Trial · NCT02318719
DS-5565 Phase III Study for Post-herpetic Neuralgia
NCT02318719, Not applicable, Completed, Daiichi Sankyo Co., Ltd.; results first posted 2020-11-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. DS-5565 Phase III Study for Post-herpetic Neuralgia. Trials, record NCT02318719. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02318719
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- DS-5565 Phase III Study for Post-herpetic Neuralgia
- NCT number
- NCT02318719
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 765 participants, actual
- Lead sponsor
- Daiichi Sankyo Co., Ltd.
- Conditions
- Post-Herpetic Neuralgia
- Interventions
- Placebo, DS-5565
- First posted
- 2014-12-17
- Last updated
- 2020-11-02
- Results first posted
- 2020-11-02
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Oral Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Baseline to Week 14 | 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 | Change in Visual Analog Scale (VAS) Pain From Baseline (Week 14) to Week 66 Following Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | 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. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Oral Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Baseline to Week 14 | Average daily pain score (ADPS) was assessed in the modified Intent-to-Treat Analysis Set. | units on a scale | MEAN |
| SECONDARY | Change in Visual Analog Scale (VAS) Pain From Baseline (Week 14) to Week 66 Following Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | From baseline (Week 14) to Week 66 | Visual analog scale (VAS) was assessed in the modified Intent-to-Treat Analysis Set. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group70
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Oral Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Placebo | Week 1 | -0.10 | Standard Deviation 0.743 | units on a scale |
| Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Oral Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | DS-5565 15 mg/Day | Week 1 | -0.39 | Standard Deviation 0.787 | units on a scale |
| Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Oral Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | DS-5565 20 mg/Day | Week 1 | -0.54 | Standard Deviation 0.783 | units on a scale |
| Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Oral Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | DS-5565 30 mg/Day | Week 1 | -0.46 | Standard Deviation 0.693 | units on a scale |
| Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Oral Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Placebo | Week 2 | -0.33 | Standard Deviation 0.902 | units on a scale |
| Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Oral Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | DS-5565 15 mg/Day | Week 2 | -0.72 | Standard Deviation 1.036 | units on a scale |
| Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Oral Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | DS-5565 20 mg/Day | Week 2 | -1.06 | Standard Deviation 0.998 | units on a scale |
| Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Oral Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | DS-5565 30 mg/Day | Week 2 | -0.95 | Standard Deviation 1.003 | units on a scale |
| Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Oral Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | Placebo | Week 3 | -0.48 | Standard Deviation 1.030 | units on a scale |
| Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Oral Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia | DS-5565 15 mg/Day | Week 3 | -0.96 | Standard Deviation 1.195 | units on a scale |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 results by groupParticipant flow35
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-blind Phase | STARTED | Placebo | 304 | |
| Double-blind Phase | STARTED | DS-5565 15 mg/Day | 153 | |
| Double-blind Phase | STARTED | DS-5565 20 mg/Day | 153 | |
| Double-blind Phase | STARTED | DS-5565 30 mg/Day | 155 | |
| Double-blind Phase | STARTED | DS-5565 Open-label Extension | 0 | |
| Double-blind Phase | Did Not Receive Treatment | Placebo | 1 | |
| Double-blind Phase | Did Not Receive Treatment | DS-5565 15 mg/Day | 1 | |
| Double-blind Phase | Did Not Receive Treatment | DS-5565 20 mg/Day | 0 | |
| Double-blind Phase | Did Not Receive Treatment | DS-5565 30 mg/Day | 0 | |
| Double-blind Phase | Did Not Receive Treatment | DS-5565 Open-label Extension | 0 |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 participant flowAdverse events125
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nasopharyngitis | Infections and infestations | Placebo | 26 | 303 | |
| other | Nasopharyngitis | Infections and infestations | DS-5565 15 mg/Day | 13 | 152 | |
| other | Nasopharyngitis | Infections and infestations | DS-5565 20 mg/Day | 16 | 153 | |
| other | Nasopharyngitis | Infections and infestations | DS-5565 30 mg/Day | 20 | 155 | |
| other | Nasopharyngitis | Infections and infestations | DS-5565 Open-label Extension | 39 | 237 | |
| other | Somnolence | Nervous system disorders | Placebo | 11 | 303 | |
| other | Somnolence | Nervous system disorders | DS-5565 15 mg/Day | 20 | 152 | |
| other | Somnolence | Nervous system disorders | DS-5565 20 mg/Day | 26 | 153 | |
| other | Somnolence | Nervous system disorders | DS-5565 30 mg/Day | 37 | 155 | |
| other | Somnolence | Nervous system disorders | DS-5565 Open-label Extension | 36 | 237 |
1 to 10 of 125Source ClinicalTrials.gov
See all 125 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 303 |
| Total, all-cause mortality | DS-5565 15 mg/Day | 0 | 152 |
| Total, all-cause mortality | DS-5565 20 mg/Day | 0 | 153 |
| Total, all-cause mortality | DS-5565 30 mg/Day | 0 | 155 |
| Total, all-cause mortality | DS-5565 Open-label Extension | 1 | 237 |
| Total, other adverse events | Placebo | 45 | 303 |
| Total, other adverse events | DS-5565 15 mg/Day | 44 | 152 |
| Total, other adverse events | DS-5565 20 mg/Day | 53 | 153 |
| Total, other adverse events | DS-5565 30 mg/Day | 72 | 155 |
| Total, other adverse events | DS-5565 Open-label Extension | 99 | 237 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02318719
GET https://conductscience.org/api/trials/v1/NCT02318719/results?page=2