Efficacy and Safety of Nocturin® 0,1 mg Tablets in Nocturia in Benign Prostate Syndrome (BPS) - Full Text View

Sponsored by:	Ferring Pharmaceuticals
Information provided by:	Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00902265

Purpose

Documentation of the efficacy and safety of Nocturin® 0,1 mg Tablet. Observation of patients with benign prostate syndrome, in whom nocturia associated with nocturnal polyuria is treated with Nocturin® 0,1 mg Tablet focusing on number of nocturnal voids, ratio of night/24-h urine volume (%), duration of first undisturbed sleep period and quality of life.

Condition
Nocturia Associated With Nocturnal Polyuria

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	Efficacy and Safety of Nocturin 0.1 mg Tablets in Treatment of Nocturia in Patients With Nocturnal Polyuria, LUTS and BPS.

Resource links provided by NLM:

MedlinePlus related topics: Urine and Urination

U.S. FDA Resources

Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:

Number of nocturnal voids [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Ratio of night/24-h urine volume (%) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Duration of first undisturbed sleep period [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Quality of life [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	500
Study Start Date:	March 2009
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 Patients with benign prostate syndrome suffering from nocturia associated with nocturnal polyuria. Drug given by prescription.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

private practices

Criteria

Inclusion Criteria:

Therapeutic need according to SPC
Written informed consent

Exclusion Criteria:

Contraindications according to SPC

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00902265

Sponsors and Collaborators

Ferring Pharmaceuticals

Investigators

Study Director:

Clinical Development Support

Ferring Pharmaceuticals

More Information

No publications provided

Responsible Party:	Ferring Pharmaceuticals ( Hjort, Director )
Study ID Numbers:	FE992026 CS33
Study First Received:	May 14, 2009
Last Updated:	May 14, 2009
ClinicalTrials.gov Identifier:	NCT00902265 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:

Signs and Symptoms
Nocturia
Urologic Diseases
Urination Disorders
Polyuria

Additional relevant MeSH terms:

Signs and Symptoms
Urological Manifestations
Nocturia

Urologic Diseases
Urination Disorders
Polyuria

ClinicalTrials.gov processed this record on September 10, 2009