AVO PMS: AVODART(Dutasteride) Post-marketing Surveillance(PMS)

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01299571
• Collaborator: (none)
• Enrollment: 3,977
• Location: 1
• Duration (Months): 67
• Patients Per Site Per Month: 59.4

Study Details

Study Description

Brief Summary

An open label, multi-centre, non-interventional post-marketing surveillance to monitor the safety and/or efficacy of AVODART administered in Korean BPH patients according to the prescribing information

Condition or Disease	Intervention/Treatment	Phase
Benign Prostatic Hyperplasia; Prostatic Hyperplasia	Drug: Dutasteride

Study Design

• Study Type: Observational
• Actual Enrollment: 3977 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: An Open Label, Multi-centre, Non-interventional Post-marketing Surveillance to Monitor the Safety and/or Efficacy of AVODART(Dutasteride) Administered in Korean BPH(Benign Prostatic Hyperplasia) Patients According to the Prescribing Information
• Study Start Date: Dec 1, 2004
• Actual Primary Completion Date: Jul 1, 2010
• Actual Study Completion Date: Jul 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Dutasteride Patients administrated dutasteride at the site	Drug: Dutasteride; Basically there is no treatment allocation. Subjects who would be administered of dutasteride at their physicians' discretion will be enrolled. Dosage regimen will be recommended according to the prescribing information. Subjects will be enrolled consecutively.

Outcome Measures

Primary Outcome Measures

1. Number of Participants With an Adverse Event [6 months]

   An adverse event is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. For a list of all adverse events occurring during the course of the study, see the table entitled "Other (Non-Serious) Adverse Events" in the Adverse Event section of the results record.

Secondary Outcome Measures

1. Number of Participants With a Serious Adverse Event [6 months]

   A serious adverse event is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or results in prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. For a list of all serious adverse events occurring during the course of the study, see the table entitled "Serious Adverse Events" in the Adverse Event section of the results record.

2. Number of Participants With the Indicated Unexpected Adverse Events [6 months]

   An adverse event is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Unexpected adverse events include those not listed in the approved product information and not described as precautions or warnings.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• The Korean BPH Patients administrated dutasteride according to the prescribing information

Exclusion Criteria:

• women and children and adolescents.

• patients with hypersensitivity to dutasteride, other 5-alpha reductase inhibitors, or any of the excipients.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Seoul		Korea, Republic of	110-749

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT01299571
• Other Study ID Numbers: 105194
• First Posted: Feb 18, 2011
• Last Update Posted: Jul 5, 2017
• Last Verified: Jun 1, 2017

• Additional relevant MeSH terms: Prostatic Hyperplasia; Hyperplasia; Dutasteride

Study Results

Participant Flow

Recruitment Details	The objective of this post-marketing surveillance (PMS) study was to assess the occurrence of adverse events reported after administration of Avodart in Korean benign prostatic hyperplasia (BPH) patients.

Arm/Group Title	Avodart 0.5 mg
Arm/Group Description	Avodart capsule containing 0.5 milligrams (mg) of dutasteride was administered orally once daily.
Period Title: Overall Study
STARTED	3977
COMPLETED	3870
NOT COMPLETED	107

Baseline Characteristics

Arm/Group Title	Avodart 0.5 mg
Arm/Group Description	Avodart capsule containing 0.5 milligrams (mg) of dutasteride was administered orally once daily
Overall Participants	3870
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	67.3 (9.1)
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	3870 100%
Race/Ethnicity, Customized (participants) [Number]
Korean	3870 100%
Not Korean	0 0%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With an Adverse Event
Description	An adverse event is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. For a list of all adverse events occurring during the course of the study, see the table entitled "Other (Non-Serious) Adverse Events" in the Adverse Event section of the results record.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Intent-to-Treat (ITT) Population: all participants who had been administered the investigational drug at least once and had completed all safety assessments

Arm/Group Title	Avodart 0.5 mg
Arm/Group Description	Avodart capsule containing 0.5 mg of dutasteride was administered orally once daily
Measure Participants	3870
Number [participants]	146 3.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Avodart 0.5 mg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percentage of participants
	Estimated Value	3.8
	Confidence Interval	() 95%; 3.2 to 4.4
	Parameter Dispersion	Type: Value:
	Estimation Comments	The estimated value represents the percentage of participants with adverse events.

2. Secondary Outcome

Title	Number of Participants With a Serious Adverse Event
Description	A serious adverse event is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or results in prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. For a list of all serious adverse events occurring during the course of the study, see the table entitled "Serious Adverse Events" in the Adverse Event section of the results record.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	Avodart 0.5 mg
Arm/Group Description	Avodart capsule containing 0.5 mg of dutasteride was administered orally once daily
Measure Participants	3870
Number [participants]	5 0.1%

3. Secondary Outcome

Title	Number of Participants With the Indicated Unexpected Adverse Events
Description	An adverse event is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Unexpected adverse events include those not listed in the approved product information and not described as precautions or warnings.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	Avodart 0.5 mg
Arm/Group Description	Avodart capsule containing 0.5 milligrams (mg) of dutasteride was administered orally once daily
Measure Participants	3870
Insomnia	2 0.1%
Mouth Dry	3 0.1%
Constipation	2 0.1%
Abdominal Pain	2 0.1%
Diarrhea	2 0.1%
Vomiting	1 0%
Colonic Polyp	1 0%
Epigastric Discomfort	1 0%
Gastroesophageal Reflux	1 0%
Hemorrhoids	1 0%
Asthenia	1 0%
Fever	1 0%
Chills	1 0%
Pain	1 0%
Spasms	1 0%
Orofacial Dyskinesia	1 0%
Embolism Pulmonary	1 0%
Thrombosis Cerebral	1 0%
Nose Congestion	1 0%
Pneumonia	1 0%
Lung Carcinoma	1 0%
Skin Eruption	1 0%
Thrombosis Venous Deep	1 0%

Adverse Events

Time Frame	6 months
Adverse Event Reporting Description	Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
Arm/Group Title	Avodart 0.5 mg
Arm/Group Description	Avodart capsule containing 0.5 milligrams (mg) of dutasteride was administered orally once daily
All Cause Mortality
	Avodart 0.5 mg
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Avodart 0.5 mg
	Affected / at Risk (%)	# Events
Total	5/3870 (0.1%)
Blood and lymphatic system disorders
Thrombosis Cerebral	1/3870 (0%)
Gastrointestinal disorders
Diarrhea	1/3870 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Carcinoma	1/3870 (0%)
Respiratory, thoracic and mediastinal disorders
Embolism Pulmonary	1/3870 (0%)
Pneumonia	1/3870 (0%)
Other (Not Including Serious) Adverse Events
	Avodart 0.5 mg
	Affected / at Risk (%)	# Events
Total	146/3870 (3.8%)
Cardiac disorders
Thrombosis Venous Deep	1/3870 (0%)
Endocrine disorders
Gynaecomastia	5/3870 (0.1%)
Gastrointestinal disorders
Dyspepsia	6/3870 (0.2%)
Mouth Dry	3/3870 (0.1%)
Constipation	2/3870 (0.1%)
Abdominal Pain	2/3870 (0.1%)
Diarrhea	1/3870 (0%)
Vomiting	1/3870 (0%)
Colonic Polyp	1/3870 (0%)
Epigastric Discomfort	1/3870 (0%)
Gastroesophageal Reflux	1/3870 (0%)
Hemorrhoids	1/3870 (0%)
General disorders
Localized Edema	1/3870 (0%)
Asthenia	1/3870 (0%)
Allergy	1/3870 (0%)
Fever	1/3870 (0%)
Chills	1/3870 (0%)
Pain	1/3870 (0%)
Nervous system disorders
Dizziness	2/3870 (0.1%)
Spasms	1/3870 (0%)
Orofacial Dyskinesia	1/3870 (0%)
Psychiatric disorders
Impotence	72/3870 (1.9%)
Libido Decreased	49/3870 (1.3%)
Insomnia	2/3870 (0.1%)
Reproductive system and breast disorders
Ejaculation Disorder	30/3870 (0.8%)
Respiratory, thoracic and mediastinal disorders
Nose Congestion	1/3870 (0%)
Skin and subcutaneous tissue disorders
Skin Eruption	1/3870 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.