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Prevention of Recurrence of Diverticulitis (PREVENT1)

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ClinicalTrials.gov Identifier: NCT00545740
Recruitment Status : Completed
First Posted : October 17, 2007
Results First Posted : January 25, 2013
Last Update Posted : June 14, 2021
Sponsor:
Information provided by (Responsible Party):
Takeda ( Shire )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Diverticulitis
Interventions Drug: SPD476 (1.2g)
Drug: SPD476 (2.4 g)
Drug: SPD476 (4.8 g)
Drug: Placebo
Enrollment 590
Recruitment Details  
Pre-assignment Details  
Arm/Group Title SPD476 (1.2 g) SPD476 (2.4 g) SPD476 (4.8 g) Placebo
Hide Arm/Group Description 1.2 g administered orally once daily 2.4 g administered orally once daily 4.8 g administered orally once daily Placebo administered orally once daily
Period Title: Overall Study
Started 145 145 151 149
Completed 70 62 55 78
Not Completed 75 83 96 71
Reason Not Completed
Lack of Efficacy             34             35             47             36
Withdrawal by Subject             17             15             16             18
Adverse Event             10             18             19             9
Lost to Follow-up             7             5             5             6
Protocol Violation             1             3             1             0
Non-compliance             0             2             1             0
Moved             2             0             1             0
Diverticulitis attack             0             0             1             1
Suspected Diverticulitis Recurrence             1             1             1             1
Site closure             1             0             0             0
Missed visit             1             0             0             0
Physician Decision             0             0             3             0
Accepted only monthly telephone calls             1             0             0             0
Sponsor decision             0             1             0             0
Lack of time             0             1             0             0
Non-adherence to visits             0             1             0             0
Patient difficulties             0             1             0             0
Husband against study             0             0             1             0
Arm/Group Title SPD476 (1.2 g) SPD476 (2.4 g) SPD476 (4.8 g) Placebo Total
Hide Arm/Group Description 1.2 g administered orally once daily 2.4 g administered orally once daily 4.8 g administered orally once daily Placebo administered orally once daily Total of all reporting groups
Overall Number of Baseline Participants 145 145 151 149 590
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 145 participants 145 participants 151 participants 149 participants 590 participants
55.1  (11.11) 54.5  (11.96) 54.5  (11.93) 57.1  (10.42) 55.3  (11.39)
[1]
Measure Description: The Safety Population was used for this baseline measure. The Safety Population consists of subjects who were randomized and took at least 1 dose of investigational product. Out of the 590 subjects randomized, 7 were never dosed with investigational product. Therefore, 583 subjects are in the Safety Population.
Age, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 145 participants 145 participants 151 participants 149 participants 590 participants
18 to <35 years
3
   2.1%
11
   7.6%
8
   5.3%
3
   2.0%
25
   4.2%
35 to <45 years
20
  13.8%
17
  11.7%
26
  17.2%
14
   9.4%
77
  13.1%
45 to <55 years
49
  33.8%
39
  26.9%
36
  23.8%
37
  24.8%
161
  27.3%
55 to <65 years
43
  29.7%
46
  31.7%
51
  33.8%
62
  41.6%
202
  34.2%
>= 65 years
28
  19.3%
30
  20.7%
29
  19.2%
31
  20.8%
118
  20.0%
[1]
Measure Description: The Safety Population was used for this baseline measure. The Safety Population consists of subjects who were randomized and took at least 1 dose of investigational product. Out of the 590 subjects randomized, 7 were never dosed with investigational product. Therefore, 583 subjects are in the Safety Population.
Sex/Gender, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 145 participants 145 participants 151 participants 149 participants 590 participants
Female
64
  44.1%
69
  47.6%
71
  47.0%
71
  47.7%
275
  46.6%
Male
79
  54.5%
74
  51.0%
79
  52.3%
76
  51.0%
308
  52.2%
[1]
Measure Description: The Safety Population was used for this baseline measure. The Safety Population consists of subjects who were randomized and took at least 1 dose of investigational product. Out of the 590 subjects randomized, 7 were never dosed with investigational product. Therefore, 583 subjects are in the Safety Population.
Region of Enrollment   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 145 participants 145 participants 151 participants 149 participants 590 participants
Argentina
5
   3.4%
3
   2.1%
4
   2.6%
3
   2.0%
15
   2.5%
Australia
3
   2.1%
5
   3.4%
6
   4.0%
5
   3.4%
19
   3.2%
Colombia
19
  13.1%
18
  12.4%
18
  11.9%
19
  12.8%
74
  12.5%
France
5
   3.4%
6
   4.1%
6
   4.0%
6
   4.0%
23
   3.9%
India
4
   2.8%
2
   1.4%
3
   2.0%
4
   2.7%
13
   2.2%
Israel
24
  16.6%
24
  16.6%
23
  15.2%
24
  16.1%
95
  16.1%
New Zealand
3
   2.1%
4
   2.8%
4
   2.6%
4
   2.7%
15
   2.5%
Spain
1
   0.7%
1
   0.7%
4
   2.6%
2
   1.3%
8
   1.4%
Sweden
9
   6.2%
9
   6.2%
11
   7.3%
9
   6.0%
38
   6.4%
United Kingdom
3
   2.1%
3
   2.1%
3
   2.0%
4
   2.7%
13
   2.2%
United States
69
  47.6%
70
  48.3%
69
  45.7%
69
  46.3%
277
  46.9%
[1]
Measure Description: This baseline measure consists of all randomized subjects (n = 590).
1.Primary Outcome
Title Percent of Subjects Without Recurrence of Diverticulitis
Hide Description 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.
Time Frame Up to 104 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) consists of all subjects who were randomized and took at least 1 dose of investigational product.
Arm/Group Title SPD476 (1.2 g) SPD476 (2.4 g) SPD476 (4.8 g) Placebo
Hide Arm/Group Description:
1.2 g administered orally once daily
2.4 g administered orally once daily
4.8 g administered orally once daily
Placebo administered orally once daily
Overall Number of Participants Analyzed 143 143 150 147
Measure Type: Number
Unit of Measure: percentage of subjects
62.2 62.9 52.7 64.6
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SPD476 (4.8 g), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.047
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection SPD476 (2.4 g), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.741
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection SPD476 (1.2 g), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.780
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
2.Secondary Outcome
Title Percent of Subjects Who Were CT-Recurrence Free of Diverticulitis
Hide Description 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.
Time Frame Up to 104 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) consists of all subjects who were randomized and took at least 1 dose of investigational product.
Arm/Group Title SPD476 (1.2 g) SPD476 (2.4 g) SPD476 (4.8 g) Placebo
Hide Arm/Group Description:
1.2 g administered orally once daily
2.4 g administered orally once daily
4.8 g administered orally once daily
Placebo administered orally once daily
Overall Number of Participants Analyzed 143 143 150 147
Measure Type: Number
Unit of Measure: percentage of subjects
61.5 62.2 52.7 63.9
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SPD476 (4.8 g), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.063
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection SPD476 (2.4 g), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.736
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection SPD476 (1.2 g), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.780
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
3.Secondary Outcome
Title Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Positive
Hide Description 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.
Time Frame Up to 104 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title SPD476 (1.2 g) SPD476 (2.4 g) SPD476 (4.8 g) Placebo
Hide Arm/Group Description:
1.2 g administered orally once daily
2.4 g administered orally once daily
4.8 g administered orally once daily
Placebo administered orally once daily
Overall Number of Participants Analyzed 52 49 55 46
Measure Type: Number
Unit of Measure: Number of CT scans
Positive 37 39 55 38
Presence of abdominal pain 30 39 54 37
15% increase in WBC from baseline 17 24 28 24
Presence in abdominal pain + 15% increase in WBC 17 24 28 23
4.Secondary Outcome
Title Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Negative
Hide Description 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.
Time Frame Up to 104 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title SPD476 (1.2 g) SPD476 (2.4 g) SPD476 (4.8 g) Placebo
Hide Arm/Group Description:
1.2 g administered orally once daily
2.4 g administered orally once daily
4.8 g administered orally once daily
Placebo administered orally once daily
Overall Number of Participants Analyzed 52 49 55 46
Measure Type: Number
Unit of Measure: Number of CT scans
Negative 19 10 5 10
Presence of abdominal pain 19 8 5 7
15% increase in WBC from baseline 5 2 2 1
Presence in abdominal pain + 15% increase in WBC 5 2 2 1
5.Secondary Outcome
Title Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Positive
Hide Description 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.
Time Frame Up to 104 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title SPD476 (1.2 g) SPD476 (2.4 g) SPD476 (4.8 g) Placebo
Hide Arm/Group Description:
1.2 g administered orally once daily
2.4 g administered orally once daily
4.8 g administered orally once daily
Placebo administered orally once daily
Overall Number of Participants Analyzed 52 49 55 46
Measure Type: Number
Unit of Measure: Number of CT scans
Positive 0 0 1 1
Presence of abdominal pain 0 0 1 1
15% increase in WBC from baseline 0 0 0 0
Presence of abdominal pain + 15% increase in WBC 0 0 0 0
6.Secondary Outcome
Title Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Negative
Hide Description 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.
Time Frame Up to 104 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title SPD476 (1.2 g) SPD476 (2.4 g) SPD476 (4.8 g) Placebo
Hide Arm/Group Description:
1.2 g administered orally once daily
2.4 g administered orally once daily
4.8 g administered orally once daily
Placebo administered orally once daily
Overall Number of Participants Analyzed 52 49 55 46
Measure Type: Number
Unit of Measure: Number of CT scans
Negative 0 3 2 3
Presence of abdominal pain 0 2 2 3
15% increase in WBC from baseline 0 1 0 1
Presence of abdominal pain + 15% increase in WBC 0 0 0 1
7.Secondary Outcome
Title Percent of Subjects Requiring Surgery for Diverticulitis
Hide Description [Not Specified]
Time Frame Up to 104 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set consists of all subjects who were randomized and took at least 1 dose of investigational product.
Arm/Group Title SPD476 (1.2 g) SPD476 (2.4 g) SPD476 (4.8 g) Placebo
Hide Arm/Group Description:
1.2 g administered orally once daily
2.4 g administered orally once daily
4.8 g administered orally once daily
Placebo administered orally once daily
Overall Number of Participants Analyzed 143 143 150 147
Measure Type: Number
Unit of Measure: percentage of subjects
2.8 2.8 3.3 2.0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title SPD476 (1.2 g) SPD476 (2.4 g) SPD476 (4.8 g) Placebo
Hide Arm/Group Description 1.2 g administered orally once daily 2.4 g administered orally once daily 4.8 g administered orally once daily Placebo administered orally once daily
All-Cause Mortality
SPD476 (1.2 g) SPD476 (2.4 g) SPD476 (4.8 g) Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
SPD476 (1.2 g) SPD476 (2.4 g) SPD476 (4.8 g) Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   16/143 (11.19%)   15/143 (10.49%)   18/150 (12.00%)   16/147 (10.88%) 
Blood and lymphatic system disorders         
Iron deficiency anemia  0/143 (0.00%)  1/143 (0.70%)  0/150 (0.00%)  0/147 (0.00%) 
Cardiac disorders         
Angina pectoris  2/143 (1.40%)  1/143 (0.70%)  1/150 (0.67%)  0/147 (0.00%) 
Coronary artery disease  0/143 (0.00%)  1/143 (0.70%)  0/150 (0.00%)  0/147 (0.00%) 
Myocardial ischemia  0/143 (0.00%)  1/143 (0.70%)  0/150 (0.00%)  0/147 (0.00%) 
Acute myocarcial infarction  1/143 (0.70%)  0/143 (0.00%)  0/150 (0.00%)  2/147 (1.36%) 
Coronary artery insufficiency  1/143 (0.70%)  0/143 (0.00%)  0/150 (0.00%)  1/147 (0.68%) 
Ear and labyrinth disorders         
Vertigo positional  0/143 (0.00%)  0/143 (0.00%)  0/150 (0.00%)  1/147 (0.68%) 
Endocrine disorders         
Autoimmune thyroiditis  0/143 (0.00%)  0/143 (0.00%)  0/150 (0.00%)  1/147 (0.68%) 
Eye disorders         
Retinal detachment  0/143 (0.00%)  0/143 (0.00%)  0/150 (0.00%)  1/147 (0.68%) 
Gastrointestinal disorders         
Dyspepsia  0/143 (0.00%)  0/143 (0.00%)  1/150 (0.67%)  0/147 (0.00%) 
Gastritis  0/143 (0.00%)  0/143 (0.00%)  1/150 (0.67%)  0/147 (0.00%) 
Pancreatitis  0/143 (0.00%)  0/143 (0.00%)  1/150 (0.67%)  0/147 (0.00%) 
Pancreatitis acute  0/143 (0.00%)  0/143 (0.00%)  1/150 (0.67%)  0/147 (0.00%) 
Enterovesical fistula  0/143 (0.00%)  1/143 (0.70%)  0/150 (0.00%)  0/147 (0.00%) 
Gastrointestinal hemorrhage  0/143 (0.00%)  1/143 (0.70%)  0/150 (0.00%)  0/147 (0.00%) 
Abdominal pain  1/143 (0.70%)  0/143 (0.00%)  0/150 (0.00%)  2/147 (1.36%) 
Large intestine perforation  1/143 (0.70%)  0/143 (0.00%)  0/150 (0.00%)  0/147 (0.00%) 
Peritoneal hematoma  1/143 (0.70%)  0/143 (0.00%)  0/150 (0.00%)  0/147 (0.00%) 
General disorders         
Pyrexia  0/143 (0.00%)  0/143 (0.00%)  1/150 (0.67%)  0/147 (0.00%) 
Chills  0/143 (0.00%)  1/143 (0.70%)  0/150 (0.00%)  0/147 (0.00%) 
Non-cardiac chest pain  1/143 (0.70%)  0/143 (0.00%)  0/150 (0.00%)  0/147 (0.00%) 
Infections and infestations         
Urinary tract infection  0/143 (0.00%)  0/143 (0.00%)  2/150 (1.33%)  0/147 (0.00%) 
Gastroenteritis  0/143 (0.00%)  1/143 (0.70%)  1/150 (0.67%)  0/147 (0.00%) 
Sepsis  1/143 (0.70%)  0/143 (0.00%)  1/150 (0.67%)  0/147 (0.00%) 
Clostridial infection  0/143 (0.00%)  0/143 (0.00%)  1/150 (0.67%)  0/147 (0.00%) 
Kidney infection  0/143 (0.00%)  0/143 (0.00%)  1/150 (0.67%)  0/147 (0.00%) 
Pneumonia primary atypical  0/143 (0.00%)  0/143 (0.00%)  1/150 (0.67%)  0/147 (0.00%) 
Viral infection  0/143 (0.00%)  0/143 (0.00%)  1/150 (0.67%)  0/147 (0.00%) 
Cellulitis  0/143 (0.00%)  1/143 (0.70%)  0/150 (0.00%)  0/147 (0.00%) 
Pneumonia  1/143 (0.70%)  0/143 (0.00%)  0/150 (0.00%)  1/147 (0.68%) 
Endophthalmitis  0/143 (0.00%)  0/143 (0.00%)  0/150 (0.00%)  1/147 (0.68%) 
Gastrointestinal infection  0/143 (0.00%)  0/143 (0.00%)  0/150 (0.00%)  1/147 (0.68%) 
Injury, poisoning and procedural complications         
Road traffic accident  2/143 (1.40%)  0/143 (0.00%)  0/150 (0.00%)  0/147 (0.00%) 
Near drowning  0/143 (0.00%)  0/143 (0.00%)  1/150 (0.67%)  0/147 (0.00%) 
Concussion  1/143 (0.70%)  0/143 (0.00%)  0/150 (0.00%)  0/147 (0.00%) 
Femoral neck fracture  1/143 (0.70%)  0/143 (0.00%)  0/150 (0.00%)  0/147 (0.00%) 
Skin injury  1/143 (0.70%)  0/143 (0.00%)  0/150 (0.00%)  0/147 (0.00%) 
Humerus fracture  0/143 (0.00%)  0/143 (0.00%)  0/150 (0.00%)  1/147 (0.68%) 
Joint dislocation  0/143 (0.00%)  0/143 (0.00%)  0/150 (0.00%)  1/147 (0.68%) 
Metabolism and nutrition disorders         
Hypercalcemia  1/143 (0.70%)  0/143 (0.00%)  0/150 (0.00%)  0/147 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Uterine cancer  2/143 (1.40%)  0/143 (0.00%)  0/150 (0.00%)  0/147 (0.00%) 
Prostate cancer  0/143 (0.00%)  0/143 (0.00%)  1/150 (0.67%)  0/147 (0.00%) 
Breast cancer  0/143 (0.00%)  1/143 (0.70%)  0/150 (0.00%)  0/147 (0.00%) 
Thyroid neoplasm  1/143 (0.70%)  0/143 (0.00%)  0/150 (0.00%)  0/147 (0.00%) 
Breast cancer in situ  0/143 (0.00%)  0/143 (0.00%)  0/150 (0.00%)  1/147 (0.68%) 
Laryngeal cancer  0/143 (0.00%)  0/143 (0.00%)  0/150 (0.00%)  1/147 (0.68%) 
Thyroid cancer  0/143 (0.00%)  0/143 (0.00%)  0/150 (0.00%)  1/147 (0.68%) 
Nervous system disorders         
Ischemic stroke  0/143 (0.00%)  1/143 (0.70%)  0/150 (0.00%)  0/147 (0.00%) 
Movement disorder  0/143 (0.00%)  1/143 (0.70%)  0/150 (0.00%)  0/147 (0.00%) 
Syncope  0/143 (0.00%)  1/143 (0.70%)  0/150 (0.00%)  0/147 (0.00%) 
Cerebral ischemia  0/143 (0.00%)  0/143 (0.00%)  0/150 (0.00%)  1/147 (0.68%) 
Psychiatric disorders         
Alcoholism  0/143 (0.00%)  0/143 (0.00%)  1/150 (0.67%)  0/147 (0.00%) 
Bipolar II disorder  0/143 (0.00%)  0/143 (0.00%)  1/150 (0.67%)  0/147 (0.00%) 
Confusional state  0/143 (0.00%)  1/143 (0.70%)  0/150 (0.00%)  0/147 (0.00%) 
Bipolar disorder  0/143 (0.00%)  0/143 (0.00%)  0/150 (0.00%)  1/147 (0.68%) 
Renal and urinary disorders         
Nephrolithiasis  0/143 (0.00%)  0/143 (0.00%)  1/150 (0.67%)  0/147 (0.00%) 
Pelvi-ureteric obstruction  0/143 (0.00%)  0/143 (0.00%)  1/150 (0.67%)  0/147 (0.00%) 
Bladder prolapse  0/143 (0.00%)  1/143 (0.70%)  0/150 (0.00%)  0/147 (0.00%) 
Renal colic  1/143 (0.70%)  0/143 (0.00%)  0/150 (0.00%)  0/147 (0.00%) 
Renal failure acute  1/143 (0.70%)  0/143 (0.00%)  0/150 (0.00%)  0/147 (0.00%) 
Stress urinary incontinence  0/143 (0.00%)  0/143 (0.00%)  0/150 (0.00%)  1/147 (0.68%) 
Reproductive system and breast disorders         
Benign prostatic hyperplasia  0/143 (0.00%)  1/143 (0.70%)  0/150 (0.00%)  0/147 (0.00%) 
Ovarian cyst  0/143 (0.00%)  0/143 (0.00%)  0/150 (0.00%)  1/147 (0.68%) 
Respiratory, thoracic and mediastinal disorders         
Chronic obstructive pulmonary disease  1/143 (0.70%)  0/143 (0.00%)  1/150 (0.67%)  0/147 (0.00%) 
Nasal septum deviation  0/143 (0.00%)  1/143 (0.70%)  0/150 (0.00%)  0/147 (0.00%) 
Sinus polyp  0/143 (0.00%)  1/143 (0.70%)  0/150 (0.00%)  0/147 (0.00%) 
Pulmonary hypertension  1/143 (0.70%)  0/143 (0.00%)  0/150 (0.00%)  0/147 (0.00%) 
Asthma  0/143 (0.00%)  0/143 (0.00%)  0/150 (0.00%)  1/147 (0.68%) 
Vascular disorders         
Aortic Aneurysm  0/143 (0.00%)  0/143 (0.00%)  0/150 (0.00%)  1/147 (0.68%) 
Hypertension  0/143 (0.00%)  0/143 (0.00%)  0/150 (0.00%)  1/147 (0.68%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
SPD476 (1.2 g) SPD476 (2.4 g) SPD476 (4.8 g) Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   109/143 (76.22%)   106/143 (74.13%)   101/150 (67.33%)   112/147 (76.19%) 
Gastrointestinal disorders         
Abdominal pain  17/143 (11.89%)  16/143 (11.19%)  18/150 (12.00%)  16/147 (10.88%) 
Diarrhea  13/143 (9.09%)  12/143 (8.39%)  12/150 (8.00%)  12/147 (8.16%) 
Flatulence  9/143 (6.29%)  5/143 (3.50%)  3/150 (2.00%)  4/147 (2.72%) 
Constpation  7/143 (4.90%)  3/143 (2.10%)  5/150 (3.33%)  8/147 (5.44%) 
General disorders         
Nausea  10/143 (6.99%)  1/143 (0.70%)  6/150 (4.00%)  5/147 (3.40%) 
Infections and infestations         
Urinary tract infection  14/143 (9.79%)  12/143 (8.39%)  8/150 (5.33%)  17/147 (11.56%) 
Nasopharyngitis  6/143 (4.20%)  15/143 (10.49%)  7/150 (4.67%)  13/147 (8.84%) 
Upper respiratory tract infection  9/143 (6.29%)  3/143 (2.10%)  10/150 (6.67%)  14/147 (9.52%) 
Sinusitis  9/143 (6.29%)  7/143 (4.90%)  5/150 (3.33%)  8/147 (5.44%) 
Influenza  5/143 (3.50%)  11/143 (7.69%)  4/150 (2.67%)  3/147 (2.04%) 
Bronchitis  7/143 (4.90%)  8/143 (5.59%)  3/150 (2.00%)  3/147 (2.04%) 
Musculoskeletal and connective tissue disorders         
Back pain  8/143 (5.59%)  5/143 (3.50%)  8/150 (5.33%)  12/147 (8.16%) 
Arthralgia  7/143 (4.90%)  5/143 (3.50%)  4/150 (2.67%)  13/147 (8.84%) 
Nervous system disorders         
Headache  13/143 (9.09%)  6/143 (4.20%)  14/150 (9.33%)  10/147 (6.80%) 
Vascular disorders         
Hypertension  5/143 (3.50%)  8/143 (5.59%)  6/150 (4.00%)  1/147 (0.68%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Shire
Phone: +1 866 842 5335
EMail: ClinicalTransparency@shire.com
Layout table for additonal information
Responsible Party: Takeda ( Shire )
ClinicalTrials.gov Identifier: NCT00545740    
Other Study ID Numbers: SPD476-313
2007-004895-37 ( EudraCT Number )
First Submitted: October 16, 2007
First Posted: October 17, 2007
Results First Submitted: December 19, 2012
Results First Posted: January 25, 2013
Last Update Posted: June 14, 2021