Trial Outcomes & Findings for Prevention of Recurrence of Diverticulitis (NCT NCT00545740)
NCT ID: NCT00545740
Last Updated: 2021-06-14
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
590 participants
Primary outcome timeframe
Up to 104 weeks
Results posted on
2021-06-14
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
|
145
|
145
|
151
|
149
|
|
Overall Study
COMPLETED
|
70
|
62
|
55
|
78
|
|
Overall Study
NOT COMPLETED
|
75
|
83
|
96
|
71
|
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
|
34
|
35
|
47
|
36
|
|
Overall Study
Withdrawal by Subject
|
17
|
15
|
16
|
18
|
|
Overall Study
Adverse Event
|
10
|
18
|
19
|
9
|
|
Overall Study
Lost to Follow-up
|
7
|
5
|
5
|
6
|
|
Overall Study
Protocol Violation
|
1
|
3
|
1
|
0
|
|
Overall Study
Non-compliance
|
0
|
2
|
1
|
0
|
|
Overall Study
Moved
|
2
|
0
|
1
|
0
|
|
Overall Study
Diverticulitis attack
|
0
|
0
|
1
|
1
|
|
Overall Study
Suspected Diverticulitis Recurrence
|
1
|
1
|
1
|
1
|
|
Overall Study
Site closure
|
1
|
0
|
0
|
0
|
|
Overall Study
Missed visit
|
1
|
0
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
3
|
0
|
|
Overall Study
Accepted only monthly telephone calls
|
1
|
0
|
0
|
0
|
|
Overall Study
Sponsor decision
|
0
|
1
|
0
|
0
|
|
Overall Study
Lack of time
|
0
|
1
|
0
|
0
|
|
Overall Study
Non-adherence to visits
|
0
|
1
|
0
|
0
|
|
Overall Study
Patient difficulties
|
0
|
1
|
0
|
0
|
|
Overall Study
Husband against study
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Prevention of Recurrence of Diverticulitis
Baseline characteristics by cohort
| Measure |
SPD476 (1.2 g)
n=145 Participants
1.2 g administered orally once daily
|
SPD476 (2.4 g)
n=145 Participants
2.4 g administered orally once daily
|
SPD476 (4.8 g)
n=151 Participants
4.8 g administered orally once daily
|
Placebo
n=149 Participants
Placebo administered orally once daily
|
Total
n=590 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
55.1 years
STANDARD_DEVIATION 11.11 • n=5 Participants
|
54.5 years
STANDARD_DEVIATION 11.96 • n=7 Participants
|
54.5 years
STANDARD_DEVIATION 11.93 • n=5 Participants
|
57.1 years
STANDARD_DEVIATION 10.42 • n=4 Participants
|
55.3 years
STANDARD_DEVIATION 11.39 • n=21 Participants
|
|
Age, Customized
18 to <35 years
|
3 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
|
Age, Customized
35 to <45 years
|
20 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
77 Participants
n=21 Participants
|
|
Age, Customized
45 to <55 years
|
49 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
161 Participants
n=21 Participants
|
|
Age, Customized
55 to <65 years
|
43 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
202 Participants
n=21 Participants
|
|
Age, Customized
>= 65 years
|
28 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
118 Participants
n=21 Participants
|
|
Sex/Gender, Customized
Female
|
64 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
71 Participants
n=4 Participants
|
275 Participants
n=21 Participants
|
|
Sex/Gender, Customized
Male
|
79 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
76 Participants
n=4 Participants
|
308 Participants
n=21 Participants
|
|
Region of Enrollment
Argentina
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Region of Enrollment
Australia
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Region of Enrollment
Colombia
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
74 Participants
n=21 Participants
|
|
Region of Enrollment
France
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Region of Enrollment
India
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Region of Enrollment
Israel
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
95 Participants
n=21 Participants
|
|
Region of Enrollment
New Zealand
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Region of Enrollment
Spain
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Region of Enrollment
Sweden
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
38 Participants
n=21 Participants
|
|
Region of Enrollment
United Kingdom
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
69 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
69 Participants
n=4 Participants
|
277 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=143 Participants
1.2 g administered orally once daily
|
SPD476 (2.4 g)
n=143 Participants
2.4 g administered orally once daily
|
SPD476 (4.8 g)
n=150 Participants
4.8 g administered orally once daily
|
Placebo
n=147 Participants
Placebo administered orally once daily
|
|---|---|---|---|---|
|
Percent of Subjects Without Recurrence of Diverticulitis
|
62.2 percentage of subjects
|
62.9 percentage of subjects
|
52.7 percentage of subjects
|
64.6 percentage of subjects
|
SECONDARY 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.
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=143 Participants
1.2 g administered orally once daily
|
SPD476 (2.4 g)
n=143 Participants
2.4 g administered orally once daily
|
SPD476 (4.8 g)
n=150 Participants
4.8 g administered orally once daily
|
Placebo
n=147 Participants
Placebo administered orally once daily
|
|---|---|---|---|---|
|
Percent of Subjects Who Were CT-Recurrence Free of Diverticulitis
|
61.5 percentage of subjects
|
62.2 percentage of subjects
|
52.7 percentage of subjects
|
63.9 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=52 Participants
1.2 g administered orally once daily
|
SPD476 (2.4 g)
n=49 Participants
2.4 g administered orally once daily
|
SPD476 (4.8 g)
n=55 Participants
4.8 g administered orally once daily
|
Placebo
n=46 Participants
Placebo administered orally once daily
|
|---|---|---|---|---|
|
Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Positive
Presence in abdominal pain + 15% increase in WBC
|
17 Number of CT scans
|
24 Number of CT scans
|
28 Number of CT scans
|
23 Number of CT scans
|
|
Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Positive
Positive
|
37 Number of CT scans
|
39 Number of CT scans
|
55 Number of CT scans
|
38 Number of CT scans
|
|
Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Positive
Presence of abdominal pain
|
30 Number of CT scans
|
39 Number of CT scans
|
54 Number of CT scans
|
37 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
|
17 Number of CT scans
|
24 Number of CT scans
|
28 Number of CT scans
|
24 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=52 Participants
1.2 g administered orally once daily
|
SPD476 (2.4 g)
n=49 Participants
2.4 g administered orally once daily
|
SPD476 (4.8 g)
n=55 Participants
4.8 g administered orally once daily
|
Placebo
n=46 Participants
Placebo administered orally once daily
|
|---|---|---|---|---|
|
Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Negative
Negative
|
19 Number of CT scans
|
10 Number of CT scans
|
5 Number of CT scans
|
10 Number of CT scans
|
|
Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Negative
Presence of abdominal pain
|
19 Number of CT scans
|
8 Number of CT scans
|
5 Number of CT scans
|
7 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
|
5 Number of CT scans
|
2 Number of CT scans
|
2 Number of CT scans
|
1 Number of CT scans
|
|
Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Negative
Presence in abdominal pain + 15% increase in WBC
|
5 Number of CT scans
|
2 Number of CT scans
|
2 Number of CT scans
|
1 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=52 Participants
1.2 g administered orally once daily
|
SPD476 (2.4 g)
n=49 Participants
2.4 g administered orally once daily
|
SPD476 (4.8 g)
n=55 Participants
4.8 g administered orally once daily
|
Placebo
n=46 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
|
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
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
Presence of 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=52 Participants
1.2 g administered orally once daily
|
SPD476 (2.4 g)
n=49 Participants
2.4 g administered orally once daily
|
SPD476 (4.8 g)
n=55 Participants
4.8 g administered orally once daily
|
Placebo
n=46 Participants
Placebo administered orally once daily
|
|---|---|---|---|---|
|
Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Negative
Presence of abdominal pain + 15% increase in WBC
|
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 Negative
Negative
|
0 Number of CT scans
|
3 Number of CT scans
|
2 Number of CT scans
|
3 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
|
0 Number of CT scans
|
2 Number of CT scans
|
2 Number of CT scans
|
3 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
|
1 Number of CT scans
|
0 Number of CT scans
|
1 Number of CT scans
|
SECONDARY outcome
Timeframe: Up to 104 weeksPopulation: Full Analysis Set consists of all subjects who were randomized and took at least 1 dose of investigational product.
Outcome measures
| Measure |
SPD476 (1.2 g)
n=143 Participants
1.2 g administered orally once daily
|
SPD476 (2.4 g)
n=143 Participants
2.4 g administered orally once daily
|
SPD476 (4.8 g)
n=150 Participants
4.8 g administered orally once daily
|
Placebo
n=147 Participants
Placebo administered orally once daily
|
|---|---|---|---|---|
|
Percent of Subjects Requiring Surgery for Diverticulitis
|
2.8 percentage of subjects
|
2.8 percentage of subjects
|
3.3 percentage of subjects
|
2.0 percentage of subjects
|
Adverse Events
SPD476 (1.2 g)
Serious events: 16 serious events
Other events: 109 other events
Deaths: 0 deaths
SPD476 (2.4 g)
Serious events: 15 serious events
Other events: 106 other events
Deaths: 0 deaths
SPD476 (4.8 g)
Serious events: 18 serious events
Other events: 101 other events
Deaths: 0 deaths
Placebo
Serious events: 16 serious events
Other events: 112 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SPD476 (1.2 g)
n=143 participants at risk
1.2 g administered orally once daily
|
SPD476 (2.4 g)
n=143 participants at risk
2.4 g administered orally once daily
|
SPD476 (4.8 g)
n=150 participants at risk
4.8 g administered orally once daily
|
Placebo
n=147 participants at risk
Placebo administered orally once daily
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anemia
|
0.00%
0/143
|
0.70%
1/143
|
0.00%
0/150
|
0.00%
0/147
|
|
Cardiac disorders
Angina pectoris
|
1.4%
2/143
|
0.70%
1/143
|
0.67%
1/150
|
0.00%
0/147
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/143
|
0.70%
1/143
|
0.00%
0/150
|
0.00%
0/147
|
|
Cardiac disorders
Myocardial ischemia
|
0.00%
0/143
|
0.70%
1/143
|
0.00%
0/150
|
0.00%
0/147
|
|
Cardiac disorders
Acute myocarcial infarction
|
0.70%
1/143
|
0.00%
0/143
|
0.00%
0/150
|
1.4%
2/147
|
|
Cardiac disorders
Coronary artery insufficiency
|
0.70%
1/143
|
0.00%
0/143
|
0.00%
0/150
|
0.68%
1/147
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/143
|
0.00%
0/143
|
0.00%
0/150
|
0.68%
1/147
|
|
Endocrine disorders
Autoimmune thyroiditis
|
0.00%
0/143
|
0.00%
0/143
|
0.00%
0/150
|
0.68%
1/147
|
|
Eye disorders
Retinal detachment
|
0.00%
0/143
|
0.00%
0/143
|
0.00%
0/150
|
0.68%
1/147
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/143
|
0.00%
0/143
|
0.67%
1/150
|
0.00%
0/147
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/143
|
0.00%
0/143
|
0.67%
1/150
|
0.00%
0/147
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/143
|
0.00%
0/143
|
0.67%
1/150
|
0.00%
0/147
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/143
|
0.00%
0/143
|
0.67%
1/150
|
0.00%
0/147
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.00%
0/143
|
0.70%
1/143
|
0.00%
0/150
|
0.00%
0/147
|
|
Gastrointestinal disorders
Gastrointestinal hemorrhage
|
0.00%
0/143
|
0.70%
1/143
|
0.00%
0/150
|
0.00%
0/147
|
|
Gastrointestinal disorders
Abdominal pain
|
0.70%
1/143
|
0.00%
0/143
|
0.00%
0/150
|
1.4%
2/147
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.70%
1/143
|
0.00%
0/143
|
0.00%
0/150
|
0.00%
0/147
|
|
Gastrointestinal disorders
Peritoneal hematoma
|
0.70%
1/143
|
0.00%
0/143
|
0.00%
0/150
|
0.00%
0/147
|
|
General disorders
Pyrexia
|
0.00%
0/143
|
0.00%
0/143
|
0.67%
1/150
|
0.00%
0/147
|
|
General disorders
Chills
|
0.00%
0/143
|
0.70%
1/143
|
0.00%
0/150
|
0.00%
0/147
|
|
General disorders
Non-cardiac chest pain
|
0.70%
1/143
|
0.00%
0/143
|
0.00%
0/150
|
0.00%
0/147
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/143
|
0.00%
0/143
|
1.3%
2/150
|
0.00%
0/147
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/143
|
0.70%
1/143
|
0.67%
1/150
|
0.00%
0/147
|
|
Infections and infestations
Sepsis
|
0.70%
1/143
|
0.00%
0/143
|
0.67%
1/150
|
0.00%
0/147
|
|
Infections and infestations
Clostridial infection
|
0.00%
0/143
|
0.00%
0/143
|
0.67%
1/150
|
0.00%
0/147
|
|
Infections and infestations
Kidney infection
|
0.00%
0/143
|
0.00%
0/143
|
0.67%
1/150
|
0.00%
0/147
|
|
Infections and infestations
Pneumonia primary atypical
|
0.00%
0/143
|
0.00%
0/143
|
0.67%
1/150
|
0.00%
0/147
|
|
Infections and infestations
Viral infection
|
0.00%
0/143
|
0.00%
0/143
|
0.67%
1/150
|
0.00%
0/147
|
|
Infections and infestations
Cellulitis
|
0.00%
0/143
|
0.70%
1/143
|
0.00%
0/150
|
0.00%
0/147
|
|
Infections and infestations
Pneumonia
|
0.70%
1/143
|
0.00%
0/143
|
0.00%
0/150
|
0.68%
1/147
|
|
Infections and infestations
Endophthalmitis
|
0.00%
0/143
|
0.00%
0/143
|
0.00%
0/150
|
0.68%
1/147
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/143
|
0.00%
0/143
|
0.00%
0/150
|
0.68%
1/147
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
1.4%
2/143
|
0.00%
0/143
|
0.00%
0/150
|
0.00%
0/147
|
|
Injury, poisoning and procedural complications
Near drowning
|
0.00%
0/143
|
0.00%
0/143
|
0.67%
1/150
|
0.00%
0/147
|
|
Injury, poisoning and procedural complications
Concussion
|
0.70%
1/143
|
0.00%
0/143
|
0.00%
0/150
|
0.00%
0/147
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.70%
1/143
|
0.00%
0/143
|
0.00%
0/150
|
0.00%
0/147
|
|
Injury, poisoning and procedural complications
Skin injury
|
0.70%
1/143
|
0.00%
0/143
|
0.00%
0/150
|
0.00%
0/147
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/143
|
0.00%
0/143
|
0.00%
0/150
|
0.68%
1/147
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/143
|
0.00%
0/143
|
0.00%
0/150
|
0.68%
1/147
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.70%
1/143
|
0.00%
0/143
|
0.00%
0/150
|
0.00%
0/147
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
1.4%
2/143
|
0.00%
0/143
|
0.00%
0/150
|
0.00%
0/147
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/143
|
0.00%
0/143
|
0.67%
1/150
|
0.00%
0/147
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/143
|
0.70%
1/143
|
0.00%
0/150
|
0.00%
0/147
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.70%
1/143
|
0.00%
0/143
|
0.00%
0/150
|
0.00%
0/147
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer in situ
|
0.00%
0/143
|
0.00%
0/143
|
0.00%
0/150
|
0.68%
1/147
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.00%
0/143
|
0.00%
0/143
|
0.00%
0/150
|
0.68%
1/147
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/143
|
0.00%
0/143
|
0.00%
0/150
|
0.68%
1/147
|
|
Nervous system disorders
Ischemic stroke
|
0.00%
0/143
|
0.70%
1/143
|
0.00%
0/150
|
0.00%
0/147
|
|
Nervous system disorders
Movement disorder
|
0.00%
0/143
|
0.70%
1/143
|
0.00%
0/150
|
0.00%
0/147
|
|
Nervous system disorders
Syncope
|
0.00%
0/143
|
0.70%
1/143
|
0.00%
0/150
|
0.00%
0/147
|
|
Nervous system disorders
Cerebral ischemia
|
0.00%
0/143
|
0.00%
0/143
|
0.00%
0/150
|
0.68%
1/147
|
|
Psychiatric disorders
Alcoholism
|
0.00%
0/143
|
0.00%
0/143
|
0.67%
1/150
|
0.00%
0/147
|
|
Psychiatric disorders
Bipolar II disorder
|
0.00%
0/143
|
0.00%
0/143
|
0.67%
1/150
|
0.00%
0/147
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/143
|
0.70%
1/143
|
0.00%
0/150
|
0.00%
0/147
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/143
|
0.00%
0/143
|
0.00%
0/150
|
0.68%
1/147
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/143
|
0.00%
0/143
|
0.67%
1/150
|
0.00%
0/147
|
|
Renal and urinary disorders
Pelvi-ureteric obstruction
|
0.00%
0/143
|
0.00%
0/143
|
0.67%
1/150
|
0.00%
0/147
|
|
Renal and urinary disorders
Bladder prolapse
|
0.00%
0/143
|
0.70%
1/143
|
0.00%
0/150
|
0.00%
0/147
|
|
Renal and urinary disorders
Renal colic
|
0.70%
1/143
|
0.00%
0/143
|
0.00%
0/150
|
0.00%
0/147
|
|
Renal and urinary disorders
Renal failure acute
|
0.70%
1/143
|
0.00%
0/143
|
0.00%
0/150
|
0.00%
0/147
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.00%
0/143
|
0.00%
0/143
|
0.00%
0/150
|
0.68%
1/147
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/143
|
0.70%
1/143
|
0.00%
0/150
|
0.00%
0/147
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/143
|
0.00%
0/143
|
0.00%
0/150
|
0.68%
1/147
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.70%
1/143
|
0.00%
0/143
|
0.67%
1/150
|
0.00%
0/147
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.00%
0/143
|
0.70%
1/143
|
0.00%
0/150
|
0.00%
0/147
|
|
Respiratory, thoracic and mediastinal disorders
Sinus polyp
|
0.00%
0/143
|
0.70%
1/143
|
0.00%
0/150
|
0.00%
0/147
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.70%
1/143
|
0.00%
0/143
|
0.00%
0/150
|
0.00%
0/147
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/143
|
0.00%
0/143
|
0.00%
0/150
|
0.68%
1/147
|
|
Vascular disorders
Aortic Aneurysm
|
0.00%
0/143
|
0.00%
0/143
|
0.00%
0/150
|
0.68%
1/147
|
|
Vascular disorders
Hypertension
|
0.00%
0/143
|
0.00%
0/143
|
0.00%
0/150
|
0.68%
1/147
|
Other adverse events
| Measure |
SPD476 (1.2 g)
n=143 participants at risk
1.2 g administered orally once daily
|
SPD476 (2.4 g)
n=143 participants at risk
2.4 g administered orally once daily
|
SPD476 (4.8 g)
n=150 participants at risk
4.8 g administered orally once daily
|
Placebo
n=147 participants at risk
Placebo administered orally once daily
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
11.9%
17/143
|
11.2%
16/143
|
12.0%
18/150
|
10.9%
16/147
|
|
Gastrointestinal disorders
Diarrhea
|
9.1%
13/143
|
8.4%
12/143
|
8.0%
12/150
|
8.2%
12/147
|
|
General disorders
Nausea
|
7.0%
10/143
|
0.70%
1/143
|
4.0%
6/150
|
3.4%
5/147
|
|
Gastrointestinal disorders
Flatulence
|
6.3%
9/143
|
3.5%
5/143
|
2.0%
3/150
|
2.7%
4/147
|
|
Gastrointestinal disorders
Constpation
|
4.9%
7/143
|
2.1%
3/143
|
3.3%
5/150
|
5.4%
8/147
|
|
Infections and infestations
Urinary tract infection
|
9.8%
14/143
|
8.4%
12/143
|
5.3%
8/150
|
11.6%
17/147
|
|
Infections and infestations
Nasopharyngitis
|
4.2%
6/143
|
10.5%
15/143
|
4.7%
7/150
|
8.8%
13/147
|
|
Infections and infestations
Upper respiratory tract infection
|
6.3%
9/143
|
2.1%
3/143
|
6.7%
10/150
|
9.5%
14/147
|
|
Infections and infestations
Sinusitis
|
6.3%
9/143
|
4.9%
7/143
|
3.3%
5/150
|
5.4%
8/147
|
|
Infections and infestations
Influenza
|
3.5%
5/143
|
7.7%
11/143
|
2.7%
4/150
|
2.0%
3/147
|
|
Infections and infestations
Bronchitis
|
4.9%
7/143
|
5.6%
8/143
|
2.0%
3/150
|
2.0%
3/147
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.6%
8/143
|
3.5%
5/143
|
5.3%
8/150
|
8.2%
12/147
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.9%
7/143
|
3.5%
5/143
|
2.7%
4/150
|
8.8%
13/147
|
|
Nervous system disorders
Headache
|
9.1%
13/143
|
4.2%
6/143
|
9.3%
14/150
|
6.8%
10/147
|
|
Vascular disorders
Hypertension
|
3.5%
5/143
|
5.6%
8/143
|
4.0%
6/150
|
0.68%
1/147
|
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