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

NCT00610155 | Completed Results

• 1 other identifier: A0081173
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Pain

Outcome Measures

Primary Outcomes (6)

• 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).

  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).

  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).

  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).

  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.

  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.

  Day 8, 22, 36

Secondary Outcomes (8)

• 36-Item Short-Form Health Survey (SF-36)

  Day 8, 22, 36

• Beck Depression Inventory (BDI)

  Day 8, 22, 36

• State and Trait Anxiety Questionnaire

  Day 8, 22, 36

• Pain Catastrophising Scale (PCS)

  Day 8, 22, 36

• Neuropathic Pain Symptom Inventory (NPSI)

  Baseline (Day -7), Day 8, 22, 36

Study Arms (3)

1

PLACEBO COMPARATOR

Drug: Placebo

2

EXPERIMENTAL

Drug: Pregabalin

3

EXPERIMENTAL

Drug: Tramadol SR

Interventions

Placebo DRUG

BID

1

Pregabalin DRUG

Dose 75 mg titrated to 150 mg, bid

2

Tramadol SR DRUG

Dose 50mg titrated to 200 mg, bid

3

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead
• University of Oxford: collaborator

Study Sites (2)

Pfizer Investigational Site

Portsmouth, Hampshire, PO3 6AD, United Kingdom

Location

Pfizer Investigational Site

Solihull, West Midlands, B91 2JL, United Kingdom

Location

MeSH Terms

Conditions

Pain

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Limitations and Caveats

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.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2008
• First Posted: February 7, 2008
• Study Start: September 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: January 22, 2021
• Results First Posted: November 28, 2013

Record last verified: 2013-09

Locations

GB (2)