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NCT02244320 Clinical Trial

Observational Study in Patients With Functional Benign Prostatic Hyperplasia Symptoms Who Switched From Phytotherapy to ALNA® (Tamsulosin)

Prostatic Hyperplasia Clinical Trial

Official title:
Observational Study in Patients With Functional BPH (Benign Prostatic Hyperplasia) Symptoms Who Switched From Phytotherapy to ALNA® (Tamsulosin)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02244320
Other study ID # 527.38
Secondary ID
Status Completed
Phase N/A
First received September 18, 2014
Last updated September 18, 2014
Start date September 2002

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 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))

Recruitment information / eligibility
Status Completed
Enrollment 4150
Est. completion date
Est. primary completion date May 2003
Accepts healthy volunteers No
Gender Male
Age group N/A and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• Tamsulosin

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 IPSS sum score Day 1, 2 months No
Primary Change in Quality-of-Life Index (QoL) rated on a 7-point scale Day 1, 2 months No
Secondary Change in sexual satisfaction rated on a 4-point scale Day 1, 2 months No
Secondary Change in maximum urinary flow rate (ml/sec) Day 1, 2 months No
Secondary Change in residual urine volume (ml) Day 1, 2 months No
Secondary Patient's global assessment of the preceding phytotherapy on a 3-point scale Day 1 No
Secondary Patient's global assessment of the therapy with ALNA® on a 3-point scale after 2 months No
Secondary Efficacy assessment of the preceding phytotherapy by physician rated on 4-point scale Day 1 No
Secondary Efficacy assessment of the therapy with ALNA® by physician rated on 4-point scale after 2 months No
Secondary Tolerability assessment of the preceding phytotherapy by physician rated on 4-point scale Day 1 No
Secondary Tolerability assessment of the therapy with ALNA® by physician rated on 4-point scale after 2 months No
Secondary Number of patients with adverse drug reactions (ADR) up to 2 months No
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