Trial · NCT00407745

A 17-Week Trial To Assess Pregabalin For The Treatment Of Nerve Pain Due To Spinal Cord Injury

NCT00407745, Phase 3, Completed, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2011-12-08

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A 17-Week Trial To Assess Pregabalin For The Treatment Of Nerve Pain Due To Spinal Cord Injury. Trials, record NCT00407745. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00407745

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Trial

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

Title: A 17-Week Trial To Assess Pregabalin For The Treatment Of Nerve Pain Due To Spinal Cord Injury
NCT number: NCT00407745
Status: Completed
Phases: Phase 3
Enrollment: 220 participants, actual
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions: Neuralgia, Spinal Cord Injuries
Interventions: placebo, pregabalin
First posted: 2006-12-05
Last updated: 2021-01-25
Results first posted: 2011-12-08

Source ClinicalTrials.gov

Registered outcomes34

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

List	Outcome	Time frame	Description
Primary	Duration Adjusted Average Change (DAAC) of Mean Pain Score	Baseline, Week 16	DAAC was derived from participant's daily pain diary, where pain was measured on an 11-point Numerical Rating Scale (NRS-Pain)ranging from 0 (did not interfere with sleep) to 10 (completely interfered \[unable to sleep due to pain\]). The DAAC was calculated as the mean of all daily pain diary rating post baseline minus the baseline score then multiplied by the proportion of the planned study duration completed by the participant.
Secondary	Change From Baseline in Weekly Mean Pain Score	Baseline, Week 16	Mean weekly score was calculated as the average of the available daily diary pain score values for the week. Pain score was measured on an 11-point numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain).
Secondary	Number of Participants With >=30% Reduction in Weekly Mean Pain Score From Baseline	Baseline, Week 16	Mean weekly score was calculated as the average of the available daily diary pain score values for the week. Pain score was measured on an 11-point numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain).
Secondary	Number of Participants With Categorical Scores on the Patient Global Impression of Change (PGIC) (Full Scale)	Baseline, Week 16	The PGIC is a participant-rated instrument measuring change in the participant's overall status on a 7-point scale: 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse.
Secondary	Change From Baseline in Weekly Mean Sleep Interference Score	Baseline, Week 16	Pain-related sleep interference was assessed on an 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered \[unable to sleep due to pain\]).
Secondary	Change From Baseline in Weekly Mean Pain Score by Week	Baseline, Week 1 through16	Mean weekly score was calculated as the average of the available daily diary pain score values for the week. Pain score was measured on an 11-point numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain).
Secondary	Number of Participants With >=50% Reduction in Weekly Mean Pain Score From Baseline	Baseline, Week 16	Mean weekly score was calculated as the average of the available daily diary pain score values for the week. Pain score was measured on an 11-point numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain).
Secondary	Change From Baseline in Modified Brief Pain Inventory Interference Scale (10-Item) (mBPI-10) Total Score	Baseline, Week 16	The Modified Brief Pain Inventory (mBPI-10) Interference Scale is a self administered questionnaire that assessed pain interference with functional activities over the past week. The items were measured on an 11 point scale, ranging from "does not interfere" (0) to "completely interferes" (10). A composite score, the pain interference index, was calculated by averaging the 10 items that comprised the scale.
Secondary	Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP) - Static Mechanical Allodynia	Baseline, Week 16	Participant rated pain scale. The pain produced by the applied stimulus (static mechanical allodynia - gentle constant mechanical pressure) was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain).
Secondary	Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP) - Dynamic Mechanical Allodynia	Baseline, Week 16	Participant rated pain scale. The pain produced by the applied stimulus (dynamic mechanical allodynia - gentle stroking with foam brush) was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain).

1 to 10 of 34Source ClinicalTrials.gov

See all 34 registered outcomes

Outcomes34

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Duration Adjusted Average Change (DAAC) of Mean Pain Score	Baseline, Week 16	mITT: all randomized participants who received at least one dose of study medication except the 8 participants who were randomized before protocol amendment 2.	score on scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Weekly Mean Pain Score	Baseline, Week 16	mITT; modified baseline observation carried forward (mBOCF) imputation: mBOCF mean pain score was defined as the baseline mean pain score for participants who discontinued double-blind treatment due to adverse event or who had no postbaseline observations and as the last observation carried forward (LOCF) mean pain score for all other participants.	score on scale	MEAN
SECONDARY	Number of Participants With >=30% Reduction in Weekly Mean Pain Score From Baseline	Baseline, Week 16	mITT; LOCF: LOCF Endpoint corresponded to the last 7 days of diary data up to and including Week 16 and applied if the Week 16 assessment was missing; (N) = number of participants that can be analyzed for the endpoint.	participants	NUMBER
SECONDARY	Number of Participants With Categorical Scores on the Patient Global Impression of Change (PGIC) (Full Scale)	Baseline, Week 16	mITT; LOCF; (N) = number of participants with data available for analysis	participants	NUMBER
SECONDARY	Change From Baseline in Weekly Mean Sleep Interference Score	Baseline, Week 16	mITT; LOCF; (n) = number of participants with data available for analysis	score on scale	MEAN
SECONDARY	Change From Baseline in Weekly Mean Pain Score by Week	Baseline, Week 1 through16	ITT population: defined as all randomized participants who took at least one dose of study medication. (This population included the 8 participants who were randomized before the protocol amendment 2). (n) = number of participants with data for analysis.	score on scale	MEAN
SECONDARY	Number of Participants With >=50% Reduction in Weekly Mean Pain Score From Baseline	Baseline, Week 16	mITT; LOCF; (N) = number of participants with data available for analysis	participants	NUMBER
OTHER_PRE_SPECIFIED	Change From Baseline in Weekly Mean Sleep Interference Score by Week	Baseline, Week 1 through 16	ITT; (n) = number of participants with data available for analysis	score on scale	MEAN
SECONDARY	Change From Baseline in Modified Brief Pain Inventory Interference Scale (10-Item) (mBPI-10) Total Score	Baseline, Week 16	mITT; LOCF; (n) = number of participants with data available for analysis	score on scale	MEAN
SECONDARY	Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP) - Static Mechanical Allodynia	Baseline, Week 16	mITT; LOCF; (n) = number of participants with data available for analysis	score on scale	MEAN

1 to 10 of 34Source ClinicalTrials.gov

See all 34 outcomes

Results by group210

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

Outcome	Group	Category	Value	Spread	Units
Duration Adjusted Average Change (DAAC) of Mean Pain Score	Pregabalin		-1.66	Standard Error 0.157	score on scale
Duration Adjusted Average Change (DAAC) of Mean Pain Score	Placebo		-1.07	Standard Error 0.149	score on scale
Change From Baseline in Weekly Mean Pain Score	Pregabalin	Baseline	6.5	Standard Deviation 1.45	score on scale
Change From Baseline in Weekly Mean Pain Score	Placebo	Baseline	6.5	Standard Deviation 1.41	score on scale
Change From Baseline in Weekly Mean Pain Score	Pregabalin	Change from baseline at endpoint	-1.9	Standard Deviation 1.91	score on scale
Change From Baseline in Weekly Mean Pain Score	Placebo	Change from baseline at endpoint	-1.2	Standard Deviation 1.78	score on scale
Number of Participants With >=30% Reduction in Weekly Mean Pain Score From Baseline	Pregabalin		48		participants
Number of Participants With >=30% Reduction in Weekly Mean Pain Score From Baseline	Placebo		33		participants
Number of Participants With Categorical Scores on the Patient Global Impression of Change (PGIC) (Full Scale)	Pregabalin	1-Very much improved	7		participants
Number of Participants With Categorical Scores on the Patient Global Impression of Change (PGIC) (Full Scale)	Placebo	1-Very much improved	2		participants

1 to 10 of 210Source ClinicalTrials.gov

See all 210 results by group

Participant flow8

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Pregabalin	112
Overall Study	STARTED	Placebo	108
Overall Study	Treated	Pregabalin	112
Overall Study	Treated	Placebo	107
Overall Study	COMPLETED	Pregabalin	93
Overall Study	COMPLETED	Placebo	91
Overall Study	NOT COMPLETED	Pregabalin	19
Overall Study	NOT COMPLETED	Placebo	17

Source ClinicalTrials.gov

Adverse events76

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
other	Vision blurred	Eye disorders	Pregabalin	7	112
other	Vision blurred	Eye disorders	Placebo	0	107
other	Constipation	Gastrointestinal disorders	Pregabalin	6	112
other	Constipation	Gastrointestinal disorders	Placebo	6	107
other	Diarrhoea	Gastrointestinal disorders	Pregabalin	6	112
other	Diarrhoea	Gastrointestinal disorders	Placebo	5	107
other	Dry mouth	Gastrointestinal disorders	Pregabalin	9	112
other	Dry mouth	Gastrointestinal disorders	Placebo	3	107
other	Nausea	Gastrointestinal disorders	Pregabalin	6	112
other	Nausea	Gastrointestinal disorders	Placebo	3	107

1 to 10 of 76Source ClinicalTrials.gov

See all 76 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	78	112
Total, other adverse events	Placebo	56	107
Total, serious adverse events	Pregabalin	9	112
Total, serious adverse events	Placebo	10	107

Source ClinicalTrials.gov

Papers4

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
23345639	DERIVED	PubMed
27448285	DERIVED	PubMed
27611736	DERIVED	PubMed
28072797	DERIVED	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 comparisons6

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Pregabalin vs Placebo: Number of Participants Having Optimal Sleep Based on Medical Outcomes Study Sleep Scale (MOS-SS)	Trial comparisons
Pregabalin vs Placebo: Number of Participants With Improved Duration of Brief Pain Attacks Based on NPSI - Duration (Item 4)	Trial comparisons
Pregabalin vs Placebo: Number of Participants With >=30% Reduction in Weekly Mean Pain Score From Baseline	Trial comparisons
Pregabalin vs Placebo: Number of Participants With Improvement in the Number of Attacks Based on NPSI - Number of Attacks (Item 7)	Trial comparisons
Pregabalin vs Placebo: Number of Participants With >=50% Reduction in Weekly Mean Pain Score From Baseline	Trial comparisons
Pregabalin vs Placebo: serious adverse events	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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