Trial · NCT01474772
Efficacy and Safety Study of Pregabalin in the Treatment of Pain on Walking in Patients With Diabetic Peripheral Neuropathy (DPN)
NCT01474772, Phase 3, Completed, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2014-11-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety Study of Pregabalin in the Treatment of Pain on Walking in Patients With Diabetic Peripheral Neuropathy (DPN). Trials, record NCT01474772. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01474772
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Study of Pregabalin in the Treatment of Pain on Walking in Patients With Diabetic Peripheral Neuropathy (DPN)
- NCT number
- NCT01474772
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 217 participants, actual
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Conditions
- Diabetic Peripheral Neuropathy
- Interventions
- Pregabalin, placebo
- First posted
- 2011-11-18
- Last updated
- 2021-01-28
- Other registries' IDs
- eudract:2011-003266-32
- Results first posted
- 2014-11-18
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Average Diabetic Peripheral Neuropathy (DPN) Pain Based on a Numeric Rating Scale (NRS) Over the Last 7 Days of Each Treatment Period (Week 6 of Each Treatment Period) | End of Period (includes both Visits 6 and 11) | The daily pain diary consisted of an 11-point numeric scale ranging from 0 ("no pain") to 10 ("worst possible pain"). Participants described their pain during the past 24 hours by having chosen the appropriate number between 0 and 10. Self-assessment was performed daily each evening before bedtime (6.00 pm to midnight) on the telephone via Interactive Voice Recognition System (IVRS). The endpoint mean pain score was defined as the mean of the last 7 daily diary pain ratings while taking study medication in each treatment period - Period 1 and Period 2, respectively. A rating of 1 - 3 was considered as mild pain; 4 - 6 as moderate pain; and 7 - 10 as severe pain. |
| Primary | DPN Pain on Walking Based on a 11-point NRS of Each Treatment Period (Week 6 of Each Treatment Period) | End of Period (includes both Visits 6 and 11) | The post-test DPN pain on walking NRS consisted of an 11-point numeric scale ranging from 0 ("no pain") to 10 ("worst possible pain"). Participants described their DPN pain in their legs and/or feet while walking during the 50-foot walk test by choosing the appropriate number between 0 and 10. The post-test DPN pain on walking NRS was completed by the participant using paper-pen administration immediately after completing the 50-foot walk test at the end of each treatment period - Period 1 and Period 2, respectively. A rating of 1 - 3 was considered as mild pain; 4 - 6 as moderate pain; and 7 - 10 as severe pain. |
| Secondary | Percentage of Participants Achieving 30% Reduction in Mean DPN Pain Score From Baseline at the End of Each Treatment Period (Week 6 of Each Treatment Period) | End of Period (includes both Visits 6 and 11) | The daily pain diary consisted of an 11-point numeric scale ranging from 0 ("no pain") to 10 ("worst possible pain"). Participants described their pain during the past 24 hours by having chosen the appropriate number between 0 and 10. Self-assessment was performed daily each evening before bedtime (6.00 pm to midnight) on the telephone via IVRS. The endpoint mean pain score was defined as the mean of the last 7 daily diary pain ratings while taking study medication in each treatment period - Period 1 and Period 2, respectively. A rating of 1 - 3 was considered as mild pain; 4 - 6 as moderate pain; and 7 - 10 as severe pain. |
| Secondary | Percentage of Participants Achieving 50% Reduction in Mean DPN Pain Score From Baseline at the End of Each Treatment Period (Week 6 of Each Treatment Period) | End of Period (includes both Visits 6 and 11) | The daily pain diary consisted of an 11-point numeric scale ranging from 0 ("no pain") to 10 ("worst possible pain"). Participants described their pain during the past 24 hours by having chosen the appropriate number between 0 and 10. Self-assessment was performed daily each evening before bedtime (6.00 pm to midnight) on the telephone via IVRS. The endpoint mean pain score was defined as the mean of the last 7 daily diary pain ratings while taking study medication in each treatment period - Period 1 and Period 2, respectively. A rating of 1 - 3 was considered as mild pain; 4 - 6 as moderate pain; and 7 - 10 as severe pain. |
| Secondary | Brief Pain Inventory-Short Form (BPI-sf) Score for Pain-Severity Domain at the End of Each Treatment Period (Week 6 of Each Treatment Period) | End of Period (includes both Visits 6 and 11) | The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. The BPI-sf consists of 5 questions: 4 items measure pain (0: no pain; 10: worst pain possible) at its "worst, "least", "average", and "now" (current pain) on an 11-point scale. Scores range from 0 - 40 with higher scores indicating greater pain severity. Another item, containing 7 sub-questions, evaluates the level of interference of pain on daily functioning (general activity, walking, work ability, mood, enjoyment of life, relations with other people, and sleep) on 11-point scales (0: does not interfere; 10: completely interferes). Scores range from 0 - 70 with higher scores indicating greater interference. |
| Secondary | BPI-sf Score for Pain-Interference Domain at the End of Each Treatment Period (Week 6 of Each Treatment Period) | End of Period (includes both Visits 6 and 11) | The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. The BPI-sf consists of 5 questions: 4 items measure pain (0: no pain; 10: worst pain possible) at its "worst, "least", "average", and "now" (current pain) on an 11-point scale. Scores range from 0 - 40 with higher scores indicating greater pain severity. Another item, containing 7 sub-questions, evaluates the level of interference of pain on daily functioning (general activity, walking, work ability, mood, enjoyment of life, relations with other people, and sleep) on 11-point scales (0: does not interfere; 10: completely interferes). Scores range from 0 - 70 with higher scores indicating greater interference. |
| Secondary | BPI-sf Score for Pain-Interference With Walking Ability at the End of Each Treatment Period (Week 6 of Each Treatment Period) | End of Period (includes both Visits 6 and 11) | The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. The BPI-sf consists of 5 questions: 4 items measure pain on an 11-point scale. Scores range from 0 - 40 with higher scores indicating greater pain severity. Another item, containing 7 sub-questions, evaluates the level of interference of pain on daily functioning (general activity, walking, work ability, mood, enjoyment of life, relations with other people, and sleep) on 11-point scales (0: does not interfere; 10: completely interferes). Scores range from 0 - 70 with higher scores indicating greater interference. The sub-score pain interference with walking ability was evaluated, as it was considered to be the most relevant in the context of this study. |
| Secondary | Daytime Total Activity Counts Per Day Measured by Actigraphy Over the Last 7 Days of Each Treatment Period (Week 6 of Each Treatment Period) | End of Period (includes both Visits 6 and 11) | Actigraphy data which measured steps and daytime activity during waking hours were assessed for the last 7 days at Baseline, Visit 6, and Visit 11. Activity counts are the units of motion. It is equal to the sum of peak accelerations each second during the epoch (60 seconds). Total activity counts per day is the sum of the activity counts for each epoch (60 seconds) during the "day" (non-sleep period). Actigraphy was performed with an accelerometer that was worn on the hip during the waking hours. It was programmed to record movements while the device was being worn. |
| Secondary | Steps Per Day Measured by Actigraphy Over the Last 7 Days of Each Treatment Period (Week 6 of Each Treatment Period) | End of Period (includes both Visits 6 and 11) | Actigraphy data which measured steps and daytime activity during waking hours were assessed for the last 7 days at Baseline, Visit 6, and Visit 11. The participants were instructed to wear the device on their hip during the waking hours. |
| Secondary | Walk 12 Questionnaire Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period) | End of Period (includes both Visits 6 and 11) | The Walk-12 is a self-administered questionnaire that assesses the impact of the participant's diabetic neuropathy over the past 2 weeks on parameters associated with walking (12 questions) based on a 5-point scale (from not at all to extremely). The total score is the sum of scores from the 12 questions, which then gets transferred to a 0-100 scale with higher scores indicating greater impairment |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Average Diabetic Peripheral Neuropathy (DPN) Pain Based on a Numeric Rating Scale (NRS) Over the Last 7 Days of Each Treatment Period (Week 6 of Each Treatment Period) | End of Period (includes both Visits 6 and 11) | All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the Intent-to-Treat (ITT) analysis (N: 203). This was the primary analysis set. | units on a scale | LEAST_SQUARES_MEAN |
| POST_HOC | Average Weekly DPN Pain Based on a NRS (Baseline, 6 Weeks in Period 1, 2 Weeks Washout and 6 Weeks in Period 2) | Baseline, 6 weeks in Period 1, 2 weeks washout and 6 weeks in Period 2 | All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). Numbers of participants analyzed are provided in section Measured Values in brackets (N: Pregabalin, Placebo). | units on a scale | MEAN |
| PRIMARY | DPN Pain on Walking Based on a 11-point NRS of Each Treatment Period (Week 6 of Each Treatment Period) | End of Period (includes both Visits 6 and 11) | All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Achieving 30% Reduction in Mean DPN Pain Score From Baseline at the End of Each Treatment Period (Week 6 of Each Treatment Period) | End of Period (includes both Visits 6 and 11) | All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set. Numbers of participants analyzed are provided in section Measured Values in brackets (N: Pregabalin, Placebo). | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving 50% Reduction in Mean DPN Pain Score From Baseline at the End of Each Treatment Period (Week 6 of Each Treatment Period) | End of Period (includes both Visits 6 and 11) | All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set. Numbers of participants analyzed are provided in section Measured Values in brackets (N: Pregabalin, Placebo). | percentage of participants | NUMBER |
| SECONDARY | Brief Pain Inventory-Short Form (BPI-sf) Score for Pain-Severity Domain at the End of Each Treatment Period (Week 6 of Each Treatment Period) | End of Period (includes both Visits 6 and 11) | All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | BPI-sf Score for Pain-Interference Domain at the End of Each Treatment Period (Week 6 of Each Treatment Period) | End of Period (includes both Visits 6 and 11) | All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | BPI-sf Score for Pain-Interference With Walking Ability at the End of Each Treatment Period (Week 6 of Each Treatment Period) | End of Period (includes both Visits 6 and 11) | All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Daytime Total Activity Counts Per Day Measured by Actigraphy Over the Last 7 Days of Each Treatment Period (Week 6 of Each Treatment Period) | End of Period (includes both Visits 6 and 11) | All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set. | counts | LEAST_SQUARES_MEAN |
| SECONDARY | Steps Per Day Measured by Actigraphy Over the Last 7 Days of Each Treatment Period (Week 6 of Each Treatment Period) | End of Period (includes both Visits 6 and 11) | All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set. | steps | LEAST_SQUARES_MEAN |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group72
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Average Diabetic Peripheral Neuropathy (DPN) Pain Based on a Numeric Rating Scale (NRS) Over the Last 7 Days of Each Treatment Period (Week 6 of Each Treatment Period) | Pregabalin | 4.73 | Standard Error 0.14 | units on a scale | |
| Average Diabetic Peripheral Neuropathy (DPN) Pain Based on a Numeric Rating Scale (NRS) Over the Last 7 Days of Each Treatment Period (Week 6 of Each Treatment Period) | Placebo | 4.96 | Standard Error 0.14 | units on a scale | |
| Average Weekly DPN Pain Based on a NRS (Baseline, 6 Weeks in Period 1, 2 Weeks Washout and 6 Weeks in Period 2) | Pregabalin | V6 (N: 101, 102) | 4.66 | Standard Deviation 1.77 | units on a scale |
| Average Weekly DPN Pain Based on a NRS (Baseline, 6 Weeks in Period 1, 2 Weeks Washout and 6 Weeks in Period 2) | Placebo | V6 (N: 101, 102) | 5.29 | Standard Deviation 1.93 | units on a scale |
| Average Weekly DPN Pain Based on a NRS (Baseline, 6 Weeks in Period 1, 2 Weeks Washout and 6 Weeks in Period 2) | Pregabalin | V11 (N: 97, 84) | 4.57 | Standard Deviation 2.22 | units on a scale |
| Average Weekly DPN Pain Based on a NRS (Baseline, 6 Weeks in Period 1, 2 Weeks Washout and 6 Weeks in Period 2) | Placebo | V11 (N: 97, 84) | 4.38 | Standard Deviation 2.17 | units on a scale |
| DPN Pain on Walking Based on a 11-point NRS of Each Treatment Period (Week 6 of Each Treatment Period) | Pregabalin | 4.28 | Standard Error 0.15 | units on a scale | |
| DPN Pain on Walking Based on a 11-point NRS of Each Treatment Period (Week 6 of Each Treatment Period) | Placebo | 4.41 | Standard Error 0.15 | units on a scale | |
| Percentage of Participants Achieving 30% Reduction in Mean DPN Pain Score From Baseline at the End of Each Treatment Period (Week 6 of Each Treatment Period) | Pregabalin | V6 (N: 101, 102) | 38.6 | percentage of participants | |
| Percentage of Participants Achieving 30% Reduction in Mean DPN Pain Score From Baseline at the End of Each Treatment Period (Week 6 of Each Treatment Period) | Placebo | V6 (N: 101, 102) | 24.5 | percentage of participants |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1 | STARTED | Pregabalin/Placebo | 101 | |
| Period 1 | STARTED | Placebo/Pregablin | 102 | |
| Period 1 | COMPLETED | Pregabalin/Placebo | 89 | |
| Period 1 | COMPLETED | Placebo/Pregablin | 99 | |
| Period 1 | NOT COMPLETED | Pregabalin/Placebo | 12 | |
| Period 1 | NOT COMPLETED | Placebo/Pregablin | 3 | |
| Washout | STARTED | Pregabalin/Placebo | 89 | |
| Washout | STARTED | Placebo/Pregablin | 99 | |
| Washout | COMPLETED | Pregabalin/Placebo | 86 | |
| Washout | COMPLETED | Placebo/Pregablin | 97 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events52
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 | Vision blurred | Eye disorders | Pregabalin | 4 | 198 | |
| other | Vision blurred | Eye disorders | Placebo | 1 | 186 | |
| other | Constipation | Gastrointestinal disorders | Pregabalin | 3 | 198 | |
| other | Constipation | Gastrointestinal disorders | Placebo | 4 | 186 | |
| other | Diarrhoea | Gastrointestinal disorders | Pregabalin | 2 | 198 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 5 | 186 | |
| other | Dry mouth | Gastrointestinal disorders | Pregabalin | 5 | 198 | |
| other | Dry mouth | Gastrointestinal disorders | Placebo | 1 | 186 | |
| other | Nausea | Gastrointestinal disorders | Pregabalin | 5 | 198 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 6 | 186 |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pregabalin | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Pregabalin | 53 | 198 |
| Total, other adverse events | Placebo | 38 | 186 |
| Total, serious adverse events | Pregabalin | 9 | 198 |
| Total, serious adverse events | Placebo | 2 | 186 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25565583 | DERIVED |
Source PubMed
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Pregabalin vs Placebo: serious adverse events |
Source Trial comparisons
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/NCT01474772
GET https://conductscience.org/api/trials/v1/NCT01474772/registered?page=2