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NCT02245542 Clinical Trial

The Impact of Alna® Ocas® on Nocturia in Patients With Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia (LUTS/BPH)

Prostatic Hyperplasia Clinical Trial

Official title:
The Impact of Alna® Ocas® on Nocturia in Patients With Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia (LUTS/BPH)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02245542
Other study ID # 527.68
Secondary ID
Status Completed
Phase N/A
First received September 18, 2014
Last updated September 18, 2014
Start date April 2005

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

Study to assess efficacy, tolerability and safety parameters of a three month ALNA®OCAS® -treatment with special respect to nocturia

Recruitment information / eligibility
Status Completed
Enrollment 5775
Est. completion date
Est. primary completion date February 2006
Accepts healthy volunteers No
Gender Male
Age group N/A and older
Eligibility Inclusion Criteria:

- Indication for treatment with ALNA®OCAS® according to the prescribing information for a minimum period of three months

Exclusion Criteria:

- Patients fulfilling one of the general or specific contraindications listed in the ALNA®OCAS® Summary of Product Characteristics (SPC), particularly patients with known hypersensitivities against tamsulosin hydrochloride or any other ingredient of the product, orthostatic dysregulation or severe liver insufficiency could not be included in the Post Marketing Study (PMS) study

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• ALNA®OCAS®

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Boehringer Ingelheim

Outcome
Type Measure Description Time frame Safety issue
Primary Change from Baseline in International Prostatic Symptom Score (IPSS) by means of a patient questionnaire Baseline, after 3 months No
Primary Change from Baseline in Nocturia quality of life by means of a patient questionnaire Baseline, after 3 months No
Secondary Change from Baseline in Maximum urinary flow rate (Qmax) Baseline, after 3 months No
Secondary Change from Baseline in residual urine volume Baseline, after 3 months No
Secondary Assessment of tolerability by investigator on 4-point scale after 3 months No
Secondary Number of patients with adverse events up to 3 months No
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