Trial Outcomes & Findings for Effectiveness of Chinese Herbal Therapy for Asthma (NCT NCT00712296)
NCT ID: NCT00712296
Last Updated: 2020-09-16
Results Overview
Summary of Laboratory data for Glucose(mg/dL), Urea(mg/dL) and Creatinine(mg/dL) in subjects enrolled in Phase 1
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
66 participants
Primary outcome timeframe
1 week after receiving active drug or placebo
Results posted on
2020-09-16
Participant Flow
Recruitment Period: 10/5/2006-3/12/2010 Location: Mount Sinai School of Medicine, New York, NY Phase I Participants Screened 55 Consented 35 Excluded 13 Withdrawn 2 Phase II Participants Screened 183 Consented 76 Excluded 19 Screen failed 11
Phase I: Time frame 1 week; Phase II: Time frame 28 weeks. Participants from Phase I were invited to participate in Phase II and were re-randomized to all three arms of Phase II.
Participant milestones
| Measure |
Active, Phase I
Patients received 3 daily doses in which 2, 4 or 6 ASHMI capsules were administered twice a day for 7 days.
|
Placebo, Phase I
Patients received placebo. (phase I)
|
Active Phase II (ASHMI 4 Caps)
Patients received active drug. 4 caps twice a day.
|
Active, Phase II (ASHMI 12 Caps )
Patients received active drug. 12 caps twice a day.
|
Placebo, Phase II
Patients received placebo. (phase II)
|
|---|---|---|---|---|---|
|
Phase I ( 1 Week)
STARTED
|
12
|
8
|
0
|
0
|
0
|
|
Phase I ( 1 Week)
COMPLETED
|
12
|
8
|
0
|
0
|
0
|
|
Phase I ( 1 Week)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Phase II (28 Weeks)
STARTED
|
0
|
0
|
15
|
16
|
15
|
|
Phase II (28 Weeks)
COMPLETED
|
0
|
0
|
2
|
1
|
3
|
|
Phase II (28 Weeks)
NOT COMPLETED
|
0
|
0
|
13
|
15
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ASHMI/Placebo was discontinued on 9/29/10.20 participants were re-randomized into the Phase II.
Baseline characteristics by cohort
| Measure |
Active, Phase I
n=12 Participants
Patients received 3 daily doses in which 2, 4, or 6 ASHMI capsules were administered twice a day for 7 days.
|
Placebo, Phase I
n=8 Participants
Patients received placebo.
|
Active, Phase II (ASHMI 4 Caps )
n=15 Participants
Patients received active drug, 4 caps twice a day
|
Active, Phase II (ASHMI 12 Caps)
n=16 Participants
Patients received active drug, 12 caps twice a day
|
Placebo, Phase II
n=15 Participants
Patients received placebo.
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Sex: Female, Male
Phase 1 · Female
|
9 Participants
n=12 Participants • ASHMI/Placebo was discontinued on 9/29/10.20 participants were re-randomized into the Phase II.
|
5 Participants
n=8 Participants • ASHMI/Placebo was discontinued on 9/29/10.20 participants were re-randomized into the Phase II.
|
—
|
—
|
—
|
14 Participants
n=20 Participants • ASHMI/Placebo was discontinued on 9/29/10.20 participants were re-randomized into the Phase II.
|
|
Age, Continuous
Phase 1
|
32 years
STANDARD_DEVIATION 7 • n=12 Participants • ASHMI/Placebo was discontinued on 9/29/10.20 participants were re-randomized into the Phase II.
|
31 years
STANDARD_DEVIATION 9 • n=8 Participants • ASHMI/Placebo was discontinued on 9/29/10.20 participants were re-randomized into the Phase II.
|
—
|
—
|
—
|
31.6 years
STANDARD_DEVIATION 8.06 • n=20 Participants • ASHMI/Placebo was discontinued on 9/29/10.20 participants were re-randomized into the Phase II.
|
|
Age, Continuous
Phase 2
|
—
|
—
|
44 years
STANDARD_DEVIATION 10 • n=15 Participants • ASHMI/Placebo was discontinued on 9/29/10.20 participants were re-randomized into the Phase II.
|
44 years
STANDARD_DEVIATION 8 • n=16 Participants • ASHMI/Placebo was discontinued on 9/29/10.20 participants were re-randomized into the Phase II.
|
40 years
STANDARD_DEVIATION 10 • n=15 Participants • ASHMI/Placebo was discontinued on 9/29/10.20 participants were re-randomized into the Phase II.
|
42.7 years
STANDARD_DEVIATION 9.04 • n=46 Participants • ASHMI/Placebo was discontinued on 9/29/10.20 participants were re-randomized into the Phase II.
|
|
Sex: Female, Male
Phase 1 · Male
|
3 Participants
n=12 Participants • ASHMI/Placebo was discontinued on 9/29/10.20 participants were re-randomized into the Phase II.
|
3 Participants
n=8 Participants • ASHMI/Placebo was discontinued on 9/29/10.20 participants were re-randomized into the Phase II.
|
—
|
—
|
—
|
6 Participants
n=20 Participants • ASHMI/Placebo was discontinued on 9/29/10.20 participants were re-randomized into the Phase II.
|
|
Sex: Female, Male
Phase 2 · Female
|
—
|
—
|
11 Participants
n=15 Participants • ASHMI/Placebo was discontinued on 9/29/10.20 participants were re-randomized into the Phase II.
|
14 Participants
n=16 Participants • ASHMI/Placebo was discontinued on 9/29/10.20 participants were re-randomized into the Phase II.
|
10 Participants
n=15 Participants • ASHMI/Placebo was discontinued on 9/29/10.20 participants were re-randomized into the Phase II.
|
35 Participants
n=46 Participants • ASHMI/Placebo was discontinued on 9/29/10.20 participants were re-randomized into the Phase II.
|
|
Sex: Female, Male
Phase 2 · Male
|
—
|
—
|
4 Participants
n=15 Participants • ASHMI/Placebo was discontinued on 9/29/10.20 participants were re-randomized into the Phase II.
|
2 Participants
n=16 Participants • ASHMI/Placebo was discontinued on 9/29/10.20 participants were re-randomized into the Phase II.
|
5 Participants
n=15 Participants • ASHMI/Placebo was discontinued on 9/29/10.20 participants were re-randomized into the Phase II.
|
11 Participants
n=46 Participants • ASHMI/Placebo was discontinued on 9/29/10.20 participants were re-randomized into the Phase II.
|
|
Race/Ethnicity, Customized
Phase 1, White
|
3 participants
n=12 Participants • ASHMI/Placebo was discontinued on 9/29/10. 20 participants were re-randomized into the Phase II.
|
6 participants
n=8 Participants • ASHMI/Placebo was discontinued on 9/29/10. 20 participants were re-randomized into the Phase II.
|
—
|
—
|
—
|
23 participants
n=20 Participants • ASHMI/Placebo was discontinued on 9/29/10. 20 participants were re-randomized into the Phase II.
|
|
Race/Ethnicity, Customized
Phase 1, Black
|
3 participants
n=12 Participants • ASHMI/Placebo was discontinued on 9/29/10. 20 participants were re-randomized into the Phase II.
|
0 participants
n=8 Participants • ASHMI/Placebo was discontinued on 9/29/10. 20 participants were re-randomized into the Phase II.
|
—
|
—
|
—
|
18 participants
n=20 Participants • ASHMI/Placebo was discontinued on 9/29/10. 20 participants were re-randomized into the Phase II.
|
|
Race/Ethnicity, Customized
Phase 1, Hispanic
|
5 participants
n=12 Participants • ASHMI/Placebo was discontinued on 9/29/10. 20 participants were re-randomized into the Phase II.
|
2 participants
n=8 Participants • ASHMI/Placebo was discontinued on 9/29/10. 20 participants were re-randomized into the Phase II.
|
—
|
—
|
—
|
19 participants
n=20 Participants • ASHMI/Placebo was discontinued on 9/29/10. 20 participants were re-randomized into the Phase II.
|
|
Race/Ethnicity, Customized
Phase 1, Asian
|
1 participants
n=12 Participants • ASHMI/Placebo was discontinued on 9/29/10. 20 participants were re-randomized into the Phase II.
|
0 participants
n=8 Participants • ASHMI/Placebo was discontinued on 9/29/10. 20 participants were re-randomized into the Phase II.
|
—
|
—
|
—
|
5 participants
n=20 Participants • ASHMI/Placebo was discontinued on 9/29/10. 20 participants were re-randomized into the Phase II.
|
|
Race/Ethnicity, Customized
Phase 1, Other
|
0 participants
n=12 Participants • ASHMI/Placebo was discontinued on 9/29/10. 20 participants were re-randomized into the Phase II.
|
0 participants
n=8 Participants • ASHMI/Placebo was discontinued on 9/29/10. 20 participants were re-randomized into the Phase II.
|
—
|
—
|
—
|
1 participants
n=20 Participants • ASHMI/Placebo was discontinued on 9/29/10. 20 participants were re-randomized into the Phase II.
|
|
Race/Ethnicity, Customized
Phase 2, White
|
—
|
—
|
5 participants
n=15 Participants • ASHMI/Placebo was discontinued on 9/29/10. 20 participants were re-randomized into the Phase II.
|
5 participants
n=16 Participants • ASHMI/Placebo was discontinued on 9/29/10. 20 participants were re-randomized into the Phase II.
|
4 participants
n=15 Participants • ASHMI/Placebo was discontinued on 9/29/10. 20 participants were re-randomized into the Phase II.
|
14 participants
n=46 Participants • ASHMI/Placebo was discontinued on 9/29/10. 20 participants were re-randomized into the Phase II.
|
|
Race/Ethnicity, Customized
Phase 2, Black
|
—
|
—
|
6 participants
n=15 Participants • ASHMI/Placebo was discontinued on 9/29/10. 20 participants were re-randomized into the Phase II.
|
7 participants
n=16 Participants • ASHMI/Placebo was discontinued on 9/29/10. 20 participants were re-randomized into the Phase II.
|
2 participants
n=15 Participants • ASHMI/Placebo was discontinued on 9/29/10. 20 participants were re-randomized into the Phase II.
|
15 participants
n=46 Participants • ASHMI/Placebo was discontinued on 9/29/10. 20 participants were re-randomized into the Phase II.
|
|
Race/Ethnicity, Customized
Phase 2, Hispanic
|
—
|
—
|
4 participants
n=15 Participants • ASHMI/Placebo was discontinued on 9/29/10. 20 participants were re-randomized into the Phase II.
|
4 participants
n=16 Participants • ASHMI/Placebo was discontinued on 9/29/10. 20 participants were re-randomized into the Phase II.
|
4 participants
n=15 Participants • ASHMI/Placebo was discontinued on 9/29/10. 20 participants were re-randomized into the Phase II.
|
12 participants
n=46 Participants • ASHMI/Placebo was discontinued on 9/29/10. 20 participants were re-randomized into the Phase II.
|
|
Race/Ethnicity, Customized
Phase 2, Asian
|
—
|
—
|
0 participants
n=15 Participants • ASHMI/Placebo was discontinued on 9/29/10. 20 participants were re-randomized into the Phase II.
|
0 participants
n=16 Participants • ASHMI/Placebo was discontinued on 9/29/10. 20 participants were re-randomized into the Phase II.
|
4 participants
n=15 Participants • ASHMI/Placebo was discontinued on 9/29/10. 20 participants were re-randomized into the Phase II.
|
4 participants
n=46 Participants • ASHMI/Placebo was discontinued on 9/29/10. 20 participants were re-randomized into the Phase II.
|
|
Race/Ethnicity, Customized
Phase 2, Other
|
—
|
—
|
0 participants
n=15 Participants • ASHMI/Placebo was discontinued on 9/29/10. 20 participants were re-randomized into the Phase II.
|
0 participants
n=16 Participants • ASHMI/Placebo was discontinued on 9/29/10. 20 participants were re-randomized into the Phase II.
|
1 participants
n=15 Participants • ASHMI/Placebo was discontinued on 9/29/10. 20 participants were re-randomized into the Phase II.
|
1 participants
n=46 Participants • ASHMI/Placebo was discontinued on 9/29/10. 20 participants were re-randomized into the Phase II.
|
PRIMARY outcome
Timeframe: 1 week after receiving active drug or placeboPopulation: For the Phase I study we used descriptive statistics to report the frequency of adverse events (AEs) among patients treated with ASHMI or placebo. Analysis was per intention to treat.
Summary of Laboratory data for Glucose(mg/dL), Urea(mg/dL) and Creatinine(mg/dL) in subjects enrolled in Phase 1
Outcome measures
| Measure |
Active Phase I Baseline
n=12 Participants
Baseline results for patients on ASHMI.
|
Active Phase I Post Treatment
n=12 Participants
Post Treatment results after 1 week for patients on ASHMI.
|
Placebo Phase I Baseline
n=8 Participants
Baseline results for participants who received placebo.
|
Placebo Phase I Post Treatment
n=8 Participants
Post Treatment results for participants who received placebo.
|
Active Phase II (ASHMI 4 Caps) Visit 5
Patients received active drug. 4 caps twice a day. at visit 5.
|
Active Phase II (ASHMI 12 Caps) Visit 5
Patients received active drug. 12 caps twice a day. at visit 5.
|
Placebo Phase II Visit 10
Patients received placebo. at visit 10.
|
Active Phase II (ASHMI 4 Caps) Visit 10
Patients received active drug. 4 caps twice a day. at visit 10.
|
Active Phase II (ASHMI 12 Caps) Visit 10
Patients received active drug. 12 caps twice a day. at visit 10.
|
|---|---|---|---|---|---|---|---|---|---|
|
Glucose, Urea and Creatinine Phase I
Glucose
|
81 mg/dL
Standard Deviation 12
|
79 mg/dL
Standard Deviation 9
|
75 mg/dL
Standard Deviation 14
|
71 mg/dL
Standard Deviation 7
|
—
|
—
|
—
|
—
|
—
|
|
Glucose, Urea and Creatinine Phase I
Urea
|
13 mg/dL
Standard Deviation 3
|
13 mg/dL
Standard Deviation 3
|
16 mg/dL
Standard Deviation 4
|
17 mg/dL
Standard Deviation 5
|
—
|
—
|
—
|
—
|
—
|
|
Glucose, Urea and Creatinine Phase I
Creatinine
|
0.8 mg/dL
Standard Deviation 0.2
|
0.8 mg/dL
Standard Deviation 0.2
|
0.9 mg/dL
Standard Deviation 0.1
|
0.9 mg/dL
Standard Deviation 0.2
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 1 week after receiving active drug or placeboPopulation: For the Phase I study we used descriptive statistics to report the frequency of adverse events (AEs) among patients treated with ASHMI or placebo. Analysis was per intention to treat.
Summary of Laboratory data for Sodium(meq/L), Potassium(meq/L), Chloride(meq/L) and CO2 (meq/L) in subjects enrolled in Phase 1
Outcome measures
| Measure |
Active Phase I Baseline
n=12 Participants
Baseline results for patients on ASHMI.
|
Active Phase I Post Treatment
n=12 Participants
Post Treatment results after 1 week for patients on ASHMI.
|
Placebo Phase I Baseline
n=8 Participants
Baseline results for participants who received placebo.
|
Placebo Phase I Post Treatment
n=8 Participants
Post Treatment results for participants who received placebo.
|
Active Phase II (ASHMI 4 Caps) Visit 5
Patients received active drug. 4 caps twice a day. at visit 5.
|
Active Phase II (ASHMI 12 Caps) Visit 5
Patients received active drug. 12 caps twice a day. at visit 5.
|
Placebo Phase II Visit 10
Patients received placebo. at visit 10.
|
Active Phase II (ASHMI 4 Caps) Visit 10
Patients received active drug. 4 caps twice a day. at visit 10.
|
Active Phase II (ASHMI 12 Caps) Visit 10
Patients received active drug. 12 caps twice a day. at visit 10.
|
|---|---|---|---|---|---|---|---|---|---|
|
Sodium, Potassium, Chloride and CO2 Phase I
Sodium (meq/L)
|
139 meq/L
Standard Deviation 2
|
140 meq/L
Standard Deviation 2
|
139 meq/L
Standard Deviation 3
|
139 meq/L
Standard Deviation 1
|
—
|
—
|
—
|
—
|
—
|
|
Sodium, Potassium, Chloride and CO2 Phase I
Potassium (meq/L)
|
4 meq/L
Standard Deviation 0.3
|
4 meq/L
Standard Deviation 0.4
|
4 meq/L
Standard Deviation 0.4
|
4 meq/L
Standard Deviation 0.2
|
—
|
—
|
—
|
—
|
—
|
|
Sodium, Potassium, Chloride and CO2 Phase I
Chloride (meq/L)
|
103 meq/L
Standard Deviation 2
|
103 meq/L
Standard Deviation 1
|
102 meq/L
Standard Deviation 1
|
102 meq/L
Standard Deviation 2
|
—
|
—
|
—
|
—
|
—
|
|
Sodium, Potassium, Chloride and CO2 Phase I
Carbon dioxide (meq/L)
|
24 meq/L
Standard Deviation 3
|
23 meq/L
Standard Deviation 2
|
24 meq/L
Standard Deviation 2
|
24 meq/L
Standard Deviation 2
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 1 week after receiving active drug and placeboPopulation: For the Phase I study we used descriptive statistics to report the frequency of adverse events (AEs) among patients treated with ASHMI or placebo. Analysis was per intention to treat.
Summary of Laboratory data for Serum glutamic pyruvic transaminase and Serum glutamic oxaloacetic transaminase in subjects enrolled in Phase 1
Outcome measures
| Measure |
Active Phase I Baseline
n=12 Participants
Baseline results for patients on ASHMI.
|
Active Phase I Post Treatment
n=12 Participants
Post Treatment results after 1 week for patients on ASHMI.
|
Placebo Phase I Baseline
n=8 Participants
Baseline results for participants who received placebo.
|
Placebo Phase I Post Treatment
n=8 Participants
Post Treatment results for participants who received placebo.
|
Active Phase II (ASHMI 4 Caps) Visit 5
Patients received active drug. 4 caps twice a day. at visit 5.
|
Active Phase II (ASHMI 12 Caps) Visit 5
Patients received active drug. 12 caps twice a day. at visit 5.
|
Placebo Phase II Visit 10
Patients received placebo. at visit 10.
|
Active Phase II (ASHMI 4 Caps) Visit 10
Patients received active drug. 4 caps twice a day. at visit 10.
|
Active Phase II (ASHMI 12 Caps) Visit 10
Patients received active drug. 12 caps twice a day. at visit 10.
|
|---|---|---|---|---|---|---|---|---|---|
|
Serum Glutamic Pyruvic Transaminase and Serum Glutamic Oxaloacetic Transaminase in Phase I
Serum glutamic pyruvic transaminase (SGPT)
|
19 IU/L
Standard Deviation 8
|
20 IU/L
Standard Deviation 8
|
21 IU/L
Standard Deviation 9
|
20 IU/L
Standard Deviation 9
|
—
|
—
|
—
|
—
|
—
|
|
Serum Glutamic Pyruvic Transaminase and Serum Glutamic Oxaloacetic Transaminase in Phase I
Serum glutamic oxaloacetic transaminase (SGOT)
|
20 IU/L
Standard Deviation 4
|
20 IU/L
Standard Deviation 7
|
24 IU/L
Standard Deviation 8
|
24 IU/L
Standard Deviation 10
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 1 week after receiving active drug and placeboPopulation: For the Phase I study we used descriptive statistics to report the frequency of adverse events (AEs) among patients treated with ASHMI or placebo. Analysis was per intention to treat.
Summary of Laboratory data for White Blood Cell(cells\*10\^3/uL), Hemoglobin(cells\*10\^3/uL) and Platelet(cells\*10\^3/uL)in subjects enrolled in Phase 1
Outcome measures
| Measure |
Active Phase I Baseline
n=12 Participants
Baseline results for patients on ASHMI.
|
Active Phase I Post Treatment
n=12 Participants
Post Treatment results after 1 week for patients on ASHMI.
|
Placebo Phase I Baseline
n=8 Participants
Baseline results for participants who received placebo.
|
Placebo Phase I Post Treatment
n=8 Participants
Post Treatment results for participants who received placebo.
|
Active Phase II (ASHMI 4 Caps) Visit 5
Patients received active drug. 4 caps twice a day. at visit 5.
|
Active Phase II (ASHMI 12 Caps) Visit 5
Patients received active drug. 12 caps twice a day. at visit 5.
|
Placebo Phase II Visit 10
Patients received placebo. at visit 10.
|
Active Phase II (ASHMI 4 Caps) Visit 10
Patients received active drug. 4 caps twice a day. at visit 10.
|
Active Phase II (ASHMI 12 Caps) Visit 10
Patients received active drug. 12 caps twice a day. at visit 10.
|
|---|---|---|---|---|---|---|---|---|---|
|
Laboratory Results for White Blood Cell, Hemoglobin and Platelet in Phase I
White Blood Cell
|
7 cells*10^3/uL
Standard Deviation 2
|
7 cells*10^3/uL
Standard Deviation 1
|
7 cells*10^3/uL
Standard Deviation 2
|
7 cells*10^3/uL
Standard Deviation 1
|
—
|
—
|
—
|
—
|
—
|
|
Laboratory Results for White Blood Cell, Hemoglobin and Platelet in Phase I
Platelet
|
292 cells*10^3/uL
Standard Deviation 81
|
238 cells*10^3/uL
Standard Deviation 123
|
281 cells*10^3/uL
Standard Deviation 60
|
273 cells*10^3/uL
Standard Deviation 64
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 1 weekPopulation: For the Phase I study descriptive statistics were used to report the frequency of adverse events (AEs) among patients treated with ASHMI or placebo. Analysis was per intention to treat.
Summary of hemoglobin as Outcome measures included laboratory data for subjects enrolled in Phase 1
Outcome measures
| Measure |
Active Phase I Baseline
n=12 Participants
Baseline results for patients on ASHMI.
|
Active Phase I Post Treatment
n=12 Participants
Post Treatment results after 1 week for patients on ASHMI.
|
Placebo Phase I Baseline
n=8 Participants
Baseline results for participants who received placebo.
|
Placebo Phase I Post Treatment
n=8 Participants
Post Treatment results for participants who received placebo.
|
Active Phase II (ASHMI 4 Caps) Visit 5
Patients received active drug. 4 caps twice a day. at visit 5.
|
Active Phase II (ASHMI 12 Caps) Visit 5
Patients received active drug. 12 caps twice a day. at visit 5.
|
Placebo Phase II Visit 10
Patients received placebo. at visit 10.
|
Active Phase II (ASHMI 4 Caps) Visit 10
Patients received active drug. 4 caps twice a day. at visit 10.
|
Active Phase II (ASHMI 12 Caps) Visit 10
Patients received active drug. 12 caps twice a day. at visit 10.
|
|---|---|---|---|---|---|---|---|---|---|
|
Hemoglobin Laboratory Results in Phase I
|
13 g/dL
Standard Deviation 0.9
|
13 g/dL
Standard Deviation 1
|
14 g/dL
Standard Deviation 2
|
14 g/dL
Standard Deviation 1
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 28 weeksPopulation: The Phase II study was terminated in September 2009 before the planned enrollment of 50 subjects was completed. As of September 29, 2009, the trial was discontinued in accordance with recommendations of the Data Safety Monitoring Board (DSMB).
Summary of Laboratory data for Glucose(mg/dL), Urea(mg/dL), Creatinine(mg/dL), Bilirubin Total(mg/dL) and Bilirubin Direct(mg/dL)in subjects in Phase II Limited to Measurements before discontinuation of ASHMI treatment
Outcome measures
| Measure |
Active Phase I Baseline
n=15 Participants
Baseline results for patients on ASHMI.
|
Active Phase I Post Treatment
n=15 Participants
Post Treatment results after 1 week for patients on ASHMI.
|
Placebo Phase I Baseline
n=16 Participants
Baseline results for participants who received placebo.
|
Placebo Phase I Post Treatment
n=10 Participants
Post Treatment results for participants who received placebo.
|
Active Phase II (ASHMI 4 Caps) Visit 5
n=11 Participants
Patients received active drug. 4 caps twice a day. at visit 5.
|
Active Phase II (ASHMI 12 Caps) Visit 5
n=10 Participants
Patients received active drug. 12 caps twice a day. at visit 5.
|
Placebo Phase II Visit 10
n=3 Participants
Patients received placebo. at visit 10.
|
Active Phase II (ASHMI 4 Caps) Visit 10
n=2 Participants
Patients received active drug. 4 caps twice a day. at visit 10.
|
Active Phase II (ASHMI 12 Caps) Visit 10
n=1 Participants
Patients received active drug. 12 caps twice a day. at visit 10.
|
|---|---|---|---|---|---|---|---|---|---|
|
Laboratory Results for Glucose, Urea, Creatinine, Bilirubin Total and Bilirubin Direct Phase II Study
Urea
|
14.8 mg/dL
Standard Deviation 4.1
|
13.3 mg/dL
Standard Deviation 5.4
|
14.1 mg/dL
Standard Deviation 5.4
|
13.9 mg/dL
Standard Deviation 2.6
|
13.3 mg/dL
Standard Deviation 2.5
|
14.2 mg/dL
Standard Deviation 4.2
|
15.0 mg/dL
Standard Deviation 2.6
|
15.0 mg/dL
Standard Deviation 8.5
|
18.0 mg/dL
|
|
Laboratory Results for Glucose, Urea, Creatinine, Bilirubin Total and Bilirubin Direct Phase II Study
Creatinine
|
0.9 mg/dL
Standard Deviation 0.2
|
0.8 mg/dL
Standard Deviation 0.2
|
0.8 mg/dL
Standard Deviation 0.1
|
0.8 mg/dL
Standard Deviation 0.1
|
0.9 mg/dL
Standard Deviation 0.3
|
0.9 mg/dL
Standard Deviation 0.2
|
1.0 mg/dL
Standard Deviation 0.1
|
0.9 mg/dL
Standard Deviation 0.1
|
0.3 mg/dL
|
|
Laboratory Results for Glucose, Urea, Creatinine, Bilirubin Total and Bilirubin Direct Phase II Study
Bilirubin Total
|
0.4 mg/dL
Standard Deviation 0.2
|
0.4 mg/dL
Standard Deviation 0.2
|
0.4 mg/dL
Standard Deviation 0.2
|
0.5 mg/dL
Standard Deviation 0.2
|
0.4 mg/dL
Standard Deviation 0.2
|
0.3 mg/dL
Standard Deviation 0.1
|
0.4 mg/dL
Standard Deviation 0.2
|
0.4 mg/dL
Standard Deviation 0.2
|
0.2 mg/dL
|
|
Laboratory Results for Glucose, Urea, Creatinine, Bilirubin Total and Bilirubin Direct Phase II Study
Glucose
|
85 mg/dL
Standard Deviation 28.4
|
79.1 mg/dL
Standard Deviation 12.1
|
77.1 mg/dL
Standard Deviation 12.8
|
99.9 mg/dL
Standard Deviation 45.9
|
77.6 mg/dL
Standard Deviation 8.8
|
72.5 mg/dL
Standard Deviation 12.6
|
92.0 mg/dL
Standard Deviation 12.0
|
95.0 mg/dL
Standard Deviation 38.2
|
101.0 mg/dL
|
|
Laboratory Results for Glucose, Urea, Creatinine, Bilirubin Total and Bilirubin Direct Phase II Study
Bilirubin Direct
|
0.1 mg/dL
Standard Deviation 0.0
|
0.1 mg/dL
Standard Deviation 0.0
|
0.1 mg/dL
Standard Deviation 0.0
|
0.1 mg/dL
Standard Deviation 0.0
|
0.1 mg/dL
Standard Deviation 0.0
|
0.1 mg/dL
Standard Deviation 0.0
|
0.1 mg/dL
Standard Deviation 0.1
|
0.1 mg/dL
Standard Deviation 0.0
|
0.1 mg/dL
|
PRIMARY outcome
Timeframe: 28 weeksPopulation: The Phase II study was terminated in September 2009 before the planned enrollment of 50 subjects was completed.
Summary of Laboratory data for Sodium(meq/L), Potassium(meq/L), Chloride(meq/L) and Bicarbonate(meq/L)in subjects in Phase II Limited to Measurements before discontinuation of ASHMI treatment
Outcome measures
| Measure |
Active Phase I Baseline
n=15 Participants
Baseline results for patients on ASHMI.
|
Active Phase I Post Treatment
n=15 Participants
Post Treatment results after 1 week for patients on ASHMI.
|
Placebo Phase I Baseline
n=16 Participants
Baseline results for participants who received placebo.
|
Placebo Phase I Post Treatment
n=10 Participants
Post Treatment results for participants who received placebo.
|
Active Phase II (ASHMI 4 Caps) Visit 5
n=11 Participants
Patients received active drug. 4 caps twice a day. at visit 5.
|
Active Phase II (ASHMI 12 Caps) Visit 5
n=10 Participants
Patients received active drug. 12 caps twice a day. at visit 5.
|
Placebo Phase II Visit 10
n=3 Participants
Patients received placebo. at visit 10.
|
Active Phase II (ASHMI 4 Caps) Visit 10
n=2 Participants
Patients received active drug. 4 caps twice a day. at visit 10.
|
Active Phase II (ASHMI 12 Caps) Visit 10
n=1 Participants
Patients received active drug. 12 caps twice a day. at visit 10.
|
|---|---|---|---|---|---|---|---|---|---|
|
Laboratory Results for Sodium,Potassium, Chloride and Bicarbonate in Phase II Study
Sodium
|
140.6 meq/L
Standard Deviation 1.6
|
140.3 meq/L
Standard Deviation 1.9
|
140.5 meq/L
Standard Deviation 2.3
|
139.5 meq/L
Standard Deviation 2.1
|
140.1 meq/L
Standard Deviation 2.2
|
139.6 meq/L
Standard Deviation 2.5
|
139.7 meq/L
Standard Deviation 1.5
|
140 meq/L
Standard Deviation 1.4
|
140.0 meq/L
|
|
Laboratory Results for Sodium,Potassium, Chloride and Bicarbonate in Phase II Study
Potassium
|
3.9 meq/L
Standard Deviation 0.4
|
4.1 meq/L
Standard Deviation 0.2
|
4.1 meq/L
Standard Deviation 0.3
|
4.1 meq/L
Standard Deviation 0.3
|
4.1 meq/L
Standard Deviation 0.1
|
4.1 meq/L
Standard Deviation 0.3
|
4.2 meq/L
Standard Deviation 0.6
|
4.1 meq/L
Standard Deviation 0.5
|
3.8 meq/L
|
|
Laboratory Results for Sodium,Potassium, Chloride and Bicarbonate in Phase II Study
Bicarbonate
|
27.2 meq/L
Standard Deviation 2.7
|
26.7 meq/L
Standard Deviation 2.5
|
27.5 meq/L
Standard Deviation 1.6
|
25.8 meq/L
Standard Deviation 2.4
|
26.2 meq/L
Standard Deviation 2.0
|
26.2 meq/L
Standard Deviation 1.7
|
27.1 meq/L
Standard Deviation 1.6
|
26.3 meq/L
Standard Deviation 2.9
|
19.2 meq/L
|
|
Laboratory Results for Sodium,Potassium, Chloride and Bicarbonate in Phase II Study
Chloride
|
102.5 meq/L
Standard Deviation 2.2
|
102.6 meq/L
Standard Deviation 1.9
|
102.6 meq/L
Standard Deviation 2.5
|
102.4 meq/L
Standard Deviation 2.2
|
102.9 meq/L
Standard Deviation 3.2
|
102.3 meq/L
Standard Deviation 3.5
|
102.3 meq/L
Standard Deviation 0.6
|
101.5 meq/L
Standard Deviation 2.1
|
108.0 meq/L
|
PRIMARY outcome
Timeframe: 28 weeksPopulation: The Phase II study was terminated in September 2009 before the planned enrollment of 50 subjects was completed. As of September 28, 2009, the trial was discontinued in accordance with recommendations of the Data Safety Monitoring Board (DSMB).
Summary of Laboratory data for Alkaline phosphatase(IU/L),Serum glutamic pyruvic transaminase(IU/L)and Serum glutamic oxaloacetic transaminase(IU/L) in subjects in Phase II study Limited to Measurements before discontinuation of ASHMI treatment
Outcome measures
| Measure |
Active Phase I Baseline
n=15 Participants
Baseline results for patients on ASHMI.
|
Active Phase I Post Treatment
n=15 Participants
Post Treatment results after 1 week for patients on ASHMI.
|
Placebo Phase I Baseline
n=16 Participants
Baseline results for participants who received placebo.
|
Placebo Phase I Post Treatment
n=10 Participants
Post Treatment results for participants who received placebo.
|
Active Phase II (ASHMI 4 Caps) Visit 5
n=11 Participants
Patients received active drug. 4 caps twice a day. at visit 5.
|
Active Phase II (ASHMI 12 Caps) Visit 5
n=10 Participants
Patients received active drug. 12 caps twice a day. at visit 5.
|
Placebo Phase II Visit 10
n=3 Participants
Patients received placebo. at visit 10.
|
Active Phase II (ASHMI 4 Caps) Visit 10
n=2 Participants
Patients received active drug. 4 caps twice a day. at visit 10.
|
Active Phase II (ASHMI 12 Caps) Visit 10
n=1 Participants
Patients received active drug. 12 caps twice a day. at visit 10.
|
|---|---|---|---|---|---|---|---|---|---|
|
Laboratory Results for Alkaline Phosphatase,Serum Glutamic Pyruvic Transaminase and Serum Glutamic Oxaloacetic Transaminase in Phase II Study
Serum glutamic pyruvic transaminase (SGPT)
|
23.9 IU/L
Standard Deviation 11.6
|
21.9 IU/L
Standard Deviation 18.2
|
21.3 IU/L
Standard Deviation 9.4
|
26.9 IU/L
Standard Deviation 11.9
|
22.0 IU/L
Standard Deviation 11.0
|
22.5 IU/L
Standard Deviation 8.6
|
24.3 IU/L
Standard Deviation 7.4
|
14.5 IU/L
Standard Deviation 4.9
|
32.0 IU/L
|
|
Laboratory Results for Alkaline Phosphatase,Serum Glutamic Pyruvic Transaminase and Serum Glutamic Oxaloacetic Transaminase in Phase II Study
Serum glutamic oxaloacetic transaminase (SGOT)
|
24.5 IU/L
Standard Deviation 8.4
|
22.0 IU/L
Standard Deviation 9.3
|
24.7 IU/L
Standard Deviation 7.3
|
24.8 IU/L
Standard Deviation 8.1
|
25.8 IU/L
Standard Deviation 9.6
|
25.6 IU/L
Standard Deviation 8.7
|
25.3 IU/L
Standard Deviation 8.9
|
21.0 IU/L
Standard Deviation 7.1
|
30.0 IU/L
|
|
Laboratory Results for Alkaline Phosphatase,Serum Glutamic Pyruvic Transaminase and Serum Glutamic Oxaloacetic Transaminase in Phase II Study
Alkaline phosphatase
|
76.0 IU/L
Standard Deviation 22.2
|
91.3 IU/L
Standard Deviation 23.0
|
76.6 IU/L
Standard Deviation 24.7
|
81.1 IU/L
Standard Deviation 24.8
|
29.7 IU/L
Standard Deviation 25.7
|
83.2 IU/L
Standard Deviation 25.0
|
61.7 IU/L
Standard Deviation 18.5
|
98.0 IU/L
Standard Deviation 5.7
|
78.0 IU/L
|
PRIMARY outcome
Timeframe: 28 weeksPopulation: The Phase II study was terminated in September 2009 before the planned enrollment of 50 subjects was completed. As of September 28, 2009,the trial was discontinued in accordance with recommendations of the Data Safety Monitoring Board (DSMB).
Summary of Laboratory data for White Blood Cell Count(cells\*10\^3/uL) and Platelet (cells\*10\^3/uL)in Phase II study Limited to Measurements before discontinuation of ASHMI treatment
Outcome measures
| Measure |
Active Phase I Baseline
n=15 Participants
Baseline results for patients on ASHMI.
|
Active Phase I Post Treatment
n=15 Participants
Post Treatment results after 1 week for patients on ASHMI.
|
Placebo Phase I Baseline
n=16 Participants
Baseline results for participants who received placebo.
|
Placebo Phase I Post Treatment
n=10 Participants
Post Treatment results for participants who received placebo.
|
Active Phase II (ASHMI 4 Caps) Visit 5
n=11 Participants
Patients received active drug. 4 caps twice a day. at visit 5.
|
Active Phase II (ASHMI 12 Caps) Visit 5
n=10 Participants
Patients received active drug. 12 caps twice a day. at visit 5.
|
Placebo Phase II Visit 10
n=3 Participants
Patients received placebo. at visit 10.
|
Active Phase II (ASHMI 4 Caps) Visit 10
n=2 Participants
Patients received active drug. 4 caps twice a day. at visit 10.
|
Active Phase II (ASHMI 12 Caps) Visit 10
n=1 Participants
Patients received active drug. 12 caps twice a day. at visit 10.
|
|---|---|---|---|---|---|---|---|---|---|
|
Laboratory Results for White Blood Cell Count and Platelet in Subjects in Phase II Study
White Blood Cell Count
|
7.2 cells*10^3/uL
Standard Deviation 2.3
|
7.6 cells*10^3/uL
Standard Deviation 2.6
|
7.2 cells*10^3/uL
Standard Deviation 1.4
|
6.5 cells*10^3/uL
Standard Deviation 2.1
|
7.5 cells*10^3/uL
Standard Deviation 2.7
|
6.8 cells*10^3/uL
Standard Deviation 1.9
|
7.9 cells*10^3/uL
Standard Deviation 2.7
|
9.4 cells*10^3/uL
Standard Deviation 0.7
|
6.2 cells*10^3/uL
|
|
Laboratory Results for White Blood Cell Count and Platelet in Subjects in Phase II Study
Platelet
|
254.5 cells*10^3/uL
Standard Deviation 74.6
|
268.2 cells*10^3/uL
Standard Deviation 49.0
|
267.1 cells*10^3/uL
Standard Deviation 89.5
|
275.0 cells*10^3/uL
Standard Deviation 86.3
|
283.3 cells*10^3/uL
Standard Deviation 58.5
|
275.6 cells*10^3/uL
Standard Deviation 119.6
|
280.0 cells*10^3/uL
Standard Deviation 133.8
|
348.5 cells*10^3/uL
Standard Deviation 29.0
|
269.0 cells*10^3/uL
|
PRIMARY outcome
Timeframe: 28 weeksPopulation: The Phase II study was terminated in September 2009 before the planned enrollment of 50 subjects was completed. As of September 28, 2009, the trial was discontinued in accordance with recommendations of the Data Safety Monitoring Board (DSMB).
Summary of Laboratory data for hemoglobin(g/dL)in subjects in Phase II study. Limited to Measurements before discontinuation of ASHMI treatment
Outcome measures
| Measure |
Active Phase I Baseline
n=15 Participants
Baseline results for patients on ASHMI.
|
Active Phase I Post Treatment
n=15 Participants
Post Treatment results after 1 week for patients on ASHMI.
|
Placebo Phase I Baseline
n=16 Participants
Baseline results for participants who received placebo.
|
Placebo Phase I Post Treatment
n=10 Participants
Post Treatment results for participants who received placebo.
|
Active Phase II (ASHMI 4 Caps) Visit 5
n=11 Participants
Patients received active drug. 4 caps twice a day. at visit 5.
|
Active Phase II (ASHMI 12 Caps) Visit 5
n=10 Participants
Patients received active drug. 12 caps twice a day. at visit 5.
|
Placebo Phase II Visit 10
n=3 Participants
Patients received placebo. at visit 10.
|
Active Phase II (ASHMI 4 Caps) Visit 10
n=2 Participants
Patients received active drug. 4 caps twice a day. at visit 10.
|
Active Phase II (ASHMI 12 Caps) Visit 10
n=1 Participants
Patients received active drug. 12 caps twice a day. at visit 10.
|
|---|---|---|---|---|---|---|---|---|---|
|
Laboratory Results for Hemoglobin in Subjects in Phase II Study
|
13.5 g/dL
Standard Deviation 1.4
|
13.5 g/dL
Standard Deviation 1.6
|
12.8 g/dL
Standard Deviation 1.2
|
13.9 g/dL
Standard Deviation 1.2
|
13.7 g/dL
Standard Deviation 1.4
|
12.9 g/dL
Standard Deviation 1.5
|
13.7 g/dL
Standard Deviation 1.7
|
13.9 g/dL
Standard Deviation 1.5
|
14.3 g/dL
|
Adverse Events
Active Phase I (ASHMI 2 Caps Twice a Day)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo Phase I (2 Caps Twice a Day)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Active Phase I (ASHMI 4 Caps)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo Phase I (4 Caps Twice a Day)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Active Phase I (ASHMI 6 Caps)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo Phase I
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Active Phase II (ASHMI 4 Caps Twice a Day)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Active Phase II (ASHMI 12 Caps)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo Phase II
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active Phase I (ASHMI 2 Caps Twice a Day)
n=4 participants at risk
Patients received 2, 4, or 6 ASHMI capsules were administered twice daily for 7 days.
|
Placebo Phase I (2 Caps Twice a Day)
n=2 participants at risk
Patients received placebo. 2 caps twice a day.
|
Active Phase I (ASHMI 4 Caps)
n=4 participants at risk
Patients received active drug. 4 caps twice a day.
|
Placebo Phase I (4 Caps Twice a Day)
n=4 participants at risk
Patients received placebo. 4 caps twice a day.
|
Active Phase I (ASHMI 6 Caps)
n=4 participants at risk
Patients received active drug. 6 caps twice a day.
|
Placebo Phase I
n=2 participants at risk
Patients received placebo.
|
Active Phase II (ASHMI 4 Caps Twice a Day)
n=15 participants at risk
Patients received active drug.Based on revised adverse event criteria on January 2010.
|
Active Phase II (ASHMI 12 Caps)
n=16 participants at risk
Patients received active drug. 12 caps twice a day.
|
Placebo Phase II
n=15 participants at risk
Patients received placebo.
|
|---|---|---|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
25.0%
1/4 • Number of events 1 • Phase I: 1 week Phase II: 28 weeks
|
50.0%
1/2 • Number of events 1 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/4 • Phase I: 1 week Phase II: 28 weeks
|
25.0%
1/4 • Number of events 1 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/4 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/2 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/15 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/16 • Phase I: 1 week Phase II: 28 weeks
|
6.7%
1/15 • Number of events 1 • Phase I: 1 week Phase II: 28 weeks
|
|
General disorders
Increased Thirst
|
25.0%
1/4 • Number of events 1 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/2 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/4 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/4 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/4 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/2 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/15 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/16 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/15 • Phase I: 1 week Phase II: 28 weeks
|
|
General disorders
Body aches and fatigue associated with subject's typical prementrual syndrome
|
25.0%
1/4 • Number of events 1 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/2 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/4 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/4 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/4 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/2 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/15 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/16 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/15 • Phase I: 1 week Phase II: 28 weeks
|
|
General disorders
Transient upper extremity itchiness
|
25.0%
1/4 • Number of events 1 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/2 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/4 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/4 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/4 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/2 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/15 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/16 • Phase I: 1 week Phase II: 28 weeks
|
20.0%
3/15 • Number of events 3 • Phase I: 1 week Phase II: 28 weeks
|
|
General disorders
Insomnia
|
0.00%
0/4 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/2 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/4 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/4 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/4 • Phase I: 1 week Phase II: 28 weeks
|
50.0%
1/2 • Number of events 1 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/15 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/16 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/15 • Phase I: 1 week Phase II: 28 weeks
|
|
General disorders
Decreased total serum bicarbonate level
|
50.0%
2/4 • Number of events 2 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/2 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/4 • Phase I: 1 week Phase II: 28 weeks
|
25.0%
1/4 • Number of events 1 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/4 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/2 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/15 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/16 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/15 • Phase I: 1 week Phase II: 28 weeks
|
|
General disorders
Back muscle injury
|
25.0%
1/4 • Number of events 1 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/2 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/4 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/4 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/4 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/2 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/15 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/16 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/15 • Phase I: 1 week Phase II: 28 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
0.00%
0/4 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/2 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/4 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/4 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/4 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/2 • Phase I: 1 week Phase II: 28 weeks
|
6.7%
1/15 • Number of events 1 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/16 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/15 • Phase I: 1 week Phase II: 28 weeks
|
|
General disorders
Glucosuria
|
0.00%
0/4 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/2 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/4 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/4 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/4 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/2 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/15 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/16 • Phase I: 1 week Phase II: 28 weeks
|
6.7%
1/15 • Number of events 1 • Phase I: 1 week Phase II: 28 weeks
|
|
General disorders
Decreased Glucose Level
|
0.00%
0/4 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/2 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/4 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/4 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/4 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/2 • Phase I: 1 week Phase II: 28 weeks
|
6.7%
1/15 • Number of events 1 • Phase I: 1 week Phase II: 28 weeks
|
12.5%
2/16 • Number of events 2 • Phase I: 1 week Phase II: 28 weeks
|
6.7%
1/15 • Number of events 1 • Phase I: 1 week Phase II: 28 weeks
|
|
General disorders
Decreased Hemoglobin Level
|
0.00%
0/4 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/2 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/4 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/4 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/4 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/2 • Phase I: 1 week Phase II: 28 weeks
|
6.7%
1/15 • Number of events 1 • Phase I: 1 week Phase II: 28 weeks
|
6.2%
1/16 • Number of events 1 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/15 • Phase I: 1 week Phase II: 28 weeks
|
|
General disorders
Decreased White Blood Cell Count
|
0.00%
0/4 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/2 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/4 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/4 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/4 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/2 • Phase I: 1 week Phase II: 28 weeks
|
6.7%
1/15 • Number of events 1 • Phase I: 1 week Phase II: 28 weeks
|
6.2%
1/16 • Number of events 1 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/15 • Phase I: 1 week Phase II: 28 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Emergency room visit for asthma exacerbation
|
0.00%
0/4 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/2 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/4 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/4 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/4 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/2 • Phase I: 1 week Phase II: 28 weeks
|
13.3%
2/15 • Number of events 2 • Phase I: 1 week Phase II: 28 weeks
|
6.2%
1/16 • Number of events 1 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/15 • Phase I: 1 week Phase II: 28 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Unscheduled physician visit for asthma exacerbation
|
0.00%
0/4 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/2 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/4 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/4 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/4 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/2 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/15 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/16 • Phase I: 1 week Phase II: 28 weeks
|
13.3%
2/15 • Number of events 2 • Phase I: 1 week Phase II: 28 weeks
|
|
Cardiac disorders
Electrocardiogram changes
|
0.00%
0/4 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/2 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/4 • Phase I: 1 week Phase II: 28 weeks
|
25.0%
1/4 • Number of events 1 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/4 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/2 • Phase I: 1 week Phase II: 28 weeks
|
6.7%
1/15 • Number of events 1 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/16 • Phase I: 1 week Phase II: 28 weeks
|
6.7%
1/15 • Number of events 1 • Phase I: 1 week Phase II: 28 weeks
|
|
Renal and urinary disorders
Trichomonas in urine
|
0.00%
0/4 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/2 • Phase I: 1 week Phase II: 28 weeks
|
25.0%
1/4 • Number of events 1 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/4 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/4 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/2 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/15 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/16 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/15 • Phase I: 1 week Phase II: 28 weeks
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/4 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/2 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/4 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/4 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/4 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/2 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/15 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/16 • Phase I: 1 week Phase II: 28 weeks
|
6.7%
1/15 • Number of events 1 • Phase I: 1 week Phase II: 28 weeks
|
|
Renal and urinary disorders
Increased Alkaline Phosphatase
|
0.00%
0/4 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/2 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/4 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/4 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/4 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/2 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/15 • Phase I: 1 week Phase II: 28 weeks
|
6.2%
1/16 • Number of events 1 • Phase I: 1 week Phase II: 28 weeks
|
6.7%
1/15 • Number of events 1 • Phase I: 1 week Phase II: 28 weeks
|
|
Renal and urinary disorders
Increased Creatine
|
0.00%
0/4 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/2 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/4 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/4 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/4 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/2 • Phase I: 1 week Phase II: 28 weeks
|
6.7%
1/15 • Number of events 1 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/16 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/15 • Phase I: 1 week Phase II: 28 weeks
|
|
Gastrointestinal disorders
Gastrointestinal symptoms
|
25.0%
1/4 • Number of events 1 • Phase I: 1 week Phase II: 28 weeks
|
100.0%
2/2 • Number of events 2 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/4 • Phase I: 1 week Phase II: 28 weeks
|
50.0%
2/4 • Number of events 2 • Phase I: 1 week Phase II: 28 weeks
|
25.0%
1/4 • Number of events 1 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/2 • Phase I: 1 week Phase II: 28 weeks
|
6.7%
1/15 • Number of events 1 • Phase I: 1 week Phase II: 28 weeks
|
6.2%
1/16 • Number of events 1 • Phase I: 1 week Phase II: 28 weeks
|
6.7%
1/15 • Number of events 1 • Phase I: 1 week Phase II: 28 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/2 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/4 • Phase I: 1 week Phase II: 28 weeks
|
25.0%
1/4 • Number of events 1 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/4 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/2 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/15 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/16 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/15 • Phase I: 1 week Phase II: 28 weeks
|
|
Gastrointestinal disorders
Elevated Liver Enzymes
|
0.00%
0/4 • Phase I: 1 week Phase II: 28 weeks
|
50.0%
1/2 • Number of events 1 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/4 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/4 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/4 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/2 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/15 • Phase I: 1 week Phase II: 28 weeks
|
0.00%
0/16 • Phase I: 1 week Phase II: 28 weeks
|
6.7%
1/15 • Number of events 1 • Phase I: 1 week Phase II: 28 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place