Trial Outcomes & Findings for Assessing the Behavior of Met DR in Subjects With Kidney Dysfunction (NCT NCT01658514)
NCT ID: NCT01658514
Last Updated: 2015-12-30
Results Overview
AUC (0-t) = Area under the curve from the time of dosing (0 h) to the time of the last quantifiable concentration following dose administration
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
39 participants
Primary outcome timeframe
from the time of dosing (0 h) to 72 hours postdose
Results posted on
2015-12-30
Participant Flow
Participant milestones
| Measure |
Sequence ABC
A = 1 dose of 1000 mg Met XR B = 1 dose of 1000 mg Met DR C = 1 dose of placebo
each treatment was separated by a wash out period of 2 to 10 days
|
Sequence CAB
A = 1 dose of 1000 mg Met XR B = 1 dose of 1000 mg Met DR C = 1 dose of placebo
each treatment was separated by a wash out period of 2 to 10 days
|
Sequence BCA
A = 1 dose of 1000 mg Met XR B = 1 dose of 1000 mg Met DR C = 1 dose of placebo
each treatment was separated by a wash out period of 2 to 10 days
|
|---|---|---|---|
|
Overall Study
STARTED
|
14
|
11
|
14
|
|
Overall Study
Completed Treatment A
|
14
|
11
|
12
|
|
Overall Study
Completed Treatment B
|
13
|
11
|
14
|
|
Overall Study
Completed Treatment C
|
13
|
11
|
12
|
|
Overall Study
Started - Normal RF Cohort Only
|
3
|
2
|
3
|
|
Overall Study
Completed - Normal RF Cohort Only
|
3
|
2
|
3
|
|
Overall Study
Started - Mild RI Cohort Only
|
4
|
3
|
4
|
|
Overall Study
Completed - Mild RI Cohort Only
|
4
|
3
|
4
|
|
Overall Study
Started - Moderate RI Cohort Only
|
4
|
4
|
4
|
|
Overall Study
Completed - Moderate RI Cohort Only
|
3
|
4
|
2
|
|
Overall Study
Started - Severe RI Cohort Only
|
3
|
2
|
3
|
|
Overall Study
Completed - Severe RI Cohort Only
|
3
|
2
|
3
|
|
Overall Study
COMPLETED
|
13
|
11
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
2
|
Reasons for withdrawal
| Measure |
Sequence ABC
A = 1 dose of 1000 mg Met XR B = 1 dose of 1000 mg Met DR C = 1 dose of placebo
each treatment was separated by a wash out period of 2 to 10 days
|
Sequence CAB
A = 1 dose of 1000 mg Met XR B = 1 dose of 1000 mg Met DR C = 1 dose of placebo
each treatment was separated by a wash out period of 2 to 10 days
|
Sequence BCA
A = 1 dose of 1000 mg Met XR B = 1 dose of 1000 mg Met DR C = 1 dose of placebo
each treatment was separated by a wash out period of 2 to 10 days
|
|---|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
2
|
Baseline Characteristics
Assessing the Behavior of Met DR in Subjects With Kidney Dysfunction
Baseline characteristics by cohort
| Measure |
Normal
n=8 Participants
Normal Renal Function = eGFR ≥90 mL/min/1.73 m²
|
Mild RI
n=11 Participants
Mild Renal Impairment = eGFR ≥60 to \<90 mL/min/1.73 m²
|
Moderate RI
n=12 Participants
Moderate Renal Impairment = eGFR ≥30 to \<60 mL/min/1.73 m²
|
Severe RI
n=8 Participants
Severe Renal Impairment = eGFR ≥15 to \<30 mL/min/1.73 m²
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
54.5 years
STANDARD_DEVIATION 11.01 • n=93 Participants
|
60.8 years
STANDARD_DEVIATION 6.62 • n=4 Participants
|
72.6 years
STANDARD_DEVIATION 3.90 • n=27 Participants
|
70.5 years
STANDARD_DEVIATION 5.50 • n=483 Participants
|
65.1 years
STANDARD_DEVIATION 9.83 • n=36 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
7 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
32 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
8 Participants
n=483 Participants
|
36 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
12 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
26 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Body Weight
|
94.9 kg
STANDARD_DEVIATION 18.02 • n=93 Participants
|
94.9 kg
STANDARD_DEVIATION 12.06 • n=4 Participants
|
94.2 kg
STANDARD_DEVIATION 14.96 • n=27 Participants
|
99.8 kg
STANDARD_DEVIATION 10.69 • n=483 Participants
|
95.7 kg
STANDARD_DEVIATION 13.73 • n=36 Participants
|
|
BMI
|
32.8 kg/m²
STANDARD_DEVIATION 3.81 • n=93 Participants
|
31.8 kg/m²
STANDARD_DEVIATION 3.79 • n=4 Participants
|
30.4 kg/m²
STANDARD_DEVIATION 3.33 • n=27 Participants
|
33.3 kg/m²
STANDARD_DEVIATION 4.09 • n=483 Participants
|
31.9 kg/m²
STANDARD_DEVIATION 3.75 • n=36 Participants
|
PRIMARY outcome
Timeframe: from the time of dosing (0 h) to 72 hours postdosePopulation: PK Evaluable Population
AUC (0-t) = Area under the curve from the time of dosing (0 h) to the time of the last quantifiable concentration following dose administration
Outcome measures
| Measure |
Met DR
n=34 Participants
One dose of 1000 mg Metformin Delayed-Release
|
Met XR
n=34 Participants
One dose of 1000 mg Metformin Extended-Release
|
|---|---|---|
|
AUC (0-t) of Plasma Metformin
Normal (N = 8)
|
5362 ng*h/mL
Standard Error 943
|
10411 ng*h/mL
Standard Error 1831
|
|
AUC (0-t) of Plasma Metformin
Mild RI (N = 10)
|
8705 ng*h/mL
Standard Error 1368
|
11788 ng*h/mL
Standard Error 1853
|
|
AUC (0-t) of Plasma Metformin
Moderate RI (N = 9)
|
11477 ng*h/mL
Standard Error 1915
|
20240 ng*h/mL
Standard Error 3377
|
|
AUC (0-t) of Plasma Metformin
Severe RI (N = 7)
|
22893 ng*h/mL
Standard Error 4307
|
43683 ng*h/mL
Standard Error 8218
|
PRIMARY outcome
Timeframe: from the time of dosing (0 h) to 72 hours postdosePopulation: PK Evaluable Population
Cmax = Maximum concentration from the time of dosing (0 h) to the time of the last quantifiable metformin concentration following dose administration
Outcome measures
| Measure |
Met DR
n=34 Participants
One dose of 1000 mg Metformin Delayed-Release
|
Met XR
n=34 Participants
One dose of 1000 mg Metformin Extended-Release
|
|---|---|---|
|
Cmax of Plasma Metformin
Moderate RI (N = 9)
|
925 ng/mL
Standard Error 139
|
1634 ng/mL
Standard Error 245
|
|
Cmax of Plasma Metformin
Normal (N = 8)
|
969 ng/mL
Standard Error 153
|
1479 ng/mL
Standard Error 234
|
|
Cmax of Plasma Metformin
Mild RI (N = 10)
|
1036 ng/mL
Standard Error 147
|
1340 ng/mL
Standard Error 189
|
|
Cmax of Plasma Metformin
Severe RI (N = 7)
|
1414 ng/mL
Standard Error 239
|
2590 ng/mL
Standard Error 438
|
PRIMARY outcome
Timeframe: from the time of dosing (0 h) to 24 hours postdosePopulation: PD Evaluable Population
To determine the exposure-response relationship of metformin and plasma lactate concentrations
Outcome measures
| Measure |
Met DR
n=34 Participants
One dose of 1000 mg Metformin Delayed-Release
|
Met XR
n=34 Participants
One dose of 1000 mg Metformin Extended-Release
|
|---|---|---|
|
Correlation of Placebo-adjusted Change From Pre-dose Value in Lactate Versus Metformin Concentration
|
0.000011129 R²
|
0.069527 R²
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Met DR
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Met XR
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=36 participants at risk
One dose of Placebo
|
Met DR
n=38 participants at risk
One dose of 1000 mg Metformin Delayed-Release
|
Met XR
n=37 participants at risk
One dose of 1000 mg Metformin Extended-Release
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/36 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
7.9%
3/38 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
10.8%
4/37 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
|
General disorders
Vessel Puncture Site Haemorrhage
|
0.00%
0/36 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
5.3%
2/38 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
2.7%
1/37 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/36 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
5.3%
2/38 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
2.7%
1/37 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/36 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
0.00%
0/38 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
5.4%
2/37 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
|
Gastrointestinal disorders
Dyspepsia
|
2.8%
1/36 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
2.6%
1/38 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
2.7%
1/37 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/36 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
2.6%
1/38 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
2.7%
1/37 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.00%
0/36 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
2.6%
1/38 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
0.00%
0/37 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
|
Gastrointestinal disorders
Constipation
|
2.8%
1/36 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
0.00%
0/38 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
0.00%
0/37 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
|
Gastrointestinal disorders
Food Poisoning
|
2.8%
1/36 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
0.00%
0/38 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
0.00%
0/37 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/36 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
2.6%
1/38 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
0.00%
0/37 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/36 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
0.00%
0/38 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
2.7%
1/37 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/36 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
0.00%
0/38 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
2.7%
1/37 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
|
General disorders
Fatigue
|
0.00%
0/36 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
0.00%
0/38 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
2.7%
1/37 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
|
General disorders
Infusion Site Haemorrhage
|
0.00%
0/36 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
2.6%
1/38 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
0.00%
0/37 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
|
General disorders
Oedema Peripheral
|
0.00%
0/36 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
2.6%
1/38 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
0.00%
0/37 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
|
General disorders
Pyrexia
|
0.00%
0/36 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
0.00%
0/38 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
2.7%
1/37 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
|
General disorders
Vessel Puncture Site Pain
|
0.00%
0/36 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
0.00%
0/38 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
2.7%
1/37 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
|
General disorders
Vessel Puncture Site Reaction
|
0.00%
0/36 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
0.00%
0/38 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
2.7%
1/37 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/36 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
2.6%
1/38 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
0.00%
0/37 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
2.8%
1/36 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
0.00%
0/38 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
0.00%
0/37 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
|
Nervous system disorders
Headache
|
0.00%
0/36 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
2.6%
1/38 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
0.00%
0/37 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/36 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
2.6%
1/38 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
0.00%
0/37 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/36 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
0.00%
0/38 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
2.7%
1/37 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
2.8%
1/36 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
0.00%
0/38 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
0.00%
0/37 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
0.00%
0/36 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
2.6%
1/38 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
0.00%
0/37 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/36 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
2.6%
1/38 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
0.00%
0/37 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
|
Respiratory, thoracic and mediastinal disorders
Throat Tightness
|
0.00%
0/36 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
2.6%
1/38 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
0.00%
0/37 • Approximately 19 to 76 days depending on the number of days before the start of Visits 2 and 3 and the number of washout days between the treatment visits.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The results of the Study may be published by INSTITUTE, however the publication shall not disclose any SPONSOR Confidential Information, the INSTITUTE shall send the SPONSOR a copy of any such proposed publication 90 days prior to submission for publication, the INSTITUTE, on request of the SPONSOR, shall delete any SPONSOR Confidential Information in the proposed publication, and the INSTITUTE shall, on the SPONSOR's request, delay submission while the SPONSOR files applications for patents.
- Publication restrictions are in place
Restriction type: OTHER