Diabetic Peripheral Neuropathic Pain
Conditions
Keywords
Diabetic Peripheral Neuropathic Pain
Brief summary
Investigate the efficacy and safety of DS-5565 in subjects with Diabetic Peripheral Neuropathic Pain (DPNP) in comparison to placebo
Detailed description
\[Double Blind Phase\] The primary objective is to compare change in the Average Daily Pain Score(ADPS) from baseline to Week 14 in Asian subjects with DPNP receiving DS-5565 versus placebo. \[Open Extension Phase\] The objective is to assess the long-term safety and efficacy of DS-5565 in subjects with DPNP.
Interventions
DRUGDS-5565
DRUGplacebo
Sponsors
CMIC Co, Ltd. Japan
Quintiles, Inc.
Quintiles Malaysia Sdn Bhd
Daiichi Sankyo Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Type 1 or type 2 diabetes mellitus at screening * Painful distal symmetric polyneuropathy * At screening, a pain scale of ≥ 40 mm
Exclusion criteria
* HbA1c (National Glycohemoglobin Standardization Program) \> 10.0%
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain | Baseline to Week 14 (post-dose 1 [15 mg QD] and post-dose 2 [20 mg and 30 mg]) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Visual Analog Scale From Baseline (Week 14) to Week 66 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain | From baseline (Week 14) to Week 66 | Visual Analog Scale (VAS) pain is a 10-point assessment tool to measure pain levels, where 0 is defined as 'no pain' and 10 is defined as 'worst possible pain'. Higher VAS pain scores indicate worse outcome. In this outcome, the change from baseline in VAS pain is being reported with negative values representing improvements in pain intensity. The larger the negative value (ie. improvement), the greater the improvement in pain intensity. |
Countries
Japan
Participant flow
Recruitment details
A total of 854 participants who met all inclusion and no exclusion criteria were enrolled; 834 were randomized to treatment in the double-blind phase. Twenty participants were excluded by the sponsor due to a serious Good Clinical Practice violation (inform consent form-related). A total of 214 participants enrolled in the open-label extension.
Pre-assignment details
Participants were randomized to DS-5565 (15, 20, or 30 mg) or placebo in the double-blind (DB) phase and open-label DS-5565 in the long-term (LT) phase. Patients who complete the DB phase may not enroll in the LT phase. DB phase determine significant difference vs placebo (\ 750 target cases). LT phase confirm long-term safety (\ 180 target cases).
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants who received an oral dose of placebo twice daily (BID) for 14 weeks. | 334 |
| DS-5565 15mg QD Participants who received an oral dose of DS-5565 15 mg QD.
During the titration period, DS-5565 was administered orally at a daily dose of 5 mg (5 mg QD) during the first week and followed by 10 mg (10 mg QD) during the second week.
During the fixed-dose period, a daily dose of 15 mg (15 mg QD) was administered orally for 12 weeks. | 166 |
| DS-5565 20 mg (10 mg BID) Participants who received an oral dose of DS-5565 20 mg (10 mg BID).
During the titration period, DS-5565 was administered orally at a daily dose of 10 mg (5 mg BID) for 1 week.
During the fixed-dose period, a daily dose of 20 mg (10 mg BID) was administered orally for 13 weeks. | 168 |
| DS-5565 30 mg (15 mg BID) Participants who received an oral dose of DS-5565 30 mg (15 mg BID).
During the titration period, DS-5565 was administered orally at a daily dose of 10 mg (5 mg BID) for the first week followed by 20 mg (10 mg BID) during the second week.
During the fixed-dose period, a daily dose of 30 mg (15 mg BID) was administered orally for 12 weeks. | 166 |
| Total | 834 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Double-blind Phase | Adverse Event | 7 | 4 | 3 | 10 | 0 |
| Double-blind Phase | Death | 0 | 0 | 2 | 0 | 0 |
| Double-blind Phase | Lost to Follow-up | 1 | 0 | 0 | 0 | 0 |
| Double-blind Phase | Other | 4 | 1 | 2 | 1 | 0 |
| Double-blind Phase | Protocol Violation | 4 | 2 | 4 | 3 | 0 |
| Double-blind Phase | Withdrawal by Subject | 9 | 5 | 7 | 10 | 0 |
| Open-label Extension Phase | Adverse Event | 0 | 0 | 0 | 0 | 21 |
| Open-label Extension Phase | Death | 0 | 0 | 0 | 0 | 1 |
| Open-label Extension Phase | Lack of Efficacy | 0 | 0 | 0 | 0 | 1 |
| Open-label Extension Phase | Withdrawal by Subject | 0 | 0 | 0 | 0 | 19 |
Baseline characteristics
| Characteristic | Placebo | DS-5565 15mg QD | DS-5565 20 mg (10 mg BID) | DS-5565 30 mg (15 mg BID) | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 136 Participants | 67 Participants | 66 Participants | 68 Participants | 337 Participants |
| Age, Categorical Between 18 and 65 years | 198 Participants | 99 Participants | 102 Participants | 98 Participants | 497 Participants |
| Age, Continuous | 61.0 years STANDARD_DEVIATION 10.5 | 61.9 years STANDARD_DEVIATION 8.4 | 61.2 years STANDARD_DEVIATION 10.1 | 61.8 years STANDARD_DEVIATION 9.4 | 61.4 years STANDARD_DEVIATION 9.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 334 Participants | 166 Participants | 168 Participants | 166 Participants | 834 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 334 Participants | 166 Participants | 168 Participants | 166 Participants | 834 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 93 Participants | 53 Participants | 47 Participants | 36 Participants | 229 Participants |
| Sex: Female, Male Male | 241 Participants | 113 Participants | 121 Participants | 130 Participants | 605 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 330 | 0 / 164 | 2 / 165 | 0 / 165 | 1 / 214 |
| other Total, other adverse events | 101 / 330 | 60 / 164 | 62 / 165 | 84 / 165 | 141 / 214 |
| serious Total, serious adverse events | 11 / 330 | 4 / 164 | 8 / 165 | 11 / 165 | 24 / 214 |
Outcome results
Primary
Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain
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.
Time frame: Baseline to Week 14 (post-dose 1 [15 mg QD] and post-dose 2 [20 mg and 30 mg])
Population: ADPS was assessed in the Modified-Intent-to-Treat Analysis Set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain | Week 9 | -1.16 units on a scale | Standard Deviation 1.42 |
| Placebo | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain | Week 8 | -1.09 units on a scale | Standard Deviation 1.39 |
| Placebo | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain | Week 12 | -1.28 units on a scale | Standard Deviation 1.5 |
| Placebo | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain | Week 10 | -1.18 units on a scale | Standard Deviation 1.44 |
| Placebo | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain | Week 11 | -1.25 units on a scale | Standard Deviation 1.46 |
| Placebo | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain | Week 7 | -1.03 units on a scale | Standard Deviation 1.31 |
| Placebo | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain | Week 3 | -0.57 units on a scale | Standard Deviation 1.08 |
| Placebo | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain | Week 1 | -0.26 units on a scale | Standard Deviation 0.79 |
| Placebo | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain | Week 14 | -1.37 units on a scale | Standard Deviation 1.6 |
| Placebo | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain | Week 4 | -0.70 units on a scale | Standard Deviation 1.12 |
| Placebo | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain | Week 2 | -0.46 units on a scale | Standard Deviation 0.96 |
| Placebo | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain | Week 5 | -0.84 units on a scale | Standard Deviation 1.17 |
| Placebo | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain | Week 13 | -1.32 units on a scale | Standard Deviation 1.55 |
| Placebo | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain | Week 6 | -0.92 units on a scale | Standard Deviation 1.25 |
| DS-5565 15mg QD | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain | Week 1 | -0.39 units on a scale | Standard Deviation 0.67 |
| DS-5565 15mg QD | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain | Week 9 | -1.13 units on a scale | Standard Deviation 1.49 |
| DS-5565 15mg QD | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain | Week 12 | -1.24 units on a scale | Standard Deviation 1.6 |
| DS-5565 15mg QD | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain | Week 4 | -0.87 units on a scale | Standard Deviation 1.13 |
| DS-5565 15mg QD | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain | Week 11 | -1.23 units on a scale | Standard Deviation 1.57 |
| DS-5565 15mg QD | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain | Week 6 | -1.01 units on a scale | Standard Deviation 1.32 |
| DS-5565 15mg QD | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain | Week 10 | -1.19 units on a scale | Standard Deviation 1.56 |
| DS-5565 15mg QD | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain | Week 8 | -1.07 units on a scale | Standard Deviation 1.49 |
| DS-5565 15mg QD | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain | Week 13 | -1.27 units on a scale | Standard Deviation 1.63 |
| DS-5565 15mg QD | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain | Week 2 | -0.60 units on a scale | Standard Deviation 0.9 |
| DS-5565 15mg QD | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain | Week 14 | -1.34 units on a scale | Standard Deviation 1.74 |
| DS-5565 15mg QD | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain | Week 5 | -0.97 units on a scale | Standard Deviation 1.2 |
| DS-5565 15mg QD | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain | Week 3 | -0.78 units on a scale | Standard Deviation 1.02 |
| DS-5565 15mg QD | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain | Week 7 | -1.06 units on a scale | Standard Deviation 1.4 |
| DS-5565 20 mg (10 mg BID) | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain | Week 7 | -1.13 units on a scale | Standard Deviation 1.59 |
| DS-5565 20 mg (10 mg BID) | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain | Week 1 | -0.40 units on a scale | Standard Deviation 0.85 |
| DS-5565 20 mg (10 mg BID) | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain | Week 2 | -0.72 units on a scale | Standard Deviation 1.12 |
| DS-5565 20 mg (10 mg BID) | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain | Week 3 | -0.84 units on a scale | Standard Deviation 1.22 |
| DS-5565 20 mg (10 mg BID) | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain | Week 4 | -0.94 units on a scale | Standard Deviation 1.38 |
| DS-5565 20 mg (10 mg BID) | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain | Week 5 | -1.06 units on a scale | Standard Deviation 1.5 |
| DS-5565 20 mg (10 mg BID) | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain | Week 6 | -1.13 units on a scale | Standard Deviation 1.52 |
| DS-5565 20 mg (10 mg BID) | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain | Week 8 | -1.26 units on a scale | Standard Deviation 1.59 |
| DS-5565 20 mg (10 mg BID) | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain | Week 9 | -1.27 units on a scale | Standard Deviation 1.56 |
| DS-5565 20 mg (10 mg BID) | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain | Week 10 | -1.33 units on a scale | Standard Deviation 1.65 |
| DS-5565 20 mg (10 mg BID) | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain | Week 11 | -1.36 units on a scale | Standard Deviation 1.64 |
| DS-5565 20 mg (10 mg BID) | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain | Week 12 | -1.36 units on a scale | Standard Deviation 1.67 |
| DS-5565 20 mg (10 mg BID) | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain | Week 13 | -1.43 units on a scale | Standard Deviation 1.72 |
| DS-5565 20 mg (10 mg BID) | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain | Week 14 | -1.47 units on a scale | Standard Deviation 1.69 |
| DS-5565 30 mg (15 mg BID) | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain | Week 9 | -1.63 units on a scale | Standard Deviation 1.76 |
| DS-5565 30 mg (15 mg BID) | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain | Week 8 | -1.53 units on a scale | Standard Deviation 1.79 |
| DS-5565 30 mg (15 mg BID) | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain | Week 14 | -1.88 units on a scale | Standard Deviation 1.88 |
| DS-5565 30 mg (15 mg BID) | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain | Week 12 | -1.82 units on a scale | Standard Deviation 1.84 |
| DS-5565 30 mg (15 mg BID) | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain | Week 5 | -1.48 units on a scale | Standard Deviation 1.68 |
| DS-5565 30 mg (15 mg BID) | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain | Week 4 | -1.43 units on a scale | Standard Deviation 1.63 |
| DS-5565 30 mg (15 mg BID) | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain | Week 7 | -1.57 units on a scale | Standard Deviation 1.72 |
| DS-5565 30 mg (15 mg BID) | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain | Week 13 | -1.85 units on a scale | Standard Deviation 1.93 |
| DS-5565 30 mg (15 mg BID) | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain | Week 3 | -1.33 units on a scale | Standard Deviation 1.49 |
| DS-5565 30 mg (15 mg BID) | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain | Week 2 | -1.00 units on a scale | Standard Deviation 1.27 |
| DS-5565 30 mg (15 mg BID) | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain | Week 10 | -1.67 units on a scale | Standard Deviation 1.83 |
| DS-5565 30 mg (15 mg BID) | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain | Week 6 | -1.58 units on a scale | Standard Deviation 1.73 |
| DS-5565 30 mg (15 mg BID) | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain | Week 1 | -0.60 units on a scale | Standard Deviation 1.01 |
| DS-5565 30 mg (15 mg BID) | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain | Week 11 | -1.69 units on a scale | Standard Deviation 1.8 |
Comparison: Week 14 change from baselinep-value: 0.877395% CI: [-0.35, 0.3]Mixed Models Analysis
Comparison: Week 14 change from baselinep-value: 0.349495% CI: [-0.48, 0.17]Mixed Models Analysis
Comparison: Week 14 change from baselinep-value: 0.002795% CI: [-0.82, -0.17]Mixed Models Analysis
Secondary
Change in Visual Analog Scale From Baseline (Week 14) to Week 66 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain
Visual Analog Scale (VAS) pain is a 10-point assessment tool to measure pain levels, where 0 is defined as 'no pain' and 10 is defined as 'worst possible pain'. Higher VAS pain scores indicate worse outcome. In this outcome, the change from baseline in VAS pain is being reported with negative values representing improvements in pain intensity. The larger the negative value (ie. improvement), the greater the improvement in pain intensity.
Time frame: From baseline (Week 14) to Week 66
Population: Visual analog scale was assessed in all enrolled participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change in Visual Analog Scale From Baseline (Week 14) to Week 66 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain | Week 16 | -0.90 units on a scale | Standard Deviation 9.19 |
| Placebo | Change in Visual Analog Scale From Baseline (Week 14) to Week 66 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain | Week 18 | -4.00 units on a scale | Standard Deviation 11.14 |
| Placebo | Change in Visual Analog Scale From Baseline (Week 14) to Week 66 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain | Week 22 | -7.00 units on a scale | Standard Deviation 12.69 |
| Placebo | Change in Visual Analog Scale From Baseline (Week 14) to Week 66 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain | Week 26 | -6.20 units on a scale | Standard Deviation 11.43 |
| Placebo | Change in Visual Analog Scale From Baseline (Week 14) to Week 66 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain | Week 30 | -7.20 units on a scale | Standard Deviation 12.62 |
| Placebo | Change in Visual Analog Scale From Baseline (Week 14) to Week 66 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain | Week 34 | -7.80 units on a scale | Standard Deviation 13.26 |
| Placebo | Change in Visual Analog Scale From Baseline (Week 14) to Week 66 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain | Week 38 | -7.30 units on a scale | Standard Deviation 15.23 |
| Placebo | Change in Visual Analog Scale From Baseline (Week 14) to Week 66 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain | Week 42 | -8.00 units on a scale | Standard Deviation 14.42 |
| Placebo | Change in Visual Analog Scale From Baseline (Week 14) to Week 66 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain | Week 46 | -8.10 units on a scale | Standard Deviation 15.78 |
| Placebo | Change in Visual Analog Scale From Baseline (Week 14) to Week 66 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain | Week 50 | -7.80 units on a scale | Standard Deviation 15.1 |
| Placebo | Change in Visual Analog Scale From Baseline (Week 14) to Week 66 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain | Week 54 | -9.20 units on a scale | Standard Deviation 14.36 |
| Placebo | Change in Visual Analog Scale From Baseline (Week 14) to Week 66 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain | Week 58 | -8.80 units on a scale | Standard Deviation 14.94 |
| Placebo | Change in Visual Analog Scale From Baseline (Week 14) to Week 66 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain | Week 62 | -10.00 units on a scale | Standard Deviation 15.39 |
| Placebo | Change in Visual Analog Scale From Baseline (Week 14) to Week 66 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain | Week 66 | -10.80 units on a scale | Standard Deviation 13.95 |