Trial Outcomes & Findings for Dose Finding Study to Treat High Phosphate Levels in the Blood. (NCT NCT02081534)
NCT ID: NCT02081534
Last Updated: 2020-09-14
Results Overview
Change in serum phosphate levels from the end of wash out (pre randomization value) to end of treatment
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
162 participants
Primary outcome timeframe
End of wash out (pre randomization value) to end of treatment (Day 29)
Results posted on
2020-09-14
Participant Flow
Participant milestones
| Measure |
1 mg Bid
1 mg AZD1722 bid
AZD1722: tenapanor, oral tablet
|
3 mg Bid
3 mg AZD1722 bid
AZD1722: tenapanor, oral tablet
|
10 mg Bid
10 mg AZD1722 bid
AZD1722: tenapanor, oral tablet
|
30 mg Bid
30 mg AZD1722 bid
AZD1722: tenapanor, oral tablet
|
3 mg od
3 mg AZD1722 od
AZD1722: tenapanor, oral tablet
|
30 mg od
30 mg AZD1722 od
AZD1722: tenapanor, oral tablet
|
Placebo
Placebo (double dummy technique)
Placebo: Placebo bid, double dummy technique
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
23
|
21
|
23
|
26
|
22
|
21
|
26
|
|
Overall Study
COMPLETED
|
18
|
13
|
19
|
13
|
18
|
12
|
22
|
|
Overall Study
NOT COMPLETED
|
5
|
8
|
4
|
13
|
4
|
9
|
4
|
Reasons for withdrawal
| Measure |
1 mg Bid
1 mg AZD1722 bid
AZD1722: tenapanor, oral tablet
|
3 mg Bid
3 mg AZD1722 bid
AZD1722: tenapanor, oral tablet
|
10 mg Bid
10 mg AZD1722 bid
AZD1722: tenapanor, oral tablet
|
30 mg Bid
30 mg AZD1722 bid
AZD1722: tenapanor, oral tablet
|
3 mg od
3 mg AZD1722 od
AZD1722: tenapanor, oral tablet
|
30 mg od
30 mg AZD1722 od
AZD1722: tenapanor, oral tablet
|
Placebo
Placebo (double dummy technique)
Placebo: Placebo bid, double dummy technique
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
5
|
4
|
3
|
10
|
2
|
8
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
1
|
1
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
3
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
2
|
1
|
1
|
0
|
Baseline Characteristics
Dose Finding Study to Treat High Phosphate Levels in the Blood.
Baseline characteristics by cohort
| Measure |
1 mg Bid
n=23 Participants
1 mg AZD1722 bid
AZD1722: tenapanor, oral tablet
|
3 mg Bid
n=21 Participants
3 mg AZD1722 bid
AZD1722: tenapanor, oral tablet
|
10 mg Bid
n=23 Participants
10 mg AZD1722 bid
AZD1722: tenapanor, oral tablet
|
30 mg Bid
n=26 Participants
30 mg AZD1722 bid
AZD1722: tenapanor, oral tablet
|
3 mg od
n=22 Participants
3 mg AZD1722 od
AZD1722: tenapanor, oral tablet
|
30 mg od
n=21 Participants
30 mg AZD1722 od
AZD1722: tenapanor, oral tablet
|
Placebo
n=26 Participants
Placebo (double dummy technique)
Placebo: Placebo bid, double dummy technique
|
Total
n=162 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
57.9 years
STANDARD_DEVIATION 14.79 • n=93 Participants
|
61.5 years
STANDARD_DEVIATION 11.21 • n=4 Participants
|
62.7 years
STANDARD_DEVIATION 12.53 • n=27 Participants
|
59.7 years
STANDARD_DEVIATION 12.96 • n=483 Participants
|
57.6 years
STANDARD_DEVIATION 15.78 • n=36 Participants
|
58.2 years
STANDARD_DEVIATION 15.75 • n=10 Participants
|
56.1 years
STANDARD_DEVIATION 13.14 • n=115 Participants
|
59.1 years
STANDARD_DEVIATION 14.1 • n=40 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
17 Participants
n=483 Participants
|
12 Participants
n=36 Participants
|
13 Participants
n=10 Participants
|
16 Participants
n=115 Participants
|
104 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
10 Participants
n=36 Participants
|
8 Participants
n=10 Participants
|
10 Participants
n=115 Participants
|
58 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
8 Participants
n=36 Participants
|
6 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
48 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
22 Participants
n=483 Participants
|
14 Participants
n=36 Participants
|
15 Participants
n=10 Participants
|
20 Participants
n=115 Participants
|
114 Participants
n=40 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
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
8 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
9 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
6 Participants
n=36 Participants
|
3 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
35 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
15 Participants
n=483 Participants
|
13 Participants
n=36 Participants
|
16 Participants
n=10 Participants
|
17 Participants
n=115 Participants
|
106 Participants
n=40 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
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
3 Participants
n=40 Participants
|
|
serum phosphorus
|
7.55 mg/dL
STANDARD_DEVIATION 1.003 • n=93 Participants
|
7.92 mg/dL
STANDARD_DEVIATION 1.005 • n=4 Participants
|
7.32 mg/dL
STANDARD_DEVIATION 1.063 • n=27 Participants
|
7.76 mg/dL
STANDARD_DEVIATION 1.183 • n=483 Participants
|
7.73 mg/dL
STANDARD_DEVIATION 1.276 • n=36 Participants
|
7.61 mg/dL
STANDARD_DEVIATION 0.847 • n=10 Participants
|
7.87 mg/dL
STANDARD_DEVIATION 1.488 • n=115 Participants
|
7.68 mg/dL
STANDARD_DEVIATION 1.124 • n=40 Participants
|
PRIMARY outcome
Timeframe: End of wash out (pre randomization value) to end of treatment (Day 29)Population: two patients in the 30 mg bid group are not included in the analysis since they had no post randomization serum phosphorus measurements
Change in serum phosphate levels from the end of wash out (pre randomization value) to end of treatment
Outcome measures
| Measure |
1 mg Bid
n=23 Participants
1 mg AZD1722 bid
AZD1722: tenapanor, oral tablet
|
3 mg Bid
n=21 Participants
3 mg AZD1722 bid
AZD1722: tenapanor, oral tablet
|
10 mg Bid
n=23 Participants
10 mg AZD1722 bid
AZD1722: tenapanor, oral tablet
|
30 mg Bid
n=24 Participants
30 mg AZD1722 bid
AZD1722: tenapanor, oral tablet
|
3 mg od
n=22 Participants
3 mg AZD1722 od
AZD1722: tenapanor, oral tablet
|
30 mg od
n=21 Participants
30 mg AZD1722 od
AZD1722: tenapanor, oral tablet
|
Placebo
n=26 Participants
Placebo (double dummy technique)
Placebo: Placebo bid, double dummy technique
|
|---|---|---|---|---|---|---|---|
|
Change in Serum Phosphate Levels
|
-.47 mg/dL
Standard Deviation 1.553
|
-1.18 mg/dL
Standard Deviation 1.391
|
-1.7 mg/dL
Standard Deviation 2.018
|
-1.98 mg/dL
Standard Deviation 2.007
|
-.56 mg/dL
Standard Deviation 1.763
|
-1.11 mg/dL
Standard Deviation 1.469
|
-.54 mg/dL
Standard Deviation 1.802
|
SECONDARY outcome
Timeframe: End of wash out (pre randomization value) to end of treatment (Day 29)Population: The number of patients analyzed are less than the randomized number since the data to accomplish the analysis was not available.
Change from baseline (end of wash out) in calcium x phosphorus product
Outcome measures
| Measure |
1 mg Bid
n=22 Participants
1 mg AZD1722 bid
AZD1722: tenapanor, oral tablet
|
3 mg Bid
n=19 Participants
3 mg AZD1722 bid
AZD1722: tenapanor, oral tablet
|
10 mg Bid
n=20 Participants
10 mg AZD1722 bid
AZD1722: tenapanor, oral tablet
|
30 mg Bid
n=23 Participants
30 mg AZD1722 bid
AZD1722: tenapanor, oral tablet
|
3 mg od
n=21 Participants
3 mg AZD1722 od
AZD1722: tenapanor, oral tablet
|
30 mg od
n=20 Participants
30 mg AZD1722 od
AZD1722: tenapanor, oral tablet
|
Placebo
n=24 Participants
Placebo (double dummy technique)
Placebo: Placebo bid, double dummy technique
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Calcium x Phosphorus Product
|
-5.16 mg/dL * mg/dL
Standard Deviation 9.75
|
-12.02 mg/dL * mg/dL
Standard Deviation 14.02
|
-12.44 mg/dL * mg/dL
Standard Deviation 15.94
|
-16.6 mg/dL * mg/dL
Standard Deviation 18.01
|
-3.59 mg/dL * mg/dL
Standard Deviation 18.59
|
-11.02 mg/dL * mg/dL
Standard Deviation 11.57
|
-2.50 mg/dL * mg/dL
Standard Deviation 13.67
|
Adverse Events
1 mg Bid
Serious events: 2 serious events
Other events: 6 other events
Deaths: 1 deaths
3 mg Bid
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
10 mg Bid
Serious events: 3 serious events
Other events: 11 other events
Deaths: 0 deaths
30 mg Bid
Serious events: 2 serious events
Other events: 17 other events
Deaths: 0 deaths
3 mg od
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
30 mg od
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Placebo
Serious events: 4 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1 mg Bid
n=23 participants at risk
1 mg AZD1722 bid
AZD1722: tenapanor, oral tablet
|
3 mg Bid
n=21 participants at risk
3 mg AZD1722 bid
AZD1722: tenapanor, oral tablet
|
10 mg Bid
n=23 participants at risk
10 mg AZD1722 bid
AZD1722: tenapanor, oral tablet
|
30 mg Bid
n=26 participants at risk
30 mg AZD1722 bid
AZD1722: tenapanor, oral tablet
|
3 mg od
n=22 participants at risk
3 mg AZD1722 od
AZD1722: tenapanor, oral tablet
|
30 mg od
n=21 participants at risk
30 mg AZD1722 od
AZD1722: tenapanor, oral tablet
|
Placebo
n=26 participants at risk
Placebo (double dummy technique)
Placebo: Placebo bid, double dummy technique
|
|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Chest pain
|
4.3%
1/23 • Number of events 1 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
0.00%
0/21 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
0.00%
0/23 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
3.8%
1/26 • Number of events 1 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
0.00%
0/22 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
0.00%
0/21 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
0.00%
0/26 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
|
Cardiac disorders
Cardiac failure
|
4.3%
1/23 • Number of events 1 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
0.00%
0/21 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
0.00%
0/23 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
0.00%
0/26 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
0.00%
0/22 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
0.00%
0/21 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
0.00%
0/26 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
|
Infections and infestations
pneumonia
|
0.00%
0/23 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
4.8%
1/21 • Number of events 1 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
0.00%
0/23 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
0.00%
0/26 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
0.00%
0/22 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
0.00%
0/21 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
3.8%
1/26 • Number of events 1 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/23 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
4.8%
1/21 • Number of events 1 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
0.00%
0/23 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
0.00%
0/26 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
0.00%
0/22 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
0.00%
0/21 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
0.00%
0/26 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
|
Infections and infestations
osteomyelitis
|
0.00%
0/23 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
0.00%
0/21 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
4.3%
1/23 • Number of events 1 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
0.00%
0/26 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
0.00%
0/22 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
0.00%
0/21 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
0.00%
0/26 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/23 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
0.00%
0/21 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
4.3%
1/23 • Number of events 1 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
0.00%
0/26 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
0.00%
0/22 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
0.00%
0/21 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
0.00%
0/26 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
|
Nervous system disorders
Syncope
|
0.00%
0/23 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
0.00%
0/21 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
4.3%
1/23 • Number of events 1 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
0.00%
0/26 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
0.00%
0/22 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
0.00%
0/21 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
0.00%
0/26 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
|
Gastrointestinal disorders
Rectal prolapse
|
0.00%
0/23 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
0.00%
0/21 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
0.00%
0/23 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
3.8%
1/26 • Number of events 1 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
0.00%
0/22 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
0.00%
0/21 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
0.00%
0/26 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/23 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
0.00%
0/21 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
0.00%
0/23 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
3.8%
1/26 • Number of events 1 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
0.00%
0/22 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
0.00%
0/21 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
0.00%
0/26 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/23 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
0.00%
0/21 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
0.00%
0/23 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
0.00%
0/26 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
4.5%
1/22 • Number of events 1 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
0.00%
0/21 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
0.00%
0/26 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
|
Gastrointestinal disorders
diarrhea
|
0.00%
0/23 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
0.00%
0/21 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
0.00%
0/23 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
0.00%
0/26 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
0.00%
0/22 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
0.00%
0/21 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
3.8%
1/26 • Number of events 1 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/23 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
0.00%
0/21 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
0.00%
0/23 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
0.00%
0/26 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
0.00%
0/22 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
0.00%
0/21 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
3.8%
1/26 • Number of events 1 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.00%
0/23 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
0.00%
0/21 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
0.00%
0/23 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
0.00%
0/26 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
0.00%
0/22 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
0.00%
0/21 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
3.8%
1/26 • Number of events 1 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
Other adverse events
| Measure |
1 mg Bid
n=23 participants at risk
1 mg AZD1722 bid
AZD1722: tenapanor, oral tablet
|
3 mg Bid
n=21 participants at risk
3 mg AZD1722 bid
AZD1722: tenapanor, oral tablet
|
10 mg Bid
n=23 participants at risk
10 mg AZD1722 bid
AZD1722: tenapanor, oral tablet
|
30 mg Bid
n=26 participants at risk
30 mg AZD1722 bid
AZD1722: tenapanor, oral tablet
|
3 mg od
n=22 participants at risk
3 mg AZD1722 od
AZD1722: tenapanor, oral tablet
|
30 mg od
n=21 participants at risk
30 mg AZD1722 od
AZD1722: tenapanor, oral tablet
|
Placebo
n=26 participants at risk
Placebo (double dummy technique)
Placebo: Placebo bid, double dummy technique
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
26.1%
6/23 • Number of events 6 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
28.6%
6/21 • Number of events 6 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
47.8%
11/23 • Number of events 11 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
65.4%
17/26 • Number of events 17 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
18.2%
4/22 • Number of events 4 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
52.4%
11/21 • Number of events 11 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
11.5%
3/26 • Number of events 3 • Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60