Trial · NCT00978341

Study to Determine if a Reduction in Pain Can be Measured in Spinal Cord Injured Patients Using a New Study Design

NCT00978341, Not applicable, Terminated, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2009-11-09

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Study to Determine if a Reduction in Pain Can be Measured in Spinal Cord Injured Patients Using a New Study Design. Trials, record NCT00978341. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00978341

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Trial

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

Title: Study to Determine if a Reduction in Pain Can be Measured in Spinal Cord Injured Patients Using a New Study Design
NCT number: NCT00978341
Status: Terminated
Phases: Not applicable
Enrollment: 15 participants, actual
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions: Spinal Cord Injuries
Interventions: Pregabalin, Placebo for pregabalin
First posted: 2009-09-16
Last updated: 2021-01-25
Results first posted: 2009-11-09
Limitations and caveats: This study was terminated prematurely.

Source ClinicalTrials.gov

Registered outcomes8

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

List	Outcome	Time frame	Description
Primary	Present Pain Intensity Score	Day 1: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours (post-dose); Day 8: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours (post-dose)	Present pain intensity score: 0-10 numeric rating scale (NRS), 0 (no pain) to 10 (worst possible pain).
Secondary	Daily Pain Score	Predose: Daily from 7 days before Visit 2 (start of Intervention 1) until the morning of Visit 5 (end of Intervention 2)	Daily Pain Score: Day 1 pain intensity over past 24 hours recorded on waking every morning. 0-10 numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain).
Secondary	Dynamic Allodynia Area	Screening, Days 1 & 8: 0 (pre-dose) & 4 hours post-dose,	Area of dynamic allodynia was assessed using a brush (SENSElab Brush 05; velocity approximately 20 millimeters per second \[mm/s\]) by stimulating along a pattern of 8 radial spokes. Stimulation was started from the non-painful perimetry. Subjects were asked to report change in sensation from non-painful to painful and the spot was marked onto the skin. The area of dynamic allodynia was determined from these 8 distances by calculating the area of an octagon (in centimeter squared \[cm2\]).
Secondary	Dynamic Allodynia Pain Score	Screening, Days 1 & 8: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, and 6 hours post-dose	Five strokes (each approx. 6 centimeters \[cm\] long) were applied with a standardized brush (SENSELab Brush 05) across the painful site (and a control site) at a constant velocity (20 millimeters per second \[mm/sec\]). Pain in response to brush stimulation of the allodynic area was recorded using an 11-point numeric rating scale from 0 (no pain) to 10 (worst possible pain). Patients were asked to give a pain rating after each brush stroke. A painful sensation was considered as representing brush allodynia.
Secondary	Punctate Allodynia Area	Screening, Days 1 & 8: 0 (pre-dose) and 4 hours post-dose	Area of punctate allodynia was determined using a von Frey filament (OptiHair2). Stimulation was started from the non-painful perimetry and repeated along a pattern of 8 radial spokes. With a movement along each spoke at steps of 5 millimeters (mm), the subjects reported sensation changes from non-painful to painful and the spot was marked on the skin. The area of punctate allodynia was determined from these 8 distances by calculating the area of an octagon (in square centimeter(s)\[cm2\]).
Secondary	Mechanical Pain Sensitivity Stimulus-Response Function	Screening, Days 1 & 8: 0 (pre-dose), & 2, 4, and 6 hours post-dose	Mechanical pain sensitivity stimulus response function was assessed at the control and painful sites using calibrated von Frey monofilaments and the SENSElab brush. Seven different von Frey monofilaments (8 -512 milliNewtons \[mN\], force increases by a factor of two from filament to filament) and the brush were applied in a predetermined pseudo-random order. Pain rating for each stimulus: 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst possible pain).
Secondary	Neuropathic Pain Symptom Inventory (NPSI)	Prior to morning dosing on Day 1 and prior to discharge on Day 8 for each period.	NPSI: subject rated questionnaire to evaluate 5 dimensions of neuropathic pain (dimensions: burning \[superficial\] spontaneous pain, pressing \[deep\] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia). Includes 10 descriptors ranging from 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each relevant dimension. Total score is calculated as the sum of scores of the 10 descriptors, range: 0-100. Higher score indicates greater intensity of pain.
Secondary	Pharmacokinetic Evaluations of Pregabalin	Day 1: 0 (pre-dose), 0.5, 1, 2, and 6 hours post-dose; Day 8: 0 (pre-dose), 1, 4, & 6 hours post-dose	Pharmacokinetic (PK) results are not presented in this report due to early termination of the trial. Pregabalin PK was not measured as there was incomplete data to conduct pharmacokinetic/pharmacodynamic analyses.

Source ClinicalTrials.gov

Outcomes8

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Present Pain Intensity Score	Day 1: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours (post-dose); Day 8: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours (post-dose)	Full analysis set (FAS): those subjects who completed both periods of the study. Combined results for At-level and Below-level neuropathic pain; At-level: located within 2 dermatomes above or below the level of spinal cord injury; Below-level: located at least 3 dermatomes below the level of spinal cord injury.	scores on scale	MEAN
SECONDARY	Daily Pain Score	Predose: Daily from 7 days before Visit 2 (start of Intervention 1) until the morning of Visit 5 (end of Intervention 2)	FAS; Combined results for At-level and Below-level of spinal cord injury.	scores on scale	MEAN
SECONDARY	Dynamic Allodynia Area	Screening, Days 1 & 8: 0 (pre-dose) & 4 hours post-dose,	FAS; Combined results for At-level and Below-level of spinal cord injury.	cm2	MEAN
SECONDARY	Dynamic Allodynia Pain Score	Screening, Days 1 & 8: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, and 6 hours post-dose	FAS; Combined results for At-level and Below-level of spinal cord injury.	scores on scale	MEAN
SECONDARY	Punctate Allodynia Area	Screening, Days 1 & 8: 0 (pre-dose) and 4 hours post-dose	FAS; combined results for At-level and Below-level spinal cord injury.	cm2	MEAN
SECONDARY	Mechanical Pain Sensitivity Stimulus-Response Function	Screening, Days 1 & 8: 0 (pre-dose), & 2, 4, and 6 hours post-dose	FAS; combined results for At-level and Below-level of spinal cord injury.	scores on scale	MEAN
SECONDARY	Neuropathic Pain Symptom Inventory (NPSI)	Prior to morning dosing on Day 1 and prior to discharge on Day 8 for each period.	FAS; Combined results for At-level and Below-level of spinal cord injury.	scores on scale	MEDIAN
SECONDARY	Pharmacokinetic Evaluations of Pregabalin	Day 1: 0 (pre-dose), 0.5, 1, 2, and 6 hours post-dose; Day 8: 0 (pre-dose), 1, 4, & 6 hours post-dose

Source ClinicalTrials.gov

Results by group154

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

Outcome	Group	Category	Value	Spread	Units
Present Pain Intensity Score	Pregabalin	Day 1: pre-dose (n=15, 14)	5.3	Standard Deviation 2.76	scores on scale
Present Pain Intensity Score	Placebo	Day 1: pre-dose (n=15, 14)	4.9	Standard Deviation 2.91	scores on scale
Present Pain Intensity Score	Pregabalin	Day 1: 0.5 hours post-dose (n=15, 14)	5.1	Standard Deviation 2.46	scores on scale
Present Pain Intensity Score	Placebo	Day 1: 0.5 hours post-dose (n=15, 14)	4.6	Standard Deviation 3.03	scores on scale
Present Pain Intensity Score	Pregabalin	Day 1: 1 hours post-dose (n=15, 14)	4.6	Standard Deviation 2.82	scores on scale
Present Pain Intensity Score	Placebo	Day 1: 1 hours post-dose (n=15, 14)	4.7	Standard Deviation 2.55	scores on scale
Present Pain Intensity Score	Pregabalin	Day 1: 2 hours post-dose (n=15, 14)	4.3	Standard Deviation 2.64	scores on scale
Present Pain Intensity Score	Placebo	Day 1: 2 hours post-dose (n=15, 14)	4.7	Standard Deviation 2.64	scores on scale
Present Pain Intensity Score	Pregabalin	Day 1: 3 hours post-dose (n=15, 14)	4.3	Standard Deviation 2.82	scores on scale
Present Pain Intensity Score	Placebo	Day 1: 3 hours post-dose (n=15, 14)	4.7	Standard Deviation 2.73	scores on scale

1 to 10 of 154Source ClinicalTrials.gov

See all 154 results by group

Participant flow18

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

Period	Milestone	Group	Participants
First Intervention	STARTED	Pregabalin First Then Placebo	8
First Intervention	STARTED	Placebo First Then Pregabalin	7
First Intervention	COMPLETED	Pregabalin First Then Placebo	8
First Intervention	COMPLETED	Placebo First Then Pregabalin	7
First Intervention	NOT COMPLETED	Pregabalin First Then Placebo	0
First Intervention	NOT COMPLETED	Placebo First Then Pregabalin	0
Washout Period of 2 Weeks	STARTED	Pregabalin First Then Placebo	8
Washout Period of 2 Weeks	STARTED	Placebo First Then Pregabalin	7
Washout Period of 2 Weeks	COMPLETED	Pregabalin First Then Placebo	7
Washout Period of 2 Weeks	COMPLETED	Placebo First Then Pregabalin	7

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events74

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	Palpitations	Cardiac disorders	Pregabalin	1	15
other	Palpitations	Cardiac disorders	Placebo	0	14
other	Dermoid cyst	Congenital, familial and genetic disorders	Pregabalin	1	15
other	Dermoid cyst	Congenital, familial and genetic disorders	Placebo	1	14
other	Eye pain	Eye disorders	Pregabalin	0	15
other	Eye pain	Eye disorders	Placebo	1	14
other	Diarrhoea	Gastrointestinal disorders	Pregabalin	1	15
other	Diarrhoea	Gastrointestinal disorders	Placebo	0	14
other	Dry mouth	Gastrointestinal disorders	Pregabalin	2	15
other	Dry mouth	Gastrointestinal disorders	Placebo	1	14

1 to 10 of 74Source ClinicalTrials.gov

See all 74 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	12	15
Total, other adverse events	Placebo	9	14
Total, serious adverse events	Pregabalin	0	15
Total, serious adverse events	Placebo	1	14

Source ClinicalTrials.gov

Papers0

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 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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