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

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Completed
CT.gov ID
NCT02244320
Collaborator
(none)
4,150
Enrollment

Study Details

Study Description

Brief 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))

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Actual Enrollment :
4150 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Observational Study in Patients With Functional BPH (Benign Prostatic Hyperplasia) Symptoms Who Switched From Phytotherapy to ALNA® (Tamsulosin)
Study Start Date :
Sep 1, 2002
Actual Primary Completion Date :
May 1, 2003

Arms and Interventions

Arm Intervention/Treatment
functional BPH

patients with functional BPH who switched from phytotherapy to ALNA®

Drug: Tamsulosin
Other Names:
  • ALNA®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in IPSS sum score [Day 1, 2 months]

    2. Change in Quality-of-Life Index (QoL) rated on a 7-point scale [Day 1, 2 months]

    Secondary Outcome Measures

    1. Change in sexual satisfaction rated on a 4-point scale [Day 1, 2 months]

    2. Change in maximum urinary flow rate (ml/sec) [Day 1, 2 months]

    3. Change in residual urine volume (ml) [Day 1, 2 months]

    4. Patient's global assessment of the preceding phytotherapy on a 3-point scale [Day 1]

    5. Patient's global assessment of the therapy with ALNA® on a 3-point scale [after 2 months]

    6. Efficacy assessment of the preceding phytotherapy by physician rated on 4-point scale [Day 1]

    7. Efficacy assessment of the therapy with ALNA® by physician rated on 4-point scale [after 2 months]

    8. Tolerability assessment of the preceding phytotherapy by physician rated on 4-point scale [Day 1]

    9. Tolerability assessment of the therapy with ALNA® by physician rated on 4-point scale [after 2 months]

    10. Number of patients with adverse drug reactions (ADR) [up to 2 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Boehringer Ingelheim

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Boehringer Ingelheim
    ClinicalTrials.gov Identifier:
    NCT02244320
    Other Study ID Numbers:
    • 527.38
    First Posted:
    Sep 19, 2014
    Last Update Posted:
    Sep 19, 2014
    Last Verified:
    Sep 1, 2014
    Additional relevant MeSH terms:
    Prostatic Hyperplasia
    Hyperplasia
    Tamsulosin

    Study Results

    No Results Posted as of Sep 19, 2014