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Trial record 26 of 117 for:    DUTASTERIDE

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

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ClinicalTrials.gov Identifier: NCT01299571
Recruitment Status : Completed
First Posted : February 18, 2011
Results First Posted : April 18, 2011
Last Update Posted : July 5, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Conditions Benign Prostatic Hyperplasia
Prostatic Hyperplasia
Intervention Drug: Dutasteride
Enrollment 3977
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.
Pre-assignment Details  
Arm/Group Title Avodart 0.5 mg
Hide 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
Reason Not Completed
Protocol Violation             107
Arm/Group Title Avodart 0.5 mg
Hide Arm/Group Description Avodart capsule containing 0.5 milligrams (mg) of dutasteride was administered orally once daily
Overall Number of Baseline Participants 3870
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3870 participants
67.3  (9.1)
[1]
Measure Description: Baseline characteristics were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants who had been administered the investigational drug at least once and had completed safety assessments.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3870 participants
Female
0
   0.0%
Male
3870
 100.0%
[1]
Measure Description: Baseline characteristics were collected in members of the ITT Population, comprised of all participants who had been administered the investigational drug at least once and had completed safety assessments.
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3870 participants
Korean 3870
Not Korean 0
[1]
Measure Description: Baseline characteristics were collected in members of the ITT Population, comprised of all participants who had been administered the investigational drug at least once and had completed safety assessments.
1.Primary Outcome
Title Number of Participants With an Adverse Event
Hide 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
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Avodart capsule containing 0.5 mg of dutasteride was administered orally once daily
Overall Number of Participants Analyzed 3870
Measure Type: Number
Unit of Measure: participants
146
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Avodart 0.5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage of participants
Estimated Value 3.8
Confidence Interval 95%
3.2 to 4.4
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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Avodart 0.5 mg
Hide Arm/Group Description:
Avodart capsule containing 0.5 mg of dutasteride was administered orally once daily
Overall Number of Participants Analyzed 3870
Measure Type: Number
Unit of Measure: participants
5
3.Secondary Outcome
Title Number of Participants With the Indicated Unexpected Adverse Events
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Avodart 0.5 mg
Hide Arm/Group Description:
Avodart capsule containing 0.5 milligrams (mg) of dutasteride was administered orally once daily
Overall Number of Participants Analyzed 3870
Measure Type: Number
Unit of Measure: participants
Insomnia 2
Mouth Dry 3
Constipation 2
Abdominal Pain 2
Diarrhea 2
Vomiting 1
Colonic Polyp 1
Epigastric Discomfort 1
Gastroesophageal Reflux 1
Hemorrhoids 1
Asthenia 1
Fever 1
Chills 1
Pain 1
Spasms 1
Orofacial Dyskinesia 1
Embolism Pulmonary 1
Thrombosis Cerebral 1
Nose Congestion 1
Pneumonia 1
Lung Carcinoma 1
Skin Eruption 1
Thrombosis Venous Deep 1
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
Hide 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 (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Avodart 0.5 mg
Affected / at Risk (%)
Total   5/3870 (0.13%) 
Blood and lymphatic system disorders   
Thrombosis Cerebral  1  1/3870 (0.03%) 
Gastrointestinal disorders   
Diarrhea  1  1/3870 (0.03%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Lung Carcinoma  1  1/3870 (0.03%) 
Respiratory, thoracic and mediastinal disorders   
Embolism Pulmonary  1  1/3870 (0.03%) 
Pneumonia  1  1/3870 (0.03%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, WHOART
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Avodart 0.5 mg
Affected / at Risk (%)
Total   146/3870 (3.77%) 
Cardiac disorders   
Thrombosis Venous Deep  1  1/3870 (0.03%) 
Endocrine disorders   
Gynaecomastia  1  5/3870 (0.13%) 
Gastrointestinal disorders   
Dyspepsia  1  6/3870 (0.16%) 
Mouth Dry  1  3/3870 (0.08%) 
Constipation  1  2/3870 (0.05%) 
Abdominal Pain  1  2/3870 (0.05%) 
Diarrhea  1  1/3870 (0.03%) 
Vomiting  1  1/3870 (0.03%) 
Colonic Polyp  1  1/3870 (0.03%) 
Epigastric Discomfort  1  1/3870 (0.03%) 
Gastroesophageal Reflux  1  1/3870 (0.03%) 
Hemorrhoids  1  1/3870 (0.03%) 
General disorders   
Localized Edema  1  1/3870 (0.03%) 
Asthenia  1  1/3870 (0.03%) 
Allergy  1  1/3870 (0.03%) 
Fever  1  1/3870 (0.03%) 
Chills  1  1/3870 (0.03%) 
Pain  1  1/3870 (0.03%) 
Nervous system disorders   
Dizziness  1  2/3870 (0.05%) 
Spasms  1  1/3870 (0.03%) 
Orofacial Dyskinesia  1  1/3870 (0.03%) 
Psychiatric disorders   
Impotence  1  72/3870 (1.86%) 
Libido Decreased  1  49/3870 (1.27%) 
Insomnia  1  2/3870 (0.05%) 
Reproductive system and breast disorders   
Ejaculation Disorder  1  30/3870 (0.78%) 
Respiratory, thoracic and mediastinal disorders   
Nose Congestion  1  1/3870 (0.03%) 
Skin and subcutaneous tissue disorders   
Skin Eruption  1  1/3870 (0.03%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, WHOART
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01299571     History of Changes
Other Study ID Numbers: 105194
First Submitted: February 17, 2011
First Posted: February 18, 2011
Results First Submitted: March 24, 2011
Results First Posted: April 18, 2011
Last Update Posted: July 5, 2017