- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02244320
Observational Study in Patients With Functional Benign Prostatic Hyperplasia Symptoms Who Switched From Phytotherapy to ALNA® (Tamsulosin)
September 18, 2014 updated by: Boehringer Ingelheim
Observational Study in Patients With Functional BPH (Benign Prostatic Hyperplasia) Symptoms Who Switched From Phytotherapy to ALNA® (Tamsulosin)
The objective of the observational study were to investigate the switch from phytotherapy to ALNA® after at least 4 weeks of phytotherapy and still presented with a symptom sum score of ≥ 8 points (International Prostate Symptom Score (IPSS))
Study Overview
Study Type
Observational
Enrollment (Actual)
4150
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Sampling Method
Non-Probability Sample
Study Population
Patients with functional BPH symptoms recruited at urologist offices
Description
Inclusion Criteria:
- Patients suffering from BPH symptoms
- Preceding treatment with a phytotherapeutic for at least 4 weeks
- IPSS sum score ≥ 8 points prior to treatment start with ALNA®
- Indication for a switch to treatment with ALNA® for a minimum period of 2 months
Exclusion Criteria:
- Patients fulfilling one of the general or specific contraindications listed in the ALNA® Summary of Product Characteristic, particularly patients with known hypersensitivities against tamsulosin hydrochloride or any other ingredient of the product, orthostatic dysregulation or severe liver insufficiency
- Patients receiving ALNA® within the 4 weeks prior to the start of the present observational 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
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
functional BPH
patients with functional BPH who switched from phytotherapy to ALNA®
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in IPSS sum score
Time Frame: Day 1, 2 months
|
Day 1, 2 months
|
Change in Quality-of-Life Index (QoL) rated on a 7-point scale
Time Frame: Day 1, 2 months
|
Day 1, 2 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in sexual satisfaction rated on a 4-point scale
Time Frame: Day 1, 2 months
|
Day 1, 2 months
|
Change in maximum urinary flow rate (ml/sec)
Time Frame: Day 1, 2 months
|
Day 1, 2 months
|
Change in residual urine volume (ml)
Time Frame: Day 1, 2 months
|
Day 1, 2 months
|
Patient's global assessment of the preceding phytotherapy on a 3-point scale
Time Frame: Day 1
|
Day 1
|
Patient's global assessment of the therapy with ALNA® on a 3-point scale
Time Frame: after 2 months
|
after 2 months
|
Efficacy assessment of the preceding phytotherapy by physician rated on 4-point scale
Time Frame: Day 1
|
Day 1
|
Efficacy assessment of the therapy with ALNA® by physician rated on 4-point scale
Time Frame: after 2 months
|
after 2 months
|
Tolerability assessment of the preceding phytotherapy by physician rated on 4-point scale
Time Frame: Day 1
|
Day 1
|
Tolerability assessment of the therapy with ALNA® by physician rated on 4-point scale
Time Frame: after 2 months
|
after 2 months
|
Number of patients with adverse drug reactions (ADR)
Time Frame: up to 2 months
|
up to 2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
September 1, 2002
Primary Completion (Actual)
May 1, 2003
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
- Pathologic Processes
- Prostatic Diseases
- Prostatic Hyperplasia
- Hyperplasia
- Physiological Effects of Drugs
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Urological Agents
- Adrenergic alpha-1 Receptor Antagonists
- Adrenergic alpha-Antagonists
- Tamsulosin
Other Study ID Numbers
- 527.38
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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