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

September 18, 2014 updated by: Boehringer Ingelheim
Study to assess efficacy, tolerability and safety parameters of a three month ALNA®OCAS® -treatment with special respect to nocturia

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

5775

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

BPH patients who are indicated for treatment with ALNA®OCAS® with special respect to nocturia recruited at urologists

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
BPH patients
Drug: ALNA®OCAS®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in International Prostatic Symptom Score (IPSS) by means of a patient questionnaire
Time Frame: Baseline, after 3 months
Baseline, after 3 months
Change from Baseline in Nocturia quality of life by means of a patient questionnaire
Time Frame: Baseline, after 3 months
Baseline, after 3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of patients with adverse events
Time Frame: up to 3 months
up to 3 months
Change from Baseline in Maximum urinary flow rate (Qmax)
Time Frame: Baseline, after 3 months
Baseline, after 3 months
Change from Baseline in residual urine volume
Time Frame: Baseline, after 3 months
Baseline, after 3 months
Assessment of tolerability by investigator on 4-point scale
Time Frame: after 3 months
after 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (ACTUAL)

February 1, 2006

Study Registration Dates

First Submitted

September 18, 2014

First Submitted That Met QC Criteria

September 18, 2014

First Posted (ESTIMATE)

September 19, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

September 19, 2014

Last Update Submitted That Met QC Criteria

September 18, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 527.68

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

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