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NCT02244268 Clinical Trial

Study to Evaluate the Effect of ALNA® (Tamsulosin) on the Primary Symptoms of Benign Prostatic Hyperplasia

Prostatic Hyperplasia Clinical Trial

Official title:
Effect of ALNA® (Tamsulosin) on the Primary Symptoms of BPH (Benign Prostatic Hyperplasia) Syndrome

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02244268
Other study ID # 527.20
Secondary ID
Status Completed
Phase N/A
First received September 18, 2014
Last updated September 18, 2014
Start date October 2000

Study information
Verified date September 2014
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Observational

Clinical Trial Summary

The aims of this observational study are to identify the primary BPH symptoms responsible for the patients to consult a urologic practice, resulting in the prescription of ALNA®, to assess the clincial efficacy on an improved occupational performance of the patients being still employed. Additionally to obtain relevant information for the 5-year report of experience with this product according to the requirements in § 49, para 6 of the German Medicines Act.

Recruitment information / eligibility
Status Completed
Enrollment 3629
Est. completion date
Est. primary completion date December 2001
Accepts healthy volunteers No
Gender Male
Age group N/A and older
Eligibility Inclusion Criteria:

- Patients suffering from symptomatic benign prostatic hyperplasia (BPH) symptoms and receiving ALNA® treatment are to be included in the observation according to the prescribing information

Exclusion Criteria:

No exclusion criteria is defined, prescribing information is to be considered

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• ALNA®

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Boehringer Ingelheim

Outcome
Type Measure Description Time frame Safety issue
Primary Change in obstructive BPH symptoms up to 12 weeks No
Primary Change in irritative BPH symptoms up to 12 weeks No
Secondary Change in Residual Urine volume up to 12 weeks No
Secondary Number of patients with adverse events up to 12 weeks No
Secondary Assessment of the number of days on sick leave up to 12 weeks No
Secondary Global assessment of efficacy by investigator on a 4-point scale after 12 weeks No
Secondary Change in Quality-of-Life Index up to 12 weeks No
Secondary Global assessment of tolerability by investigator on a 4-point scale after 12 weeks No
Secondary Changes in urinary flow rate up to 12 weeks
See also
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