Trial Outcomes & Findings for Value of Liquid Potassium Magnesium Citrate in Controlling Hypertension (NCT NCT01682837)
NCT ID: NCT01682837
Last Updated: 2017-04-28
Results Overview
This is the average systolic blood pressure over a 24 hour period.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
35 participants
Primary outcome timeframe
4 weeks
Results posted on
2017-04-28
Participant Flow
Participant milestones
| Measure |
All Study Participants
Participants received the following study drug in random order: Potassium Magnesium Citrate (KMgCit) powder, Potassium Citrate (KCit) powder, Potassium Chloride (KCl) powder and Placebo. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout. Individual study drug assignments per randomization is provided in the comments for each study period.
|
|---|---|
|
Baseline
STARTED
|
35
|
|
Baseline
COMPLETED
|
30
|
|
Baseline
NOT COMPLETED
|
5
|
|
First Intervention (4 Weeks)
STARTED
|
30
|
|
First Intervention (4 Weeks)
Received KMgCit
|
8
|
|
First Intervention (4 Weeks)
Received KCit
|
8
|
|
First Intervention (4 Weeks)
Received KCl
|
7
|
|
First Intervention (4 Weeks)
Received Placebo
|
7
|
|
First Intervention (4 Weeks)
COMPLETED
|
30
|
|
First Intervention (4 Weeks)
NOT COMPLETED
|
0
|
|
Second Intervention (4 Weeks)
STARTED
|
30
|
|
Second Intervention (4 Weeks)
Received KMgCit
|
7
|
|
Second Intervention (4 Weeks)
Received KCit
|
6
|
|
Second Intervention (4 Weeks)
Received KCl
|
8
|
|
Second Intervention (4 Weeks)
Received Placebo
|
9
|
|
Second Intervention (4 Weeks)
COMPLETED
|
30
|
|
Second Intervention (4 Weeks)
NOT COMPLETED
|
0
|
|
Third Intervention (4 Weeks)
STARTED
|
30
|
|
Third Intervention (4 Weeks)
Received KMgCit
|
9
|
|
Third Intervention (4 Weeks)
Received KCit
|
7
|
|
Third Intervention (4 Weeks)
Received KCl
|
7
|
|
Third Intervention (4 Weeks)
Received Placebo
|
7
|
|
Third Intervention (4 Weeks)
COMPLETED
|
30
|
|
Third Intervention (4 Weeks)
NOT COMPLETED
|
0
|
|
Fourth Intervention (4 Weeks)
STARTED
|
30
|
|
Fourth Intervention (4 Weeks)
Received KMgCit
|
6
|
|
Fourth Intervention (4 Weeks)
Received KCit
|
9
|
|
Fourth Intervention (4 Weeks)
Received KCl
|
8
|
|
Fourth Intervention (4 Weeks)
Received Placebo
|
7
|
|
Fourth Intervention (4 Weeks)
COMPLETED
|
30
|
|
Fourth Intervention (4 Weeks)
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
All Study Participants
Participants received the following study drug in random order: Potassium Magnesium Citrate (KMgCit) powder, Potassium Citrate (KCit) powder, Potassium Chloride (KCl) powder and Placebo. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout. Individual study drug assignments per randomization is provided in the comments for each study period.
|
|---|---|
|
Baseline
Withdrawal by Subject
|
5
|
Baseline Characteristics
Value of Liquid Potassium Magnesium Citrate in Controlling Hypertension
Baseline characteristics by cohort
| Measure |
All Study Participants
n=30 Participants
Participants received the following study drug in random order: Potassium Magnesium Citrate powder, Potassium Citrate powder, Potassium Chloride powder, Placebo. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.
|
|---|---|
|
Age, Continuous
|
54 years
STANDARD_DEVIATION 12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
|
BMI
|
31 kg/m^2
STANDARD_DEVIATION 5 • n=5 Participants
|
|
Office Systolic Blood Pressure
|
125 mmHg
STANDARD_DEVIATION 11 • n=5 Participants
|
|
Office Diastolic Blood Pressure
|
81 mmHg
STANDARD_DEVIATION 8 • n=5 Participants
|
|
Office Heart Rate
|
72 beats per minute
STANDARD_DEVIATION 11 • n=5 Participants
|
|
24-hr Systolic Blood Pressure Average
|
126 mmHg
STANDARD_DEVIATION 10 • n=5 Participants
|
|
24-hr Diastolic Blood Pressure Average
|
79 mmHg
STANDARD_DEVIATION 10 • n=5 Participants
|
|
24-hr Heart Rate Average
|
76 beats per minute
STANDARD_DEVIATION 11 • n=5 Participants
|
|
24-hr Daytime Systolic Blood Pressure
|
129 mmHg
STANDARD_DEVIATION 10 • n=5 Participants
|
|
24-hr Daytime Diastolic Blood Pressure
|
81 mmHg
STANDARD_DEVIATION 11 • n=5 Participants
|
|
24-hr Daytime Heart Rate
|
77 beats per minute
STANDARD_DEVIATION 11 • n=5 Participants
|
|
24-hr Nighttime Systolic Blood Pressure
|
117 mmHg
STANDARD_DEVIATION 12 • n=5 Participants
|
|
24-hr Nighttime Diastolic Blood Pressure
|
71 mmHg
STANDARD_DEVIATION 10 • n=5 Participants
|
|
24-hr Nighttime Heart Rate
|
70 beats per minute
STANDARD_DEVIATION 11 • n=5 Participants
|
|
Serum Calcium
|
9.5 mg/dl
STANDARD_DEVIATION 0.5 • n=5 Participants
|
|
Serum Phosphorus
|
3.6 mg/dl
STANDARD_DEVIATION 0.1 • n=5 Participants
|
|
Serum Magnesium
|
2.2 mg/dl
STANDARD_DEVIATION 0.3 • n=5 Participants
|
|
Serum Sodium
|
139 meq/L
STANDARD_DEVIATION 2 • n=5 Participants
|
|
Serum Potassium
|
4.2 meq/L
STANDARD_DEVIATION 0.3 • n=5 Participants
|
|
Serum Chloride (meq/L)
|
105 meq/L
STANDARD_DEVIATION 2 • n=5 Participants
|
|
Serum Bicarbonate
|
23 meq/L
STANDARD_DEVIATION 2 • n=5 Participants
|
|
Serum Urea Nitrogen
|
13.7 mg/dl
STANDARD_DEVIATION 3.5 • n=5 Participants
|
|
Serum Creatinine (mg/dl)
|
0.9 mg/dl
STANDARD_DEVIATION 0.2 • n=5 Participants
|
|
Serum Albumin
|
4.2 g/dl
STANDARD_DEVIATION 0.6 • n=5 Participants
|
|
Serum Parathyroid Hormone
|
59 pg/ml
STANDARD_DEVIATION 31 • n=5 Participants
|
|
Serum 1,25-Dihydroxyvitamin D
|
73 pg/ml
STANDARD_DEVIATION 34 • n=5 Participants
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: All participants who completed the study completed all 4 phases.
This is the average systolic blood pressure over a 24 hour period.
Outcome measures
| Measure |
Potassium Magnesium Citrate Powder Phase
n=30 Participants
Participants undergoing the Potassium Magnesium Citrate powder phase of the study.
|
Potassium Citrate Powder Phase
n=30 Participants
Participants undergoing the Potassium Citrate powder phase of the study.
|
Potassium Chloride Powder Phase
n=30 Participants
Participants undergoing the Potassium Chloride powder phase of the study.
|
Placebo Phase
n=30 Participants
Participants undergoing the Placebo phase of the study.
|
|---|---|---|---|---|
|
24-hour Average Systolic Blood Pressure
|
127 mmHg
Standard Deviation 11
|
127 mmHg
Standard Deviation 10
|
126 mmHg
Standard Deviation 9
|
129 mmHg
Standard Deviation 13
|
PRIMARY outcome
Timeframe: 4 weeksThe average diastolic blood pressure over a 24 hour period.
Outcome measures
| Measure |
Potassium Magnesium Citrate Powder Phase
n=30 Participants
Participants undergoing the Potassium Magnesium Citrate powder phase of the study.
|
Potassium Citrate Powder Phase
n=30 Participants
Participants undergoing the Potassium Citrate powder phase of the study.
|
Potassium Chloride Powder Phase
n=30 Participants
Participants undergoing the Potassium Chloride powder phase of the study.
|
Placebo Phase
n=30 Participants
Participants undergoing the Placebo phase of the study.
|
|---|---|---|---|---|
|
24-hour Average Diastolic Blood Pressure
|
79 mmHg
Standard Deviation 10
|
78 mmHg
Standard Deviation 9
|
78 mmHg
Standard Deviation 9
|
80 mmHg
Standard Deviation 11
|
SECONDARY outcome
Timeframe: 4 weeksOutcome measures
| Measure |
Potassium Magnesium Citrate Powder Phase
n=30 Participants
Participants undergoing the Potassium Magnesium Citrate powder phase of the study.
|
Potassium Citrate Powder Phase
n=30 Participants
Participants undergoing the Potassium Citrate powder phase of the study.
|
Potassium Chloride Powder Phase
n=30 Participants
Participants undergoing the Potassium Chloride powder phase of the study.
|
Placebo Phase
n=30 Participants
Participants undergoing the Placebo phase of the study.
|
|---|---|---|---|---|
|
Office Systolic Blood Pressure
|
124 mmHg
Standard Deviation 11
|
125 mmHg
Standard Deviation 13
|
127 mmHg
Standard Deviation 11
|
129 mmHg
Standard Deviation 12
|
SECONDARY outcome
Timeframe: 4 weeksOutcome measures
| Measure |
Potassium Magnesium Citrate Powder Phase
n=30 Participants
Participants undergoing the Potassium Magnesium Citrate powder phase of the study.
|
Potassium Citrate Powder Phase
n=30 Participants
Participants undergoing the Potassium Citrate powder phase of the study.
|
Potassium Chloride Powder Phase
n=30 Participants
Participants undergoing the Potassium Chloride powder phase of the study.
|
Placebo Phase
n=30 Participants
Participants undergoing the Placebo phase of the study.
|
|---|---|---|---|---|
|
Office Diastolic Blood Pressure
|
81 mmHg
Standard Deviation 9
|
81 mmHg
Standard Deviation 8
|
80 mmHg
Standard Deviation 9
|
81 mmHg
Standard Deviation 9
|
SECONDARY outcome
Timeframe: 4 weeksOutcome measures
| Measure |
Potassium Magnesium Citrate Powder Phase
n=30 Participants
Participants undergoing the Potassium Magnesium Citrate powder phase of the study.
|
Potassium Citrate Powder Phase
n=30 Participants
Participants undergoing the Potassium Citrate powder phase of the study.
|
Potassium Chloride Powder Phase
n=30 Participants
Participants undergoing the Potassium Chloride powder phase of the study.
|
Placebo Phase
n=30 Participants
Participants undergoing the Placebo phase of the study.
|
|---|---|---|---|---|
|
Serum C-terminal Telopeptide (CTX)
|
0.46 ng/ml
Standard Deviation 0.28
|
0.46 ng/ml
Standard Deviation 0.28
|
0.45 ng/ml
Standard Deviation 0.25
|
0.49 ng/ml
Standard Deviation 0.33
|
SECONDARY outcome
Timeframe: 4 weeks of treatmentOutcome measures
| Measure |
Potassium Magnesium Citrate Powder Phase
n=30 Participants
Participants undergoing the Potassium Magnesium Citrate powder phase of the study.
|
Potassium Citrate Powder Phase
n=30 Participants
Participants undergoing the Potassium Citrate powder phase of the study.
|
Potassium Chloride Powder Phase
n=30 Participants
Participants undergoing the Potassium Chloride powder phase of the study.
|
Placebo Phase
n=30 Participants
Participants undergoing the Placebo phase of the study.
|
|---|---|---|---|---|
|
24-hour Urinary Calcium
|
158 mg/day
Standard Deviation 94
|
148 mg/day
Standard Deviation 78
|
160 mg/day
Standard Deviation 92
|
181 mg/day
Standard Deviation 101
|
SECONDARY outcome
Timeframe: 4 weeksOutcome measures
| Measure |
Potassium Magnesium Citrate Powder Phase
n=30 Participants
Participants undergoing the Potassium Magnesium Citrate powder phase of the study.
|
Potassium Citrate Powder Phase
n=30 Participants
Participants undergoing the Potassium Citrate powder phase of the study.
|
Potassium Chloride Powder Phase
n=30 Participants
Participants undergoing the Potassium Chloride powder phase of the study.
|
Placebo Phase
n=30 Participants
Participants undergoing the Placebo phase of the study.
|
|---|---|---|---|---|
|
Carotid to Femoral Pulse Wave Velocity
|
8.7 m/s
Standard Deviation 1.7
|
8.8 m/s
Standard Deviation 1.6
|
8.7 m/s
Standard Deviation 1.5
|
8.9 m/s
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: 4 weeksOutcome measures
| Measure |
Potassium Magnesium Citrate Powder Phase
n=30 Participants
Participants undergoing the Potassium Magnesium Citrate powder phase of the study.
|
Potassium Citrate Powder Phase
n=30 Participants
Participants undergoing the Potassium Citrate powder phase of the study.
|
Potassium Chloride Powder Phase
n=30 Participants
Participants undergoing the Potassium Chloride powder phase of the study.
|
Placebo Phase
n=30 Participants
Participants undergoing the Placebo phase of the study.
|
|---|---|---|---|---|
|
Central Aortic Systolic Blood Pressure
|
121 mmHg
Standard Deviation 11
|
125 mmHg
Standard Deviation 16
|
123 mmHg
Standard Deviation 13
|
126 mmHg
Standard Deviation 14
|
SECONDARY outcome
Timeframe: 4 weeksOutcome measures
| Measure |
Potassium Magnesium Citrate Powder Phase
n=30 Participants
Participants undergoing the Potassium Magnesium Citrate powder phase of the study.
|
Potassium Citrate Powder Phase
n=30 Participants
Participants undergoing the Potassium Citrate powder phase of the study.
|
Potassium Chloride Powder Phase
n=30 Participants
Participants undergoing the Potassium Chloride powder phase of the study.
|
Placebo Phase
n=30 Participants
Participants undergoing the Placebo phase of the study.
|
|---|---|---|---|---|
|
Central Aortic Diastolic Blood Pressure
|
77 mmHg
Standard Deviation 7
|
76 mmHg
Standard Deviation 7
|
77 mmHg
Standard Deviation 9
|
79 mmHg
Standard Deviation 8
|
Adverse Events
Potassium Magnesium Citrate Powder Phase
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Potassium Citrate Powder Phase
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Potassium Chloride Powder Phase
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Placebo Phase
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Potassium Magnesium Citrate Powder Phase
n=30 participants at risk
Participants undergoing the Potassium Magnesium Citrate powder phase of the study.
|
Potassium Citrate Powder Phase
n=30 participants at risk
Participants undergoing the Potassium Citrate powder phase of the study.
|
Potassium Chloride Powder Phase
n=30 participants at risk
Participants undergoing the Potassium Chloride powder phase of the study.
|
Placebo Phase
n=30 participants at risk
Participants undergoing the Placebo phase of the study.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
6.7%
2/30 • Number of events 2 • Adverse event data was collected during each subject's study period. Each study period was 4 weeks in duration.
Systematic assessments were collected by a side effect questionaire which asked about Vomiting, Nausea, Belching, Diarrhea, Loose Bowel Movements, Pain/Cramp, Melena, Dyspepsia, Anorexia, Dysphagia, Dysgeusia and Other.
|
3.3%
1/30 • Number of events 1 • Adverse event data was collected during each subject's study period. Each study period was 4 weeks in duration.
Systematic assessments were collected by a side effect questionaire which asked about Vomiting, Nausea, Belching, Diarrhea, Loose Bowel Movements, Pain/Cramp, Melena, Dyspepsia, Anorexia, Dysphagia, Dysgeusia and Other.
|
3.3%
1/30 • Number of events 1 • Adverse event data was collected during each subject's study period. Each study period was 4 weeks in duration.
Systematic assessments were collected by a side effect questionaire which asked about Vomiting, Nausea, Belching, Diarrhea, Loose Bowel Movements, Pain/Cramp, Melena, Dyspepsia, Anorexia, Dysphagia, Dysgeusia and Other.
|
3.3%
1/30 • Number of events 1 • Adverse event data was collected during each subject's study period. Each study period was 4 weeks in duration.
Systematic assessments were collected by a side effect questionaire which asked about Vomiting, Nausea, Belching, Diarrhea, Loose Bowel Movements, Pain/Cramp, Melena, Dyspepsia, Anorexia, Dysphagia, Dysgeusia and Other.
|
|
Gastrointestinal disorders
Belching
|
0.00%
0/30 • Adverse event data was collected during each subject's study period. Each study period was 4 weeks in duration.
Systematic assessments were collected by a side effect questionaire which asked about Vomiting, Nausea, Belching, Diarrhea, Loose Bowel Movements, Pain/Cramp, Melena, Dyspepsia, Anorexia, Dysphagia, Dysgeusia and Other.
|
3.3%
1/30 • Number of events 1 • Adverse event data was collected during each subject's study period. Each study period was 4 weeks in duration.
Systematic assessments were collected by a side effect questionaire which asked about Vomiting, Nausea, Belching, Diarrhea, Loose Bowel Movements, Pain/Cramp, Melena, Dyspepsia, Anorexia, Dysphagia, Dysgeusia and Other.
|
6.7%
2/30 • Number of events 3 • Adverse event data was collected during each subject's study period. Each study period was 4 weeks in duration.
Systematic assessments were collected by a side effect questionaire which asked about Vomiting, Nausea, Belching, Diarrhea, Loose Bowel Movements, Pain/Cramp, Melena, Dyspepsia, Anorexia, Dysphagia, Dysgeusia and Other.
|
0.00%
0/30 • Adverse event data was collected during each subject's study period. Each study period was 4 weeks in duration.
Systematic assessments were collected by a side effect questionaire which asked about Vomiting, Nausea, Belching, Diarrhea, Loose Bowel Movements, Pain/Cramp, Melena, Dyspepsia, Anorexia, Dysphagia, Dysgeusia and Other.
|
|
Gastrointestinal disorders
Diarrhea
|
3.3%
1/30 • Number of events 1 • Adverse event data was collected during each subject's study period. Each study period was 4 weeks in duration.
Systematic assessments were collected by a side effect questionaire which asked about Vomiting, Nausea, Belching, Diarrhea, Loose Bowel Movements, Pain/Cramp, Melena, Dyspepsia, Anorexia, Dysphagia, Dysgeusia and Other.
|
0.00%
0/30 • Adverse event data was collected during each subject's study period. Each study period was 4 weeks in duration.
Systematic assessments were collected by a side effect questionaire which asked about Vomiting, Nausea, Belching, Diarrhea, Loose Bowel Movements, Pain/Cramp, Melena, Dyspepsia, Anorexia, Dysphagia, Dysgeusia and Other.
|
3.3%
1/30 • Number of events 1 • Adverse event data was collected during each subject's study period. Each study period was 4 weeks in duration.
Systematic assessments were collected by a side effect questionaire which asked about Vomiting, Nausea, Belching, Diarrhea, Loose Bowel Movements, Pain/Cramp, Melena, Dyspepsia, Anorexia, Dysphagia, Dysgeusia and Other.
|
3.3%
1/30 • Number of events 1 • Adverse event data was collected during each subject's study period. Each study period was 4 weeks in duration.
Systematic assessments were collected by a side effect questionaire which asked about Vomiting, Nausea, Belching, Diarrhea, Loose Bowel Movements, Pain/Cramp, Melena, Dyspepsia, Anorexia, Dysphagia, Dysgeusia and Other.
|
|
Gastrointestinal disorders
Loose Bowel Movement
|
0.00%
0/30 • Adverse event data was collected during each subject's study period. Each study period was 4 weeks in duration.
Systematic assessments were collected by a side effect questionaire which asked about Vomiting, Nausea, Belching, Diarrhea, Loose Bowel Movements, Pain/Cramp, Melena, Dyspepsia, Anorexia, Dysphagia, Dysgeusia and Other.
|
0.00%
0/30 • Adverse event data was collected during each subject's study period. Each study period was 4 weeks in duration.
Systematic assessments were collected by a side effect questionaire which asked about Vomiting, Nausea, Belching, Diarrhea, Loose Bowel Movements, Pain/Cramp, Melena, Dyspepsia, Anorexia, Dysphagia, Dysgeusia and Other.
|
13.3%
4/30 • Number of events 6 • Adverse event data was collected during each subject's study period. Each study period was 4 weeks in duration.
Systematic assessments were collected by a side effect questionaire which asked about Vomiting, Nausea, Belching, Diarrhea, Loose Bowel Movements, Pain/Cramp, Melena, Dyspepsia, Anorexia, Dysphagia, Dysgeusia and Other.
|
0.00%
0/30 • Adverse event data was collected during each subject's study period. Each study period was 4 weeks in duration.
Systematic assessments were collected by a side effect questionaire which asked about Vomiting, Nausea, Belching, Diarrhea, Loose Bowel Movements, Pain/Cramp, Melena, Dyspepsia, Anorexia, Dysphagia, Dysgeusia and Other.
|
|
Gastrointestinal disorders
Pain and/or Cramps
|
0.00%
0/30 • Adverse event data was collected during each subject's study period. Each study period was 4 weeks in duration.
Systematic assessments were collected by a side effect questionaire which asked about Vomiting, Nausea, Belching, Diarrhea, Loose Bowel Movements, Pain/Cramp, Melena, Dyspepsia, Anorexia, Dysphagia, Dysgeusia and Other.
|
3.3%
1/30 • Number of events 1 • Adverse event data was collected during each subject's study period. Each study period was 4 weeks in duration.
Systematic assessments were collected by a side effect questionaire which asked about Vomiting, Nausea, Belching, Diarrhea, Loose Bowel Movements, Pain/Cramp, Melena, Dyspepsia, Anorexia, Dysphagia, Dysgeusia and Other.
|
3.3%
1/30 • Number of events 2 • Adverse event data was collected during each subject's study period. Each study period was 4 weeks in duration.
Systematic assessments were collected by a side effect questionaire which asked about Vomiting, Nausea, Belching, Diarrhea, Loose Bowel Movements, Pain/Cramp, Melena, Dyspepsia, Anorexia, Dysphagia, Dysgeusia and Other.
|
3.3%
1/30 • Number of events 1 • Adverse event data was collected during each subject's study period. Each study period was 4 weeks in duration.
Systematic assessments were collected by a side effect questionaire which asked about Vomiting, Nausea, Belching, Diarrhea, Loose Bowel Movements, Pain/Cramp, Melena, Dyspepsia, Anorexia, Dysphagia, Dysgeusia and Other.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/30 • Adverse event data was collected during each subject's study period. Each study period was 4 weeks in duration.
Systematic assessments were collected by a side effect questionaire which asked about Vomiting, Nausea, Belching, Diarrhea, Loose Bowel Movements, Pain/Cramp, Melena, Dyspepsia, Anorexia, Dysphagia, Dysgeusia and Other.
|
0.00%
0/30 • Adverse event data was collected during each subject's study period. Each study period was 4 weeks in duration.
Systematic assessments were collected by a side effect questionaire which asked about Vomiting, Nausea, Belching, Diarrhea, Loose Bowel Movements, Pain/Cramp, Melena, Dyspepsia, Anorexia, Dysphagia, Dysgeusia and Other.
|
0.00%
0/30 • Adverse event data was collected during each subject's study period. Each study period was 4 weeks in duration.
Systematic assessments were collected by a side effect questionaire which asked about Vomiting, Nausea, Belching, Diarrhea, Loose Bowel Movements, Pain/Cramp, Melena, Dyspepsia, Anorexia, Dysphagia, Dysgeusia and Other.
|
3.3%
1/30 • Number of events 1 • Adverse event data was collected during each subject's study period. Each study period was 4 weeks in duration.
Systematic assessments were collected by a side effect questionaire which asked about Vomiting, Nausea, Belching, Diarrhea, Loose Bowel Movements, Pain/Cramp, Melena, Dyspepsia, Anorexia, Dysphagia, Dysgeusia and Other.
|
|
Gastrointestinal disorders
Dysgeusia
|
6.7%
2/30 • Number of events 3 • Adverse event data was collected during each subject's study period. Each study period was 4 weeks in duration.
Systematic assessments were collected by a side effect questionaire which asked about Vomiting, Nausea, Belching, Diarrhea, Loose Bowel Movements, Pain/Cramp, Melena, Dyspepsia, Anorexia, Dysphagia, Dysgeusia and Other.
|
6.7%
2/30 • Number of events 3 • Adverse event data was collected during each subject's study period. Each study period was 4 weeks in duration.
Systematic assessments were collected by a side effect questionaire which asked about Vomiting, Nausea, Belching, Diarrhea, Loose Bowel Movements, Pain/Cramp, Melena, Dyspepsia, Anorexia, Dysphagia, Dysgeusia and Other.
|
40.0%
12/30 • Number of events 18 • Adverse event data was collected during each subject's study period. Each study period was 4 weeks in duration.
Systematic assessments were collected by a side effect questionaire which asked about Vomiting, Nausea, Belching, Diarrhea, Loose Bowel Movements, Pain/Cramp, Melena, Dyspepsia, Anorexia, Dysphagia, Dysgeusia and Other.
|
6.7%
2/30 • Number of events 2 • Adverse event data was collected during each subject's study period. Each study period was 4 weeks in duration.
Systematic assessments were collected by a side effect questionaire which asked about Vomiting, Nausea, Belching, Diarrhea, Loose Bowel Movements, Pain/Cramp, Melena, Dyspepsia, Anorexia, Dysphagia, Dysgeusia and Other.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place