Trial · NCT01701362

Placebo-controlled Safety and Efficacy Study of Pregabalin in Subjects With Post-traumatic Peripheral Neuropathic Pain

NCT01701362, Phase 3, Completed, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2017-06-07

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Placebo-controlled Safety and Efficacy Study of Pregabalin in Subjects With Post-traumatic Peripheral Neuropathic Pain. Trials, record NCT01701362. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01701362

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Placebo-controlled Safety and Efficacy Study of Pregabalin in Subjects With Post-traumatic Peripheral Neuropathic Pain
NCT number: NCT01701362
Status: Completed
Phases: Phase 3
Enrollment: 542 participants, actual
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions: Neuropathic Pain
Interventions: pregabalin, placebo
First posted: 2012-10-05
Last updated: 2021-01-28
Other registries' IDs: eudract:2012-003304-12
Results first posted: 2017-06-07

Source ClinicalTrials.gov

Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Baseline Mean Pain Score	Baseline	This is based on the daily pain dairy and is defined as the baseline mean pain diary score. The Daily Pain Diary consists of an 11-point numeric rating scale (NRS) ranging from 0 ("no pain") to 10 ("worst possible pain"). Subjects describe their pain during the past 24 hours by choosing the appropriate number between 0 and 10.
Primary	Change From Baseline to Week 15 in Weekly Mean Pain Score	up to Week 15	This is based on the daily pain diary and is defined as the change from baseline to week 15 in mean pain diary score. The Daily Pain Diary consists of an 11-point numeric rating scale (NRS) ranging from 0 ("no pain") to 10 ("worst possible pain"). Subjects describe their pain during the past 24 hours by choosing the appropriate number between 0 and 10.
Secondary	Patient Global Impression of Change (PGIC) at Week 15	Week 15	A self administered instrument that measures changes in participants' overall status on a scale ranging from 1 (very much improved) to 7 (very much worse). The PGIC is based on the Clinical Global Impression of Change, which is a validated scale.
Secondary	Change From Baseline in Overall Weekly Mean Sleep Interference Score (SIRS)	up to Week 15	This is an 11-point NRS ranging from 0 ("pain does not interfere with sleep") to 10 ("pain completely interferes with sleep" \[unable to sleep due to pain\]). Participants describe how pain has interfered with their sleep during the past 24 hours. Please note that the data for Baseline (raw scores) have been included in the below table to read the change from Baseline data in context. Note: Weekly mean SIRS scores were derived from the daily sleep diary and calculated as the mean of the available scores in the 7 days. Generally, week 'n' mean SIRS scores were defined as the mean of the 7 daily diary SIRS scores from Day 2+7 (n-1) to Day 1+7\*n. For participants with multiple diary scores collected on the same day, the average of all non-missing scores for that day was used in any analyses or data listings. "Overall" is the pooled average sleep interference score for each subject across all post-baseline/randomization weeks.
Secondary	Change From Baseline in Pain Severity Index (Brief Pain Inventory-short Form [BPI-sf])	Week 15	A self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during the 24 hour period prior to evaluation. The BPI-sf consists of 5 questions. Four items measure pain on 11-point response scales from 0 (No Pain) to 10 (Pain as bad as you can imagine). In the above scale, score 0 indicates the better outcome whereas score 10 indicates the worse outcome.
Secondary	Change From Baseline in Pain Interference Index (BPI-sf)	Week 15	BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during the 24 hour period prior to evaluation. It consists of 7 sub-questions that evaluates the level of pain interference with daily functioning on 11-point response scales from 0 (does not interfere) to 10 (completely interferes). The BPI-sf pain interference index was calculated as average of the seven individual pain interference scores.
Secondary	Change From Baseline to Endpoint in Quality of Life Using EuroQol (EQ-5D) Health State Profile Scores	Week 15	A self-administered questionnaire designed to assess health related quality of life in terms of a single index value or utility score. There are 5 dimensions: mobility, self-care, usual activities, pain/ discomfort, and anxiety/ depression. Each dimension is rated on a 3 point response scale and the scores are combined to form a single index value between 0 and 1 with higher scores being more positive (better health status). The EQ-5D was completed by the subject at week-0 and week-15/ET where 30% responder and 50% responder status would be defined for each participants based on the percent change from baseline (week 0/Randomization) to each visit week in mean pain score and participant global impression of change (PGIC). PGIC is a self-administered instrument that measures change in participant's overall status on a scale ranging from 1 (very much improved) to 7 (very much worse). It is based on the Clinical Global Impression of Change CGIC), which is a validated scale.
Secondary	Baseline Scores in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score.	Baseline	MOS-SS is a self administered measure consisting of twelve items that assess the key constructs of sleep. Instrument scored results in 7 subscales: sleep disturbance, snoring, awaken short of breath or with headache, quantity of sleep, optimal sleep, sleep adequacy, somnolence. Two index measures that assess sleep disturbance was also constructed to provide composite scores. Sleep disturbance, snoring, somnolence, awaken short of breath, and the 9 items sleep problems index all have score ranges from 0 (no sleep problems) to 100 (greater sleep problems), therefore a negative change indicates improvement. Sleep adequacy is scored 0 (least sleep adequacy) to 100 (better sleep adequacy), therefore a positive change indicates improvement. Quantity of sleep is scored 0 (less quantity of sleep) to 24 (greater quantity of sleep), therefore a positive change indicates improvement. Optimal sleep is scored Yes if average hours of sleep is in range of 7-8 hours.
Secondary	Mean Change From Baseline in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score.	Week 15	MOS-SS is a self administered measure consisting of twelve items that assess the key constructs of sleep. Instrument scored results in 7 subscales: sleep disturbance, snoring, awaken short of breath or with headache, quantity of sleep, optimal sleep, sleep adequacy, somnolence. Two index measures that assess sleep disturbance was also constructed to provide composite scores. Sleep disturbance, snoring, somnolence, awaken short of breath, and the 9 items sleep problems index all have score ranges from 0 (no sleep problems) to 100 (greater sleep problems), therefore a negative change indicates improvement. Sleep adequacy is scored 0 (least sleep adequacy) to 100 (better sleep adequacy), therefore a positive change indicates improvement. Quantity of sleep is scored 0 (less quantity of sleep) to 24 (greater quantity of sleep), therefore a positive change indicates improvement. Optimal sleep is scored Yes if average hours of sleep is in range of 7-8 hours.
Secondary	Percentage of Participants in MOS-SS With Optimal Sleep Status.	Week 15	MOS-SS optimal sleep status analyzed on a scale of four parameters: any improvements, no change, any worsening and not applicable.

1 to 10 of 12Source ClinicalTrials.gov

See all 12 registered outcomes

Outcomes12

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Baseline Mean Pain Score	Baseline	Intent to Treat (ITT) population: all randomized participants who took at least one dose of study drug	units on a scale	MEAN
PRIMARY	Change From Baseline to Week 15 in Weekly Mean Pain Score	up to Week 15	ITT population: all randomized participants who took at least one dose of study drug	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Patient Global Impression of Change (PGIC) at Week 15	Week 15	ITT population: all randomized participants who took at least one dose of study drug	Participants	NUMBER
SECONDARY	Change From Baseline in Overall Weekly Mean Sleep Interference Score (SIRS)	up to Week 15	ITT population: all randomized participants who took at least one dose of study drug	units on a scale	MEAN
SECONDARY	Change From Baseline in Pain Severity Index (Brief Pain Inventory-short Form [BPI-sf])	Week 15	ITT population: all randomized participants who took at least one dose of study drug	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Pain Interference Index (BPI-sf)	Week 15	ITT population: all randomized participants who took at least one dose of study drug	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline to Endpoint in Quality of Life Using EuroQol (EQ-5D) Health State Profile Scores	Week 15	ITT population: all randomized participants who took at least one dose of study drug	Units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Baseline Scores in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score.	Baseline	ITT population: all randomized participants who took at least one dose of study drug.	Units on a scale	MEDIAN
SECONDARY	Mean Change From Baseline in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score.	Week 15	ITT population: all randomized participants who took at least one dose of study drug.	Units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Percentage of Participants in MOS-SS With Optimal Sleep Status.	Week 15	ITT population: all randomized subjects who took at least one dose of study drug	Percentage of participants	NUMBER

1 to 10 of 12Source ClinicalTrials.gov

See all 12 outcomes

Results by group170

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Baseline Mean Pain Score	Pregabalin		6.41	Standard Deviation 1.30	units on a scale
Baseline Mean Pain Score	Placebo		6.54	Standard Deviation 1.30	units on a scale
Change From Baseline to Week 15 in Weekly Mean Pain Score	Pregabalin		-2.12	Standard Error 0.15	units on a scale
Change From Baseline to Week 15 in Weekly Mean Pain Score	Placebo		-1.90	Standard Error 0.16	units on a scale
Patient Global Impression of Change (PGIC) at Week 15	Pregabalin	Very much improved	52		Participants
Patient Global Impression of Change (PGIC) at Week 15	Placebo	Very much improved	41		Participants
Patient Global Impression of Change (PGIC) at Week 15	Pregabalin	Much improved	105		Participants
Patient Global Impression of Change (PGIC) at Week 15	Placebo	Much improved	79		Participants
Patient Global Impression of Change (PGIC) at Week 15	Pregabalin	Minimally improved	61		Participants
Patient Global Impression of Change (PGIC) at Week 15	Placebo	Minimally improved	62		Participants

1 to 10 of 170Source ClinicalTrials.gov

See all 170 results by group

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Pregabalin	275
Overall Study	STARTED	Placebo	267
Overall Study	TREATED	Pregabalin	274
Overall Study	TREATED	Placebo	265
Overall Study	COMPLETED	Pregabalin	233
Overall Study	COMPLETED	Placebo	211
Overall Study	NOT COMPLETED	Pregabalin	42
Overall Study	NOT COMPLETED	Placebo	56

Source ClinicalTrials.gov

Adverse events34

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	Nausea	Gastrointestinal disorders	Pregabalin	14	274	15
other	Nausea	Gastrointestinal disorders	Placebo	8	265	8
other	Fatigue	General disorders	Pregabalin	14	274	16
other	Fatigue	General disorders	Placebo	10	265	10
other	Dizziness	Nervous system disorders	Pregabalin	40	274	51
other	Dizziness	Nervous system disorders	Placebo	11	265	13
other	Somnolence	Nervous system disorders	Pregabalin	27	274	31
other	Somnolence	Nervous system disorders	Placebo	9	265	10
serious	Atrial fibrillation	Cardiac disorders	Pregabalin	1	274	1
serious	Atrial fibrillation	Cardiac disorders	Placebo	0	265	0

1 to 10 of 34Source ClinicalTrials.gov

See all 34 adverse events

Adverse 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	75	274
Total, other adverse events	Placebo	33	265
Total, serious adverse events	Pregabalin	2	274
Total, serious adverse events	Placebo	7	265

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
30242745	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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

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Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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