Trial · NCT01496365
Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
NCT01496365, Phase 2, Completed, Daiichi Sankyo; results first posted 2021-01-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy. Trials, record NCT01496365. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01496365
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
- NCT number
- NCT01496365
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 452 participants, actual
- Lead sponsor
- Daiichi Sankyo
- Conditions
- Diabetic Peripheral Neuropathy
- Interventions
- DS-5565 tablet, pregabalin capsule, Placebo tablet, placebo capsule
- First posted
- 2011-12-21
- Last updated
- 2021-01-05
- Results first posted
- 2021-01-05
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change From Baseline to Week 5 in Average Daily Pain Score (ADPS) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Baseline up to Week 5 postdose, up to 10 months total follow up | Average daily pain score (ADPS) is a participant-reported instrument that measures pain intensity using an 11-point numeric rating scale (NRS) where 0 is defined as no pain and 10 is defined as worst possible pain. Higher scores indicate worse pain intensity level. The change from baseline to Week 5 is reported where a negative value is considered an improvement in pain intensity. A minimally meaningful effect was defined as a decrease of at least 1.0 point \[scale of 0 to 10\] versus placebo). |
| Secondary | Least Square Means of Average Daily Pain Score by Week Mixed Effects Model for Repeated Measures (MMRM) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Baseline up to Week 5 postdose, up to 10 months total follow up | Average daily pain score (ADPS) is a participant-reported instrument that measures pain intensity using an 11-point numeric rating scale (NRS) where 0 is defined as no pain and 10 is defined as worst possible pain. Higher scores indicate worse pain intensity level. The least square means of ADPS (assessed by MMRM) are reported where a negative value is considered an improvement in pain intensity. A minimally meaningful effect was defined as a decrease of at least 1.0 point \[scale of 0 to 10\] versus placebo). |
| Secondary | Average Daily Pain Score Responder Rates Based on ≥30% and ≥50% Decrease From Baseline at Endpoint) Following Treatment With DS-5565 or Placebo Compared to Pregabalin | Baseline up to Week 5 postdose, up to 10 months total follow up | Average daily pain score (ADPS) is a participant-reported instrument that measures pain intensity using an 11-point numeric rating scale (NRS) where 0 is defined as no pain and 10 is defined as worst possible pain. Higher scores indicate worse pain intensity level. |
| Secondary | Mean Change From Baseline to End-of-Treatment in Average Daily Sleep Interference Score Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Baseline up to Week 5 postdose, up to 10 months total follow up | Average Daily Sleep Interference Score (ADSIS) is the weekly average of patient-reported sleep interference (rated every morning on a numerical scale of 0 = "pain did not interfere with sleep" to 10 = "pain completely interfered with sleep" over the past 24 h), where higher scores indicate worse outcome.The change from baseline to Week 5 in ADSIS is being reported as the average of the last 7 available daily scores. The greater the negative value, the greater the improvement in sleep. |
| Secondary | Short-Form McGill Pain Questionnaire (SF-MPQ) Sensory and Affective Scores Change From Baseline to Endpoint Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Baseline up to Week 5 postdose, up to 10 months total follow up | The SF-MPQ sensory score is the sum of 11 pain descriptors each scored from 0 to 3: throbbing, shooting, stabbing, sharp cramping, gnawing, hot-burning, aching, heavy, tender, and splitting. Thus, the SF-MPQ sensory score ranges from 0 to 33, where lower scores indicate a better outcome. The SF-MPQ affective score is the sum of four pain descriptors each scored from 0 to 3: tiring-exhausting, sickening, fearful, and punishing cruel. Thus, SF-MPQ affective score ranges from 0 to 12, where lower scores indicate a better outcome. The change from baseline to Week 5 in SF-MPQ sensory and affective scores are being reported. The greater the negative value, the greater the improvement in sensory and affective scores. |
| Secondary | Short-Form McGill Pain Questionnaire (SF-MPQ) Total Score and Visual Analog Scale Change From Baseline to Endpoint Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Baseline up to Week 5 postdose, up to 10 months total follow up | The SF-MPQ sensory score is the sum of 11 pain descriptors each scored from 0 to 3: throbbing, shooting, stabbing, sharp cramping, gnawing, hot-burning, aching, heavy, tender, and splitting. Thus, the SF-MPQ sensory score ranges from 0 to 33, where lower scores indicate a better outcome. The SF-MPQ affective score is the sum of four pain descriptors each scored from 0 to 3: tiring-exhausting, sickening, fearful, and punishing cruel. Thus, SF-MPQ affective score ranges from 0 to 12, where lower scores indicate a better outcome. The SF-MPQ total score comprises the sum of the sensory and affective scores. The SF-MPQ VAS ranges from 0 (no pain) to 100 (worst possible pain), where lower scores indicate a better outcome. The change from baseline to Week 5 in SF-MPQ total score and VAS are being reported. The greater the negative value, the greater the improvement in total score (sensory and affective scores) and VAS pain. |
| Secondary | Short-Form McGill Pain Questionnaire (SF-MPQ) Present Pain Intensity Change From Baseline to Endpoint Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Baseline up to Week 5 postdose, up to 10 months total follow up | The SF-MPQ present pain intensity ranges from 0 (no pain) to 5 (excruciating), where lower scores indicate a better outcome. The change from baseline to Week 5 in SF-MPQ present pain intensity is being reported. The greater the negative value, the greater the improvement in present pain intensity. |
| Secondary | Mean Change From Baseline to Endpoint of Modified Brief Pain Inventory (BPI) Subscale, Interference With Daily Functions, Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Baseline up to Week 5 postdose, up to 10 months total follow up | The Modified Brief Pain Inventory (BPI) includes Interference with Daily Functions Subscale, Worst Pain Intensity, Least Pain Intensity, Average Pain Intensity, Pain Right Now, and Relief From Pain. The range of interference subscale is 0-10, where lower scores indicate a better outcome. The change from baseline to Week 5 in Modified Brief Pain Inventory is being reported. The greater the negative value, the greater the improvement in interference with daily functions. |
| Secondary | Mean Change From Baseline to Endpoint of Modified BPI Subscales, Worst, Least and Average Pain Intensity, Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Baseline up to Week 5 postdose, up to 10 months total follow up | The Modified Brief Pain Inventory (BPI) includes Interference with Daily Functions Subscale, Worst Pain Intensity, Least Pain Intensity, Average Pain Intensity, Pain Right Now, and Relief From Pain. The range of worst pain intensity in the last 24 hours is 0-10, where lower scores indicate a better outcome. The range of least pain intensity in the last 24 hours is 0-10, where lower scores indicate a better outcome. The range of average pain intensity in the last 24 hours is 0-10, where lower scores indicate a better outcome. The change from baseline to Week 5 in Modified Brief Pain Inventory is being reported. The greater the negative value, the greater the improvement in worst, least, and average pain intensity. |
| Secondary | Mean Change From Baseline to Endpoint of Modified BPI Subscale, Pain Right Now, Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Baseline up to Week 5 postdose, up to 10 months total follow up | The Modified Brief Pain Inventory (BPI) includes Interference with Daily Functions Subscale, Worst Pain Intensity, Least Pain Intensity, Average Pain Intensity, Pain Right Now, and Relief From Pain. The range of pain right now is 0-10, where lower scores indicate a better outcome. The change from baseline to Week 5 in Modified Brief Pain Inventory is being reported. For pain right now, the greater the negative value, the greater the improvement. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change From Baseline to Week 5 in Average Daily Pain Score (ADPS) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Baseline up to Week 5 postdose, up to 10 months total follow up | ADPS was assessed in the Full Analysis Set. | units on a scale | MEAN |
| SECONDARY | Least Square Means of Average Daily Pain Score by Week Mixed Effects Model for Repeated Measures (MMRM) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Baseline up to Week 5 postdose, up to 10 months total follow up | ADPS was assessed in the Full Analysis Set. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Average Daily Pain Score Responder Rates Based on ≥30% and ≥50% Decrease From Baseline at Endpoint) Following Treatment With DS-5565 or Placebo Compared to Pregabalin | Baseline up to Week 5 postdose, up to 10 months total follow up | ADPS was assessed in the Full Analysis Set. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Change From Baseline to End-of-Treatment in Average Daily Sleep Interference Score Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Baseline up to Week 5 postdose, up to 10 months total follow up | ADSIS was assessed in the Full Analysis Set. | units on a scale | MEAN |
| SECONDARY | Short-Form McGill Pain Questionnaire (SF-MPQ) Sensory and Affective Scores Change From Baseline to Endpoint Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Baseline up to Week 5 postdose, up to 10 months total follow up | SF-MPQ sensory and affective scores were assessed in the Full Analysis Set. | units on a scale | MEAN |
| SECONDARY | Short-Form McGill Pain Questionnaire (SF-MPQ) Total Score and Visual Analog Scale Change From Baseline to Endpoint Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Baseline up to Week 5 postdose, up to 10 months total follow up | SF-MPQ total score and VAS pain were assessed in the Full Analysis Set. | units on a scale | MEAN |
| SECONDARY | Short-Form McGill Pain Questionnaire (SF-MPQ) Present Pain Intensity Change From Baseline to Endpoint Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Baseline up to Week 5 postdose, up to 10 months total follow up | SF-MPQ present pain intensity was assessed in the Full Analysis Set. | units on a scale | MEAN |
| SECONDARY | Mean Change From Baseline to Endpoint of Modified Brief Pain Inventory (BPI) Subscale, Interference With Daily Functions, Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Baseline up to Week 5 postdose, up to 10 months total follow up | Modified BPI was assessed in the Full Analysis Set. | units on a scale | MEAN |
| SECONDARY | Mean Change From Baseline to Endpoint of Modified BPI Subscales, Worst, Least and Average Pain Intensity, Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Baseline up to Week 5 postdose, up to 10 months total follow up | Modified BPI was assessed in the Full Analysis Set. | units on a scale | MEAN |
| SECONDARY | Mean Change From Baseline to Endpoint of Modified BPI Subscale, Pain Right Now, Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Baseline up to Week 5 postdose, up to 10 months total follow up | Modified BPI was assessed in the Full Analysis Set. | units on a scale | MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group350
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change From Baseline to Week 5 in Average Daily Pain Score (ADPS) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Placebo | -1.86 | Standard Deviation 2.18 | units on a scale | |
| Mean Change From Baseline to Week 5 in Average Daily Pain Score (ADPS) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Pregabalin 150 mg BID | -1.79 | Standard Deviation 2.27 | units on a scale | |
| Mean Change From Baseline to Week 5 in Average Daily Pain Score (ADPS) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | DS-5565 5mg QD | -2.04 | Standard Deviation 2.22 | units on a scale | |
| Mean Change From Baseline to Week 5 in Average Daily Pain Score (ADPS) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | DS-5565 10 mg QD | -2.32 | Standard Deviation 2.17 | units on a scale | |
| Mean Change From Baseline to Week 5 in Average Daily Pain Score (ADPS) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | DS-5565 15 mg QD | -2.66 | Standard Deviation 2.37 | units on a scale | |
| Mean Change From Baseline to Week 5 in Average Daily Pain Score (ADPS) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | DS-5565 10 mg BID | -2.64 | Standard Deviation 2.45 | units on a scale | |
| Mean Change From Baseline to Week 5 in Average Daily Pain Score (ADPS) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | DS-5565 15 mg BID | -2.79 | Standard Deviation 2.43 | units on a scale | |
| Least Square Means of Average Daily Pain Score by Week Mixed Effects Model for Repeated Measures (MMRM) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Placebo | Week 1 | -0.55 | 95% Confidence Interval -0.81 to -0.29 | units on a scale |
| Least Square Means of Average Daily Pain Score by Week Mixed Effects Model for Repeated Measures (MMRM) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Pregabalin 150 mg BID | Week 1 | -1.10 | 95% Confidence Interval -1.49 to -0.72 | units on a scale |
| Least Square Means of Average Daily Pain Score by Week Mixed Effects Model for Repeated Measures (MMRM) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | DS-5565 5mg QD | Week 1 | -0.68 | 95% Confidence Interval -1.04 to -0.31 | units on a scale |
1 to 10 of 350Source ClinicalTrials.gov
See all 350 results by groupParticipant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 112 | |
| Overall Study | STARTED | Pregabalin 150 mg BID | 56 | |
| Overall Study | STARTED | DS-5565 5mg QD | 57 | |
| Overall Study | STARTED | DS-5565 10 mg QD | 57 | |
| Overall Study | STARTED | DS-5565 15 mg QD | 57 | |
| Overall Study | STARTED | DS-5565 10 mg BID | 56 | |
| Overall Study | STARTED | DS-5565 15 mg BID | 57 | |
| Overall Study | COMPLETED | Placebo | 97 | |
| Overall Study | COMPLETED | Pregabalin 150 mg BID | 41 | |
| Overall Study | COMPLETED | DS-5565 5mg QD | 51 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events1,680
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 | Dizziness | Nervous system disorders | Placebo | 2 | 108 | |
| other | Dizziness | Nervous system disorders | Pregabalin 150 mg BID | 3 | 50 | |
| other | Dizziness | Nervous system disorders | DS-5565 5mg QD | 0 | 55 | |
| other | Dizziness | Nervous system disorders | DS-5565 10 mg QD | 7 | 56 | |
| other | Dizziness | Nervous system disorders | DS-5565 15 mg QD | 6 | 53 | |
| other | Dizziness | Nervous system disorders | DS-5565 10 mg BID | 4 | 56 | |
| other | Dizziness | Nervous system disorders | DS-5565 15 mg BID | 9 | 57 | |
| other | Headache | Nervous system disorders | Placebo | 4 | 108 | |
| other | Headache | Nervous system disorders | Pregabalin 150 mg BID | 2 | 50 | |
| other | Headache | Nervous system disorders | DS-5565 5mg QD | 6 | 55 |
1 to 10 of 1,680Source ClinicalTrials.gov
See all 1,680 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 108 |
| Total, all-cause mortality | Pregabalin 150 mg BID | 0 | 50 |
| Total, all-cause mortality | DS-5565 5mg QD | 0 | 55 |
| Total, all-cause mortality | DS-5565 10 mg QD | 0 | 56 |
| Total, all-cause mortality | DS-5565 15 mg QD | 0 | 53 |
| Total, all-cause mortality | DS-5565 10 mg BID | 0 | 56 |
| Total, all-cause mortality | DS-5565 15 mg BID | 0 | 57 |
| Total, other adverse events | Placebo | 48 | 108 |
| Total, other adverse events | Pregabalin 150 mg BID | 30 | 50 |
| Total, other adverse events | DS-5565 5mg QD | 29 | 55 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT01496365
GET https://conductscience.org/api/trials/v1/NCT01496365/results?page=2