NCT02244320

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))

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,150

participants targeted

Target at P75+ for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2003

Completed
11.4 years until next milestone

First Submitted

Initial submission to the registry

September 18, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 19, 2014

Completed
Last Updated

September 19, 2014

Status Verified

September 1, 2014

Enrollment Period

8 months

First QC Date

September 18, 2014

Last Update Submit

September 18, 2014

Conditions

Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (2)

  • Change in IPSS sum score

    Day 1, 2 months

  • Change in Quality-of-Life Index (QoL) rated on a 7-point scale

    Day 1, 2 months

Secondary Outcomes (10)

  • Change in sexual satisfaction rated on a 4-point scale

    Day 1, 2 months

  • Change in maximum urinary flow rate (ml/sec)

    Day 1, 2 months

  • Change in residual urine volume (ml)

    Day 1, 2 months

  • Patient's global assessment of the preceding phytotherapy on a 3-point scale

    Day 1

  • Patient's global assessment of the therapy with ALNA® on a 3-point scale

    after 2 months

  • +5 more secondary outcomes

Study Arms (1)

functional BPH

patients with functional BPH who switched from phytotherapy to ALNA®

Drug: Tamsulosin

Interventions

TamsulosinDRUG
Also known as: ALNA®
functional BPH

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with functional BPH symptoms recruited at urologist offices

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Tamsulosin

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur Compounds

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2014

First Posted

September 19, 2014

Study Start

September 1, 2002

Primary Completion

May 1, 2003

Last Updated

September 19, 2014

Record last verified: 2014-09