Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT01771809
Previous Study | Return to List | Next Study

Long-Term Safety Of PF-00547659 In Ulcerative Colitis (TURANDOT II)

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: NCT01771809
Recruitment Status : Completed
First Posted : January 18, 2013
Results First Posted : April 18, 2019
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
Shire

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Ulcerative Colitis
Interventions Drug: 75mg SHP647 (PF-00547659)
Drug: 225mg SHP647 (PF-00547659)
Enrollment 330
Recruitment Details The study was conducted at 101 centers in 21 countries between 18 Mar 2013 (first participant first visit) and 13 Dec 2017 (last participant last visit).
Pre-assignment Details A total of 331 participants were randomized and 330 participants received treatment in the study. One participant discontinued due to adverse event prior to receiving treatment.
Arm/Group Title SHP647 75 mg SHP647 225 mg
Hide Arm/Group Description Participants received 75 milligrams (mg) of SHP647 subcutaneous (SC) injection every 4 weeks for 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen. During the first 72 weeks, a one time dose escalation to 225 mg of SHP647 SC injection every 4 weeks was allowed after 8 weeks of the study for participants who experienced clinical deterioration or unacceptably low level of response to the investigational product. The decision to escalate was guided by the response and relapse criteria tempered by clinical judgment. Following the first 72 weeks, participants received 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen. Participants received 225 mg of SHP647 SC injection every 4 weeks for 72 weeks followed by 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen.
Period Title: Overall Study
Started 164 166
Completed 93 83
Not Completed 71 83
Reason Not Completed
Adverse Event             4             12
Protocol Violation             0             1
Withdrawal by Subject             34             42
Lost to Follow-up             1             3
Other (Insufficient clinical response)             22             20
Death             1             0
Other (other)             9             5
Arm/Group Title SHP647 75 mg SHP647 225 mg Total
Hide Arm/Group Description Participants received 75 mg of SHP647 SC injection every 4 weeks for 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen. During the first 72 weeks, a one time dose escalation to 225 mg of SHP647 SC injection every 4 weeks was allowed after 8 weeks of the study for participants who experienced clinical deterioration or unacceptably low level of response to the investigational product. The decision to escalate was guided by the response and relapse criteria tempered by clinical judgment. Following the first 72 weeks, participants received 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen. Participants received 225 mg of SHP647 SC injection every 4 weeks for 72 weeks followed by 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen. Total of all reporting groups
Overall Number of Baseline Participants 164 166 330
Hide Baseline Analysis Population Description
Safety analysis set (SAS) consisted of all enrolled participants who had received at least 1 dose of SHP647.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 164 participants 166 participants 330 participants
40.5  (12.75) 41.1  (13.68) 40.8  (13.21)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 164 participants 166 participants 330 participants
Female
62
  37.8%
70
  42.2%
132
  40.0%
Male
102
  62.2%
96
  57.8%
198
  60.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 164 participants 166 participants 330 participants
Hispanic or Latino
4
   2.4%
6
   3.6%
10
   3.0%
Not Hispanic or Latino
160
  97.6%
160
  96.4%
320
  97.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 164 participants 166 participants 330 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
11
   6.7%
15
   9.0%
26
   7.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
   1.8%
2
   1.2%
5
   1.5%
White
148
  90.2%
143
  86.1%
291
  88.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Other
2
   1.2%
6
   3.6%
8
   2.4%
1.Primary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), and Who Withdrew From Treatment Due to Treatment-Emergent Adverse Events (TEAEs)
Hide Description An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant who was administered a product or medical device; the event did not need to necessarily have a causal relationship with the treatment or usage. A serious adverse event (SAE) was any untoward medical occurrence at any dose that resulted in death, was life threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in congenital anomaly/birth defect. Number of participants with TEAEs, STEAEs, and those withdrew from treatment due to TEAEs were reported.
Time Frame From start of study drug administration up to 168 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
SAS consisted of all enrolled participants who had received at least 1 dose of SHP647.
Arm/Group Title SHP647 75 mg SHP647 225 mg
Hide Arm/Group Description:
Participants received 75 mg of SHP647 SC injection every 4 weeks for 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen. During the first 72 weeks, a one time dose escalation to 225 mg of SHP647 SC injection every 4 weeks was allowed after 8 weeks of the study for participants who experienced clinical deterioration or unacceptably low level of response to the investigational product. The decision to escalate was guided by the response and relapse criteria tempered by clinical judgment. Following the first 72 weeks, participants received 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen.
Participants received 225 mg of SHP647 SC injection every 4 weeks for 72 weeks followed by 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen.
Overall Number of Participants Analyzed 164 166
Measure Type: Count of Participants
Unit of Measure: Participants
Participants with any TEAE
146
  89.0%
147
  88.6%
Participants with any TESAE
34
  20.7%
40
  24.1%
Participants who withdrew treatment due to TEAE
12
   7.3%
23
  13.9%
2.Secondary Outcome
Title Percentage of Participants With Mucosal Healing at Week 16
Hide Description Mucosal healing was defined as an absolute Mayo subscore for endoscopy of 0 or 1 (based on centrally read score) as assessed by flexible sigmoidoscopy or colonoscopy. The Mayo score is a tool designed to measure disease activity for ulcerative colitis (UC). The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores (stool frequency, rectal bleeding, findings on flexible sigmoidoscopy, and physician's global assessment [PGA]) each graded 0 to 3 with the higher score indicating more severe disease activity. The percentage of participants with mucosal healing at week 16 was reported.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
SAS consisted of all enrolled participants who had received at least 1 dose of SHP647.
Arm/Group Title SHP647 75 mg SHP647 225 mg
Hide Arm/Group Description:
Participants received 75 mg of SHP647 SC injection every 4 weeks for 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen. During the first 72 weeks, a one time dose escalation to 225 mg of SHP647 SC injection every 4 weeks was allowed after 8 weeks of the study for participants who experienced clinical deterioration or unacceptably low level of response to the investigational product. The decision to escalate was guided by the response and relapse criteria tempered by clinical judgment. Following the first 72 weeks, participants received 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen.
Participants received 225 mg of SHP647 SC injection every 4 weeks for 72 weeks followed by 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen.
Overall Number of Participants Analyzed 164 166
Measure Type: Number
Unit of Measure: Percentage of participants
27.4 29.5
3.Secondary Outcome
Title Serum Trough Concentrations of SHP647 Versus Time
Hide Description Serum trough concentrations of SHP647 versus time was reported.
Time Frame Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72 and 156
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic (PK) set consisted of all participants who received at least 1 dose of SHP647 and for whom at least 1 postdose PK sample was collected. Here 'Number of Participants Analyzed' refers to the number of participants evaluable for specific timepoint.
Arm/Group Title SHP647 75 mg SHP647 225 mg
Hide Arm/Group Description:
Participants received 75 mg of SHP647 SC injection every 4 weeks for 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen. During the first 72 weeks, a one time dose escalation to 225 mg of SHP647 SC injection every 4 weeks was allowed after 8 weeks of the study for participants who experienced clinical deterioration or unacceptably low level of response to the investigational product. The decision to escalate was guided by the response and relapse criteria tempered by clinical judgment. Following the first 72 weeks, participants received 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen.
Participants received 225 mg of SHP647 SC injection every 4 weeks for 72 weeks followed by 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen.
Overall Number of Participants Analyzed 163 164
Mean (Standard Deviation)
Unit of Measure: Micrograms/liter (ug/L)
Baseline Number Analyzed 113 participants 117 participants
6398.62  (8584.412) 8064.41  (10629.768)
Week 4 Number Analyzed 156 participants 160 participants
5496.56  (4026.759) 16787.31  (7807.292)
Week 8 Number Analyzed 155 participants 157 participants
6245.79  (3371.708) 20345.29  (9286.956)
Week 12 Number Analyzed 157 participants 155 participants
9038.72  (5540.836) 23915.87  (10434.073)
Week 16 Number Analyzed 141 participants 149 participants
10445.24  (6387.004) 24772.35  (11970.153)
Week 20 Number Analyzed 124 participants 124 participants
10928.76  (7900.859) 25582.98  (11767.775)
Week 24 Number Analyzed 115 participants 123 participants
11145.54  (8019.864) 27832.20  (12469.086)
Week 28 Number Analyzed 111 participants 121 participants
12978.11  (8772.285) 27797.77  (13070.361)
Week 32 Number Analyzed 110 participants 119 participants
12926.04  (8798.671) 28381.93  (11748.573)
Week 36 Number Analyzed 110 participants 110 participants
12785.55  (9182.501) 29666.64  (13997.231)
Week 40 Number Analyzed 102 participants 109 participants
13004.90  (9544.675) 28947.34  (12151.971)
Week 44 Number Analyzed 100 participants 102 participants
13337.50  (8620.549) 29855.69  (13605.897)
Week 48 Number Analyzed 104 participants 99 participants
14061.44  (9257.991) 30010.61  (14014.183)
Week 52 Number Analyzed 99 participants 98 participants
14192.83  (9326.176) 28917.76  (14545.617)
Week 56 Number Analyzed 98 participants 97 participants
15179.77  (10405.996) 29985.88  (14122.172)
Week 60 Number Analyzed 96 participants 90 participants
15133.54  (9673.602) 29086.78  (12606.888)
Week 64 Number Analyzed 91 participants 91 participants
15354.29  (10112.098) 31613.08  (13712.478)
Week 68 Number Analyzed 89 participants 96 participants
15584.38  (10407.781) 30609.08  (14331.857)
Week 72 Number Analyzed 88 participants 90 participants
15006.48  (9390.020) 31342.89  (14012.311)
Week 156 Number Analyzed 79 participants 81 participants
983.49  (1485.708) 1893.88  (4530.680)
4.Secondary Outcome
Title Number of Participants With Positive Anti-drug (SHP647) Antibodies (ADA)
Hide Description The anti-drug antibodies (ADA) positive was defined as ADA log base 2 titer greater than or equal to (>=) 4.64. The number of participants with positive ADA was reported.
Time Frame Baseline, Week 8, 16, 24, 40, 48, 64 and 156
Hide Outcome Measure Data
Hide Analysis Population Description
The SAS consisted of all enrolled participants who had received at least 1 dose of SHP647. Here, "number of participants analyzed" refers to the number of participants evaluable for this outcome at specific time points.
Arm/Group Title SHP647 75 mg SHP647 225 mg
Hide Arm/Group Description:
Participants received 75 mg of SHP647 SC injection every 4 weeks for 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen. During the first 72 weeks, a one time dose escalation to 225 mg of SHP647 SC injection every 4 weeks was allowed after 8 weeks of the study for participants who experienced clinical deterioration or unacceptably low level of response to the investigational product. The decision to escalate was guided by the response and relapse criteria tempered by clinical judgment. Following the first 72 weeks, participants received 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen.
Participants received 225 mg of SHP647 SC injection every 4 weeks for 72 weeks followed by 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen.
Overall Number of Participants Analyzed 164 166
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline Number Analyzed 148 participants 153 participants
9
   6.1%
10
   6.5%
Week 8 Number Analyzed 143 participants 151 participants
3
   2.1%
1
   0.7%
Week 16 Number Analyzed 140 participants 144 participants
1
   0.7%
1
   0.7%
Week 24 Number Analyzed 106 participants 119 participants
1
   0.9%
1
   0.8%
Week 40 Number Analyzed 94 participants 104 participants
1
   1.1%
2
   1.9%
Week 48 Number Analyzed 97 participants 92 participants
1
   1.0%
0
   0.0%
Week 64 Number Analyzed 83 participants 86 participants
1
   1.2%
0
   0.0%
Week 156 Number Analyzed 73 participants 81 participants
0
   0.0%
1
   1.2%
5.Secondary Outcome
Title Number of Participants With Positive Neutralizing Antibodies (NAb)
Hide Description The positive Neutralizing Antibodies (NAb) was defined as NAb titer greater than or equal to (>=) 0.903. The number of participants with NAb was reported. Here "inconclusive" refers to participants who were neither reported as positive nor negative for NAb and anti-drug antibodies (ADA) positive was defined as ADA log base 2 titer greater than or equal to (>=) 4.64.
Time Frame Baseline, Week 8, 16, 24, 40, 48, 64 and 156
Hide Outcome Measure Data
Hide Analysis Population Description
Here, "number of participants analyzed" refers to the number of participants evaluable for this outcome at specific time points with non-missing ADA sample.
Arm/Group Title SHP647 75 mg SHP647 225 mg
Hide Arm/Group Description:
Participants received 75 mg of SHP647 SC injection every 4 weeks for 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen. During the first 72 weeks, a one time dose escalation to 225 mg of SHP647 SC injection every 4 weeks was allowed after 8 weeks of the study for participants who experienced clinical deterioration or unacceptably low level of response to the investigational product. The decision to escalate was guided by the response and relapse criteria tempered by clinical judgment. Following the first 72 weeks, participants received 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen.
Participants received 225 mg of SHP647 SC injection every 4 weeks for 72 weeks followed by 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen.
Overall Number of Participants Analyzed 148 153
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline: Without +ADA Number Analyzed 148 participants 153 participants
139
  93.9%
143
  93.5%
Baseline: With +ADA, with +NAb Number Analyzed 148 participants 153 participants
0
   0.0%
4
   2.6%
Baseline: With +ADA, without +NAb Number Analyzed 148 participants 153 participants
0
   0.0%
1
   0.7%
Baseline: With +ADA, with inconclusive NAb Number Analyzed 148 participants 153 participants
8
   5.4%
5
   3.3%
Baseline: With +ADA, missing NAb Number Analyzed 148 participants 153 participants
1
   0.7%
0
   0.0%
Week 8: Without +ADA Number Analyzed 143 participants 151 participants
140
  97.9%
150
  99.3%
Week 8: With +ADA, with +NAb Number Analyzed 143 participants 151 participants
1
   0.7%
1
   0.7%
Week 8: With +ADA, without +NAb Number Analyzed 143 participants 151 participants
2
   1.4%
0
   0.0%
Week 16: Without +ADA Number Analyzed 140 participants 144 participants
139
  99.3%
143
  99.3%
Week 16: With +ADA, with +NAb Number Analyzed 140 participants 144 participants
0
   0.0%
1
   0.7%
Week 16: With +ADA, without +NAb Number Analyzed 140 participants 144 participants
1
   0.7%
0
   0.0%
Week 24: Without +ADA Number Analyzed 106 participants 119 participants
105
  99.1%
118
  99.2%
Week 24: With +ADA, with +NAb Number Analyzed 106 participants 119 participants
0
   0.0%
1
   0.8%
Week 24: With +ADA, without +NAb Number Analyzed 106 participants 119 participants
1
   0.9%
0
   0.0%
Week 40: Without +ADA Number Analyzed 94 participants 104 participants
93
  98.9%
102
  98.1%
Week 40: With +ADA, with +NAb Number Analyzed 94 participants 104 participants
1
   1.1%
2
   1.9%
Week 40: With +ADA, without +NAb Number Analyzed 94 participants 104 participants
0
   0.0%
0
   0.0%
Week 48: Without +ADA Number Analyzed 97 participants 92 participants
96
  99.0%
92
 100.0%
Week 48: With +ADA, with +NAb Number Analyzed 97 participants 92 participants
1
   1.0%
0
   0.0%
Week 48: With +ADA, without +NAb Number Analyzed 97 participants 92 participants
0
   0.0%
0
   0.0%
Week 64: Without +ADA Number Analyzed 83 participants 86 participants
82
  98.8%
86
 100.0%
Week 64: With +ADA, with +NAb Number Analyzed 83 participants 86 participants
0
   0.0%
0
   0.0%
Week 64: With +ADA, without +NAb Number Analyzed 83 participants 86 participants
1
   1.2%
0
   0.0%
Week 156: Without +ADA Number Analyzed 73 participants 81 participants
73
 100.0%
80
  98.8%
Week 156: With +ADA, with +NAb Number Analyzed 73 participants 81 participants
0
   0.0%
0
   0.0%
Week 156: With +ADA, without +NAb Number Analyzed 73 participants 81 participants
0
   0.0%
1
   1.2%
Time Frame From start of study drug administration up to 168 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title SHP647 75 mg SHP647 225 mg
Hide Arm/Group Description Participants received 75 mg of SHP647 SC injection every 4 weeks for 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen. During the first 72 weeks, a one time dose escalation to 225 mg of SHP647 SC injection every 4 weeks was allowed after 8 weeks of the study for participants who experienced clinical deterioration or unacceptably low level of response to the investigational product. The decision to escalate was guided by the response and relapse criteria tempered by clinical judgment. Following the first 72 weeks, participants received 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen. Participants received 225 mg of SHP647 SC injection every 4 weeks for 72 weeks followed by 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen.
All-Cause Mortality
SHP647 75 mg SHP647 225 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   1/164 (0.61%)      0/166 (0.00%)    
Hide Serious Adverse Events
SHP647 75 mg SHP647 225 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   34/164 (20.73%)      40/166 (24.10%)    
Blood and lymphatic system disorders     
Anaemia * 1  2/164 (1.22%)  2 1/166 (0.60%)  3
Cardiac disorders     
Angina pectoris * 1  1/164 (0.61%)  1 0/166 (0.00%)  0
Arrhythmia * 1  0/164 (0.00%)  0 1/166 (0.60%)  1
Atrial fibrillation * 1  0/164 (0.00%)  0 1/166 (0.60%)  1
Atrial flutter * 1  0/164 (0.00%)  0 1/166 (0.60%)  1
Myocardial infarction * 1  1/164 (0.61%)  1 0/166 (0.00%)  0
Supraventricular tachycardia * 1  1/164 (0.61%)  1 0/166 (0.00%)  0
Congenital, familial and genetic disorders     
Arrhythmogenic right ventricular dysplasia * 1  1/164 (0.61%)  1 0/166 (0.00%)  0
Eye disorders     
Retinal detachment * 1  1/164 (0.61%)  1 0/166 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain * 1  0/164 (0.00%)  0 1/166 (0.60%)  1
Anal fissure * 1  0/164 (0.00%)  0 1/166 (0.60%)  1
Colitis ulcerative * 1  15/164 (9.15%)  19 18/166 (10.84%)  19
Diarrhoea * 1  1/164 (0.61%)  1 0/166 (0.00%)  0
Duodenal ulcer * 1  1/164 (0.61%)  1 0/166 (0.00%)  0
Enteritis * 1  1/164 (0.61%)  1 0/166 (0.00%)  0
Large intestinal stenosis * 1  1/164 (0.61%)  1 0/166 (0.00%)  0
Nausea * 1  0/164 (0.00%)  0 1/166 (0.60%)  1
Small intestinal obstruction * 1  0/164 (0.00%)  0 1/166 (0.60%)  1
Vomiting * 1  1/164 (0.61%)  1 1/166 (0.60%)  1
General disorders     
Non-Cardiac chest pain * 1  0/164 (0.00%)  0 1/166 (0.60%)  1
Pyrexia * 1  1/164 (0.61%)  1 0/166 (0.00%)  0
Immune system disorders     
Drug hypersensitivity * 1  1/164 (0.61%)  1 0/166 (0.00%)  0
Serum sickness * 1  1/164 (0.61%)  1 0/166 (0.00%)  0
Infections and infestations     
Anal abscess * 1  0/164 (0.00%)  0 1/166 (0.60%)  1
Appendicitis * 1  0/164 (0.00%)  0 1/166 (0.60%)  1
Cellulitis * 1  1/164 (0.61%)  1 0/166 (0.00%)  0
Chronic sinusitis * 1  1/164 (0.61%)  1 0/166 (0.00%)  0
Clostridium difficile infection * 1  1/164 (0.61%)  1 0/166 (0.00%)  0
Gastroenteritis * 1  2/164 (1.22%)  2 1/166 (0.60%)  1
Gastroenteritis viral * 1  0/164 (0.00%)  0 1/166 (0.60%)  1
Meningitis listeria * 1  0/164 (0.00%)  0 1/166 (0.60%)  1
Meningitis viral * 1  1/164 (0.61%)  1 0/166 (0.00%)  0
Pelvic abscess * 1  1/164 (0.61%)  1 1/166 (0.60%)  1
Pharyngitis * 1  0/164 (0.00%)  0 1/166 (0.60%)  1
Pneumonia * 1  1/164 (0.61%)  1 1/166 (0.60%)  1
Upper respiratory tract infection * 1  0/164 (0.00%)  0 1/166 (0.60%)  1
Viral infection * 1  1/164 (0.61%)  1 0/166 (0.00%)  0
Injury, poisoning and procedural complications     
Anastomotic fistula * 1  0/164 (0.00%)  0 1/166 (0.60%)  1
Anastomotic stenosis * 1  0/164 (0.00%)  0 1/166 (0.60%)  1
Clavicle fracture * 1  0/164 (0.00%)  0 1/166 (0.60%)  1
Lumbar vertebral fracture * 1  0/164 (0.00%)  0 1/166 (0.60%)  1
Rib fracture * 1  0/164 (0.00%)  0 1/166 (0.60%)  1
Road traffic accident * 1  0/164 (0.00%)  0 1/166 (0.60%)  1
Stoma complication * 1  0/164 (0.00%)  0 1/166 (0.60%)  1
Investigations     
Blood creatine phosphokinase increased * 1  1/164 (0.61%)  1 0/166 (0.00%)  0
Blood iron decreased * 1  0/164 (0.00%)  0 1/166 (0.60%)  1
Metabolism and nutrition disorders     
Decreased appetite * 1  0/164 (0.00%)  0 1/166 (0.60%)  1
Dehydration * 1  0/164 (0.00%)  0 2/166 (1.20%)  2
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  0/164 (0.00%)  0 1/166 (0.60%)  1
Neck pain * 1  0/164 (0.00%)  0 1/166 (0.60%)  1
Osteoarthritis * 1  0/164 (0.00%)  0 1/166 (0.60%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Lung neoplasm malignant * 1  0/164 (0.00%)  0 1/166 (0.60%)  1
Serous cystadenocarcinoma ovary * 1  1/164 (0.61%)  1 0/166 (0.00%)  0
Nervous system disorders     
Basilar migraine * 1  0/164 (0.00%)  0 1/166 (0.60%)  1
Epilepsy * 1  0/164 (0.00%)  0 1/166 (0.60%)  1
Headache * 1  0/164 (0.00%)  0 2/166 (1.20%)  2
Syncope * 1  0/164 (0.00%)  0 1/166 (0.60%)  1
Typical aura without headache * 1  0/164 (0.00%)  0 1/166 (0.60%)  1
Pregnancy, puerperium and perinatal conditions     
Pregnancy * 1  0/164 (0.00%)  0 1/166 (0.60%)  1
Psychiatric disorders     
Depression * 1  0/164 (0.00%)  0 1/166 (0.60%)  1
Suicide attempt * 1  1/164 (0.61%)  1 0/166 (0.00%)  0
Renal and urinary disorders     
Calculus urinary * 1  0/164 (0.00%)  0 1/166 (0.60%)  1
Nephrolithiasis * 1  1/164 (0.61%)  1 0/166 (0.00%)  0
Renal colic * 1  0/164 (0.00%)  0 1/166 (0.60%)  1
Reproductive system and breast disorders     
Gynaecomastia * 1  1/164 (0.61%)  1 0/166 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease * 1  0/164 (0.00%)  0 1/166 (0.60%)  1
Pulmonary embolism * 1  1/164 (0.61%)  1 0/166 (0.00%)  0
1
Term from vocabulary, MedDRA 19.1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
SHP647 75 mg SHP647 225 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   116/164 (70.73%)      119/166 (71.69%)    
Gastrointestinal disorders     
Abdominal pain * 1  9/164 (5.49%)  14 20/166 (12.05%)  33
Colitis ulcerative * 1  41/164 (25.00%)  52 36/166 (21.69%)  50
Diarrhoea * 1  11/164 (6.71%)  13 7/166 (4.22%)  11
Nausea * 1  8/164 (4.88%)  10 19/166 (11.45%)  20
Vomiting * 1  10/164 (6.10%)  10 7/166 (4.22%)  7
General disorders     
Influenza like illness * 1  8/164 (4.88%)  11 9/166 (5.42%)  10
Pyrexia * 1  14/164 (8.54%)  20 7/166 (4.22%)  10
Infections and infestations     
Bronchitis * 1  10/164 (6.10%)  12 8/166 (4.82%)  12
Clostridium difficile infection * 1  11/164 (6.71%)  12 4/166 (2.41%)  4
Gastroenteritis * 1  18/164 (10.98%)  25 13/166 (7.83%)  17
Influenza * 1  8/164 (4.88%)  9 15/166 (9.04%)  19
Nasopharyngitis * 1  20/164 (12.20%)  27 28/166 (16.87%)  44
Pharyngitis * 1  2/164 (1.22%)  2 17/166 (10.24%)  20
Sinusitis * 1  7/164 (4.27%)  11 10/166 (6.02%)  14
Upper respiratory tract infection * 1  23/164 (14.02%)  34 20/166 (12.05%)  35
Urinary tract infection * 1  11/164 (6.71%)  15 10/166 (6.02%)  12
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  27/164 (16.46%)  41 29/166 (17.47%)  42
Back pain * 1  12/164 (7.32%)  15 18/166 (10.84%)  20
Nervous system disorders     
Headache * 1  17/164 (10.37%)  23 21/166 (12.65%)  56
Respiratory, thoracic and mediastinal disorders     
Cough * 1  20/164 (12.20%)  20 11/166 (6.63%)  12
Skin and subcutaneous tissue disorders     
Rash * 1  8/164 (4.88%)  9 13/166 (7.83%)  13
1
Term from vocabulary, MedDRA 19.1
*
Indicates events were collected by non-systematic assessment
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: Shire
ClinicalTrials.gov Identifier: NCT01771809    
Other Study ID Numbers: A7281010
2012-002031-28 ( EudraCT Number )
TURANDOT II ( Other Identifier: Alias Study Number )
First Submitted: January 8, 2013
First Posted: January 18, 2013
Results First Submitted: December 11, 2018
Results First Posted: April 18, 2019
Last Update Posted: April 18, 2019