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Prevention of Recurrence of Diverticulitis (PREVENT2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00545103
Recruitment Status : Completed
First Posted : October 17, 2007
Results First Posted : December 19, 2012
Last Update Posted : June 12, 2014
Sponsor:
Information provided by (Responsible Party):
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, MMX™ mesalazine, 1.2g extended release tablet
Drug: Placebo
Enrollment 592
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 148 148 150 146
Completed 73 70 74 76
Not Completed 75 78 76 70
Reason Not Completed
Lack of Efficacy             48             45             31             27
Withdrawal by Subject             6             10             18             22
Adverse Event             11             12             17             10
Lost to Follow-up             4             6             3             4
Protocol Violation             1             2             3             0
Suspected recurrence of diverticulitis             1             0             0             3
Difficult to open package             0             0             0             1
Investigational product not taken             1             0             0             1
Wish to start a family             0             0             0             1
Diverticulitis crisis             0             0             0             1
Personal reasons             1             0             0             0
Subject's decision             1             0             0             0
Noncompliance             0             1             0             0
Investigator decision             0             0             1             0
Subject moved             0             1             0             0
Use of prohibited medication             0             0             1             0
Does not want to take study drug anymore             1             0             1             0
Subject met endpoint under protocol v. 1             0             0             1             0
Death             0             1             0             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 148 147 149 142 586
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 148 participants 147 participants 149 participants 142 participants 586 participants
57.8  (10.88) 54.2  (10.10) 56.7  (11.76) 55.7  (11.15) 56.1  (11.04)
[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 592 subjects randomized, 6 were never dosed with investigational product. Therefore, 586 subjects are in the Safety Population.
Age, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 148 participants 147 participants 149 participants 142 participants 586 participants
18 to < 35 years 1 4 5 6 16
35 to < 45 years 16 21 18 16 71
45 to < 55 years 42 50 41 40 173
55 to < 65 years 45 48 45 45 183
>= 65 years 44 24 40 35 143
[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 592 subjects randomized, 6 were never dosed with investigational product. Therefore, 586 subjects are in the Safety Population.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 148 participants 147 participants 149 participants 142 participants 586 participants
Female
83
  56.1%
71
  48.3%
88
  59.1%
72
  50.7%
314
  53.6%
Male
65
  43.9%
76
  51.7%
61
  40.9%
70
  49.3%
272
  46.4%
[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 592 subjects randomized, 6 were never dosed with investigational product. Therefore, 586 subjects are in the Safety Population.
Region of Enrollment   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 148 participants 147 participants 149 participants 142 participants 586 participants
United States 89 88 88 86 351
Hungary 2 3 6 3 14
Canada 5 5 4 5 19
Finland 4 5 5 4 18
Brazil 10 9 10 11 40
Romania 10 12 11 9 42
South Africa 14 16 15 15 60
Netherlands 5 3 5 5 18
Germany 7 6 4 4 21
Italy 2 1 2 4 9
[1]
Measure Description: This baseline measure consists of all randomized subjects (n = 592).
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 148 147 149 142
Measure Type: Number
Unit of Measure: percentage of subjects
62.8 59.2 69.1 67.6
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
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.778
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
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.159
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
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.368
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
2.Secondary Outcome
Title Percent of Subjects Who Are 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
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 148 147 149 142
Measure Type: Number
Unit of Measure: percentage of subjects
62.8 59.2 69.1 66.9
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
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.685
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
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.198
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
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.441
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 55 52 51 40
Measure Type: Number
Unit of Measure: Number of CT Scans
Positive 49 45 35 30
Presence of abdominal pain 48 39 34 29
15% increase in WBC from baseline 23 24 18 11
Abdominal pain + 15% increase in WBC 23 22 18 11
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 55 52 51 40
Measure Type: Number
Unit of Measure: Number of CT Scans
Negative 9 8 22 15
Presence of abdominal pain 8 6 17 12
15% increase in WBC from Baseline 1 2 4 4
Abdominal pain + 15% increase in WBC 1 2 4 3
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 55 52 51 40
Measure Type: Number
Unit of Measure: Number of CT Scans
Positive 0 0 1 1
Presence of abdominal pain 0 0 0 1
15% increase in WBC from baseline 0 0 0 0
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 55 52 51 40
Measure Type: Number
Unit of Measure: Number of CT Scans
Negative 1 0 0 0
Presence of abdominal pain 1 0 0 0
15% increase in WBC from baseline 0 0 0 0
Abdominal pain + 15% increase in WBC 0 0 0 0
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
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 148 147 149 142
Measure Type: Number
Unit of Measure: percentage of subjects
4.7 2.7 2.0 1.4
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   9/148 (6.08%)   13/147 (8.84%)   14/149 (9.40%)   15/142 (10.56%) 
Blood and lymphatic system disorders         
Agranulocytosis  0/148 (0.00%)  0/147 (0.00%)  1/149 (0.67%)  0/142 (0.00%) 
Cardiac disorders         
Angina pectoris  0/148 (0.00%)  1/147 (0.68%)  1/149 (0.67%)  1/142 (0.70%) 
Atrial fibrillation  1/148 (0.68%)  1/147 (0.68%)  0/149 (0.00%)  0/142 (0.00%) 
Cardiac failure  0/148 (0.00%)  0/147 (0.00%)  1/149 (0.67%)  0/142 (0.00%) 
Ventricular extrasystoles  0/148 (0.00%)  1/147 (0.68%)  0/149 (0.00%)  0/142 (0.00%) 
Supraventricular tachycardia  1/148 (0.68%)  0/147 (0.00%)  0/149 (0.00%)  0/142 (0.00%) 
Gastrointestinal disorders         
Gastroesophogeal reflux disease  0/148 (0.00%)  0/147 (0.00%)  1/149 (0.67%)  0/142 (0.00%) 
Small intestinal hemorrhage  0/148 (0.00%)  0/147 (0.00%)  1/149 (0.67%)  0/142 (0.00%) 
Abdominal pain  0/148 (0.00%)  1/147 (0.68%)  0/149 (0.00%)  1/142 (0.70%) 
Gastrointestinal hemorrhage  0/148 (0.00%)  1/147 (0.68%)  0/149 (0.00%)  0/142 (0.00%) 
Hiatus hernia  0/148 (0.00%)  1/147 (0.68%)  0/149 (0.00%)  0/142 (0.00%) 
Nausea  0/148 (0.00%)  1/147 (0.68%)  0/149 (0.00%)  0/142 (0.00%) 
Esophagitis  0/148 (0.00%)  1/147 (0.68%)  0/149 (0.00%)  0/142 (0.00%) 
Abdominal pain lower  0/148 (0.00%)  0/147 (0.00%)  0/149 (0.00%)  1/142 (0.70%) 
Abdominal pain upper  0/148 (0.00%)  0/147 (0.00%)  0/149 (0.00%)  1/142 (0.70%) 
Dyspepsia  0/148 (0.00%)  0/147 (0.00%)  0/149 (0.00%)  1/142 (0.70%) 
Mallory-Weiss syndrome  0/148 (0.00%)  0/147 (0.00%)  0/149 (0.00%)  1/142 (0.70%) 
General disorders         
Chest pain  0/148 (0.00%)  0/147 (0.00%)  2/149 (1.34%)  0/142 (0.00%) 
Multi-organ failure/Death  0/148 (0.00%)  1/147 (0.68%)  0/149 (0.00%)  0/142 (0.00%) 
Chest discomfort  1/148 (0.68%)  0/147 (0.00%)  0/149 (0.00%)  0/142 (0.00%) 
Hepatobiliary disorders         
Cholangitis acute  0/148 (0.00%)  0/147 (0.00%)  1/149 (0.67%)  0/142 (0.00%) 
Cholecystitis  0/148 (0.00%)  0/147 (0.00%)  0/149 (0.00%)  1/142 (0.70%) 
Infections and infestations         
Pneumonia  1/148 (0.68%)  0/147 (0.00%)  1/149 (0.67%)  2/142 (1.41%) 
Subcutaneous abscess  0/148 (0.00%)  0/147 (0.00%)  1/149 (0.67%)  0/142 (0.00%) 
Appendicitis  0/148 (0.00%)  1/147 (0.68%)  0/149 (0.00%)  0/142 (0.00%) 
Bronchitis  1/148 (0.68%)  0/147 (0.00%)  0/149 (0.00%)  0/142 (0.00%) 
Peridiverticular abscess  1/148 (0.68%)  0/147 (0.00%)  0/149 (0.00%)  0/142 (0.00%) 
Pharyngitis  1/148 (0.68%)  0/147 (0.00%)  0/149 (0.00%)  0/142 (0.00%) 
Borrelia infection  0/148 (0.00%)  0/147 (0.00%)  0/149 (0.00%)  1/142 (0.70%) 
Pneumonia viral  0/148 (0.00%)  0/147 (0.00%)  0/149 (0.00%)  1/142 (0.70%) 
Viral pericarditis  0/148 (0.00%)  0/147 (0.00%)  0/149 (0.00%)  1/142 (0.70%) 
Injury, poisoning and procedural complications         
Humerus fracture  0/148 (0.00%)  0/147 (0.00%)  1/149 (0.67%)  0/142 (0.00%) 
Ankle fracture  0/148 (0.00%)  1/147 (0.68%)  0/149 (0.00%)  0/142 (0.00%) 
Patella fracture  0/148 (0.00%)  1/147 (0.68%)  0/149 (0.00%)  0/142 (0.00%) 
Post procedural edema  0/148 (0.00%)  1/147 (0.68%)  0/149 (0.00%)  0/142 (0.00%) 
Radius fracture  0/148 (0.00%)  1/147 (0.68%)  0/149 (0.00%)  0/142 (0.00%) 
Hip fracture  1/148 (0.68%)  0/147 (0.00%)  0/149 (0.00%)  0/142 (0.00%) 
Metabolism and nutrition disorders         
Type 2 diabetes mellitus  0/148 (0.00%)  0/147 (0.00%)  1/149 (0.67%)  0/142 (0.00%) 
Musculoskeletal and connective tissue disorders         
Intervertebral disc protrusion  0/148 (0.00%)  1/147 (0.68%)  0/149 (0.00%)  0/142 (0.00%) 
Arthritis  0/148 (0.00%)  0/147 (0.00%)  0/149 (0.00%)  1/142 (0.70%) 
Rotator cuff syndrome  0/148 (0.00%)  0/147 (0.00%)  0/149 (0.00%)  1/142 (0.70%) 
Spinal column stenosis  0/148 (0.00%)  0/147 (0.00%)  0/149 (0.00%)  1/142 (0.70%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Ovarian granulosa-theca cell tumor  0/148 (0.00%)  0/147 (0.00%)  1/149 (0.67%)  0/142 (0.00%) 
Renal cell carcinoma  0/148 (0.00%)  0/147 (0.00%)  1/149 (0.67%)  0/142 (0.00%) 
Squamous cell carcinoma  0/148 (0.00%)  0/147 (0.00%)  1/149 (0.67%)  0/142 (0.00%) 
Breast cancer  0/148 (0.00%)  1/147 (0.68%)  0/149 (0.00%)  0/142 (0.00%) 
Cardiac neoplasm unspecified  0/148 (0.00%)  1/147 (0.68%)  0/149 (0.00%)  0/142 (0.00%) 
Prostate cancer  0/148 (0.00%)  1/147 (0.68%)  0/149 (0.00%)  0/142 (0.00%) 
Malignant melanoma  0/148 (0.00%)  0/147 (0.00%)  0/149 (0.00%)  1/142 (0.70%) 
Nervous system disorders         
Cerebrovascular accident  0/148 (0.00%)  2/147 (1.36%)  0/149 (0.00%)  0/142 (0.00%) 
Syncope  0/148 (0.00%)  0/147 (0.00%)  1/149 (0.67%)  0/142 (0.00%) 
Transient ischemic attack  1/148 (0.68%)  0/147 (0.00%)  0/149 (0.00%)  0/142 (0.00%) 
Psychiatric disorders         
Panic attack  0/148 (0.00%)  0/147 (0.00%)  0/149 (0.00%)  1/142 (0.70%) 
Reproductive system and breast disorders         
Ovarian cyst  0/148 (0.00%)  0/147 (0.00%)  1/149 (0.67%)  0/142 (0.00%) 
Uterovaginal prolapse  1/148 (0.68%)  0/147 (0.00%)  0/149 (0.00%)  0/142 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Dyspnea  1/148 (0.68%)  0/147 (0.00%)  0/149 (0.00%)  1/142 (0.70%) 
Vascular disorders         
Hypotension  0/148 (0.00%)  1/147 (0.68%)  0/149 (0.00%)  0/142 (0.00%) 
Intra-abdominal hemorrhage  0/148 (0.00%)  1/147 (0.68%)  0/149 (0.00%)  0/142 (0.00%) 
Femoral arterial stenosis  0/148 (0.00%)  0/147 (0.00%)  0/149 (0.00%)  1/142 (0.70%) 
Hemorrhage  0/148 (0.00%)  0/147 (0.00%)  0/149 (0.00%)  1/142 (0.70%) 
Hypertension  0/148 (0.00%)  0/147 (0.00%)  0/149 (0.00%)  1/142 (0.70%) 
Thrombosis  0/148 (0.00%)  0/147 (0.00%)  0/149 (0.00%)  1/142 (0.70%) 
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   108/148 (72.97%)   111/147 (75.51%)   110/149 (73.83%)   105/142 (73.94%) 
Gastrointestinal disorders         
Abdominal pain  19/148 (12.84%)  19/147 (12.93%)  15/149 (10.07%)  12/142 (8.45%) 
Diarrhea  15/148 (10.14%)  15/147 (10.20%)  18/149 (12.08%)  12/142 (8.45%) 
Nausea  5/148 (3.38%)  8/147 (5.44%)  10/149 (6.71%)  11/142 (7.75%) 
Dyspepsia  5/148 (3.38%)  11/147 (7.48%)  6/149 (4.03%)  6/142 (4.23%) 
Constipation  9/148 (6.08%)  6/147 (4.08%)  6/149 (4.03%)  12/142 (8.45%) 
Abdominal pain lower  5/148 (3.38%)  2/147 (1.36%)  10/149 (6.71%)  7/142 (4.93%) 
Infections and infestations         
Urinary tract infection  11/148 (7.43%)  14/147 (9.52%)  10/149 (6.71%)  7/142 (4.93%) 
Sinusitis  12/148 (8.11%)  8/147 (5.44%)  10/149 (6.71%)  11/142 (7.75%) 
Influenza  11/148 (7.43%)  8/147 (5.44%)  9/149 (6.04%)  11/142 (7.75%) 
Bronchitis  8/148 (5.41%)  7/147 (4.76%)  9/149 (6.04%)  7/142 (4.93%) 
Nasopharyngitis  5/148 (3.38%)  10/147 (6.80%)  8/149 (5.37%)  9/142 (6.34%) 
Musculoskeletal and connective tissue disorders         
Back pain  10/148 (6.76%)  11/147 (7.48%)  11/149 (7.38%)  12/142 (8.45%) 
Nervous system disorders         
Headache  14/148 (9.46%)  10/147 (6.80%)  14/149 (9.40%)  13/142 (9.15%) 
Respiratory, thoracic and mediastinal disorders         
Cough  9/148 (6.08%)  3/147 (2.04%)  4/149 (2.68%)  2/142 (1.41%) 
Vascular disorders         
Hypertension  6/148 (4.05%)  8/147 (5.44%)  2/149 (1.34%)  8/142 (5.63%) 
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
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Name/Title: Study Physician
Organization: Shire Development LLC
Phone: +1 866 842 5335
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Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT00545103    
Other Study ID Numbers: SPD476-314
2007-004896-20 ( EudraCT Number )
First Submitted: October 16, 2007
First Posted: October 17, 2007
Results First Submitted: October 11, 2012
Results First Posted: December 19, 2012
Last Update Posted: June 12, 2014