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Phase II Dose Finding Study of RDEA3170 Versus Placebo in Japanese Patients With Gout or Asymptomatic Hyperuricemia

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ClinicalTrials.gov Identifier: NCT02078219
Recruitment Status : Completed
First Posted : March 5, 2014
Results First Posted : September 24, 2019
Last Update Posted : September 24, 2019
Sponsor:
Collaborator:
Ardea Biosciences, Inc.
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Gout and Hyperuricemia
Interventions Drug: RDEA3170
Drug: Allopurinol
Drug: Placebo
Enrollment 204
Recruitment Details Of the 381 subjects who were screened in the study, 204 were randomized into one of the treatment groups. All 204 randomized subjects received at least 1 dose of randomized study medication. The first patient was enrolled on 11 March 2014 and the last enrolled patient completed the Last visit on 13 March 2015.
Pre-assignment Details 204 were randomized into one of the following treatment groups; allopurinol, placebo, RDEA3170 Group 1, Group 2 and Group 3. Of the enrolled subjects, 177 were withdrawn prior to randomization because of ‘eligibility criteria not fulfill’ (176 subjects) or ‘patient decision’ (1 subject).
Arm/Group Title Allopurinol 200 mg Treatment Group RDEA3170 Placebo Treatment Group RDEA3170 Treatment Group 1 RDEA3170 Treatment Group 2 RDEA3170 Treatment Group 3
Hide Arm/Group Description 100 mg qd for 4 weeks and allopurinol 100 mg bid for 20 weeks RDEA3170 matching placebo qd for 24 weeks RDEA3170 2.5 mg once daily (qd) for 4 weeks followed by RDEA3170 5 mg qd for 12 weeks followed by RDEA3170 7.5 mg qd for 8 weeks RDEA3170 2.5 mg qd for 4 weeks followed by RDEA3170 5 mg qd for 4 weeks followed by RDEA3170 10 mg qd for 8 weeks followed by RDEA3170 12.5 mg qd for 8 weeks RDEA3170 2.5 mg qd for 4 weeks followed by RDEA3170 5 mg qd for 4 weeks followed by RDEA3170 12.5 mg qd for 8 weeks followed by RDEA3170 15 mg qd for 8 weeks
Period Title: Overall Study
Started 41 40 41 41 41
Completed 38 36 35 37 39
Not Completed 3 4 6 4 2
Reason Not Completed
Other             2             2             3             0             1
Withdrawal by Subject             0             1             0             1             1
Protocol Violation             0             0             0             1             0
Death             0             0             0             1             0
Adverse Event             1             1             3             1             0
Arm/Group Title Allopurinol 200 mg Treatment Group RDEA3170 Placebo Treatment Group RDEA3170 Treatment Group 1 RDEA3170 Treatment Group 2 RDEA3170 Treatment Group 3 Total
Hide Arm/Group Description 100 mg qd for 4 weeks and allopurinol 100 mg bid for 20 weeks RDEA3170 matching placebo qd for 24 weeks RDEA3170 2.5 mg once daily (qd) for 4 weeks followed by RDEA3170 5 mg qd for 12 weeks followed by RDEA3170 7.5 mg qd for 8 weeks RDEA3170 2.5 mg qd for 4 weeks followed by RDEA3170 5 mg qd for 4 weeks followed by RDEA3170 10 mg qd for 8 weeks followed by RDEA3170 12.5 mg qd for 8 weeks RDEA3170 2.5 mg qd for 4 weeks followed by RDEA3170 5 mg qd for 4 weeks followed by RDEA3170 12.5 mg qd for 8 weeks followed by RDEA3170 15 mg qd for 8 weeks Total of all reporting groups
Overall Number of Baseline Participants 41 40 41 41 41 204
Hide Baseline Analysis Population Description
No subject was excluded from the safety and efficacy analysis sets. Some data points of 3 subjects who have incompliance were excluded from the PK analyses due to incorrect dose of RDEA3170
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 41 participants 40 participants 41 participants 41 participants 41 participants 204 participants
51.0  (10.6) 54.5  (10.3) 51.3  (9.3) 52.7  (10.0) 52.3  (10.7) 52.3  (10.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 40 participants 41 participants 41 participants 41 participants 204 participants
Female
0
   0.0%
1
   2.5%
0
   0.0%
1
   2.4%
2
   4.9%
4
   2.0%
Male
41
 100.0%
39
  97.5%
41
 100.0%
40
  97.6%
39
  95.1%
200
  98.0%
1.Primary Outcome
Title Percent Changes of Serum Uric Acid Levels From Baseline Levels
Hide Description The primary objective of the study is to compare percent changes of serum uric acid levels from baseline levels after 16 weeks of dosing between RDEA3170 treatment groups and the placebo treatment group.
Time Frame Baseline and Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis set
Arm/Group Title RDEA3170 Treatment Group 1 RDEA3170 Treatment Group 2 RDEA3170 Treatment Group 3 RDEA3170 Placebo Treatment Group Allopurinol 200 mg Treatment Group
Hide Arm/Group Description:
RDEA3170 2.5 mg once daily (qd) for 4 weeks followed by RDEA3170 5 mg qd for 12 weeks followed by RDEA3170 7.5 mg qd for 8 weeks
RDEA3170 2.5 mg qd for 4 weeks followed by RDEA3170 5 mg qd for 4 weeks followed by RDEA3170 10 mg qd for 8 weeks followed by RDEA3170 12.5 mg qd for 8 weeks
RDEA3170 2.5 mg qd for 4 weeks followed by RDEA3170 5 mg qd for 4 weeks followed by RDEA3170 12.5 mg qd for 8 weeks followed by RDEA3170 15 mg qd for 8 weeks
RDEA3170 matching placebo qd for 24 weeks
Allopurinol 100 mg qd for 4 weeks followed by allopurinol 100 mg twice daily (bid) for 20 weeks
Overall Number of Participants Analyzed 41 41 41 40 41
Mean (Standard Deviation)
Unit of Measure: Percent change
-30.93  (17.80) -49.91  (18.38) -54.32  (13.40) -2.05  (9.29) -39.09  (11.54)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RDEA3170 Treatment Group 1, RDEA3170 Placebo Treatment Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA, LOCF
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -29.28
Confidence Interval (2-Sided) 95%
-36.99 to -21.57
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection RDEA3170 Treatment Group 2, RDEA3170 Placebo Treatment Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA, LOCF
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -49.25
Confidence Interval (2-Sided) 95%
-56.97 to -41.52
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection RDEA3170 Treatment Group 3, RDEA3170 Placebo Treatment Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA, LOCF
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -53.33
Confidence Interval (2-Sided) 95%
-61.00 to -45.67
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL
Hide Description To compare the percentage of subjects whose serum uric acid levels are ≤ 6.0 mg/dL between RDEA3170 treatment groups and the placebo treatment group at each study visit
Time Frame Weeks 1,2,4,6,8,10,12,16,18,20,24
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis set
Arm/Group Title RDEA3170 Treatment Group 1 RDEA3170 Treatment Group 2 RDEA3170 Treatment Group 3 RDEA3170 Placebo Treatment Group Allopurinol 200 mg Treatment Group
Hide Arm/Group Description:
RDEA3170 2.5 mg once daily (qd) for 4 weeks followed by RDEA3170 5 mg qd for 12 weeks followed by RDEA3170 7.5 mg qd for 8 weeks
RDEA3170 2.5 mg qd for 4 weeks followed by RDEA3170 5 mg qd for 4 weeks followed by RDEA3170 10 mg qd for 8 weeks followed by RDEA3170 12.5 mg qd for 8 weeks
RDEA3170 2.5 mg qd for 4 weeks followed by RDEA3170 5 mg qd for 4 weeks followed by RDEA3170 12.5 mg qd for 8 weeks followed by RDEA3170 15 mg qd for 8 weeks
RDEA3170 matching placebo qd for 24 weeks
Allopurinol 100 mg qd for 4 weeks followed by allopurinol 100 mg twice daily (bid) for 20 weeks
Overall Number of Participants Analyzed 41 41 41 40 41
Measure Type: Number
Unit of Measure: % subjects
Week 1 26.8 31.7 39.0 0 19.5
Week 2 29.3 34.1 34.1 0 19.5
Week 4 26.8 31.7 39.0 0 17.1
Week 6 70.7 61.0 82.9 0 73.2
Week 8 53.7 56.1 78.0 0 65.9
Week 10 46.3 78.0 92.7 0 61.0
Week 12 53.7 85.4 92.7 0 75.6
Week 16 51.2 95.1 97.6 0 78.0
Week 18 63.4 92.7 95.1 0 73.2
Week 20 61.0 82.9 92.7 0 78.0
Week 24 68.3 82.9 87.8 0 75.6
3.Secondary Outcome
Title Percent Change in sUA
Hide Description To compare percent change in sUA at each study visit.
Time Frame Baseline, Weeks 1,2,4,6,8,10,12,16,18,20,24
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis set
Arm/Group Title RDEA3170 Treatment Group 1 RDEA3170 Treatment Group 2 RDEA3170 Treatment Group 3 RDEA3170 Placebo Treatment Group Allopurinol 200 mg Treatment Group
Hide Arm/Group Description:
RDEA3170 2.5 mg once daily (qd) for 4 weeks followed by RDEA3170 5 mg qd for 12 weeks followed by RDEA3170 7.5 mg qd for 8 weeks
RDEA3170 2.5 mg qd for 4 weeks followed by RDEA3170 5 mg qd for 4 weeks followed by RDEA3170 10 mg qd for 8 weeks followed by RDEA3170 12.5 mg qd for 8 weeks
RDEA3170 2.5 mg qd for 4 weeks followed by RDEA3170 5 mg qd for 4 weeks followed by RDEA3170 12.5 mg qd for 8 weeks followed by RDEA3170 15 mg qd for 8 weeks
RDEA3170 matching placebo qd for 24 weeks
Allopurinol 100 mg qd for 4 weeks followed by allopurinol 100 mg twice daily (bid) for 20 weeks
Overall Number of Participants Analyzed 41 41 41 40 41
Mean (Standard Deviation)
Unit of Measure: % Change
Week 1 -19.72  (10.93) -20.29  (17.51) -19.93  (22.98) -0.25  (8.57) -20.74  (7.72)
Week 2 -21.03  (11.87) -20.28  (16.87) -20.93  (10.68) -0.53  (7.20) -20.80  (9.37)
Week 4 -22.95  (10.86) -19.66  (17.24) -24.21  (10.69) 0.97  (8.70) -20.60  (8.83)
Week 6 -32.05  (13.05) -31.26  (19.83) -35.24  (10.74) -0.01  (9.86) -37.06  (8.72)
Week 8 -27.94  (16.54) -30.19  (19.22) -32.11  (13.96) 0.55  (9.50) -36.51  (11.14)
Week 10 -24.69  (18.81) -37.61  (18.35) -44.38  (12.33) -0.27  (9.53) -33.42  (11.28)
Week 12 -28.08  (18.22) -45.77  (17.94) -51.17  (16.19) 0.43  (7.89) -37.96  (10.65)
Week 16 -30.93  (17.80) -49.91  (18.38) -54.32  (13.40) -2.05  (9.29) -39.09  (11.54)
Week 18 -32.94  (18.11) -49.04  (19.19) -54.70  (13.32) -2.86  (8.55) -38.59  (10.32)
Week 20 -32.96  (18.69) -47.20  (21.46) -53.60  (12.92) -2.27  (8.76) -38.00  (11.11)
Week 24 -35.73  (19.49) -47.34  (21.39) -54.46  (18.97) -4.67  (10.36) -37.77  (11.47)
4.Secondary Outcome
Title Absolute Change of Serum Uric Acid Levels From Baseline Levels
Hide Description To compare the absolute change of serum uric acid levels from baseline levels
Time Frame Baseline, Weeks 1,2,4,6,8,10,12,16,18,20,24
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis set
Arm/Group Title RDEA3170 Treatment Group 1 RDEA3170 Treatment Group 2 RDEA3170 Treatment Group 3 RDEA3170 Placebo Treatment Group Allopurinol 200 mg Treatment Group
Hide Arm/Group Description:
RDEA3170 2.5 mg once daily (qd) for 4 weeks followed by RDEA3170 5 mg qd for 12 weeks followed by RDEA3170 7.5 mg qd for 8 weeks
RDEA3170 2.5 mg qd for 4 weeks followed by RDEA3170 5 mg qd for 4 weeks followed by RDEA3170 10 mg qd for 8 weeks followed by RDEA3170 12.5 mg qd for 8 weeks
RDEA3170 2.5 mg qd for 4 weeks followed by RDEA3170 5 mg qd for 4 weeks followed by RDEA3170 12.5 mg qd for 8 weeks followed by RDEA3170 15 mg qd for 8 weeks
RDEA3170 matching placebo qd for 24 weeks
Allopurinol 100 mg qd for 4 weeks followed by allopurinol 100 mg twice daily (bid) for 20 weeks
Overall Number of Participants Analyzed 41 41 41 40 41
Mean (Standard Deviation)
Unit of Measure: mg/dL
Week 1 Number Analyzed 41 participants 41 participants 41 participants 40 participants 40 participants
-1.68  (1.01) -1.74  (1.48) -1.68  (2.10) -0.05  (0.77) -1.82  (0.73)
Week 2 Number Analyzed 41 participants 41 participants 41 participants 40 participants 41 participants
-1.81  (1.11) -1.75  (1.45) -1.78  (0.98) -0.07  (0.64) -1.83  (0.90)
Week 4 Number Analyzed 41 participants 41 participants 41 participants 40 participants 41 participants
-2.01  (1.09) -1.72  (1.48) -2.07  (1.01) 0.06  (0.76) -1.83  (0.89)
Week 6 Number Analyzed 41 participants 41 participants 41 participants 40 participants 41 participants
-2.78  (1.34) -2.66  (1.73) -3.00  (1.09) -0.04  (0.81) -3.26  (0.93)
Week 8 Number Analyzed 41 participants 41 participants 41 participants 40 participants 41 participants
-2.44  (1.48) -2.61  (1.75) -2.74  (1.23) 0.02  (0.85) -3.22  (1.09)
Week 10 Number Analyzed 41 participants 41 participants 41 participants 40 participants 41 participants
-2.19  (1.65) -3.22  (1.78) -3.75  (1.19) -0.06  (0.79) -2.96  (1.13)
Week 12 Number Analyzed 41 participants 41 participants 41 participants 40 participants 41 participants
-2.44  (1.56) -3.85  (1.62) -4.33  (1.45) 0.02  (0.70) -3.35  (1.09)
Week 16 Number Analyzed 41 participants 41 participants 41 participants 40 participants 41 participants
-2.67  (1.48) -4.24  (1.82) -4.57  (1.28) -0.22  (0.81) -3.44  (1.10)
Week 18 Number Analyzed 41 participants 41 participants 41 participants 40 participants 41 participants
-2.86  (1.54) -4.17  (1.82) -4.62  (1.27) -0.27  (0.75) -3.40  (1.06)
Week 20 Number Analyzed 41 participants 41 participants 41 participants 40 participants 41 participants
-2.87  (1.61) -3.98  (1.97) -4.52  (1.15) -0.22  (0.75) -3.35  (1.15)
Week 24 Number Analyzed 41 participants 41 participants 41 participants 40 participants 41 participants
-3.10  (1.67) -3.99  (1.96) -4.57  (1.64) -0.42  (0.90) -3.31  (1.10)
Time Frame Adverse Events and serious adverse events will be collected from the time of informed consent throughout the treatment period and the follow-up period.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Allopurinol 200 mg Treatment Group RDEA3170 Placebo Treatment Group RDEA3170 Treatment Group 1 RDEA3170 Treatment Group 2 RDEA3170 Treatment Group 3
Hide Arm/Group Description allopurinol 100 mg qd for 4 weeks followed by allopurinol 100 mg twice daily (bid) for 20 weeks. RDEA3170 matching placebo qd for 24 weeks RDEA3170 2.5 mg once daily (qd) for 4 weeks followed by RDEA3170 5 mg qd for 12 weeks followed by RDEA3170 7.5 mg qd for 8 weeks RDEA3170 2.5 mg qd for 4 weeks followed by RDEA3170 5 mg qd for 4 weeks followed by RDEA3170 10 mg qd for 8 weeks followed by RDEA3170 12.5 mg qd for 8 weeks RDEA3170 2.5 mg qd for 4 weeks followed by RDEA3170 5 mg qd for 4 weeks followed by RDEA3170 12.5 mg qd for 8 weeks followed by RDEA3170 15 mg qd for 8 weeks
All-Cause Mortality
Allopurinol 200 mg Treatment Group RDEA3170 Placebo Treatment Group RDEA3170 Treatment Group 1 RDEA3170 Treatment Group 2 RDEA3170 Treatment Group 3
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Allopurinol 200 mg Treatment Group RDEA3170 Placebo Treatment Group RDEA3170 Treatment Group 1 RDEA3170 Treatment Group 2 RDEA3170 Treatment Group 3
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/41 (2.44%)   1/40 (2.50%)   1/41 (2.44%)   1/41 (2.44%)   0/41 (0.00%) 
Cardiac disorders           
Silent myocardial infarction  1  0/41 (0.00%)  0/40 (0.00%)  1/41 (2.44%)  0/41 (0.00%)  0/41 (0.00%) 
Hepatobiliary disorders           
Bile duct stone  1  1/41 (2.44%)  0/40 (0.00%)  0/41 (0.00%)  0/41 (0.00%)  0/41 (0.00%) 
Injury, poisoning and procedural complications           
Hand fracture  1  0/41 (0.00%)  1/40 (2.50%)  0/41 (0.00%)  0/41 (0.00%)  0/41 (0.00%) 
Nervous system disorders           
Subarachnoid haemorrhage  1  0/41 (0.00%)  0/40 (0.00%)  0/41 (0.00%)  1/41 (2.44%)  0/41 (0.00%) 
VIIth nerve paralysis  1  0/41 (0.00%)  0/40 (0.00%)  0/41 (0.00%)  1/41 (2.44%)  0/41 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA version 17.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Allopurinol 200 mg Treatment Group RDEA3170 Placebo Treatment Group RDEA3170 Treatment Group 1 RDEA3170 Treatment Group 2 RDEA3170 Treatment Group 3
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   22/41 (53.66%)   23/40 (57.50%)   26/41 (63.41%)   26/41 (63.41%)   21/41 (51.22%) 
Cardiac disorders           
Tachycardia  1  0/41 (0.00%)  0/40 (0.00%)  0/41 (0.00%)  0/41 (0.00%)  1/41 (2.44%) 
Silent myocardial infarction  1  0/41 (0.00%)  0/40 (0.00%)  1/41 (2.44%)  0/41 (0.00%)  0/41 (0.00%) 
Atrial fibrillation  1  1/41 (2.44%)  0/40 (0.00%)  0/41 (0.00%)  0/41 (0.00%)  0/41 (0.00%) 
Ear and labyrinth disorders           
Tinnitus  1  0/41 (0.00%)  1/40 (2.50%)  0/41 (0.00%)  0/41 (0.00%)  0/41 (0.00%) 
Vertigo positional  1  0/41 (0.00%)  1/40 (2.50%)  0/41 (0.00%)  0/41 (0.00%)  0/41 (0.00%) 
Eye disorders           
Conjunctivitis  1  0/41 (0.00%)  0/40 (0.00%)  0/41 (0.00%)  1/41 (2.44%)  0/41 (0.00%) 
Conjunctivitis allergic  1  0/41 (0.00%)  0/40 (0.00%)  0/41 (0.00%)  0/41 (0.00%)  1/41 (2.44%) 
Dry eye  1  0/41 (0.00%)  0/40 (0.00%)  0/41 (0.00%)  1/41 (2.44%)  0/41 (0.00%) 
Glaucoma  1  0/41 (0.00%)  0/40 (0.00%)  0/41 (0.00%)  0/41 (0.00%)  1/41 (2.44%) 
Gastrointestinal disorders           
Diarrhoea  1  1/41 (2.44%)  0/40 (0.00%)  1/41 (2.44%)  1/41 (2.44%)  2/41 (4.88%) 
Constipation  1  0/41 (0.00%)  0/40 (0.00%)  1/41 (2.44%)  2/41 (4.88%)  0/41 (0.00%) 
Abdominal discomfort  1  0/41 (0.00%)  0/40 (0.00%)  1/41 (2.44%)  0/41 (0.00%)  1/41 (2.44%) 
Abdominal pain  1  0/41 (0.00%)  0/40 (0.00%)  1/41 (2.44%)  0/41 (0.00%)  1/41 (2.44%) 
Enterocolitis  1  0/41 (0.00%)  0/40 (0.00%)  0/41 (0.00%)  1/41 (2.44%)  1/41 (2.44%) 
Abdominal pain upper  1  2/41 (4.88%)  0/40 (0.00%)  0/41 (0.00%)  0/41 (0.00%)  1/41 (2.44%) 
Gastritis  1  0/41 (0.00%)  2/40 (5.00%)  1/41 (2.44%)  0/41 (0.00%)  0/41 (0.00%) 
Gastritis erosive  1  0/41 (0.00%)  0/40 (0.00%)  1/41 (2.44%)  0/41 (0.00%)  0/41 (0.00%) 
Gastritis haemorrhagic  1  0/41 (0.00%)  0/40 (0.00%)  1/41 (2.44%)  0/41 (0.00%)  0/41 (0.00%) 
Haemorrhoids  1  0/41 (0.00%)  0/40 (0.00%)  0/41 (0.00%)  0/41 (0.00%)  1/41 (2.44%) 
Nausea  1  1/41 (2.44%)  0/40 (0.00%)  0/41 (0.00%)  1/41 (2.44%)  0/41 (0.00%) 
Stomatitis  1  0/41 (0.00%)  0/40 (0.00%)  1/41 (2.44%)  0/41 (0.00%)  0/41 (0.00%) 
Contact stomatitis  1  0/41 (0.00%)  0/40 (0.00%)  0/41 (0.00%)  0/41 (0.00%)  1/41 (2.44%) 
Chronic gastritis  1  1/41 (2.44%)  0/40 (0.00%)  0/41 (0.00%)  0/41 (0.00%)  0/41 (0.00%) 
Dyspepsia  1  0/41 (0.00%)  1/40 (2.50%)  0/41 (0.00%)  0/41 (0.00%)  0/41 (0.00%) 
Gastric polyps  1  1/41 (2.44%)  0/40 (0.00%)  0/41 (0.00%)  0/41 (0.00%)  0/41 (0.00%) 
General disorders           
Fatigue  1  1/41 (2.44%)  0/40 (0.00%)  0/41 (0.00%)  1/41 (2.44%)  0/41 (0.00%) 
Local swelling  1  0/41 (0.00%)  0/40 (0.00%)  0/41 (0.00%)  1/41 (2.44%)  0/41 (0.00%) 
Oedema peripheral  1  0/41 (0.00%)  1/40 (2.50%)  0/41 (0.00%)  0/41 (0.00%)  0/41 (0.00%) 
Pyrexia  1  1/41 (2.44%)  0/40 (0.00%)  0/41 (0.00%)  0/41 (0.00%)  0/41 (0.00%) 
Hepatobiliary disorders           
Bile duct stone  1  1/41 (2.44%)  0/40 (0.00%)  0/41 (0.00%)  0/41 (0.00%)  0/41 (0.00%) 
Cholangitis acute  1  1/41 (2.44%)  0/40 (0.00%)  0/41 (0.00%)  0/41 (0.00%)  0/41 (0.00%) 
Infections and infestations           
Nasopharyngitis  1  7/41 (17.07%)  7/40 (17.50%)  9/41 (21.95%)  8/41 (19.51%)  6/41 (14.63%) 
Pharyngitis  1  2/41 (4.88%)  0/40 (0.00%)  2/41 (4.88%)  1/41 (2.44%)  0/41 (0.00%) 
Bronchitis  1  1/41 (2.44%)  0/40 (0.00%)  0/41 (0.00%)  2/41 (4.88%)  1/41 (2.44%) 
Gastroenteritis  1  1/41 (2.44%)  0/40 (0.00%)  0/41 (0.00%)  0/41 (0.00%)  2/41 (4.88%) 
Conjunctivitis viral  1  0/41 (0.00%)  0/40 (0.00%)  1/41 (2.44%)  0/41 (0.00%)  0/41 (0.00%) 
Gingivitis  1  0/41 (0.00%)  0/40 (0.00%)  0/41 (0.00%)  1/41 (2.44%)  0/41 (0.00%) 
Influenza  1  0/41 (0.00%)  0/40 (0.00%)  0/41 (0.00%)  1/41 (2.44%)  0/41 (0.00%) 
Nasal vestibulitis  1  0/41 (0.00%)  0/40 (0.00%)  1/41 (2.44%)  0/41 (0.00%)  0/41 (0.00%) 
Sinusitis  1  0/41 (0.00%)  0/40 (0.00%)  0/41 (0.00%)  1/41 (2.44%)  0/41 (0.00%) 
Tonsillitis  1  1/41 (2.44%)  0/40 (0.00%)  1/41 (2.44%)  0/41 (0.00%)  0/41 (0.00%) 
Urethritis  1  0/41 (0.00%)  0/40 (0.00%)  0/41 (0.00%)  0/41 (0.00%)  1/41 (2.44%) 
Dermatitis infected  1  1/41 (2.44%)  0/40 (0.00%)  0/41 (0.00%)  0/41 (0.00%)  0/41 (0.00%) 
Herpes virus infection  1  0/41 (0.00%)  1/40 (2.50%)  0/41 (0.00%)  0/41 (0.00%)  0/41 (0.00%) 
Periodontitis  1  0/41 (0.00%)  1/40 (2.50%)  0/41 (0.00%)  0/41 (0.00%)  0/41 (0.00%) 
Oral herpes  1  1/41 (2.44%)  0/40 (0.00%)  0/41 (0.00%)  0/41 (0.00%)  0/41 (0.00%) 
Injury, poisoning and procedural complications           
Contusion  1  1/41 (2.44%)  1/40 (2.50%)  1/41 (2.44%)  0/41 (0.00%)  1/41 (2.44%) 
Ligament sprain  1  0/41 (0.00%)  0/40 (0.00%)  0/41 (0.00%)  0/41 (0.00%)  1/41 (2.44%) 
Head injury  1  0/41 (0.00%)  0/40 (0.00%)  0/41 (0.00%)  1/41 (2.44%)  0/41 (0.00%) 
Patella fracture  1  0/41 (0.00%)  0/40 (0.00%)  0/41 (0.00%)  0/41 (0.00%)  1/41 (2.44%) 
Excoriation  1  0/41 (0.00%)  0/40 (0.00%)  1/41 (2.44%)  0/41 (0.00%)  0/41 (0.00%) 
Thermal burn  1  0/41 (0.00%)  0/40 (0.00%)  0/41 (0.00%)  0/41 (0.00%)  1/41 (2.44%) 
Muscle contusion  1  0/41 (0.00%)  0/40 (0.00%)  1/41 (2.44%)  0/41 (0.00%)  0/41 (0.00%) 
Meniscus injury  1  0/41 (0.00%)  0/40 (0.00%)  1/41 (2.44%)  0/41 (0.00%)  0/41 (0.00%) 
Fall  1  0/41 (0.00%)  1/40 (2.50%)  0/41 (0.00%)  0/41 (0.00%)  0/41 (0.00%) 
Hand fracture  1  1/41 (2.44%)  1/40 (2.50%)  0/41 (0.00%)  0/41 (0.00%)  0/41 (0.00%) 
Rib fracture  1  1/41 (2.44%)  0/40 (0.00%)  0/41 (0.00%)  0/41 (0.00%)  0/41 (0.00%) 
Spinal compression fracture  1  0/41 (0.00%)  1/40 (2.50%)  0/41 (0.00%)  0/41 (0.00%)  0/41 (0.00%) 
Venomous sting  1  0/41 (0.00%)  1/40 (2.50%)  0/41 (0.00%)  0/41 (0.00%)  0/41 (0.00%) 
Procedural pain  1  0/41 (0.00%)  1/40 (2.50%)  0/41 (0.00%)  0/41 (0.00%)  0/41 (0.00%) 
Foreign body  1  1/41 (2.44%)  0/40 (0.00%)  0/41 (0.00%)  0/41 (0.00%)  0/41 (0.00%) 
Investigations           
Blood creatinine increased  1  0/41 (0.00%)  0/40 (0.00%)  2/41 (4.88%)  1/41 (2.44%)  0/41 (0.00%) 
Weight increased  1  1/41 (2.44%)  0/40 (0.00%)  0/41 (0.00%)  0/41 (0.00%)  0/41 (0.00%) 
Metabolism and nutrition disorders           
Dehydration  1  0/41 (0.00%)  0/40 (0.00%)  1/41 (2.44%)  0/41 (0.00%)  0/41 (0.00%) 
Musculoskeletal and connective tissue disorders           
Back pain  1  1/41 (2.44%)  1/40 (2.50%)  1/41 (2.44%)  4/41 (9.76%)  2/41 (4.88%) 
Arthralgia  1  0/41 (0.00%)  2/40 (5.00%)  1/41 (2.44%)  2/41 (4.88%)  1/41 (2.44%) 
Periarthritis  1  1/41 (2.44%)  0/40 (0.00%)  1/41 (2.44%)  1/41 (2.44%)  1/41 (2.44%) 
Pain in extremity  1  0/41 (0.00%)  2/40 (5.00%)  0/41 (0.00%)  1/41 (2.44%)  1/41 (2.44%) 
Arthritis  1  0/41 (0.00%)  0/40 (0.00%)  0/41 (0.00%)  1/41 (2.44%)  0/41 (0.00%) 
Joint swelling  1  0/41 (0.00%)  0/40 (0.00%)  0/41 (0.00%)  1/41 (2.44%)  0/41 (0.00%) 
Myalgia  1  0/41 (0.00%)  0/40 (0.00%)  1/41 (2.44%)  0/41 (0.00%)  0/41 (0.00%) 
Tenosynovitis  1  0/41 (0.00%)  0/40 (0.00%)  0/41 (0.00%)  1/41 (2.44%)  0/41 (0.00%) 
Intervertebral disc protrusion  1  1/41 (2.44%)  0/40 (0.00%)  0/41 (0.00%)  0/41 (0.00%)  1/41 (2.44%) 
Tendon pain  1  0/41 (0.00%)  0/40 (0.00%)  0/41 (0.00%)  1/41 (2.44%)  0/41 (0.00%) 
Arthropathy  1  1/41 (2.44%)  0/40 (0.00%)  0/41 (0.00%)  0/41 (0.00%)  0/41 (0.00%) 
Lumbar spinal stenosis  1  0/41 (0.00%)  1/40 (2.50%)  0/41 (0.00%)  0/41 (0.00%)  0/41 (0.00%) 
Neck pain  1  1/41 (2.44%)  0/40 (0.00%)  0/41 (0.00%)  0/41 (0.00%)  0/41 (0.00%) 
Osteoarthritis  1  0/41 (0.00%)  2/40 (5.00%)  0/41 (0.00%)  0/41 (0.00%)  0/41 (0.00%) 
Spondylolisthesis  1  1/41 (2.44%)  0/40 (0.00%)  0/41 (0.00%)  0/41 (0.00%)  0/41 (0.00%) 
Nervous system disorders           
Headache  1  1/41 (2.44%)  0/40 (0.00%)  1/41 (2.44%)  1/41 (2.44%)  0/41 (0.00%) 
Somnolence  1  0/41 (0.00%)  0/40 (0.00%)  0/41 (0.00%)  1/41 (2.44%)  0/41 (0.00%) 
Subarachnoid haemorrhage  1  0/41 (0.00%)  0/40 (0.00%)  0/41 (0.00%)  1/41 (2.44%)  0/41 (0.00%) 
VIIth nerve paralysis  1  0/41 (0.00%)  0/40 (0.00%)  0/41 (0.00%)  1/41 (2.44%)  0/41 (0.00%) 
Psychiatric disorders           
Insomnia  1  0/41 (0.00%)  0/40 (0.00%)  1/41 (2.44%)  1/41 (2.44%)  0/41 (0.00%) 
Depression  1  0/41 (0.00%)  0/40 (0.00%)  0/41 (0.00%)  0/41 (0.00%)  1/41 (2.44%) 
Renal and urinary disorders           
Renal impairment  1  0/41 (0.00%)  0/40 (0.00%)  0/41 (0.00%)  1/41 (2.44%)  0/41 (0.00%) 
Dysuria  1  0/41 (0.00%)  0/40 (0.00%)  0/41 (0.00%)  0/41 (0.00%)  1/41 (2.44%) 
Urinary retention  1  0/41 (0.00%)  0/40 (0.00%)  0/41 (0.00%)  0/41 (0.00%)  1/41 (2.44%) 
Respiratory, thoracic and mediastinal disorders           
Upper respiratory tract inflammation  1  1/41 (2.44%)  2/40 (5.00%)  1/41 (2.44%)  0/41 (0.00%)  2/41 (4.88%) 
Epistaxis  1  0/41 (0.00%)  0/40 (0.00%)  0/41 (0.00%)  0/41 (0.00%)  1/41 (2.44%) 
Skin and subcutaneous tissue disorders           
Chronic pigmented purpura  1  0/41 (0.00%)  1/40 (2.50%)  0/41 (0.00%)  0/41 (0.00%)  0/41 (0.00%) 
Rash  1  0/41 (0.00%)  0/40 (0.00%)  1/41 (2.44%)  1/41 (2.44%)  0/41 (0.00%) 
Miliaria  1  0/41 (0.00%)  0/40 (0.00%)  1/41 (2.44%)  0/41 (0.00%)  0/41 (0.00%) 
Eczema  1  0/41 (0.00%)  3/40 (7.50%)  0/41 (0.00%)  0/41 (0.00%)  0/41 (0.00%) 
Pruritus  1  1/41 (2.44%)  0/40 (0.00%)  0/41 (0.00%)  0/41 (0.00%)  0/41 (0.00%) 
Vascular disorders           
Hypertension  1  2/41 (4.88%)  1/40 (2.50%)  1/41 (2.44%)  1/41 (2.44%)  1/41 (2.44%) 
Peripheral arterial occlusive disease  1  0/41 (0.00%)  0/40 (0.00%)  1/41 (2.44%)  0/41 (0.00%)  0/41 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA version 17.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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
Layout table for Results Point of Contact information
Name/Title: Fredrik Erlandsson, MD
Organization: Study Information Center AstraZeneca
Phone: +1 877-240-9479
EMail: information.center@astrazeneca.com
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02078219     History of Changes
Other Study ID Numbers: D5491C00001
RDEA3170-203 ( Other Identifier: Ardea Biosciences, Inc. )
First Submitted: February 26, 2014
First Posted: March 5, 2014
Results First Submitted: July 19, 2017
Results First Posted: September 24, 2019
Last Update Posted: September 24, 2019