Trial Outcomes & Findings for Study Comparing SUBA™-Itraconazole With SPORANOX® (Itraconazole) in the Treatment of Onychomycosis (NCT NCT00791219)
NCT ID: NCT00791219
Last Updated: 2020-08-25
Results Overview
If the lower bound 95% confidence interval of the difference between the proportion of patients in the Test group compared to the Reference group considered a Therapeutic Cure at Visit 7 was greater than 20 then non-inferiority was considered to have been demonstrated
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
175 participants
Primary outcome timeframe
Week 24
Results posted on
2020-08-25
Participant Flow
Participant milestones
| Measure |
Placebo
Two placebo capsules taken approximately 30 minutes prior to breakfast
Placebo: Two placebo capsules taken approximately 30 minutes prior to breakfast
|
Test
100 mg approximately 30 minutes prior to breakfast for 12 weeks of SUBA™-Itraconazole 50 mg capsules (HalcyGen Ltd)
SUBA-itraconazole: 100 mg approximately 30 minutes prior to breakfast for 12 weeks of SUBA™-Itraconazole 50 mg capsules (HalcyGen Ltd)
|
Reference
200 mg taken with breakfast of SPORANOX® (itraconazole) 100 mg capsules (Janssen Pharma).
Itraconazole: 200 mg taken with breakfast of SPORANOX® (itraconazole) 100 mg capsules (Janssen Pharma).
|
|---|---|---|---|
|
Overall Study
STARTED
|
24
|
76
|
75
|
|
Overall Study
COMPLETED
|
19
|
60
|
61
|
|
Overall Study
NOT COMPLETED
|
5
|
16
|
14
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study Comparing SUBA™-Itraconazole With SPORANOX® (Itraconazole) in the Treatment of Onychomycosis
Baseline characteristics by cohort
| Measure |
Placebo
n=24 Participants
Two placebo capsules taken approximately 30 minutes prior to breakfast
Placebo: Two placebo capsules taken approximately 30 minutes prior to breakfast
|
Test
n=76 Participants
100 mg approximately 30 minutes prior to breakfast for 12 weeks of SUBA™-Itraconazole 50 mg capsules (HalcyGen Ltd)
SUBA-itraconazole: 100 mg approximately 30 minutes prior to breakfast for 12 weeks of SUBA™-Itraconazole 50 mg capsules (HalcyGen Ltd)
|
Reference
n=75 Participants
200 mg taken with breakfast of SPORANOX® (itraconazole) 100 mg capsules (Janssen Pharma).
Itraconazole: 200 mg taken with breakfast of SPORANOX® (itraconazole) 100 mg capsules (Janssen Pharma).
|
Total
n=175 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
50.29 years of age
n=5 Participants
|
47.41 years of age
n=7 Participants
|
48.64 years of age
n=5 Participants
|
48.78 years of age
n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
126 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
164 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
76 participants
n=7 Participants
|
75 participants
n=5 Participants
|
175 participants
n=4 Participants
|
|
Percentage of toe infected
|
61.42 percentage
STANDARD_DEVIATION 15.99 • n=5 Participants
|
55.08 percentage
STANDARD_DEVIATION 15.70 • n=7 Participants
|
58.32 percentage
STANDARD_DEVIATION 14.99 • n=5 Participants
|
58.27 percentage
STANDARD_DEVIATION 15.56 • n=4 Participants
|
|
Infecting organism - T.rubrum
|
24 participants
n=5 Participants
|
72 participants
n=7 Participants
|
69 participants
n=5 Participants
|
165 participants
n=4 Participants
|
|
Presence of infecting organism - T.mentagrophytes
|
0 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
9 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Week 24Population: The Efficacy evaluation was performed on the intent to treat population, which included all patients that met all the following criteria; positive baseline mycological culture, dosed with the study drug at least once and had at least one post-baseline evaluation
If the lower bound 95% confidence interval of the difference between the proportion of patients in the Test group compared to the Reference group considered a Therapeutic Cure at Visit 7 was greater than 20 then non-inferiority was considered to have been demonstrated
Outcome measures
| Measure |
Placebo
n=24 Participants
Two placebo capsules taken approximately 30 minutes prior to breakfast
Placebo: Two placebo capsules taken approximately 30 minutes prior to breakfast
|
Test
n=76 Participants
100 mg approximately 30 minutes prior to breakfast for 12 weeks of SUBA™-Itraconazole 50 mg capsules (HalcyGen Ltd)
SUBA-itraconazole: 100 mg approximately 30 minutes prior to breakfast for 12 weeks of SUBA™-Itraconazole 50 mg capsules (HalcyGen Ltd)
|
Reference
n=74 Participants
200 mg taken with breakfast of SPORANOX® (itraconazole) 100 mg capsules (Janssen Pharma).
Itraconazole: 200 mg taken with breakfast of SPORANOX® (itraconazole) 100 mg capsules (Janssen Pharma).
|
|---|---|---|---|
|
Non-inferiority Will be Determined by Evaluating the Difference Between the Proportion of Patients in the Test and Reference Treatment Groups Who Are Considered a "Therapeutic Cure" at the End of Study Visit (Week 24)
|
0 Participants
|
8 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Week 24Population: The Efficacy evaluation was performed on the intent to treat population, which included all patients that met all the following criteria; positive baseline mycological culture, dosed with the study drug at least once and had at least one post-baseline evaluation
If the lower bound 95% confidence interval of the difference between the proportion of patients in the Test group compared to the Reference group considered a Clinical Cure at Visit 7 was greater than 20 then non-inferiority was considered to have been demonstrated
Outcome measures
| Measure |
Placebo
n=24 Participants
Two placebo capsules taken approximately 30 minutes prior to breakfast
Placebo: Two placebo capsules taken approximately 30 minutes prior to breakfast
|
Test
n=76 Participants
100 mg approximately 30 minutes prior to breakfast for 12 weeks of SUBA™-Itraconazole 50 mg capsules (HalcyGen Ltd)
SUBA-itraconazole: 100 mg approximately 30 minutes prior to breakfast for 12 weeks of SUBA™-Itraconazole 50 mg capsules (HalcyGen Ltd)
|
Reference
n=74 Participants
200 mg taken with breakfast of SPORANOX® (itraconazole) 100 mg capsules (Janssen Pharma).
Itraconazole: 200 mg taken with breakfast of SPORANOX® (itraconazole) 100 mg capsules (Janssen Pharma).
|
|---|---|---|---|
|
Non-inferiority Will be Determined by Evaluating the Difference Between the Proportion of Patients in the Test and Reference Treatment Groups Who Are Considered a "Clinical Cure" at the End of Study Visit (Week 24)
|
0 Participants
|
12 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Week 24Population: The Efficacy evaluation was performed on the intent to treat population, which included all patients that met all the following criteria; positive baseline mycological culture, dosed with the study drug at least once and had at least one post-baseline evaluation
If the lower bound 95% confidence interval of the difference between the proportion of patients in the Test group compared to the Reference group considered a Mycological Cure at Visit 7 was greater than 20 then non-inferiority was considered to have been demonstrated
Outcome measures
| Measure |
Placebo
n=24 Participants
Two placebo capsules taken approximately 30 minutes prior to breakfast
Placebo: Two placebo capsules taken approximately 30 minutes prior to breakfast
|
Test
n=76 Participants
100 mg approximately 30 minutes prior to breakfast for 12 weeks of SUBA™-Itraconazole 50 mg capsules (HalcyGen Ltd)
SUBA-itraconazole: 100 mg approximately 30 minutes prior to breakfast for 12 weeks of SUBA™-Itraconazole 50 mg capsules (HalcyGen Ltd)
|
Reference
n=74 Participants
200 mg taken with breakfast of SPORANOX® (itraconazole) 100 mg capsules (Janssen Pharma).
Itraconazole: 200 mg taken with breakfast of SPORANOX® (itraconazole) 100 mg capsules (Janssen Pharma).
|
|---|---|---|---|
|
Non-inferiority Will be Determined by Evaluating the Difference Between the Proportion of Patients in the Test and Reference Treatment Groups Who Are Considered a "Mycological Cure" at the End of Study Visit (Week 24)
|
1 Participants
|
25 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: Week 12Population: The Efficacy evaluation was performed on the intent to treat population, which included all patients that met all the following criteria; positive baseline mycological culture, dosed with the study drug at least once and had at least one post-baseline evaluation
If the lower bound 95% confidence interval of the difference between the proportion of patients in the test group compared to the reference group considered a cure at the visit being analyzed was greater than -20 then non-inferiority was considered to have been demonstrated
Outcome measures
| Measure |
Placebo
n=24 Participants
Two placebo capsules taken approximately 30 minutes prior to breakfast
Placebo: Two placebo capsules taken approximately 30 minutes prior to breakfast
|
Test
n=76 Participants
100 mg approximately 30 minutes prior to breakfast for 12 weeks of SUBA™-Itraconazole 50 mg capsules (HalcyGen Ltd)
SUBA-itraconazole: 100 mg approximately 30 minutes prior to breakfast for 12 weeks of SUBA™-Itraconazole 50 mg capsules (HalcyGen Ltd)
|
Reference
n=74 Participants
200 mg taken with breakfast of SPORANOX® (itraconazole) 100 mg capsules (Janssen Pharma).
Itraconazole: 200 mg taken with breakfast of SPORANOX® (itraconazole) 100 mg capsules (Janssen Pharma).
|
|---|---|---|---|
|
The Proportion of Patients in Each Treatment Group Who Are Considered a "Therapeutic Cure" at the End of Treatment Visit (Week 12) 12).
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: week 12Population: The Efficacy evaluation was performed on the intent to treat population, which included all patients that met all the following criteria; positive baseline mycological culture, dosed with the study drug at least once and had at least one post-baseline evaluation
If the lower bound 95% confidence interval of the difference between the proportion of patients in the test group compared to the reference group considered a cure at the visit being analyzed was greater than -20 then non-inferiority was considered to have been demonstrated
Outcome measures
| Measure |
Placebo
n=24 Participants
Two placebo capsules taken approximately 30 minutes prior to breakfast
Placebo: Two placebo capsules taken approximately 30 minutes prior to breakfast
|
Test
n=76 Participants
100 mg approximately 30 minutes prior to breakfast for 12 weeks of SUBA™-Itraconazole 50 mg capsules (HalcyGen Ltd)
SUBA-itraconazole: 100 mg approximately 30 minutes prior to breakfast for 12 weeks of SUBA™-Itraconazole 50 mg capsules (HalcyGen Ltd)
|
Reference
n=74 Participants
200 mg taken with breakfast of SPORANOX® (itraconazole) 100 mg capsules (Janssen Pharma).
Itraconazole: 200 mg taken with breakfast of SPORANOX® (itraconazole) 100 mg capsules (Janssen Pharma).
|
|---|---|---|---|
|
Non-inferiority Will be Determined by Evaluating the Difference Between the Proportion of Patients in the Test and Reference Treatment Groups Who Are Considered a "Clinical Cure" at the End of Study Visit (Week 12)
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: week 12Population: The Efficacy evaluation was performed on the intent to treat population, which included all patients that met all the following criteria; positive baseline mycological culture, dosed with the study drug at least once and had at least one post-baseline evaluation
If the lower bound 95% confidence interval of the difference between the proportion of patients in the test group compared to the reference group considered a cure at the visit being analyzed was greater than -20 then non-inferiority was considered to have been demonstrated
Outcome measures
| Measure |
Placebo
n=24 Participants
Two placebo capsules taken approximately 30 minutes prior to breakfast
Placebo: Two placebo capsules taken approximately 30 minutes prior to breakfast
|
Test
n=76 Participants
100 mg approximately 30 minutes prior to breakfast for 12 weeks of SUBA™-Itraconazole 50 mg capsules (HalcyGen Ltd)
SUBA-itraconazole: 100 mg approximately 30 minutes prior to breakfast for 12 weeks of SUBA™-Itraconazole 50 mg capsules (HalcyGen Ltd)
|
Reference
n=74 Participants
200 mg taken with breakfast of SPORANOX® (itraconazole) 100 mg capsules (Janssen Pharma).
Itraconazole: 200 mg taken with breakfast of SPORANOX® (itraconazole) 100 mg capsules (Janssen Pharma).
|
|---|---|---|---|
|
Non-inferiority Will be Determined by Evaluating the Difference Between the Proportion of Patients in the Test and Reference Treatment Groups Who Are Considered a "Mycological Cure" at the End of Study Visit (Week 12)
|
3 Participants
|
16 Participants
|
16 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: week 6Population: The Efficacy evaluation was performed on the intent to treat population, which included all patients that met all the following criteria; positive baseline mycological culture, dosed with the study drug at least once and had at least one post-baseline evaluation
All primary and secondary endpoints were tested for superiority against Placebo. The intent to treat (ITT) was used for all superiority testing. For the three primary endpoints and all four dichotomous secondary endpoints, if the difference between the proportion of patients considered a cure in the Test or Reference group was statistically greater (p \< 0.05) than the proportion of patients considered a cure in the Placebo group, then superiority of that treatment over placebo was considered to have been demonstrated. A one-sided continuity corrected Z-test was used for superiority testing.
Outcome measures
| Measure |
Placebo
n=24 Participants
Two placebo capsules taken approximately 30 minutes prior to breakfast
Placebo: Two placebo capsules taken approximately 30 minutes prior to breakfast
|
Test
n=76 Participants
100 mg approximately 30 minutes prior to breakfast for 12 weeks of SUBA™-Itraconazole 50 mg capsules (HalcyGen Ltd)
SUBA-itraconazole: 100 mg approximately 30 minutes prior to breakfast for 12 weeks of SUBA™-Itraconazole 50 mg capsules (HalcyGen Ltd)
|
Reference
n=74 Participants
200 mg taken with breakfast of SPORANOX® (itraconazole) 100 mg capsules (Janssen Pharma).
Itraconazole: 200 mg taken with breakfast of SPORANOX® (itraconazole) 100 mg capsules (Janssen Pharma).
|
|---|---|---|---|
|
Superiority of Test Treatment Over Placebo for Mycological Cure
|
0 Participants
|
11 Participants
|
5 Participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Test
Serious events: 2 serious events
Other events: 42 other events
Deaths: 0 deaths
Reference
Serious events: 1 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=24 participants at risk
Two placebo capsules taken approximately 30 minutes prior to breakfast
Placebo: Two placebo capsules taken approximately 30 minutes prior to breakfast
|
Test
n=76 participants at risk
100 mg approximately 30 minutes prior to breakfast for 12 weeks of SUBA™-Itraconazole 50 mg capsules (HalcyGen Ltd)
SUBA-itraconazole: 100 mg approximately 30 minutes prior to breakfast for 12 weeks of SUBA™-Itraconazole 50 mg capsules (HalcyGen Ltd)
|
Reference
n=75 participants at risk
200 mg taken with breakfast of SPORANOX® (itraconazole) 100 mg capsules (Janssen Pharma).
Itraconazole: 200 mg taken with breakfast of SPORANOX® (itraconazole) 100 mg capsules (Janssen Pharma).
|
|---|---|---|---|
|
Vascular disorders
Pulmonary Embolism
|
0.00%
0/24 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
1.3%
1/76 • Number of events 1 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
0.00%
0/75 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
|
Musculoskeletal and connective tissue disorders
Lumbar Spinal Stenosis
|
0.00%
0/24 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
0.00%
0/76 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
1.3%
1/75 • Number of events 1 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protusion
|
0.00%
0/24 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
1.3%
1/76 • Number of events 1 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
0.00%
0/75 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
Other adverse events
| Measure |
Placebo
n=24 participants at risk
Two placebo capsules taken approximately 30 minutes prior to breakfast
Placebo: Two placebo capsules taken approximately 30 minutes prior to breakfast
|
Test
n=76 participants at risk
100 mg approximately 30 minutes prior to breakfast for 12 weeks of SUBA™-Itraconazole 50 mg capsules (HalcyGen Ltd)
SUBA-itraconazole: 100 mg approximately 30 minutes prior to breakfast for 12 weeks of SUBA™-Itraconazole 50 mg capsules (HalcyGen Ltd)
|
Reference
n=75 participants at risk
200 mg taken with breakfast of SPORANOX® (itraconazole) 100 mg capsules (Janssen Pharma).
Itraconazole: 200 mg taken with breakfast of SPORANOX® (itraconazole) 100 mg capsules (Janssen Pharma).
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/24 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
2.6%
2/76 • Number of events 2 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
0.00%
0/75 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
|
Ear and labyrinth disorders
Acoustic Stimulation Tests Abnormal
|
0.00%
0/24 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
2.6%
2/76 • Number of events 2 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
4.0%
3/75 • Number of events 3 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/24 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
3.9%
3/76 • Number of events 3 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
2.7%
2/75 • Number of events 2 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
|
Injury, poisoning and procedural complications
Arthropod Bite
|
4.2%
1/24 • Number of events 1 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
0.00%
0/76 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
0.00%
0/75 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/24 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
3.9%
3/76 • Number of events 3 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
1.3%
1/75 • Number of events 1 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
4.2%
1/24 • Number of events 1 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
1.3%
1/76 • Number of events 1 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
1.3%
1/75 • Number of events 1 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/24 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
1.3%
1/76 • Number of events 1 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
2.7%
2/75 • Number of events 2 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/24 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
2.6%
2/76 • Number of events 2 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
4.0%
3/75 • Number of events 3 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
|
Psychiatric disorders
Depressed Mood
|
4.2%
1/24 • Number of events 1 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
0.00%
0/76 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
0.00%
0/75 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
4.2%
1/24 • Number of events 1 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
0.00%
0/76 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
0.00%
0/75 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
4.2%
1/24 • Number of events 1 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
0.00%
0/76 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
0.00%
0/75 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
|
Nervous system disorders
Dizziness
|
4.2%
1/24 • Number of events 1 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
1.3%
1/76 • Number of events 1 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
0.00%
0/75 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
|
Reproductive system and breast disorders
Erectile Dysfunction
|
4.2%
1/24 • Number of events 1 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
0.00%
0/76 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
0.00%
0/75 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
4.2%
1/24 • Number of events 1 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
1.3%
1/76 • Number of events 1 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
0.00%
0/75 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
|
Nervous system disorders
Headache
|
8.3%
2/24 • Number of events 2 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
9.2%
7/76 • Number of events 7 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
10.7%
8/75 • Number of events 8 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
4.2%
1/24 • Number of events 1 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
0.00%
0/76 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
0.00%
0/75 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
|
Vascular disorders
Hypertension
|
4.2%
1/24 • Number of events 1 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
1.3%
1/76 • Number of events 1 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
2.7%
2/75 • Number of events 2 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
|
Nervous system disorders
Insomnia
|
0.00%
0/24 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
2.6%
2/76 • Number of events 2 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
0.00%
0/75 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/24 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
0.00%
0/76 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
2.7%
2/75 • Number of events 2 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
8.3%
2/24 • Number of events 2 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
9.2%
7/76 • Number of events 7 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
6.7%
5/75 • Number of events 5 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/24 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
2.6%
2/76 • Number of events 2 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
0.00%
0/75 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
|
Gastrointestinal disorders
Ooropharyngeal Pain
|
0.00%
0/24 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
2.6%
2/76 • Number of events 2 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
0.00%
0/75 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
4.2%
1/24 • Number of events 1 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
2.6%
2/76 • Number of events 2 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
5.3%
4/75 • Number of events 4 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
4.2%
1/24 • Number of events 1 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
2.6%
2/76 • Number of events 2 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
0.00%
0/75 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
|
Nervous system disorders
Sinus Headache
|
0.00%
0/24 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
2.6%
2/76 • Number of events 2 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
0.00%
0/75 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
4.2%
1/24 • Number of events 1 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
2.6%
2/76 • Number of events 2 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
0.00%
0/75 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
|
Nervous system disorders
Tension Headache
|
4.2%
1/24 • Number of events 1 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
0.00%
0/76 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
1.3%
1/75 • Number of events 1 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
|
Ear and labyrinth disorders
Tinnitus
|
4.2%
1/24 • Number of events 1 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
0.00%
0/76 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
2.7%
2/75 • Number of events 2 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Congestion
|
4.2%
1/24 • Number of events 1 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
1.3%
1/76 • Number of events 1 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
0.00%
0/75 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Infection
|
0.00%
0/24 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
0.00%
0/76 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
4.0%
3/75 • Number of events 3 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
|
Nervous system disorders
Vertigo
|
4.2%
1/24 • Number of events 1 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
0.00%
0/76 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
1.3%
1/75 • Number of events 1 • The safety profile of each treatment group was evaluated by comparing adverse events, monitoring vital signs, EKG parameters, audiology testing, and changes in clinical laboratory results obtained throughout the study, which included the 12 week treatment period and the End of Study Visit at Week 24.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60