PainNCT00610155

A Methodology Study Of Brain Imaging Of Pain-Killers In Post-Traumatic Neuropathic Pain Patients

A study testing Pregabalin and Tramadol SR in people with Pain, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 2 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This study is a methodology study designed to discover whether a brain imaging technology is a better way of compare the relative sensitivities of fMRI and subjective psychometric assessments of pain to multiple doses of pregabalin and tramadol SR in a cross-over clinical study design. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Pain
What is being tested?: Pregabalin and Tramadol SR
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 18 participants
Where: 2 sitesUnited Kingdom
Study dates: Sep 2008to Jul 2010
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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of neuropathic pain associated with brush allodynia in specific dermatomes.
Brush allodynia score of ≥4 and calculated average pain score of ≥3 on an 11-point numerical rating scale by the completion of down-titration of existing medications.
Right-handed

Who cannot join

Subjects with trigeminal neuralgia, central pain (due to cerebrovascular lesions, multiple sclerosis and/or traumatic spinal cord injuries including spinal surgery).
Phantom limb pain, painful diabetic neuropathy.
Subjects with any other co-existing pain which he/she or a qualified pain physician cannot differentiate from NeP of peripheral origin.
Subjects with diabetes mellitus and with an HbA1C value of >10% upon measurement at screening.

Trial locations and contacts

2 sites in 1 country.

United Kingdom2 sites

Pfizer Investigational Site
Portsmouth, Hampshire, PO3 6AD
Pfizer Investigational Site
Solihull, West Midlands, B91 2JL

Other trials in United Kingdom

About this study

Official title: A Methodology Study To Assess The Feasibility Of Using Functional Magnetic Resonance Imaging (fRMI) To Quantify The Effects Of Analgesic Drugs In Post-Traumatic Neuropathic Pain Subjects

Conditions: Pain
Being tested: Placebo, Pregabalin, Tramadol SR
Medical subject headings: Pain

What participants receive

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

PlaceboDrug
BID
PregabalinDrug
Dose 75 mg titrated to 150 mg, bid
Tramadol SRDrug
Dose 50mg titrated to 200 mg, bid

Study groups in NCT00610155
Study group	Role	What they receive
1	Placebo comparator	Not described Receives: Drug: Placebo
2	Experimental	Not described Receives: Drug: Pregabalin
3	Experimental	Not described Receives: Drug: Tramadol SR

What is being measured

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

Voxel-wise Blood Oxygen Level Dependent (BOLD) Using Functional Magnetic Resonance Imaging (fMRI) of Brain Activation Signals Across the Whole Brain
BOLD brain activation signals in whole brain was assessed using Contrast Parameter Estimates (COPE) images in response to dynamic mechanical allodynia of the affected side (DMAa), dynamic mechanical allodynia of the control side (DMAc), thermal pain (TH) and checkerboard visual stimuli (VIS).
Measured: Day 8, 22, 36
Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Dynamic Mechanical Allodynia of the Affected Side (DMAa)
BOLD brain activation signals in pre-defined region of interest(ROI):anterior cingulate cortex(ACC);left,right anterior cortex([AIC_L ],[AIC_R]);left,right mid-insular cortex([MIC_L],[MIC_R]);left,right posterior insular cortex([PIC_L],[PIC_R]);left,right amygdala([Amyg_L],[Amyg_R]);primary,secondary somatosensory cortex([S1],[S2]);sensory part of thalamus(SensTHAL);midbrain reticular formation(MRF);nucleus cuneiformis(NucCun);periaqueductal gray(PAG). Prior to ROI analysis, a prelimanary anlysis was performed, wherein it was concluded that ROI analysis was to be carried out for DMAa, DMAc amd TH only. In voxel BOLD analysis,signal change is unit less measure but approximated to percent signal change by grand scaling(effects divided by 10000 to get percent signal change).
Measured: Day 8, 22, 36
Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Dynamic Mechanical Allodynia of the Control Side (DMAc)
BOLD brain activation signals in pre-defined ROI. ROI were ACC; AIC_L; AIC_R; MIC_L; MIC_R; PIC_L; PIC_R; Amyg_L; Amyg_R; S1; S2; SensTHAL; MRF; NucCun; PAG. Prior to ROI analysis, a prelimanary anlysis was performed, wherein it was concluded that ROI analysis was to be carried out for DMAa, DMAc amd TH only. In voxel BOLD analysis, signal change is unit less measure but is approximated to percent signal change here by grand scaling (dividing effects by 10000 to get percent signal change).
Measured: Day 8, 22, 36
Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Thermal Stimulation (TH)
BOLD brain activation signals in pre-defined ROI. ROI were ACC; AIC_L; AIC_R; MIC_L; MIC_R; PIC_L; PIC_R; Amyg_L; Amyg_R; S1; S2; SensTHAL; MRF; NucCun; PAG. Prior to ROI analysis, a prelimanary anlysis was performed, wherein it was concluded that ROI analysis was to be carried out for DMAa, DMAc amd TH only. In voxel BOLD analysis, signal change is unit less measure but is approximated to percent signal change here by grand scaling (dividing effects by 10000 to get percent signal change).
Measured: Day 8, 22, 36
Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Visual Stimulation (VIS)
BOLD brain activation signals in pre-defined ROI in response to checkerboard visual stimuli (flashing at 2 Hz). ROI were ACC; AIC_L; AIC_R; MIC_L; MIC_R; PIC_L; PIC_R; Amyg_L; Amyg_R; S1; S2; SensTHAL; MRF; NucCun; PAG. Prior to ROI analysis, a prelimanary anlysis was performed, wherein it was concluded that ROI analysis was to be carried out for DMAa, DMAc amd TH only.
Measured: Day 8, 22, 36
Arterial Spin Labelling (ASL) Using fMRI of Brain Activation Signals Across the Whole Brain and in Defined Brain Regions
Continuous ASL sequence fMRI imaging modality assessing brain activation signals across the whole brain and in defined ROI to assess effects of evoked pain along with changes in regional cerebral blood flow (rCBF). ROI were ACC; AIC_L; AIC_R; MIC_L; MIC_R; PIC_L; PIC_R; Amyg_L; Amyg_R; S1; S2; SensTHAL; MRF; NucCun; PAG.
Measured: Day 8, 22, 36

Secondary outcomes (8)

36-Item Short-Form Health Survey (SF-36)
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
Measured: Day 8, 22, 36
Beck Depression Inventory (BDI)
BDI is a 21 item participant rated inventory evaluating depression symptoms, cognition, and physical symptoms of fatigue, weight loss, lack of interest in sex. Individual items are scored on a 4 point scale (0 to 3), with 0=none/absent and 3=most severe. Total score: 0 to 63; higher score indicate more depression.
Measured: Day 8, 22, 36
State and Trait Anxiety Questionnaire
Self-report scale completed by the participant. Separate scales measure state (20 items) and trait (20 items) anxiety. The participant report how they feel "right now at this moment" for state anxiety and how they "generally" feel for trait anxiety. The "state" items are scored as: 1 (not at all), 2 (somewhat true), 3 (moderately true), 4 (very much so). The "trait" items are scored as: 1 (almost never), 2 (sometimes), 3 (often), 4 (almost always). Scores range from 20-80 for each scale. Higher scores indicate more impaired participants.
Measured: Day 8, 22, 36
Pain Catastrophising Scale (PCS)
The PCS is a self-administered questionnaire with 13 items, each scored from 0 (not at all) to 4 (all the time) for extent to which participant catastrophizes postoperative pain. Total score is sum of scores for all questions (range: 0 to 52); Subscale scores: Rumination (sum of scores for 4 items; range: 0 to 16); Magnification (sum of scores for 3 items; range: 0 to 12); and Helplessness (sum of scores for 6 items; range: 0 to 24); higher scores indicate greater extent of pain catastrophizing.
Measured: Day 8, 22, 36
Neuropathic Pain Symptom Inventory (NPSI)
NPSI: participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 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 of the relevant dimensions and a total score of 0-100. Higher score indicate a greater intensity of pain.
Measured: Baseline (Day -7), Day 8, 22, 36
Daily Pain Score
Daily Pain Score: Day 1 pain intensity over past 24 hours recorded on waking every morning using 0-10 numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain). The daily pain scores for an average of the last 7 days and an average of last 3 days were calculated.
Measured: Day -35 through Day 36
Present Pain Intensity Score (PPIS)
Participants answered: "Please rate your pain from 0-10 that best describes the intensity of pain right now". PPIS assessed on 0-10 numeric rating scale (NRS), 0 (no pain) to 10 (worst possible pain).
Measured: Day 8, 22, 36
Doleur Neuropathic 4 (DN4) Score
DN4 questionnaire provides a simple diagnosis of Neuropathic pain (NeP) by asking for yes/no answers to 4 questions (10 sub questions in total). Each question was scored on a scale of 0 (No) and 1 (Yes). Total score was calculated as sum of the 10 individual questions. Total score range 0-10, higher score indicated more neuropathic pain.
Measured: Day -35

Timeline

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

Sep 2008Jul 2010

First posted7 Feb 2008 (estimated)
Study startSep 2008
Primary completionJul 2010
Study completionJul 2010

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 PainStudies 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: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00610155
Sponsor's protocol ID: A0081173
Status last verified: Sep 2013
First submitted: 14 Jan 2008
Last updated: 22 Jan 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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

Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain

All Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Methodology Study To Assess The Feasibility Of Using Functional Magnetic Resonance Imaging (fRMI) To Quantify The Effects Of Analgesic Drugs In Post-Traumatic Neuropathic Pain Subjects
ClinicalTrials.gov ID: NCT00610155
Acronym / sponsor ID: A0081173
Conditions: Pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
Collaborators: University of Oxford
Study start: Sep 2008
Primary completion: Jul 2010 (actual)
Study completion: Jul 2010 (actual)
First posted: 7 Feb 2008 (estimated)
Results: Posted 28 Nov 2013

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
1	Placebo comparator	Drug: Placebo
2	Experimental	Drug: Pregabalin
3	Experimental	Drug: Tramadol SR

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Diagnosis of neuropathic pain associated with brush allodynia in specific dermatomes.
Brush allodynia score of ≥4 and calculated average pain score of ≥3 on an 11-point numerical rating scale by the completion of down-titration of existing medications.
Right-handed

Key exclusion criteria (4 listed)

Subjects with trigeminal neuralgia, central pain (due to cerebrovascular lesions, multiple sclerosis and/or traumatic spinal cord injuries including spinal surgery).
Phantom limb pain, painful diabetic neuropathy.
Subjects with any other co-existing pain which he/she or a qualified pain physician cannot differentiate from NeP of peripheral origin.
Subjects with diabetes mellitus and with an HbA1C value of >10% upon measurement at screening.

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
PlaceboBID	Drug	1
PregabalinDose 75 mg titrated to 150 mg, bid	Drug	2
Tramadol SRDose 50mg titrated to 200 mg, bid	Drug	3

Primary outcome

Voxel-wise Blood Oxygen Level Dependent (BOLD) Using Functional Magnetic Resonance Imaging (fMRI) of Brain Activation Signals Across the Whole Brain
Time frame: Day 8, 22, 36
BOLD brain activation signals in whole brain was assessed using Contrast Parameter Estimates (COPE) images in response to dynamic mechanical allodynia of the affected side (DMAa), dynamic mechanical allodynia of the control side (DMAc), thermal pain (TH) and checkerboard visual stimuli (VIS).
Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Dynamic Mechanical Allodynia of the Affected Side (DMAa)
Time frame: Day 8, 22, 36
BOLD brain activation signals in pre-defined region of interest(ROI):anterior cingulate cortex(ACC);left,right anterior cortex([AIC_L ],[AIC_R]);left,right mid-insular cortex([MIC_L],[MIC_R]);left,right posterior insular cortex([PIC_L],[PIC_R]);left,right amygdala([Amyg_L],[Amyg_R]);primary,secondary somatosensory cortex([S1],[S2]);sensory part of thalamus(SensTHAL);midbrain reticular formation(MRF);nucleus cuneiformis(NucCun);periaqueductal gray(PAG). Prior to ROI analysis, a prelimanary anlysis was performed, wherein it was concluded that ROI analysis was to be carried out for DMAa, DMAc amd TH only. In voxel BOLD analysis,signal change is unit less measure but approximated to percent signal change by grand scaling(effects divided by 10000 to get percent signal change).
Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Dynamic Mechanical Allodynia of the Control Side (DMAc)
Time frame: Day 8, 22, 36
BOLD brain activation signals in pre-defined ROI. ROI were ACC; AIC_L; AIC_R; MIC_L; MIC_R; PIC_L; PIC_R; Amyg_L; Amyg_R; S1; S2; SensTHAL; MRF; NucCun; PAG. Prior to ROI analysis, a prelimanary anlysis was performed, wherein it was concluded that ROI analysis was to be carried out for DMAa, DMAc amd TH only. In voxel BOLD analysis, signal change is unit less measure but is approximated to percent signal change here by grand scaling (dividing effects by 10000 to get percent signal change).
Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Thermal Stimulation (TH)
Time frame: Day 8, 22, 36
BOLD brain activation signals in pre-defined ROI. ROI were ACC; AIC_L; AIC_R; MIC_L; MIC_R; PIC_L; PIC_R; Amyg_L; Amyg_R; S1; S2; SensTHAL; MRF; NucCun; PAG. Prior to ROI analysis, a prelimanary anlysis was performed, wherein it was concluded that ROI analysis was to be carried out for DMAa, DMAc amd TH only. In voxel BOLD analysis, signal change is unit less measure but is approximated to percent signal change here by grand scaling (dividing effects by 10000 to get percent signal change).
Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Visual Stimulation (VIS)
Time frame: Day 8, 22, 36
BOLD brain activation signals in pre-defined ROI in response to checkerboard visual stimuli (flashing at 2 Hz). ROI were ACC; AIC_L; AIC_R; MIC_L; MIC_R; PIC_L; PIC_R; Amyg_L; Amyg_R; S1; S2; SensTHAL; MRF; NucCun; PAG. Prior to ROI analysis, a prelimanary anlysis was performed, wherein it was concluded that ROI analysis was to be carried out for DMAa, DMAc amd TH only.
Arterial Spin Labelling (ASL) Using fMRI of Brain Activation Signals Across the Whole Brain and in Defined Brain Regions
Time frame: Day 8, 22, 36
Continuous ASL sequence fMRI imaging modality assessing brain activation signals across the whole brain and in defined ROI to assess effects of evoked pain along with changes in regional cerebral blood flow (rCBF). ROI were ACC; AIC_L; AIC_R; MIC_L; MIC_R; PIC_L; PIC_R; Amyg_L; Amyg_R; S1; S2; SensTHAL; MRF; NucCun; PAG.

8 secondary outcomes

36-Item Short-Form Health Survey (SF-36)
Time frame: Day 8, 22, 36
Beck Depression Inventory (BDI)
Time frame: Day 8, 22, 36
State and Trait Anxiety Questionnaire
Time frame: Day 8, 22, 36
Pain Catastrophising Scale (PCS)
Time frame: Day 8, 22, 36
Neuropathic Pain Symptom Inventory (NPSI)
Time frame: Baseline (Day -7), Day 8, 22, 36
Daily Pain Score
Time frame: Day -35 through Day 36
Present Pain Intensity Score (PPIS)
Time frame: Day 8, 22, 36
Doleur Neuropathic 4 (DN4) Score
Time frame: Day -35

Results and safety

Results posted to the registry on 28 Nov 2013, 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 Then Tramadol Then Placebo	4	4
Tramadol Then Placebo Then Pregabalin	3	3
Placebo Then Pregabalin Then Tramadol	4	3
Pregabalin Then Placebo Then Tramadol	3	3
Placebo Then Tramadol Then Pregabalin	3	3
Tramadol Then Pregabalin Then Placebo	1	1

Primary outcome: Voxel-wise Blood Oxygen Level Dependent (BOLD) Using Functional Magnetic Resonance Imaging (fMRI) of Brain Activation Signals Across the Whole Brain

Time frame: Day 8, 22, 36

Population analysed: Data not available to report, as BOLD brain activation signals in whole brain were obtained as specific Contrast Parameter Estimates (COPE) images only, as per planned analysis.

Primary outcome: Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Dynamic Mechanical Allodynia of the Affected Side (DMAa)

Time frame: Day 8, 22, 36. Least squares mean (Standard Error). Unit: percent signal change

Measure	Pregabalin n = 16	Tramadol n = 16	Placebo n = 16
ACC	-17.3 (9.7)	18.6 (9.7)	7.4 (9.7)
AIC_L	8.1 (8.8)	23.3 (8.8)	30.8 (8.8)
AIC_R	11.1 (10.0)	21.9 (10.0)	17.1 (10.0)
MIC_L	3.8 (8.4)	23.4 (8.4)	30.0 (8.4)
MIC_R	8.6 (8.4)	13.4 (8.4)	18.3 (8.4)
PIC_L	-6.8 (5.2)	-5.8 (5.2)	-0.3 (5.2)
PIC_R	-13.6 (8.5)	2.9 (8.5)	6.5 (8.5)
Amyg_L	-5.7 (10.2)	5.5 (10.2)	8.5 (10.2)

Population analysed: BOLD analysis set included all participants who completed all the 3 treatment periods of the study.

Primary outcome: Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Dynamic Mechanical Allodynia of the Control Side (DMAc)

Time frame: Day 8, 22, 36. Least squares mean (Standard Error). Unit: percent signal change

Measure	Pregabalin n = 16	Tramadol n = 16	Placebo n = 16
ACC	-22.3 (12.0)	-3.7 (12.0)	0.2 (12.0)
AIC_L	-13.5 (8.0)	18.2 (8.0)	20.2 (8.0)
AIC_R	-10.6 (7.4)	10.3 (7.4)	20.2 (7.4)
MIC_L	-7.6 (8.4)	9.7 (8.4)	9.0 (8.4)
MIC_R	-9.2 (6.2)	2.8 (6.2)	0.7 (6.2)
PIC_L	-14.9 (6.9)	-8.1 (6.9)	0.8 (6.9)
PIC_R	-17.2 (9.4)	2.4 (9.4)	6.3 (9.4)
Amyg_L	-14.3 (7.3)	1.5 (7.3)	-3.4 (7.3)

Population analysed: BOLD analysis set included all participants who completed all the 3 treatment periods of the study.

Primary outcome: Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Thermal Stimulation (TH)

Time frame: Day 8, 22, 36. Least squares mean (Standard Error). Unit: percent signal change

Measure	Pregabalin n = 16	Tramadol n = 16	Placebo n = 16
ACC	102.2 (25.9)	92.5 (25.8)	83.3 (25.8)
AIC_L	92.1 (21.9)	103.4 (21.8)	118.7 (21.8)
AIC_R	121.7 (20.7)	104.6 (20.6)	104.0 (20.6)
MIC_L	93.4 (19.6)	105.2 (19.5)	100.4 (19.5)
MIC_R	106.6 (17.3)	71.1 (17.3)	92.0 (17.3)
PIC_L	31.2 (16.0)	44.6 (15.9)	34.2 (15.9)
PIC_R	75.3 (20.1)	95.5 (20.0)	91.8 (20.0)
Amyg_L	29.7 (16.5)	24.9 (16.5)	36.4 (16.5)

Population analysed: BOLD analysis set included all participants who completed all the 3 treatment periods of the study.

8 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 17 (0%)	14 of 17 (82.4%)	Not reported
Tramadol	0 of 17 (0%)	14 of 17 (82.4%)	Not reported
Placebo	0 of 18 (0%)	11 of 18 (61.1%)	Not reported

Limitations and caveats (from the sponsor): Results for primary outcome, BOLD activation signals(whole brain) was not available to reported, as DMAa, DMAc, TH and VIS were captured as COPE images only, which could not be included in basic results format.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Pain

Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain

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

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

Questions about this trial

What is this clinical trial studying?

A study testing Pregabalin and Tramadol SR in people with Pain, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 2 sites in United Kingdom.

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 3 inclusion and 4 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: finished, as of the sponsor's last update on 22 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 2 sites in United Kingdom. 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. Some participants in this study may receive a placebo. 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 28 Nov 2013). 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?

Voxel-wise Blood Oxygen Level Dependent (BOLD) Using Functional Magnetic Resonance Imaging (fMRI) of Brain Activation Signals Across the Whole Brain (time frame: Day 8, 22, 36). The study lists 6 primary outcomes in all. 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 NCT00610155.

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 22 Jan 2021.