard Error

Times patient wet at catheterization

Baseline and Week 14

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

Secondary

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.

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.

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.

Posted

Number

Participants

From first drug administration until 28 days after last study drug administration, upto 160 days

ID	Title	Description
OG000	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.
OG001	Tamsulosin - Low Dose Level

Secondary

Post Void Residual Volume at Week 14

Median change from baseline to Week 14 in post void residual (mL) by study treatment.

Treated Set (TS). Number of particiapants Analysed are the number of participants whose data were available for this endpoint.

Posted

Median

Standard Deviation

Baseline and Week 14.

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.	1	41	13	41
EG001	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.	1	120	19	120
EG002	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.	0	80	14	80
EG003	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.	0	40	8	40

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Death	General disorders	11.1	Systematic Assessment	EG0000 affected41 at risk EG0011 affected120 at risk EG0020 affected80 at risk EG0030 affected40 at risk
Shunt malfunction	Injury, poisoning and procedural complications	11.1	Systematic Assessment	EG0001 affected41 at risk EG0010 affected120 at risk EG0020 affected80 at risk EG003
Haematoma	Vascular disorders	11.1	Systematic Assessment	EG0001 affected41 at risk EG0010 affected120 at risk EG0020 affected80 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain	Gastrointestinal disorders	11.1	Systematic Assessment	EG0006 affected41 at risk EG0011 affected120 at risk EG0021 affected80 at risk EG0030 affected40 at risk
Constipation	Gastrointestinal disorders	11.1	Systematic Assessment	EG0003 affected41 at risk EG0010 affected120 at risk EG0020 affected80 at risk EG003
Vomiting	Gastrointestinal disorders	11.1	Systematic Assessment	EG0005 affected41 at risk EG0012 affected120 at risk EG0024 affected80 at risk EG003
Influenza	Infections and infestations	11.1	Systematic Assessment	EG0003 affected41 at risk EG0013 affected120 at risk EG0021 affected80 at risk EG003
Nasopharyngitis	Infections and infestations	11.1	Systematic Assessment	EG0001 affected41 at risk EG0015 affected120 at risk EG0024 affected80 at risk EG003
Urinary tract infection	Infections and infestations	11.1	Systematic Assessment	EG0004 affected41 at risk EG0018 affected120 at risk EG0022 affected80 at risk EG003
Headache	Nervous system disorders	11.1	Systematic Assessment	EG0006 affected41 at risk EG0011 affected120 at risk EG0023 affected80 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	11.1	Systematic Assessment	EG0000 affected41 at risk EG0011 affected120 at risk EG0025 affected80 at risk EG003

Company makes no warranties or representations of any kind as to the posting, expressed or implied, including warranties of merchantability and fitness for a particular purpose, and shall not be liable for any damages.

Certain Agreements

ID	Term
D001750	Urinary Bladder, Neurogenic

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D001745	Urinary Bladder Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D000077409	Tamsulosin

Ancestor Terms

ID	Term
D000096926	Benzenesulfonamides
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D013450	Sulfones
D013457	Sulfur Compounds

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.

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.