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Scoring Clinical Index For Onychomycosis in Toenail Onychomycosis Treating With Itraconazole Capsules

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ClinicalTrials.gov Identifier: NCT00871728
Recruitment Status : Completed
First Posted : March 30, 2009
Results First Posted : June 14, 2013
Last Update Posted : July 2, 2013
Sponsor:
Information provided by (Responsible Party):
Janssen Korea, Ltd., Korea

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Onychomycosis, Toe
Intervention Drug: Itraconazole
Enrollment 132
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Itraconazole
Hide Arm/Group Description Itraconazole (ICZ) capsule was administered in 3 cycles (Week 1, Week 5 and Week 9) and each cycle consists of taking 2 capsules of 100 milligram (mg) each, orally twice daily, continuously for 1 week and then not taking medication for next 3 weeks. Total duration of treatment was 49 weeks.
Period Title: Overall Study
Started 132
Treated 130
Completed 112
Not Completed 20
Reason Not Completed
Adverse Event             1
Protocol Violation             7
Lost to Follow-up             2
Failed to Visit Hospital             4
Participant Non-compliance             1
Withdrawal of Informed Consent             5
Arm/Group Title Itraconazole
Hide Arm/Group Description Itraconazole (ICZ) capsule was administered in 3 cycles (Week 1, Week 5 and Week 9) and each cycle consists of taking 2 capsules of 100 milligram (mg) each, orally twice daily, continuously for 1 week and then not taking medication for next 3 weeks. Total duration of treatment was 49 weeks.
Overall Number of Baseline Participants 117
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 117 participants
44.6  (10.42)
[1]
Measure Description: Data presented only for 117 participants as they were part of Full Analysis Set (FAS) population.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 117 participants
Female
47
  40.2%
Male
70
  59.8%
[1]
Measure Description: Data presented only for 117 participants as they were part of FAS population.
1.Primary Outcome
Title Percentage of Participants Showing 10 Percent or Higher Response in Scoring Clinical Index for Onychomycosis (SCIO) Score at Week 5
Hide Description The SCIO is based on clinical state and its items include major factors that can have an effect on the outcome of onychomycosis treatment. The factors include the clinical form, depth of an infected area and subungal hyperkeratosis. The SCIO score range from 1 to 30 and higher score indicates more severity. The score is classified into 7 steps and as there is treatment for each step, treatment based on the clinical state can be applied consistently. Percentage of participants who show an improvement in SCIO score by 10 percent or more at Week 5 compared to Baseline were reported.
Time Frame Baseline and Week 5
Hide Outcome Measure Data
Hide Analysis Population Description
The Full analysis set (FAS) population included all participants except for those participants who violated the major selection and exclusion criteria or did not take the study medication even once or those participants who didn’t participate in Week 5 assessment.
Arm/Group Title Itraconazole
Hide Arm/Group Description:
Itraconazole (ICZ) capsule was administered in 3 cycles (Week 1, Week 5 and Week 9) and each cycle consists of taking 2 capsules of 100 milligram (mg) each, orally twice daily, continuously for 1 week and then not taking medication for next 3 weeks. Total duration of treatment was 49 weeks.
Overall Number of Participants Analyzed 117
Measure Type: Number
Unit of Measure: percentage of participants
25.6
2.Primary Outcome
Title Percentage of Participants Showing 10 Percent or Higher Response in Scoring Clinical Index for Onychomycosis (SCIO) Score at Week 9
Hide Description The SCIO is based on clinical state and its items include major factors that can have an effect on the outcome of onychomycosis treatment. The factors include the clinical form, depth of an infected area and subungal hyperkeratosis. The SCIO score range from 1 to 30 and higher score indicates more severity. The score is classified into 7 steps and as there is treatment for each step, treatment based on the clinical state can be applied consistently. Percentage of participants who show an improvement in SCIO score by 10 percent or more at Week 9 compared to Baseline were reported.
Time Frame Baseline and Week 9
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS population included all participants except for those participants who violated the major selection and exclusion criteria or did not take the study medication even once or those participants who didn’t participate in Week 5 assessment.
Arm/Group Title Itraconazole
Hide Arm/Group Description:
Itraconazole (ICZ) capsule was administered in 3 cycles (Week 1, Week 5 and Week 9) and each cycle consists of taking 2 capsules of 100 milligram (mg) each, orally twice daily, continuously for 1 week and then not taking medication for next 3 weeks. Total duration of treatment was 49 weeks.
Overall Number of Participants Analyzed 117
Measure Type: Number
Unit of Measure: percentage of participants
50.4
3.Primary Outcome
Title Percentage of Participants Showing 10 Percent or Higher Response in Scoring Clinical Index for Onychomycosis (SCIO) Score at Week 13
Hide Description The SCIO is based on clinical state and its items include major factors that can have an effect on the outcome of onychomycosis treatment. The factors include the clinical form, depth of an infected area and subungal hyperkeratosis. The SCIO score range from 1 to 30 and higher score indicates more severity. The score is classified into 7 steps and as there is treatment for each step, treatment based on the clinical state can be applied consistently. Percentage of participants who show an improvement in SCIO score by 10 percent or more at Week 13 compared to Baseline were reported.
Time Frame Baseline and Week 13
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS population included all participants except for those participants who violated the major selection and exclusion criteria or did not take the study medication even once or those participants who didn’t participate in Week 5 assessment.
Arm/Group Title Itraconazole
Hide Arm/Group Description:
Itraconazole (ICZ) capsule was administered in 3 cycles (Week 1, Week 5 and Week 9) and each cycle consists of taking 2 capsules of 100 milligram (mg) each, orally twice daily, continuously for 1 week and then not taking medication for next 3 weeks. Total duration of treatment was 49 weeks.
Overall Number of Participants Analyzed 117
Measure Type: Number
Unit of Measure: percentage of participants
80.3
4.Primary Outcome
Title Percentage of Participants Showing 10 Percent or Higher Response in Scoring Clinical Index for Onychomycosis (SCIO) Score at Week 25
Hide Description The SCIO is based on clinical state and its items include major factors that can have an effect on the outcome of onychomycosis treatment. The factors include the clinical form, depth of an infected area and subungal hyperkeratosis. The SCIO score range from 1 to 30 and higher score indicates more severity. The score is classified into 7 steps and as there is treatment for each step, treatment based on the clinical state can be applied consistently. Percentage of participants who show an improvement in SCIO score by 10 percent or more at Week 25 compared to Baseline were reported.
Time Frame Baseline and Week 25
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS population included all participants except for those participants who violated the major selection and exclusion criteria or did not take the study medication even once or those participants who didn’t participate in Week 5 assessment.
Arm/Group Title Itraconazole
Hide Arm/Group Description:
Itraconazole (ICZ) capsule was administered in 3 cycles (Week 1, Week 5 and Week 9) and each cycle consists of taking 2 capsules of 100 milligram (mg) each, orally twice daily, continuously for 1 week and then not taking medication for next 3 weeks. Total duration of treatment was 49 weeks.
Overall Number of Participants Analyzed 117
Measure Type: Number
Unit of Measure: percentage of participants
84.6
5.Primary Outcome
Title Percentage of Participants Showing 10 Percent or Higher Response in Scoring Clinical Index for Onychomycosis (SCIO) Score at Week 37
Hide Description The SCIO is based on clinical state and its items include major factors that can have an effect on the outcome of onychomycosis treatment. The factors include the clinical form, depth of an infected area and subungal hyperkeratosis. The SCIO score range from 1 to 30 and higher score indicates more severity. The score is classified into 7 steps and as there is treatment for each step, treatment based on the clinical state can be applied consistently. Percentage of participants who show an improvement in SCIO score by 10 percent or more at Week 37 compared to Baseline were reported.
Time Frame Baseline and Week 37
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS population included all participants except for those participants who violated the major selection and exclusion criteria or did not take the study medication even once or those participants who didn’t participate in Week 5 assessment.
Arm/Group Title Itraconazole
Hide Arm/Group Description:
Itraconazole (ICZ) capsule was administered in 3 cycles (Week 1, Week 5 and Week 9) and each cycle consists of taking 2 capsules of 100 milligram (mg) each, orally twice daily, continuously for 1 week and then not taking medication for next 3 weeks. Total duration of treatment was 49 weeks.
Overall Number of Participants Analyzed 117
Measure Type: Number
Unit of Measure: percentage of participants
86.3
6.Primary Outcome
Title Percentage of Participants Showing 10 Percent or Higher Response in Scoring Clinical Index for Onychomycosis (SCIO) Score at Week 49
Hide Description The SCIO is based on clinical state and its items include major factors that can have an effect on the outcome of onychomycosis treatment. The factors include the clinical form, depth of an infected area and subungal hyperkeratosis. The SCIO score range from 1 to 30 and higher score indicates more severity. The score is classified into 7 steps and as there is treatment for each step, treatment based on the clinical state can be applied consistently. Percentage of participants who show an improvement in SCIO score by 10 percent or more at Week 49 compared to Baseline were reported.
Time Frame Baseline and Week 49
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS population included all participants except for those participants who violated the major selection and exclusion criteria or did not take the study medication even once or those participants who didn’t participate in Week 5 assessment.
Arm/Group Title Itraconazole
Hide Arm/Group Description:
Itraconazole (ICZ) capsule was administered in 3 cycles (Week 1, Week 5 and Week 9) and each cycle consists of taking 2 capsules of 100 milligram (mg) each, orally twice daily, continuously for 1 week and then not taking medication for next 3 weeks. Total duration of treatment was 49 weeks.
Overall Number of Participants Analyzed 117
Measure Type: Number
Unit of Measure: percentage of participants
80.3
7.Secondary Outcome
Title Percentage of Participants Showing Mycological Cure
Hide Description Mycological cure was defined as a case in which the results of both potassium hydroxide (KOH) smear test and bacterial identification test (BIT) were found to be negative at each pre-defined time point.
Time Frame Week 13, 25, 37 and 49
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS population, missing values imputed using last observation carried forward (LOCF) method. 'n' included those participants who were evaluable for this measure at specific time points.
Arm/Group Title Itraconazole
Hide Arm/Group Description:
Itraconazole (ICZ) capsule was administered in 3 cycles (Week 1, Week 5 and Week 9) and each cycle consists of taking 2 capsules of 100 milligram (mg) each, orally twice daily, continuously for 1 week and then not taking medication for next 3 weeks. Total duration of treatment was 49 weeks.
Overall Number of Participants Analyzed 117
Measure Type: Number
Unit of Measure: percentage of participants
Negative KOH Smear Test : Week 13 (n=109) 70.6
Negative KOH Smear Test : Week 25 (n=103) 83.5
Negative KOH Smear Test : Week 37 (n=102) 90.2
Negative KOH Smear Test : Week 49 (n=99) 83.8
Negative BIT : Week 13 (n=108) 64.8
Negative BIT : Week 25 (n=103) 79.6
Negative BIT : Week 37 (n=102) 81.4
Negative BIT : Week 49 (n=97) 82.5
Time Frame From Screening up to 49 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Itraconazole
Hide Arm/Group Description Itraconazole (ICZ) capsule was administered in 3 cycles (Week 1, Week 5 and Week 9) and each cycle consists of taking 2 capsules of 100 milligram (mg) each, orally twice daily, continuously for 1 week and then not taking medication for next 3 weeks. Total duration of treatment was 49 weeks.
All-Cause Mortality
Itraconazole
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Itraconazole
Affected / at Risk (%)
Total   1/130 (0.77%) 
Gastrointestinal disorders   
Dyspepsia * 1  1/130 (0.77%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 15.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Itraconazole
Affected / at Risk (%)
Total   35/130 (26.92%) 
Blood and lymphatic system disorders   
Lymphadenitis * 1  1/130 (0.77%) 
Cardiac disorders   
Palpitations * 1  1/130 (0.77%) 
Congenital, familial and genetic disorders   
Mucopolysaccharidosis * 1  1/130 (0.77%) 
Gastrointestinal disorders   
Dyspepsia * 1  6/130 (4.62%) 
Constipation * 1  2/130 (1.54%) 
Diarrhoea * 1  2/130 (1.54%) 
Abdominal discomfort * 1  1/130 (0.77%) 
Gastritis * 1  1/130 (0.77%) 
Gastrooesophageal reflux disease * 1  1/130 (0.77%) 
Haematochezia * 1  1/130 (0.77%) 
Vomiting * 1  1/130 (0.77%) 
General disorders   
Adverse event * 1  3/130 (2.31%) 
Oedema peripheral * 1  1/130 (0.77%) 
Infections and infestations   
Sinusitis * 1  3/130 (2.31%) 
Upper respiratory tract infection * 1  2/130 (1.54%) 
Acute tonsillitis * 1  1/130 (0.77%) 
Genital herpes * 1  1/130 (0.77%) 
Nasopharyngitis * 1  1/130 (0.77%) 
Paronychia * 1  1/130 (0.77%) 
Injury, poisoning and procedural complications   
Epicondylitis * 1  1/130 (0.77%) 
Fall * 1  1/130 (0.77%) 
Investigations   
Alanine aminotransferase increased * 1  1/130 (0.77%) 
Aspartate aminotransferase increased * 1  1/130 (0.77%) 
Musculoskeletal and connective tissue disorders   
Myofascial pain syndrome * 1  2/130 (1.54%) 
Musculoskeletal pain * 1  1/130 (0.77%) 
Pain in extremity * 1  1/130 (0.77%) 
Nervous system disorders   
Dizziness * 1  2/130 (1.54%) 
Headache * 1  1/130 (0.77%) 
Dementia * 1  1/130 (0.77%) 
Somnolence * 1  1/130 (0.77%) 
Renal and urinary disorders   
Dysuria * 1  1/130 (0.77%) 
Proteinuria * 1  1/130 (0.77%) 
Pyuria * 1  1/130 (0.77%) 
Respiratory, thoracic and mediastinal disorders   
Cough * 1  3/130 (2.31%) 
Oropharyngeal pain * 1  2/130 (1.54%) 
Rhinorrhoea * 1  2/130 (1.54%) 
Sputum * 1  2/130 (1.54%) 
Asthma * 1  1/130 (0.77%) 
Skin and subcutaneous tissue disorders   
Urticaria * 1  2/130 (1.54%) 
Dermatitis contact * 1  2/130 (1.54%) 
Eczema * 1  2/130 (1.54%) 
Dyshidrosis * 1  1/130 (0.77%) 
Alopecia * 1  1/130 (0.77%) 
Drug eruption * 1  1/130 (0.77%) 
Pruritus generalised * 1  1/130 (0.77%) 
Rash * 1  1/130 (0.77%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 15.0
Initially it was planned to assess clinical cure rate but analysis for clinical cure rate following the administration of the study drug was replaced by change in SCIO scores which was the primary endpoint.
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.
PI cannot provide any trial related information to external parties’ without mutual agreement with the sponsor. This is valid even after the contract is canceled.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Research Associate
Organization: Clinical Research Team, Medical Affairs, Medical Dept. Janssen Korea
Phone: +82-2-2094-4879
Layout table for additonal information
Responsible Party: Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier: NCT00871728     History of Changes
Other Study ID Numbers: CR013837
ITR-KOR-4078
First Submitted: February 13, 2009
First Posted: March 30, 2009
Results First Submitted: April 29, 2013
Results First Posted: June 14, 2013
Last Update Posted: July 2, 2013