Trial Outcomes & Findings for Prevention of Recurrence of Diverticulitis (NCT NCT00545103)
NCT ID: NCT00545103
Last Updated: 2021-06-11
Results Overview
Recurrence of diverticulitis is defined as the presence of each and all of the following 3 items: 1) abdominal pain, 2) a 15% increase in white blood cell count from baseline, 3) bowel wall thickening (\>5 mm) and/or fat stranding as evidenced by spiral computerized axial tomography (CT) scan; OR surgical intervention for diverticular disease. Withdrawals are considered as recurrences.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
592 participants
Primary outcome timeframe
up to 104 Weeks
Results posted on
2021-06-11
Participant Flow
Participant milestones
| Measure |
SPD476 (1.2 g)
1.2 g administered orally once daily
|
SPD476 (2.4 g)
2.4 g administered orally once daily
|
SPD476 (4.8 g)
4.8 g administered orally once daily
|
Placebo
Placebo administered orally once daily
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
148
|
148
|
150
|
146
|
|
Overall Study
COMPLETED
|
73
|
70
|
74
|
76
|
|
Overall Study
NOT COMPLETED
|
75
|
78
|
76
|
70
|
Reasons for withdrawal
| Measure |
SPD476 (1.2 g)
1.2 g administered orally once daily
|
SPD476 (2.4 g)
2.4 g administered orally once daily
|
SPD476 (4.8 g)
4.8 g administered orally once daily
|
Placebo
Placebo administered orally once daily
|
|---|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
48
|
45
|
31
|
27
|
|
Overall Study
Withdrawal by Subject
|
6
|
10
|
18
|
22
|
|
Overall Study
Adverse Event
|
11
|
12
|
17
|
10
|
|
Overall Study
Lost to Follow-up
|
4
|
6
|
3
|
4
|
|
Overall Study
Protocol Violation
|
1
|
2
|
3
|
0
|
|
Overall Study
Suspected recurrence of diverticulitis
|
1
|
0
|
0
|
3
|
|
Overall Study
Difficult to open package
|
0
|
0
|
0
|
1
|
|
Overall Study
Investigational product not taken
|
1
|
0
|
0
|
1
|
|
Overall Study
Wish to start a family
|
0
|
0
|
0
|
1
|
|
Overall Study
Diverticulitis crisis
|
0
|
0
|
0
|
1
|
|
Overall Study
Personal reasons
|
1
|
0
|
0
|
0
|
|
Overall Study
Subject's decision
|
1
|
0
|
0
|
0
|
|
Overall Study
Noncompliance
|
0
|
1
|
0
|
0
|
|
Overall Study
Investigator decision
|
0
|
0
|
1
|
0
|
|
Overall Study
Subject moved
|
0
|
1
|
0
|
0
|
|
Overall Study
Use of prohibited medication
|
0
|
0
|
1
|
0
|
|
Overall Study
Does not want to take study drug anymore
|
1
|
0
|
1
|
0
|
|
Overall Study
Subject met endpoint under protocol v. 1
|
0
|
0
|
1
|
0
|
|
Overall Study
Death
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Prevention of Recurrence of Diverticulitis
Baseline characteristics by cohort
| Measure |
SPD476 (1.2 g)
n=148 Participants
1.2 g administered orally once daily
|
SPD476 (2.4 g)
n=147 Participants
2.4 g administered orally once daily
|
SPD476 (4.8 g)
n=149 Participants
4.8 g administered orally once daily
|
Placebo
n=142 Participants
Placebo administered orally once daily
|
Total
n=586 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
57.8 years
STANDARD_DEVIATION 10.88 • n=5 Participants
|
54.2 years
STANDARD_DEVIATION 10.10 • n=7 Participants
|
56.7 years
STANDARD_DEVIATION 11.76 • n=5 Participants
|
55.7 years
STANDARD_DEVIATION 11.15 • n=4 Participants
|
56.1 years
STANDARD_DEVIATION 11.04 • n=21 Participants
|
|
Age, Customized
18 to < 35 years
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Age, Customized
35 to < 45 years
|
16 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
71 Participants
n=21 Participants
|
|
Age, Customized
45 to < 55 years
|
42 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
173 Participants
n=21 Participants
|
|
Age, Customized
55 to < 65 years
|
45 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
183 Participants
n=21 Participants
|
|
Age, Customized
>= 65 years
|
44 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
143 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
83 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
72 Participants
n=4 Participants
|
314 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
65 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
70 Participants
n=4 Participants
|
272 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
89 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
86 Participants
n=4 Participants
|
351 Participants
n=21 Participants
|
|
Region of Enrollment
Hungary
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Region of Enrollment
Canada
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Region of Enrollment
Finland
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Region of Enrollment
Brazil
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
|
Region of Enrollment
Romania
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
|
Region of Enrollment
South Africa
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
60 Participants
n=21 Participants
|
|
Region of Enrollment
Netherlands
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Region of Enrollment
Germany
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
|
Region of Enrollment
Italy
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: up to 104 WeeksPopulation: Full Analysis Set (FAS) consists of all subjects who were randomized and took at least 1 dose of investigational product.
Recurrence of diverticulitis is defined as the presence of each and all of the following 3 items: 1) abdominal pain, 2) a 15% increase in white blood cell count from baseline, 3) bowel wall thickening (\>5 mm) and/or fat stranding as evidenced by spiral computerized axial tomography (CT) scan; OR surgical intervention for diverticular disease. Withdrawals are considered as recurrences.
Outcome measures
| Measure |
SPD476 (1.2 g)
n=148 Participants
1.2 g administered orally once daily
|
SPD476 (2.4 g)
n=147 Participants
2.4 g administered orally once daily
|
SPD476 (4.8 g)
n=149 Participants
4.8 g administered orally once daily
|
Placebo
n=142 Participants
Placebo administered orally once daily
|
|---|---|---|---|---|
|
Percent of Subjects Without Recurrence of Diverticulitis
|
62.8 percentage of subjects
|
59.2 percentage of subjects
|
69.1 percentage of subjects
|
67.6 percentage of subjects
|
SECONDARY outcome
Timeframe: up to 104 weeksPopulation: Full Analysis Set
CT-recurrence of diverticulitis is defined as: a positive spiral CT scan for diverticulitis showing, at a minimum, fat stranding with or without bowel wall thickening \>5 mm or surgical intervention for diverticular disease. Withdrawals considered as CT-recurrences.
Outcome measures
| Measure |
SPD476 (1.2 g)
n=148 Participants
1.2 g administered orally once daily
|
SPD476 (2.4 g)
n=147 Participants
2.4 g administered orally once daily
|
SPD476 (4.8 g)
n=149 Participants
4.8 g administered orally once daily
|
Placebo
n=142 Participants
Placebo administered orally once daily
|
|---|---|---|---|---|
|
Percent of Subjects Who Are CT-Recurrence Free of Diverticulitis
|
62.8 percentage of subjects
|
59.2 percentage of subjects
|
69.1 percentage of subjects
|
66.9 percentage of subjects
|
SECONDARY outcome
Timeframe: up to 104 WeeksPopulation: Suspected Recurrence of Diverticulitis consists of subjects in the Full Analysis Set who had a CT scan performed. Since subjects may have had more than one suspected recurrence, counts are of the number of CT scans, not the number of subjects.
A positive CT scan was defined as a CT scan that showed bowel wall thickening (\>5 mm) and/or fat stranding as read by the central reader.
Outcome measures
| Measure |
SPD476 (1.2 g)
n=55 Participants
1.2 g administered orally once daily
|
SPD476 (2.4 g)
n=52 Participants
2.4 g administered orally once daily
|
SPD476 (4.8 g)
n=51 Participants
4.8 g administered orally once daily
|
Placebo
n=40 Participants
Placebo administered orally once daily
|
|---|---|---|---|---|
|
Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Positive
Positive
|
49 Number of CT Scans
|
45 Number of CT Scans
|
35 Number of CT Scans
|
30 Number of CT Scans
|
|
Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Positive
Presence of abdominal pain
|
48 Number of CT Scans
|
39 Number of CT Scans
|
34 Number of CT Scans
|
29 Number of CT Scans
|
|
Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Positive
15% increase in WBC from baseline
|
23 Number of CT Scans
|
24 Number of CT Scans
|
18 Number of CT Scans
|
11 Number of CT Scans
|
|
Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Positive
Abdominal pain + 15% increase in WBC
|
23 Number of CT Scans
|
22 Number of CT Scans
|
18 Number of CT Scans
|
11 Number of CT Scans
|
SECONDARY outcome
Timeframe: up to 104 weeksPopulation: Suspected Recurrence of Diverticulitis consists of subjects in the Full Analysis Set who had a CT scan performed. Since subjects may have had more than one suspected recurrence, counts are of the number of CT scans, not the number of subjects.
A negative CT scan was defined as a CT scan that did not show bowel wall thickening (\>5 mm) and/or fat stranding as read by the central reader.
Outcome measures
| Measure |
SPD476 (1.2 g)
n=55 Participants
1.2 g administered orally once daily
|
SPD476 (2.4 g)
n=52 Participants
2.4 g administered orally once daily
|
SPD476 (4.8 g)
n=51 Participants
4.8 g administered orally once daily
|
Placebo
n=40 Participants
Placebo administered orally once daily
|
|---|---|---|---|---|
|
Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Negative
Negative
|
9 Number of CT Scans
|
8 Number of CT Scans
|
22 Number of CT Scans
|
15 Number of CT Scans
|
|
Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Negative
Presence of abdominal pain
|
8 Number of CT Scans
|
6 Number of CT Scans
|
17 Number of CT Scans
|
12 Number of CT Scans
|
|
Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Negative
15% increase in WBC from Baseline
|
1 Number of CT Scans
|
2 Number of CT Scans
|
4 Number of CT Scans
|
4 Number of CT Scans
|
|
Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Negative
Abdominal pain + 15% increase in WBC
|
1 Number of CT Scans
|
2 Number of CT Scans
|
4 Number of CT Scans
|
3 Number of CT Scans
|
SECONDARY outcome
Timeframe: up to 104 weeksPopulation: Suspected Recurrence of Diverticulitis consists of subjects in the Full Analysis Set who had a CT scan performed. Since subjects may have had more than one suspected recurrence, counts are of the number of CT scans, not the number of subjects.
A positive CT scan was defined as a CT scan that showed bowel wall thickening (\>5 mm) and/or fat stranding as read by the central reader.
Outcome measures
| Measure |
SPD476 (1.2 g)
n=55 Participants
1.2 g administered orally once daily
|
SPD476 (2.4 g)
n=52 Participants
2.4 g administered orally once daily
|
SPD476 (4.8 g)
n=51 Participants
4.8 g administered orally once daily
|
Placebo
n=40 Participants
Placebo administered orally once daily
|
|---|---|---|---|---|
|
Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Positive
Positive
|
0 Number of CT Scans
|
0 Number of CT Scans
|
1 Number of CT Scans
|
1 Number of CT Scans
|
|
Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Positive
Presence of abdominal pain
|
0 Number of CT Scans
|
0 Number of CT Scans
|
0 Number of CT Scans
|
1 Number of CT Scans
|
|
Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Positive
15% increase in WBC from baseline
|
0 Number of CT Scans
|
0 Number of CT Scans
|
0 Number of CT Scans
|
0 Number of CT Scans
|
|
Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Positive
Abdominal pain + 15% increase in WBC
|
0 Number of CT Scans
|
0 Number of CT Scans
|
0 Number of CT Scans
|
0 Number of CT Scans
|
SECONDARY outcome
Timeframe: up to 104 weeksPopulation: Suspected Recurrence of Diverticulitis consists of subjects in the Full Analysis Set who had a CT scan performed. Since subjects may have had more than one suspected recurrence, counts are of the number of CT scans, not the number of subjects.
A negative CT scan was defined as a CT scan that did not show bowel wall thickening (\>5 mm) and/or fat stranding as read by the central reader.
Outcome measures
| Measure |
SPD476 (1.2 g)
n=55 Participants
1.2 g administered orally once daily
|
SPD476 (2.4 g)
n=52 Participants
2.4 g administered orally once daily
|
SPD476 (4.8 g)
n=51 Participants
4.8 g administered orally once daily
|
Placebo
n=40 Participants
Placebo administered orally once daily
|
|---|---|---|---|---|
|
Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Negative
Negative
|
1 Number of CT Scans
|
0 Number of CT Scans
|
0 Number of CT Scans
|
0 Number of CT Scans
|
|
Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Negative
Presence of abdominal pain
|
1 Number of CT Scans
|
0 Number of CT Scans
|
0 Number of CT Scans
|
0 Number of CT Scans
|
|
Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Negative
15% increase in WBC from baseline
|
0 Number of CT Scans
|
0 Number of CT Scans
|
0 Number of CT Scans
|
0 Number of CT Scans
|
|
Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Negative
Abdominal pain + 15% increase in WBC
|
0 Number of CT Scans
|
0 Number of CT Scans
|
0 Number of CT Scans
|
0 Number of CT Scans
|
SECONDARY outcome
Timeframe: up to 104 WeeksPopulation: Full Analysis Set
Outcome measures
| Measure |
SPD476 (1.2 g)
n=148 Participants
1.2 g administered orally once daily
|
SPD476 (2.4 g)
n=147 Participants
2.4 g administered orally once daily
|
SPD476 (4.8 g)
n=149 Participants
4.8 g administered orally once daily
|
Placebo
n=142 Participants
Placebo administered orally once daily
|
|---|---|---|---|---|
|
Percent of Subjects Requiring Surgery for Diverticulitis
|
4.7 percentage of subjects
|
2.7 percentage of subjects
|
2.0 percentage of subjects
|
1.4 percentage of subjects
|
Adverse Events
SPD476 (1.2 g)
Serious events: 9 serious events
Other events: 108 other events
Deaths: 0 deaths
SPD476 (2.4 g)
Serious events: 13 serious events
Other events: 111 other events
Deaths: 0 deaths
SPD476 (4.8 g)
Serious events: 14 serious events
Other events: 110 other events
Deaths: 0 deaths
Placebo
Serious events: 15 serious events
Other events: 105 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SPD476 (1.2 g)
n=148 participants at risk
1.2 g administered orally once daily
|
SPD476 (2.4 g)
n=147 participants at risk
2.4 g administered orally once daily
|
SPD476 (4.8 g)
n=149 participants at risk
4.8 g administered orally once daily
|
Placebo
n=142 participants at risk
Placebo administered orally once daily
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Agranulocytosis
|
0.00%
0/148
|
0.00%
0/147
|
0.67%
1/149
|
0.00%
0/142
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/148
|
0.68%
1/147
|
0.67%
1/149
|
0.70%
1/142
|
|
Cardiac disorders
Atrial fibrillation
|
0.68%
1/148
|
0.68%
1/147
|
0.00%
0/149
|
0.00%
0/142
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/148
|
0.00%
0/147
|
0.67%
1/149
|
0.00%
0/142
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/148
|
0.68%
1/147
|
0.00%
0/149
|
0.00%
0/142
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.68%
1/148
|
0.00%
0/147
|
0.00%
0/149
|
0.00%
0/142
|
|
Gastrointestinal disorders
Gastroesophogeal reflux disease
|
0.00%
0/148
|
0.00%
0/147
|
0.67%
1/149
|
0.00%
0/142
|
|
Gastrointestinal disorders
Small intestinal hemorrhage
|
0.00%
0/148
|
0.00%
0/147
|
0.67%
1/149
|
0.00%
0/142
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/148
|
0.68%
1/147
|
0.00%
0/149
|
0.70%
1/142
|
|
Gastrointestinal disorders
Gastrointestinal hemorrhage
|
0.00%
0/148
|
0.68%
1/147
|
0.00%
0/149
|
0.00%
0/142
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/148
|
0.68%
1/147
|
0.00%
0/149
|
0.00%
0/142
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/148
|
0.68%
1/147
|
0.00%
0/149
|
0.00%
0/142
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/148
|
0.68%
1/147
|
0.00%
0/149
|
0.00%
0/142
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/148
|
0.00%
0/147
|
0.00%
0/149
|
0.70%
1/142
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/148
|
0.00%
0/147
|
0.00%
0/149
|
0.70%
1/142
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/148
|
0.00%
0/147
|
0.00%
0/149
|
0.70%
1/142
|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
0.00%
0/148
|
0.00%
0/147
|
0.00%
0/149
|
0.70%
1/142
|
|
General disorders
Chest pain
|
0.00%
0/148
|
0.00%
0/147
|
1.3%
2/149
|
0.00%
0/142
|
|
General disorders
Multi-organ failure/Death
|
0.00%
0/148
|
0.68%
1/147
|
0.00%
0/149
|
0.00%
0/142
|
|
General disorders
Chest discomfort
|
0.68%
1/148
|
0.00%
0/147
|
0.00%
0/149
|
0.00%
0/142
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.00%
0/148
|
0.00%
0/147
|
0.67%
1/149
|
0.00%
0/142
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/148
|
0.00%
0/147
|
0.00%
0/149
|
0.70%
1/142
|
|
Infections and infestations
Pneumonia
|
0.68%
1/148
|
0.00%
0/147
|
0.67%
1/149
|
1.4%
2/142
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/148
|
0.00%
0/147
|
0.67%
1/149
|
0.00%
0/142
|
|
Infections and infestations
Appendicitis
|
0.00%
0/148
|
0.68%
1/147
|
0.00%
0/149
|
0.00%
0/142
|
|
Infections and infestations
Bronchitis
|
0.68%
1/148
|
0.00%
0/147
|
0.00%
0/149
|
0.00%
0/142
|
|
Infections and infestations
Peridiverticular abscess
|
0.68%
1/148
|
0.00%
0/147
|
0.00%
0/149
|
0.00%
0/142
|
|
Infections and infestations
Pharyngitis
|
0.68%
1/148
|
0.00%
0/147
|
0.00%
0/149
|
0.00%
0/142
|
|
Infections and infestations
Borrelia infection
|
0.00%
0/148
|
0.00%
0/147
|
0.00%
0/149
|
0.70%
1/142
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/148
|
0.00%
0/147
|
0.00%
0/149
|
0.70%
1/142
|
|
Infections and infestations
Viral pericarditis
|
0.00%
0/148
|
0.00%
0/147
|
0.00%
0/149
|
0.70%
1/142
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/148
|
0.00%
0/147
|
0.67%
1/149
|
0.00%
0/142
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/148
|
0.68%
1/147
|
0.00%
0/149
|
0.00%
0/142
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.00%
0/148
|
0.68%
1/147
|
0.00%
0/149
|
0.00%
0/142
|
|
Injury, poisoning and procedural complications
Post procedural edema
|
0.00%
0/148
|
0.68%
1/147
|
0.00%
0/149
|
0.00%
0/142
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/148
|
0.68%
1/147
|
0.00%
0/149
|
0.00%
0/142
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.68%
1/148
|
0.00%
0/147
|
0.00%
0/149
|
0.00%
0/142
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/148
|
0.00%
0/147
|
0.67%
1/149
|
0.00%
0/142
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/148
|
0.68%
1/147
|
0.00%
0/149
|
0.00%
0/142
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/148
|
0.00%
0/147
|
0.00%
0/149
|
0.70%
1/142
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/148
|
0.00%
0/147
|
0.00%
0/149
|
0.70%
1/142
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/148
|
0.00%
0/147
|
0.00%
0/149
|
0.70%
1/142
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian granulosa-theca cell tumor
|
0.00%
0/148
|
0.00%
0/147
|
0.67%
1/149
|
0.00%
0/142
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/148
|
0.00%
0/147
|
0.67%
1/149
|
0.00%
0/142
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/148
|
0.00%
0/147
|
0.67%
1/149
|
0.00%
0/142
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/148
|
0.68%
1/147
|
0.00%
0/149
|
0.00%
0/142
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cardiac neoplasm unspecified
|
0.00%
0/148
|
0.68%
1/147
|
0.00%
0/149
|
0.00%
0/142
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/148
|
0.68%
1/147
|
0.00%
0/149
|
0.00%
0/142
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/148
|
0.00%
0/147
|
0.00%
0/149
|
0.70%
1/142
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/148
|
1.4%
2/147
|
0.00%
0/149
|
0.00%
0/142
|
|
Nervous system disorders
Syncope
|
0.00%
0/148
|
0.00%
0/147
|
0.67%
1/149
|
0.00%
0/142
|
|
Nervous system disorders
Transient ischemic attack
|
0.68%
1/148
|
0.00%
0/147
|
0.00%
0/149
|
0.00%
0/142
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/148
|
0.00%
0/147
|
0.00%
0/149
|
0.70%
1/142
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/148
|
0.00%
0/147
|
0.67%
1/149
|
0.00%
0/142
|
|
Reproductive system and breast disorders
Uterovaginal prolapse
|
0.68%
1/148
|
0.00%
0/147
|
0.00%
0/149
|
0.00%
0/142
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.68%
1/148
|
0.00%
0/147
|
0.00%
0/149
|
0.70%
1/142
|
|
Vascular disorders
Hypotension
|
0.00%
0/148
|
0.68%
1/147
|
0.00%
0/149
|
0.00%
0/142
|
|
Vascular disorders
Intra-abdominal hemorrhage
|
0.00%
0/148
|
0.68%
1/147
|
0.00%
0/149
|
0.00%
0/142
|
|
Vascular disorders
Femoral arterial stenosis
|
0.00%
0/148
|
0.00%
0/147
|
0.00%
0/149
|
0.70%
1/142
|
|
Vascular disorders
Hemorrhage
|
0.00%
0/148
|
0.00%
0/147
|
0.00%
0/149
|
0.70%
1/142
|
|
Vascular disorders
Hypertension
|
0.00%
0/148
|
0.00%
0/147
|
0.00%
0/149
|
0.70%
1/142
|
|
Vascular disorders
Thrombosis
|
0.00%
0/148
|
0.00%
0/147
|
0.00%
0/149
|
0.70%
1/142
|
Other adverse events
| Measure |
SPD476 (1.2 g)
n=148 participants at risk
1.2 g administered orally once daily
|
SPD476 (2.4 g)
n=147 participants at risk
2.4 g administered orally once daily
|
SPD476 (4.8 g)
n=149 participants at risk
4.8 g administered orally once daily
|
Placebo
n=142 participants at risk
Placebo administered orally once daily
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
12.8%
19/148
|
12.9%
19/147
|
10.1%
15/149
|
8.5%
12/142
|
|
Gastrointestinal disorders
Diarrhea
|
10.1%
15/148
|
10.2%
15/147
|
12.1%
18/149
|
8.5%
12/142
|
|
Gastrointestinal disorders
Nausea
|
3.4%
5/148
|
5.4%
8/147
|
6.7%
10/149
|
7.7%
11/142
|
|
Gastrointestinal disorders
Dyspepsia
|
3.4%
5/148
|
7.5%
11/147
|
4.0%
6/149
|
4.2%
6/142
|
|
Gastrointestinal disorders
Constipation
|
6.1%
9/148
|
4.1%
6/147
|
4.0%
6/149
|
8.5%
12/142
|
|
Gastrointestinal disorders
Abdominal pain lower
|
3.4%
5/148
|
1.4%
2/147
|
6.7%
10/149
|
4.9%
7/142
|
|
Infections and infestations
Urinary tract infection
|
7.4%
11/148
|
9.5%
14/147
|
6.7%
10/149
|
4.9%
7/142
|
|
Infections and infestations
Sinusitis
|
8.1%
12/148
|
5.4%
8/147
|
6.7%
10/149
|
7.7%
11/142
|
|
Infections and infestations
Influenza
|
7.4%
11/148
|
5.4%
8/147
|
6.0%
9/149
|
7.7%
11/142
|
|
Infections and infestations
Bronchitis
|
5.4%
8/148
|
4.8%
7/147
|
6.0%
9/149
|
4.9%
7/142
|
|
Infections and infestations
Nasopharyngitis
|
3.4%
5/148
|
6.8%
10/147
|
5.4%
8/149
|
6.3%
9/142
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.8%
10/148
|
7.5%
11/147
|
7.4%
11/149
|
8.5%
12/142
|
|
Nervous system disorders
Headache
|
9.5%
14/148
|
6.8%
10/147
|
9.4%
14/149
|
9.2%
13/142
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.1%
9/148
|
2.0%
3/147
|
2.7%
4/149
|
1.4%
2/142
|
|
Vascular disorders
Hypertension
|
4.1%
6/148
|
5.4%
8/147
|
1.3%
2/149
|
5.6%
8/142
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
- Publication restrictions are in place
Restriction type: OTHER