Trial Outcomes & Findings for DS-5565 Phase III Study for Renal Impairment in Japanese Subjects (NCT NCT02607280)
NCT ID: NCT02607280
Last Updated: 2021-05-13
Results Overview
Each participant recorded a pain score in the electronic patient diary once daily from the day after the screening visit (Visit 1) to the end of treatment/early termination visit (Visit 10). Prior to taking the study drug each morning, the participant selected the number that best described his or her pain over the past 24 hours on a scale of 0 (no pain) to 10 (worst possible pain). Higher ADPS scores indicated worse outcome. ADPS was the weekly average pain score based on the pain scores from the electronic patient diaries (Pain diary). In this outcome, the change from baseline in ADPS is being reported with negative values representing improvements in average daily pain. The larger the negative value (ie. improvement), the greater the improvement in average daily pain.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
35 participants
Primary outcome timeframe
Baseline to Week 14
Results posted on
2021-05-13
Participant Flow
A total of 35 participants who met all inclusion criteria and no exclusion criteria were enrolled in the study from December 2015 to March 2017 at 1 clinic site in Japan.
Participant milestones
| Measure |
Moderate Renal Impairment
Participants with moderate RI (creatinine clearance: 30 to 59 mL/min) received DS-5565 2.5 mg BID for the first week and DS-5565 5 mg BID for the second week of the titration period and subsequently received a fixed dose of DS-5565 7.5mg BID for 12 weeks.
|
Severe Renal Impairment
Participants with severe RI (creatinine clearance: 15 to 29 mL/min) received DS-5565 2.5 mg QD for the first week and DS-5565 5 mg QD for the second week of the titration period and subsequently received the fixed dose of DS-5565 7.5 mg QD for 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
5
|
|
Overall Study
Received Study Drug
|
30
|
5
|
|
Overall Study
COMPLETED
|
26
|
4
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
| Measure |
Moderate Renal Impairment
Participants with moderate RI (creatinine clearance: 30 to 59 mL/min) received DS-5565 2.5 mg BID for the first week and DS-5565 5 mg BID for the second week of the titration period and subsequently received a fixed dose of DS-5565 7.5mg BID for 12 weeks.
|
Severe Renal Impairment
Participants with severe RI (creatinine clearance: 15 to 29 mL/min) received DS-5565 2.5 mg QD for the first week and DS-5565 5 mg QD for the second week of the titration period and subsequently received the fixed dose of DS-5565 7.5 mg QD for 12 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
0
|
|
Overall Study
Decrease in CrCl <15
|
0
|
1
|
Baseline Characteristics
DS-5565 Phase III Study for Renal Impairment in Japanese Subjects
Baseline characteristics by cohort
| Measure |
Moderate Renal Impairment
n=30 Participants
Participants with moderate RI (creatinine clearance: 30 to 59 mL/min) received DS-5565 2.5 mg BID for the first week and DS-5565 5 mg BID for the second week of the titration period and subsequently received a fixed dose of DS-5565 7.5mg BID for 12 weeks.
|
Severe Renal Impairment
n=5 Participants
Participants with severe RI (creatinine clearance: 15 to 29 mL/min) received DS-5565 2.5 mg QD for the first week and DS-5565 5 mg QD for the second week of the titration period and subsequently received the fixed dose of DS-5565 7.5 mg QD for 12 weeks.
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
27 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Age, Continuous
|
73.8 years
STANDARD_DEVIATION 7.69 • n=99 Participants
|
71.0 years
STANDARD_DEVIATION 4.06 • n=107 Participants
|
73.4 years
STANDARD_DEVIATION 7.31 • n=206 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
30 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
Japan
|
30 participants
n=99 Participants
|
5 participants
n=107 Participants
|
35 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 14Population: ADPS was assessed in the All Enrolled Participants.
Each participant recorded a pain score in the electronic patient diary once daily from the day after the screening visit (Visit 1) to the end of treatment/early termination visit (Visit 10). Prior to taking the study drug each morning, the participant selected the number that best described his or her pain over the past 24 hours on a scale of 0 (no pain) to 10 (worst possible pain). Higher ADPS scores indicated worse outcome. ADPS was the weekly average pain score based on the pain scores from the electronic patient diaries (Pain diary). In this outcome, the change from baseline in ADPS is being reported with negative values representing improvements in average daily pain. The larger the negative value (ie. improvement), the greater the improvement in average daily pain.
Outcome measures
| Measure |
Moderate Renal Impairment
n=30 Participants
Participants with moderate RI (creatinine clearance: 30 to 59 mL/min) received DS-5565 2.5 mg BID for the first week and DS-5565 5 mg BID for the second week of the titration period and subsequently received a fixed dose of DS-5565 7.5mg BID for 12 weeks.
|
Severe Renal Impairment
n=5 Participants
Participants with severe RI (creatinine clearance: 15 to 29 mL/min) received DS-5565 2.5 mg QD for the first week and DS-5565 5 mg QD for the second week of the titration period and subsequently received the fixed dose of DS-5565 7.5 mg QD for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Average Daily Pain Score (ADPS) at Each Week
Week 1
|
-0.14 units on a scale
Standard Deviation 0.680
|
-0.20 units on a scale
Standard Deviation 0.217
|
|
Change From Baseline in Average Daily Pain Score (ADPS) at Each Week
Week 2
|
-0.37 units on a scale
Standard Deviation 0.940
|
-0.50 units on a scale
Standard Deviation 0.937
|
|
Change From Baseline in Average Daily Pain Score (ADPS) at Each Week
Week 3
|
-0.85 units on a scale
Standard Deviation 1.294
|
-1.83 units on a scale
Standard Deviation 1.859
|
|
Change From Baseline in Average Daily Pain Score (ADPS) at Each Week
Week 4
|
-1.13 units on a scale
Standard Deviation 1.318
|
-2.07 units on a scale
Standard Deviation 2.375
|
|
Change From Baseline in Average Daily Pain Score (ADPS) at Each Week
Week 5
|
-0.90 units on a scale
Standard Deviation 1.361
|
-1.89 units on a scale
Standard Deviation 2.278
|
|
Change From Baseline in Average Daily Pain Score (ADPS) at Each Week
Week 6
|
-0.92 units on a scale
Standard Deviation 1.285
|
-1.82 units on a scale
Standard Deviation 1.922
|
|
Change From Baseline in Average Daily Pain Score (ADPS) at Each Week
Week 7
|
-1.22 units on a scale
Standard Deviation 1.402
|
-1.93 units on a scale
Standard Deviation 1.732
|
|
Change From Baseline in Average Daily Pain Score (ADPS) at Each Week
Week 8
|
-1.29 units on a scale
Standard Deviation 1.554
|
-2.04 units on a scale
Standard Deviation 1.735
|
|
Change From Baseline in Average Daily Pain Score (ADPS) at Each Week
Week 9
|
-1.36 units on a scale
Standard Deviation 1.540
|
-2.21 units on a scale
Standard Deviation 1.980
|
|
Change From Baseline in Average Daily Pain Score (ADPS) at Each Week
Week 10
|
-1.33 units on a scale
Standard Deviation 1.562
|
-2.32 units on a scale
Standard Deviation 1.914
|
|
Change From Baseline in Average Daily Pain Score (ADPS) at Each Week
Week 11
|
-1.43 units on a scale
Standard Deviation 1.664
|
-2.07 units on a scale
Standard Deviation 1.584
|
|
Change From Baseline in Average Daily Pain Score (ADPS) at Each Week
Week 12
|
-1.59 units on a scale
Standard Deviation 1.636
|
-2.10 units on a scale
Standard Deviation 1.728
|
|
Change From Baseline in Average Daily Pain Score (ADPS) at Each Week
Week 13
|
-1.84 units on a scale
Standard Deviation 1.650
|
-2.25 units on a scale
Standard Deviation 1.700
|
|
Change From Baseline in Average Daily Pain Score (ADPS) at Each Week
Week 14
|
-1.90 units on a scale
Standard Deviation 1.697
|
-2.52 units on a scale
Standard Deviation 2.026
|
Adverse Events
Moderate Renal Impairment
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
Severe Renal Impairment
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Moderate Renal Impairment
n=30 participants at risk
Participants with moderate RI (creatinine clearance: 30 to 59 mL/min) received DS-5565 2.5 mg BID for the first week and DS-5565 5 mg BID for the second week of the titration period and subsequently received a fixed dose of DS-5565 7.5mg BID for 12 weeks.
|
Severe Renal Impairment
n=5 participants at risk
Participants with severe RI (creatinine clearance: 15 to 29 mL/min) received DS-5565 2.5 mg QD for the first week and DS-5565 5 mg QD for the second week of the titration period and subsequently received the fixed dose of DS-5565 7.5 mg QD for 12 weeks.
|
|---|---|---|
|
Cardiac disorders
Angina pectoris
|
3.3%
1/30 • Adverse event data were collected from baseline up to 7 days after last dose, up to 1 year 3 months.
Any adverse event (AE) that emerges on or after first dosing and during the duration of the study treatment (having been absent prior to treatment) or worsens relative to the pre-treatment state.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 7 days after last dose, up to 1 year 3 months.
Any adverse event (AE) that emerges on or after first dosing and during the duration of the study treatment (having been absent prior to treatment) or worsens relative to the pre-treatment state.
|
Other adverse events
| Measure |
Moderate Renal Impairment
n=30 participants at risk
Participants with moderate RI (creatinine clearance: 30 to 59 mL/min) received DS-5565 2.5 mg BID for the first week and DS-5565 5 mg BID for the second week of the titration period and subsequently received a fixed dose of DS-5565 7.5mg BID for 12 weeks.
|
Severe Renal Impairment
n=5 participants at risk
Participants with severe RI (creatinine clearance: 15 to 29 mL/min) received DS-5565 2.5 mg QD for the first week and DS-5565 5 mg QD for the second week of the titration period and subsequently received the fixed dose of DS-5565 7.5 mg QD for 12 weeks.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
20.0%
6/30 • Adverse event data were collected from baseline up to 7 days after last dose, up to 1 year 3 months.
Any adverse event (AE) that emerges on or after first dosing and during the duration of the study treatment (having been absent prior to treatment) or worsens relative to the pre-treatment state.
|
40.0%
2/5 • Adverse event data were collected from baseline up to 7 days after last dose, up to 1 year 3 months.
Any adverse event (AE) that emerges on or after first dosing and during the duration of the study treatment (having been absent prior to treatment) or worsens relative to the pre-treatment state.
|
|
Nervous system disorders
Somnolence
|
13.3%
4/30 • Adverse event data were collected from baseline up to 7 days after last dose, up to 1 year 3 months.
Any adverse event (AE) that emerges on or after first dosing and during the duration of the study treatment (having been absent prior to treatment) or worsens relative to the pre-treatment state.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 7 days after last dose, up to 1 year 3 months.
Any adverse event (AE) that emerges on or after first dosing and during the duration of the study treatment (having been absent prior to treatment) or worsens relative to the pre-treatment state.
|
|
Nervous system disorders
Dizziness
|
6.7%
2/30 • Adverse event data were collected from baseline up to 7 days after last dose, up to 1 year 3 months.
Any adverse event (AE) that emerges on or after first dosing and during the duration of the study treatment (having been absent prior to treatment) or worsens relative to the pre-treatment state.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 7 days after last dose, up to 1 year 3 months.
Any adverse event (AE) that emerges on or after first dosing and during the duration of the study treatment (having been absent prior to treatment) or worsens relative to the pre-treatment state.
|
|
Nervous system disorders
Sensory disturbance
|
6.7%
2/30 • Adverse event data were collected from baseline up to 7 days after last dose, up to 1 year 3 months.
Any adverse event (AE) that emerges on or after first dosing and during the duration of the study treatment (having been absent prior to treatment) or worsens relative to the pre-treatment state.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 7 days after last dose, up to 1 year 3 months.
Any adverse event (AE) that emerges on or after first dosing and during the duration of the study treatment (having been absent prior to treatment) or worsens relative to the pre-treatment state.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.7%
2/30 • Adverse event data were collected from baseline up to 7 days after last dose, up to 1 year 3 months.
Any adverse event (AE) that emerges on or after first dosing and during the duration of the study treatment (having been absent prior to treatment) or worsens relative to the pre-treatment state.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 7 days after last dose, up to 1 year 3 months.
Any adverse event (AE) that emerges on or after first dosing and during the duration of the study treatment (having been absent prior to treatment) or worsens relative to the pre-treatment state.
|
|
Gastrointestinal disorders
Nausea
|
6.7%
2/30 • Adverse event data were collected from baseline up to 7 days after last dose, up to 1 year 3 months.
Any adverse event (AE) that emerges on or after first dosing and during the duration of the study treatment (having been absent prior to treatment) or worsens relative to the pre-treatment state.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 7 days after last dose, up to 1 year 3 months.
Any adverse event (AE) that emerges on or after first dosing and during the duration of the study treatment (having been absent prior to treatment) or worsens relative to the pre-treatment state.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.7%
2/30 • Adverse event data were collected from baseline up to 7 days after last dose, up to 1 year 3 months.
Any adverse event (AE) that emerges on or after first dosing and during the duration of the study treatment (having been absent prior to treatment) or worsens relative to the pre-treatment state.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 7 days after last dose, up to 1 year 3 months.
Any adverse event (AE) that emerges on or after first dosing and during the duration of the study treatment (having been absent prior to treatment) or worsens relative to the pre-treatment state.
|
|
General disorders
Oedema peripheral
|
6.7%
2/30 • Adverse event data were collected from baseline up to 7 days after last dose, up to 1 year 3 months.
Any adverse event (AE) that emerges on or after first dosing and during the duration of the study treatment (having been absent prior to treatment) or worsens relative to the pre-treatment state.
|
20.0%
1/5 • Adverse event data were collected from baseline up to 7 days after last dose, up to 1 year 3 months.
Any adverse event (AE) that emerges on or after first dosing and during the duration of the study treatment (having been absent prior to treatment) or worsens relative to the pre-treatment state.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place