Spinal Cord InjuriesNCT00978341

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

A study testing Pregabalin in people with Spinal Cord Injuries, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 4 sites in Australia.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The study is designed to assess if spinal cord injury patients have reduced pain after taking either pregabalin or placebo in a cross over design. Patients had either pain at the level of their injury or below the level of their injury. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Spinal Cord Injuries
What is being tested?: Pregabalin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 15 participants
Where: 4 sitesAustralia
Study dates: Feb 2007to Oct 2008
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

subjects who are outpatients or inpatients
written informed consent obtained (signed by the subject or the subject's legally acceptable representative)
traumatic spinal cord injury of at least 1 year duration with a nonprogressive, i.e., chronic, stage of at least 6 months duration
At-level neuropathic pain: spontaneous or evoked pain with neuropathic features (sharp, shooting, electric or burning pain sensation) in the region of sensory disturbance in a segmental pattern and located within two dermatomes above or below the level of spinal cord injury
Below-level neuropathic pain: spontaneous or evoked pain with neuropathic features (sharp, shooting, electric or burning pain sensation) in the region of sensory disturbance located at least three dermatomes below the level of spinal cord injury

Who cannot join

spinal cord injury (subjects with central pain and musculoskeletal pain must be able to make a distinction between the two)
subjects who have previously not responded to 300 mg/day pregabalin: a non-responder is defined as a subject who has a reduction in pain score of less than 30% from baseline

Trial locations and contacts

4 sites in 1 country.

Australia4 sites

Pfizer Investigational Site
Heidelberg, Victoria, 3084
Pfizer Investigational Site
Randwick, New South Wales, 2031
Pfizer Investigational Site
St Leonards, New South Wales, 2065
Pfizer Investigational Site
Warrawong, New South Wales, 2502

Other trials in Australia

About this study

Official title: A Methodology Study to Assess the Ability of a Randomised, Double Blind, Placebo Controlled, Crossover Trial Design in Spinal Cord Injury Patients With Pain of Neuropathic Origin to Detect Improvement in Pain Endpoints Using Pregabalin as a Benchmark Compound

Read the detailed description

This methodology study was terminated on October 13, 2008 based on interim results for an exploratory, novel endpoint. The results of the primary analysis at the interim for N=12 patients showed results that generally favored pregabalin but were not statistically significant compared to placebo. Based on the estimated conditional power, this result is unlikely to change with full recruitment of N=24 patients and therefore the data monitoring committee recommended termination of the trial. The decision to terminate the trial was not based on any safety concerns.

Conditions: Spinal Cord Injuries
Being tested: Pregabalin, Placebo for pregabalin
Keywords: Clinical Trial Methodology study Neuropathic pain in Spinal cord injury patients Pain endpoints Crossover design
Medical subject headings: Spinal Cord Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PregabalinDrug
Pregabalin 150mg capsules BID for 7.5 days
Placebo for pregabalinDrug
Placebo capsules BID for 7.5 days

Study groups in NCT00978341
Study group	Role	What they receive
Pregabalin	Experimental	Not described Receives: Drug: Pregabalin
Placebo	Other	Not described Receives: Drug: Placebo for pregabalin

What is being measured

The primary outcome is the main question the study is designed to answer.

Present Pain Intensity Score
Present pain intensity score: 0-10 numeric rating scale (NRS), 0 (no pain) to 10 (worst possible pain).
Measured: 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)

Secondary outcomes (7)

Daily Pain Score
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).
Measured: Predose: Daily from 7 days before Visit 2 (start of Intervention 1) until the morning of Visit 5 (end of Intervention 2)
Dynamic Allodynia Area
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]).
Measured: Screening, Days 1 & 8: 0 (pre-dose) & 4 hours post-dose,
Dynamic Allodynia Pain Score
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.
Measured: Screening, Days 1 & 8: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, and 6 hours post-dose
Punctate Allodynia Area
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]).
Measured: Screening, Days 1 & 8: 0 (pre-dose) and 4 hours post-dose
Mechanical Pain Sensitivity Stimulus-Response Function
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).
Measured: Screening, Days 1 & 8: 0 (pre-dose), & 2, 4, and 6 hours post-dose
Neuropathic Pain Symptom Inventory (NPSI)
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.
Measured: Prior to morning dosing on Day 1 and prior to discharge on Day 8 for each period.
Pharmacokinetic Evaluations of Pregabalin
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.
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2007Oct 2008

First posted16 Sep 2009 (estimated)
Study startFeb 2007
Primary completionOct 2008
Study completionOct 2008

Why it stopped: See Detailed Description

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00978341
Sponsor's protocol ID: A0081141
Status last verified: Jan 2010
First submitted: 15 Sep 2009
Last updated: 25 Jan 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Spinal Cord Injuries trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Methodology Study to Assess the Ability of a Randomised, Double Blind, Placebo Controlled, Crossover Trial Design in Spinal Cord Injury Patients With Pain of Neuropathic Origin to Detect Improvement in Pain Endpoints Using Pregabalin as a Benchmark Compound
ClinicalTrials.gov ID: NCT00978341
Acronym / sponsor ID: A0081141
Conditions: Spinal Cord Injuries
Keywords: Clinical Trial Methodology study Neuropathic pain in Spinal cord injury patients Pain endpoints Crossover design
Study type: Interventional
Recruitment status: TerminatedReason stopped: See Detailed Description
Enrolment: 15 participants (actual)
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
Study start: Feb 2007
Primary completion: Oct 2008 (actual)
Study completion: Oct 2008 (actual)
First posted: 16 Sep 2009 (estimated)
Results: Posted 9 Nov 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Pregabalin	Experimental	Drug: Pregabalin
Placebo	Other	Drug: Placebo for pregabalin

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

subjects who are outpatients or inpatients
written informed consent obtained (signed by the subject or the subject's legally acceptable representative)
traumatic spinal cord injury of at least 1 year duration with a nonprogressive, i.e., chronic, stage of at least 6 months duration
At-level neuropathic pain: spontaneous or evoked pain with neuropathic features (sharp, shooting, electric or burning pain sensation) in the region of sensory disturbance in a segmental pattern and located within two dermatomes above or below the level of spinal cord injury
Below-level neuropathic pain: spontaneous or evoked pain with neuropathic features (sharp, shooting, electric or burning pain sensation) in the region of sensory disturbance located at least three dermatomes below the level of spinal cord injury

Key exclusion criteria (2 listed)

spinal cord injury (subjects with central pain and musculoskeletal pain must be able to make a distinction between the two)
subjects who have previously not responded to 300 mg/day pregabalin: a non-responder is defined as a subject who has a reduction in pain score of less than 30% from baseline

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PregabalinPregabalin 150mg capsules BID for 7.5 days	Drug	Pregabalin
Placebo for pregabalinPlacebo capsules BID for 7.5 days	Drug	Placebo

Primary outcome

Present Pain Intensity Score
Time frame: 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).

7 secondary outcomes

Daily Pain Score
Time frame: Predose: Daily from 7 days before Visit 2 (start of Intervention 1) until the morning of Visit 5 (end of Intervention 2)
Dynamic Allodynia Area
Time frame: Screening, Days 1 & 8: 0 (pre-dose) & 4 hours post-dose,
Dynamic Allodynia Pain Score
Time frame: Screening, Days 1 & 8: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, and 6 hours post-dose
Punctate Allodynia Area
Time frame: Screening, Days 1 & 8: 0 (pre-dose) and 4 hours post-dose
Mechanical Pain Sensitivity Stimulus-Response Function
Time frame: Screening, Days 1 & 8: 0 (pre-dose), & 2, 4, and 6 hours post-dose
Neuropathic Pain Symptom Inventory (NPSI)
Time frame: Prior to morning dosing on Day 1 and prior to discharge on Day 8 for each period.
Pharmacokinetic Evaluations of Pregabalin
Time frame: 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

Results and safety

Results posted to the registry on 9 Nov 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pregabalin First Then Placebo	8	8
Placebo First Then Pregabalin	7	7

Primary outcome: Present Pain Intensity Score

Time frame: 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). Mean (Standard Deviation). Unit: scores on scale

Measure	Pregabalin n = 15	Placebo n = 14
Day 1: pre-dose (n=15, 14)	5.3 (2.76)	4.9 (2.91)
Day 1: 0.5 hours post-dose (n=15, 14)	5.1 (2.46)	4.6 (3.03)
Day 1: 1 hours post-dose (n=15, 14)	4.6 (2.82)	4.7 (2.55)
Day 1: 2 hours post-dose (n=15, 14)	4.3 (2.64)	4.7 (2.64)
Day 1: 3 hours post-dose (n=15, 14)	4.3 (2.82)	4.7 (2.73)
Day 1: 4 hours post-dose (n=15, 14)	4.1 (2.79)	4.6 (2.98)
Day 1: 5 hours post-dose (n=15, 14)	3.9 (3.01)	4.9 (3.02)
Day 1: 6 hours post-dose (n=15, 14)	3.9 (2.89)	5.1 (2.91)

Pregabalin vs Placebo: Mean Difference (Final Values): 0.20 (95% CI -0.83 to 1.22), p = 0.6797, ANOVA
Pregabalin vs Placebo: Mean Difference (Final Values): -0.38 (95% CI -1.54 to 0.77), p = 0.4811, ANOVA
Pregabalin vs Placebo: Mean Difference (Final Values): -0.67 (95% CI -1.67 to 0.33), p = 0.1693, ANOVA

Population analysed: 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.

7 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pregabalin	0 of 15 (0%)	12 of 15 (80%)	Not reported
Placebo	1 of 14 (7.1%)	9 of 14 (64.3%)	Not reported

Limitations and caveats (from the sponsor): This study was terminated prematurely.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Pregabalin in people with Spinal Cord Injuries, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 4 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 25 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Nov 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Present Pain Intensity Score (time frame: 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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00978341.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2021; AzTrials last refreshed its copy on 30 Oct 2026.