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Trial record 18 of 22322 for:    Placebo AND subjects

A Safety Study to Assess the Effects of Therapeutic and Supratherapeutic Exenatide Concentrations on QT Interval in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT01297062
Recruitment Status : Completed
First Posted : February 16, 2011
Results First Posted : May 31, 2012
Last Update Posted : April 14, 2015
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor)
Condition Healthy Subjects
Interventions Drug: Exenatide
Drug: Moxifloxacin
Drug: Placebo comparator
Enrollment 94
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo-Exenatide-Moxifloxacin Sequence Exenatide-Moxifloxacin-Placebo Sequence Moxifloxacin-Placebo-Exenatide Sequence Moxifloxacin-Exenatide-Placebo Sequence Placebo-Moxifloxacin-Exenatiden Sequence Exenatide-Placebo-Moxifloxacin Sequence Non-Randomized
Hide Arm/Group Description

Placebo comparator in Period I; Exenatide in Period II; Moxifloxacin with placebo infusion in Period III;

Exenatide - stepped intravenous (IV) infusion to gradually deliver levels of exenatide at concentrations of approximately 200 pg/mL (Day 1), 300 pg/mL (Day 2), and 500 pg/mL (Day 3)

Moxifloxacin - Placebo intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) with single oral dose of Moxifloxacin (400 mg) on Day 2

Placebo - intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) on Day 1, Day 2, and Day 3

Exenatide in Period I; Moxifloxacin with placebo infusion in Period II; Placebo comparator in Period III

Exenatide - stepped intravenous (IV) infusion to gradually deliver levels of exenatide at concentrations of approximately 200 pg/mL (Day 1), 300 pg/mL (Day 2), and 500 pg/mL (Day 3)

Moxifloxacin - Placebo intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) with single oral dose of Moxifloxacin (400 mg) on Day 2

Placebo - intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) on Day 1, Day 2, and Day 3

Moxifloxacin with placebo infusion in Period I; Placebo comparator in Period II; Exenatide in Period III

Exenatide - stepped intravenous (IV) infusion to gradually deliver levels of exenatide at concentrations of approximately 200 pg/mL (Day 1), 300 pg/mL (Day 2), and 500 pg/mL (Day 3)

Moxifloxacin - Placebo intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) with single oral dose of Moxifloxacin (400 mg) on Day 2

Placebo - intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) on Day 1, Day 2, and Day 3

Moxifloxacin with placebo infusion in Period I; Exenatide in Period II; Placebo comparator in Period III

Exenatide - stepped intravenous (IV) infusion to gradually deliver levels of exenatide at concentrations of approximately 200 pg/mL (Day 1), 300 pg/mL (Day 2), and 500 pg/mL (Day 3)

Moxifloxacin - Placebo intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) with single oral dose of Moxifloxacin (400 mg) on Day 2

Placebo - intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) on Day 1, Day 2, and Day 3

Placebo comparator in Period I; Moxifloxacin with placebo infusion in Period II; Exenatide in Period III

Exenatide - stepped intravenous (IV) infusion to gradually deliver levels of exenatide at concentrations of approximately 200 pg/mL (Day 1), 300 pg/mL (Day 2), and 500 pg/mL (Day 3)

Moxifloxacin - Placebo intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) with single oral dose of Moxifloxacin (400 mg) on Day 2

Placebo - intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) on Day 1, Day 2, and Day 3

Exenatide in Period I; Placebo comparator in Period II; Moxifloxacin with placebo infusion in Period III

Exenatide - stepped intravenous (IV) infusion to gradually deliver levels of exenatide at concentrations of approximately 200 pg/mL (Day 1), 300 pg/mL (Day 2), and 500 pg/mL (Day 3)

Moxifloxacin - Placebo intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) with single oral dose of Moxifloxacin (400 mg) on Day 2

Placebo - intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) on Day 1, Day 2, and Day 3

Not Randomized
Period Title: Overall Study
Started 15 14 14 14 15 14 8
Intent to Treat (ITT) 15 14 14 14 15 14 0
Evaluable Population 11 12 12 13 13 13 0
Completed 11 13 12 13 13 13 0
Not Completed 4 1 2 1 2 1 8
Reason Not Completed
Adverse Event             2             0             1             0             0             0             0
Physician Decision             1             0             1             0             0             0             6
Protocol Violation             0             0             0             0             1             0             0
Subject Decision             1             1             0             1             1             1             2
Arm/Group Title Placebo-Exenatide-Moxifloxacin Sequence Exenatide-Moxifloxacin-Placebo Sequence Moxifloxacin-Placebo-Exenatide Sequence Moxifloxacin-Exenatide-Placebo Sequence Placebo-Moxifloxacin-Exenatiden Sequence Exenatide-Placebo-Moxifloxacin Sequence Total
Hide Arm/Group Description Placebo comparator in Period I; Exenatide in Period II; Moxifloxacin with placebo infusion in Period III Exenatide in Period I; Moxifloxacin with placebo infusion in Period II; Placebo comparator in Period III Moxifloxacin with placebo infusion in Period I; Placebo comparator in Period II; Exenatide in Period III Moxifloxacin with placebo infusion in Period I; Exenatide in Period II; Placebo comparator in Period III Placebo comparator in Period I; Moxifloxacin with placebo infusion in Period II; Exenatide in Period III Exenatide in Period I; Placebo comparator in Period II; Moxifloxacin with placebo infusion in Period III Total of all reporting groups
Overall Number of Baseline Participants 15 14 14 14 15 14 86
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 14 participants 14 participants 14 participants 15 participants 14 participants 86 participants
41.5  (8.98) 45.1  (11.43) 43.7  (11.56) 37.8  (10.66) 43.3  (13.74) 41.0  (10.50) 42.1  (11.16)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 14 participants 14 participants 14 participants 15 participants 14 participants 86 participants
Female
0
   0.0%
2
  14.3%
3
  21.4%
0
   0.0%
2
  13.3%
1
   7.1%
8
   9.3%
Male
15
 100.0%
12
  85.7%
11
  78.6%
14
 100.0%
13
  86.7%
13
  92.9%
78
  90.7%
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilogram
Number Analyzed 15 participants 14 participants 14 participants 14 participants 15 participants 14 participants 86 participants
87.66  (8.107) 81.16  (11.235) 90.77  (12.375) 93.66  (11.704) 89.71  (7.726) 90.71  (11.251) 88.94  (10.899)
1.Primary Outcome
Title Comparison of Least Squares (LS) Mean Changes From Baseline in Population-based Corrected QT Intervals (QTcP) Between Exenatide and Placebo on Day 1 Averaged Over 1300h, 1400h, 1500h (Target Steady State Exenatide Concentration of 200 pg/mL)
Hide Description Factors in QT correction formulas were first estimated using pre-therapy data. The most appropriate correction method (QTcP) minimized the mean squared individual QTc/RR regression slope with on-exenatide data. Adequacy of correction was validated with on-placebo data. Change from baseline in QTcP was analyzed by a mixed-effects model for repeated measures (MMRM) between exenatide and placebo.
Time Frame Baseline, Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable Population included all ITT subjects who completed all ECG assessment periods and have valid ECG measurements and no vomiting in any ECG data extraction window. No missing value was imputed.
Arm/Group Title Exenatide Placebo
Hide Arm/Group Description:
Exenatide
Placebo Comparator
Overall Number of Participants Analyzed 74 74
Least Squares Mean (90% Confidence Interval)
Unit of Measure: msec
-2.25
(-3.30 to -1.20)
-0.89
(-1.88 to 0.10)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exenatide, Placebo
Comments 60 evaluable subjects gives more than 90% power to show non-inferiority of exenatide versus placebo, using t-test in 2-way crossover, alpha=0.05, true difference of 5 msec, and standard deviation of the within-subject difference of 10.04 msec.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority is established if the upper limit of 2-sided 90% confidence interval (CI), equivalent to the upper limit of 1-sided 95% CI, for change from baseline in QTcP (exenatide - placebo) is below 10 msec.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments No adjustment on CI for the primary outcome measure.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -1.36
Confidence Interval (2-Sided) 90%
-2.21 to -0.50
Estimation Comments The MMRM includes Treatment (Exenatide versus Placebo), Day, Time, Period, Sequence, and Day-Time-Treatment interaction as fixed effects, subject random intercept.
2.Primary Outcome
Title Comparison of LS Mean Changes From Baseline in QTcP Intervals Between Exenatide and Placebo on Day 2 Averaged Over 1300h, 1400h, 1500h (Target Steady State Exenatide Concentration of 300 pg/mL)
Hide Description Factors in QT correction formulas were first estimated using pre-therapy data. The most appropriate correction method (QTcP) minimized the mean squared individual QTc/RR regression slope with on-exenatide data. Adequacy of correction was validated with on-placebo data. Change from baseline in QTcP was analyzed by a MMRM between exenatide and placebo.
Time Frame Baseline, Day 2
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable Population. No imputation for missing value was used.
Arm/Group Title Exenatide Placebo
Hide Arm/Group Description:
Exenatide
Placebo Comparator
Overall Number of Participants Analyzed 74 74
Least Squares Mean (90% Confidence Interval)
Unit of Measure: msec
-2.58
(-3.64 to -1.52)
-0.56
(-1.54 to 0.43)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exenatide, Placebo
Comments 60 evaluable subjects gives more than 90% power to show non-inferiority of exenatide versus placebo, using t-test in 2-way crossover, alpha=0.05, true difference of 5 msec, and standard deviation of the within-subject difference of 10.04 msec.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority is established if the upper limit of 2-sided 90% CI, equivalent to the upper limit of 1-sided 95% CI, for change from baseline in QTcP (exenatide - placebo) is below 10 msec.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments No adjustment on CI for the primary outcome measure.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -2.02
Confidence Interval (2-Sided) 90%
-2.88 to -1.16
Estimation Comments The MMRM includes Treatment (Exenatide versus Placebo), Day, Time, Period, Sequence, and Day-Time-Treatment interaction as fixed effects, subject random intercept.
3.Primary Outcome
Title Comparison of LS Mean Changes From Baseline in QTcP Intervals Between Exenatide and Placebo on Day 3 Averaged Over 1300h, 1400h, 1500h (Target Steady State Exenatide Concentration of 500 pg/mL)
Hide Description Factors in QT correction formulas were first estimated using pre-therapy data. The most appropriate correction method (QTcP) minimized the mean squared individual QTc/RR regression slope with on-exenatide data. Adequacy of correction was validated with on-placebo data. Change from baseline in QTcP was analyzed by a MMRM between exenatide and placebo.
Time Frame Baseline, Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable Population. No imputation for missing value was used.
Arm/Group Title Exenatide Placebo
Hide Arm/Group Description:
Exenatide
Placebo Comparator
Overall Number of Participants Analyzed 74 74
Least Squares Mean (90% Confidence Interval)
Unit of Measure: msec
-3.54
(-4.66 to -2.42)
-2.41
(-3.44 to -1.38)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exenatide, Placebo
Comments 60 evaluable subjects gives more than 90% power to show non-inferiority of exenatide versus placebo, using t-test in 2-way crossover, alpha=0.05, true difference of 5 msec, and standard deviation of the within-subject difference of 10.04 msec.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority is established if the upper limit of 2-sided 90% CI, equivalent to the upper limit of 1-sided 95% CI, for change from baseline in QTcP (exenatide - placebo) is below 10 msec.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments No adjustment on CI for the primary outcome measure.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -1.13
Confidence Interval (2-Sided) 90%
-2.11 to -0.15
Estimation Comments The MMRM includes Treatment (Exenatide versus Placebo), Day, Time, Period, Sequence, and Day-Time-Treatment interaction as fixed effects, subject random intercept.
4.Secondary Outcome
Title Assay Sensitivity of Moxifloxacin at 1000h (1 Hour Post-administration of Moxifloxacin) on Day 2
Hide Description Change from baseline in QTcP was analyzed by a MMRM between moxifloxacin and placebo.
Time Frame Baseline, Day 2
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable Population. No imputation for missing value was used.
Arm/Group Title Moxifloxacin Placebo
Hide Arm/Group Description:
Moxifloxacin with placebo infusion
Placebo Comparator
Overall Number of Participants Analyzed 74 74
Least Squares Mean (90% Confidence Interval)
Unit of Measure: msec
1.91
(0.12 to 3.70)
-3.56
(-5.14 to -1.98)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Moxifloxacin, Placebo
Comments Assay sensitivity of moxifloxacin is established if the lower limit of the 2-sided 90% CI for difference in change from baseline in QTcP (moxifloxacin - placebo) is greater than 5 msec.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 5.47
Confidence Interval (2-Sided) 90%
2.82 to 8.12
Estimation Comments The MMRM includes Treatment (Moxifloxacin versus Placebo), Time, Period, Sequence, and Time-Treatment interaction as fixed effects, subject random intercept. Multiplicity adjusted CI for the mean difference is shown.
5.Secondary Outcome
Title Assay Sensitivity of Moxifloxacin at 1100h (2 Hour Post-administration of Moxifloxacin) on Day 2
Hide Description Change from baseline in QTcP was analyzed by a MMRM between moxifloxacin and placebo.
Time Frame Baseline, Day 2
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable Population. No imputation for missing value was used.
Arm/Group Title Moxifloxacin Placebo
Hide Arm/Group Description:
Moxifloxacin with placebo infusion
Placebo Comparator
Overall Number of Participants Analyzed 74 74
Least Squares Mean (90% Confidence Interval)
Unit of Measure: msec
9.75
(8.20 to 11.30)
-0.81
(-2.26 to 0.63)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Moxifloxacin, Placebo
Comments Assay sensitivity of moxifloxacin is established if the lower limit of the 2-sided 90% CI for difference in change from baseline in QTcP (moxifloxacin - placebo) is greater than 5 msec.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 10.56
Confidence Interval (2-Sided) 90%
8.46 to 12.67
Estimation Comments The MMRM includes Treatment (Moxifloxacin versus Placebo), Time, Period, Sequence, and Time-Treatment interaction as fixed effects, subject random intercept. Multiplicity adjusted CI for the mean difference is shown.
6.Secondary Outcome
Title Assay Sensitivity of Moxifloxacin at 1200h (3 Hour Post-administration of Moxifloxacin) on Day 2
Hide Description Change from baseline in QTcP was analyzed by a MMRM between moxifloxacin and placebo.
Time Frame Baseline, Day 2
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable Population. No imputation for missing value was used.
Arm/Group Title Moxifloxacin Placebo
Hide Arm/Group Description:
Moxifloxacin with placebo infusion
Placebo Comparator
Overall Number of Participants Analyzed 74 74
Least Squares Mean (90% Confidence Interval)
Unit of Measure: msec
12.47
(10.79 to 14.15)
1.56
(0.18 to 2.93)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Moxifloxacin, Placebo
Comments Assay sensitivity of moxifloxacin is established if the lower limit of the 2-sided 90% CI for difference in change from baseline in QTcP (moxifloxacin - placebo) is greater than 5 msec.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 10.92
Confidence Interval (2-Sided) 90%
8.71 to 13.13
Estimation Comments The MMRM includes Treatment (Moxifloxacin versus Placebo), Time, Period, Sequence, and Time-Treatment interaction as fixed effects, subject random intercept. Multiplicity adjusted CI for the mean difference is shown.
7.Secondary Outcome
Title Number of Subjects With QTcP Interval >450msec at Any Timepoint on Any Day in Exenatide and Placebo
Hide Description Number of subjects with QTcP > 450 msec at any timepoint on any day was summarized by frequency for exenatide and placebo.
Time Frame Day 1, 2, or 3
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable Population. No imputation for missing value was used.
Arm/Group Title Exenatide Placebo
Hide Arm/Group Description:
Exenatide
Placebo Comparator
Overall Number of Participants Analyzed 74 74
Measure Type: Number
Unit of Measure: participants
0 0
8.Secondary Outcome
Title Number of Subjects With Increase of QTcP Interval From Baseline >30msec at Any Timepoint on Any Day in Exenatide and Placebo
Hide Description Number of subjects with increase of QTcP interval from baseline >30 msec at any timepoint on any day was summarized by frequency for exenatide and placebo.
Time Frame Baseline, Day 1, 2, or 3
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable Population. No imputation for missing value was used.
Arm/Group Title Exenatide Placebo
Hide Arm/Group Description:
Exenatide
Placebo Comparator
Overall Number of Participants Analyzed 74 74
Measure Type: Number
Unit of Measure: particpants
0 0
9.Secondary Outcome
Title Plasma Exenatide Concentrations at Steady State on Day 1, 2 and 3
Hide Description The plasma exenatide concentration at steady state was descriptively summarized by geometric mean, standard error, and its effect on placebo-adjusted change from baseline in QTcP was assessed.
Time Frame Baseline, Day 1, 2, and 3
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable Population. No imputation for missing value was used. Day 1, 2, and 3 exenatide concentration < LLOQ was set to missing.
Arm/Group Title Exenatide
Hide Arm/Group Description:
Exenatide
Overall Number of Participants Analyzed 68
Geometric Mean (Standard Error)
Unit of Measure: pg/mL
Day 1 252.74  (8.454)
Day 2 399.14  (11.936)
Day 3 626.65  (21.159)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exenatide
Comments The analysis is to test the significance of the linear regression slope (null hypothesis: slope equal to zero) between placebo-adjusted change from baseline in QTcP and exenatide concentration.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5962
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value 0.0008
Confidence Interval (2-Sided) 90%
-0.0017 to 0.0033
Estimation Comments The linear mixed-effects model includes placebo-adjusted change from baseline in QTcP as response, plasma exenatide concentration as covariate, fixed intercept of zero, subject random slope.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Exenatide Placebo Moxifloxacin
Hide Arm/Group Description Exenatide Placebo Comparator Moxifloxacin with placebo infusion
All-Cause Mortality
Exenatide Placebo Moxifloxacin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Exenatide Placebo Moxifloxacin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/80 (0.00%)   0/84 (0.00%)   1/80 (1.25%) 
Investigations       
BLOOD CREATINE PHOSPHOKINASE INCREASED * 1  0/80 (0.00%)  0/84 (0.00%)  1/80 (1.25%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Exenatide Placebo Moxifloxacin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   65/80 (81.25%)   10/84 (11.90%)   8/80 (10.00%) 
Gastrointestinal disorders       
NAUSEA * 1  36/80 (45.00%)  1/84 (1.19%)  2/80 (2.50%) 
VOMITING * 1  23/80 (28.75%)  0/84 (0.00%)  1/80 (1.25%) 
GASTROOESOPHAGEAL REFLUX DISEASE * 1  18/80 (22.50%)  3/84 (3.57%)  2/80 (2.50%) 
DYSPEPSIA * 1  14/80 (17.50%)  2/84 (2.38%)  0/80 (0.00%) 
ABDOMINAL DISTENSION * 1  8/80 (10.00%)  0/84 (0.00%)  0/80 (0.00%) 
CONSTIPATION * 1  7/80 (8.75%)  0/84 (0.00%)  0/80 (0.00%) 
ABDOMINAL PAIN * 1  6/80 (7.50%)  0/84 (0.00%)  0/80 (0.00%) 
DIARRHOEA * 1  4/80 (5.00%)  0/84 (0.00%)  1/80 (1.25%) 
General disorders       
EARLY SATIETY * 1  4/80 (5.00%)  0/84 (0.00%)  0/80 (0.00%) 
Metabolism and nutrition disorders       
DECREASED APPETITE * 1  15/80 (18.75%)  0/84 (0.00%)  0/80 (0.00%) 
Nervous system disorders       
HEADACHE * 1  16/80 (20.00%)  6/84 (7.14%)  2/80 (2.50%) 
DYSGEUSIA * 1  7/80 (8.75%)  0/84 (0.00%)  2/80 (2.50%) 
DIZZINESS * 1  6/80 (7.50%)  1/84 (1.19%)  0/80 (0.00%) 
Skin and subcutaneous tissue disorders       
DERMATITIS CONTACT * 1  5/80 (6.25%)  1/84 (1.19%)  1/80 (1.25%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.1
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.
Results Point of Contact
Name/Title: Peter Ohman, Medical Science Director
Organization: AstraZeneca
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01297062     History of Changes
Other Study ID Numbers: BCB112
First Submitted: February 9, 2011
First Posted: February 16, 2011
Results First Submitted: April 27, 2012
Results First Posted: May 31, 2012
Last Update Posted: April 14, 2015