Trial Outcomes & Findings for The Efficacy of AZD1722 in Constipation Predominant Irritable Bowel Syndrome (IBS-C) (NCT NCT01923428)
NCT ID: NCT01923428
Last Updated: 2020-04-08
Results Overview
Weekly complete spontaneous bowel movement resaponders defined as an increase of one or more bowel movement per week from baseline for 6 of the 12 weeks
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
356 participants
Primary outcome timeframe
12 weeks
Results posted on
2020-04-08
Participant Flow
Participant milestones
| Measure |
5 mg BID
AZD1722
|
20 mg BID
AZD1722
|
50 mg BID
AZD1722
|
Placebo
Placebo
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
88
|
89
|
89
|
90
|
|
Overall Study
COMPLETED
|
69
|
77
|
78
|
80
|
|
Overall Study
NOT COMPLETED
|
19
|
12
|
11
|
10
|
Reasons for withdrawal
| Measure |
5 mg BID
AZD1722
|
20 mg BID
AZD1722
|
50 mg BID
AZD1722
|
Placebo
Placebo
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
8
|
6
|
3
|
3
|
|
Overall Study
Withdrawal by Subject
|
5
|
3
|
0
|
4
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
5
|
0
|
|
Overall Study
Protocol Violation
|
3
|
0
|
2
|
1
|
|
Overall Study
Non Compliance to treatment
|
1
|
2
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
1
|
1
|
Baseline Characteristics
The Efficacy of AZD1722 in Constipation Predominant Irritable Bowel Syndrome (IBS-C)
Baseline characteristics by cohort
| Measure |
Total
n=356 Participants
Total of all reporting groups
|
5 mg BID
n=88 Participants
AZD1722
|
20 mg BID
n=89 Participants
AZD1722
|
50 mg BID
n=89 Participants
AZD1722
|
Placebo
n=90 Participants
Placebo
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=21 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
331 Participants
n=21 Participants
|
84 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
81 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
25 Participants
n=21 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
309 Participants
n=21 Participants
|
76 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
77 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=21 Participants
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
105 Participants
n=21 Participants
|
22 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
251 Participants
n=21 Participants
|
66 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
61 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=21 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=21 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=21 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=21 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
76 Participants
n=21 Participants
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
270 Participants
n=21 Participants
|
69 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=21 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=21 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
BMI
|
28.7 kg/m^2
STANDARD_DEVIATION 5.36 • n=21 Participants
|
29.5 kg/m^2
STANDARD_DEVIATION 5.65 • n=5 Participants
|
28.5 kg/m^2
STANDARD_DEVIATION 5.27 • n=7 Participants
|
28.3 kg/m^2
STANDARD_DEVIATION 4.87 • n=5 Participants
|
28.7 kg/m^2
STANDARD_DEVIATION 5.63 • n=4 Participants
|
PRIMARY outcome
Timeframe: 12 weeksWeekly complete spontaneous bowel movement resaponders defined as an increase of one or more bowel movement per week from baseline for 6 of the 12 weeks
Outcome measures
| Measure |
5 mg BID
n=87 Participants
AZD1722
|
20 mg BID
n=87 Participants
AZD1722
|
50 mg BID
n=84 Participants
AZD1722
|
Placebo
n=89 Participants
Placebo
|
|---|---|---|---|---|
|
Percent Complete Spontaneous Bowel Movement Responders vs Placebo
|
35 Participants
|
38 Participants
|
51 Participants
|
30 Participants
|
Adverse Events
5 mg BID
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
20 mg BID
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
50 mg BID
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
5 mg BID
n=88 participants at risk
AZD1722
AZD1722
|
20 mg BID
n=89 participants at risk
AZD1722
AZD1722
|
50 mg BID
n=89 participants at risk
AZD1722
AZD1722
|
Placebo
n=90 participants at risk
Placebo
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Osteomyelitis
|
0.00%
0/88
|
0.00%
0/89
|
0.00%
0/89
|
1.1%
1/90 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal neoplasm
|
1.1%
1/88 • Number of events 1
|
0.00%
0/89
|
0.00%
0/89
|
0.00%
0/90
|
|
Infections and infestations
Urinary Tract Infection
|
1.1%
1/88 • Number of events 1
|
0.00%
0/89
|
0.00%
0/89
|
0.00%
0/90
|
|
Gastrointestinal disorders
small intestinal obstruction
|
0.00%
0/88
|
1.1%
1/89 • Number of events 1
|
0.00%
0/89
|
0.00%
0/90
|
Other adverse events
| Measure |
5 mg BID
n=88 participants at risk
AZD1722
AZD1722
|
20 mg BID
n=89 participants at risk
AZD1722
AZD1722
|
50 mg BID
n=89 participants at risk
AZD1722
AZD1722
|
Placebo
n=90 participants at risk
Placebo
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
8.0%
7/88 • Number of events 7
|
12.4%
11/89 • Number of events 11
|
11.2%
10/89 • Number of events 10
|
0.00%
0/90
|
|
Infections and infestations
Urinary Tract Infection
|
3.4%
3/88 • Number of events 3
|
2.2%
2/89 • Number of events 2
|
5.6%
5/89 • Number of events 5
|
4.4%
4/90 • Number of events 4
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60