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| Name | Class |
|---|---|
| University of Oxford | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator |
| |
| 2 | Experimental |
| |
| 3 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | BID |
| |
| Pregabalin |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Day 8, 22, 36 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Portsmouth | Hampshire | PO3 6AD | United Kingdom | ||
| Pfizer Investigational Site |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Pregabalin Then Tramadol Then Placebo | Pregabalin (PGB) capsule titrated to 150 milligram (mg) orally twice daily for 7 days in first intervention period; followed by tramadol (TMD) sustained release (SR) capsule titrated to 200 mg orally twice daily for 7 days in second intervention period; then matching placebo (PBO) capsule orally for 7 days in third intervention period. A placebo wash-out period of 7 days was maintained between each period. |
| FG001 | Tramadol Then Placebo Then Pregabalin | Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in first intervention period; followed by matching placebo capsule orally for 7 days in second intervention period; then pregabalin capsule titrated to 150 mg orally twice daily for 7 days in third intervention period. A placebo wash-out period of 7 days was maintained between each period. |
| FG002 | Placebo Then Pregabalin Then Tramadol | Matching placebo capsule orally for 7 days in first intervention period; followed by pregabalin capsule titrated to 150 mg orally twice daily for 7 days in second intervention period; then tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in third intervention period. A placebo wash-out period of 7 days was maintained between each period. |
| FG003 | Pregabalin Then Placebo Then Tramadol | Pregabalin capsule titrated to 150 mg orally twice daily for 7 days in first intervention period; followed by matching placebo capsule orally for 7 days in second intervention period; then tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in third intervention period. A placebo wash-out period of 7 days was maintained between each period. |
| FG004 | Placebo Then Tramadol Then Pregabalin | Matching placebo capsule orally for 7 days in first intervention period; followed by tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in second intervention period; then pregabalin capsule titrated to 150 mg orally twice daily for 7 days in third intervention period. A placebo wash-out period of 7 days was maintained between each period. |
| FG005 | Tramadol Then Pregabalin Then Placebo | Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in first intervention period; followed by pregabalin capsule titrated to 150 mg orally twice daily for 7 days in second intervention period; then matching placebo capsule orally for 7 days in third intervention period. A placebo wash-out period of 7 days was maintained between each period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
|
| ||||||||||||||||||
| Washout Period 1 (7 Days) |
| |||||||||||||||||||
| Period 2 |
| |||||||||||||||||||
| Washout Period 2 (7 Days) |
| |||||||||||||||||||
| Period 3 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | Includes all participants enrolled in the study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | 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. | Posted | Day 8, 22, 36 |
|
Not provided
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pregabalin | Pregabalin capsule titrated to 150 mg orally twice daily for 7 days in either of the intervention periods. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA 13.1 | Non-systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
Not provided
Not provided
Not provided
Not provided
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| Drug |
Dose 75 mg titrated to 150 mg, bid |
|
| Tramadol SR | Drug | Dose 50mg titrated to 200 mg, bid |
|
| 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 |
| 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. | 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. | 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. | 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. | 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. | 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). | 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. | Day -35 |
| Solihull |
| West Midlands |
| B91 2JL |
| United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Tramadol |
Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in either of the intervention periods. |
| OG002 | Placebo | Matching placebo capsule orally for 7 days in either of the intervention periods. |
|
| Primary | 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). | BOLD analysis set included all participants who completed all the 3 treatment periods of the study. | Posted | Least Squares Mean | Standard Error | percent signal change | Day 8, 22, 36 |
|
|
|
| Primary | 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). | BOLD analysis set included all participants who completed all the 3 treatment periods of the study. | Posted | Least Squares Mean | Standard Error | percent signal change | Day 8, 22, 36 |
|
|
|
| Primary | 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). | BOLD analysis set included all participants who completed all the 3 treatment periods of the study. | Posted | Least Squares Mean | Standard Error | percent signal change | Day 8, 22, 36 |
|
|
|
| Primary | 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. | For VIS, based on preliminary analysis results, it was not considered significant to collect data according to Investigator's opinion. | Posted | Day 8, 22, 36 |
|
|
| Primary | 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. | Data was not analyzed since these methods were not technically robust enough to make any clear conclusions. | Posted | Day 8, 22, 36 |
|
|
| Secondary | 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). | Data for this outcome measure was plotted against treatment for each participant as per planned analysis but not statistically summarized for analysis. | Posted | Day 8, 22, 36 |
|
|
| Secondary | 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. | Data for this outcome measure was plotted against treatment for each participant as per planned analysis but not statistically summarized for analysis. | Posted | Day 8, 22, 36 |
|
|
| Secondary | 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. | Data for this outcome measure was plotted against treatment for each participant as per planned analysis but not statistically summarized for analysis. | Posted | Day 8, 22, 36 |
|
|
| Secondary | 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. | Data for this outcome measure was plotted against treatment for each participant as per planned analysis but not statistically summarized for analysis. | Posted | Day 8, 22, 36 |
|
|
| Secondary | 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. | Data for this outcome measure was plotted against treatment for each participant as per planned analysis but not statistically summarized for analysis. | Posted | Baseline (Day -7), Day 8, 22, 36 |
|
|
| Secondary | 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. | FAS included all the participants who were enrolled in the study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | Least Squares Mean | Standard Error | units on a scale | Day -35 through Day 36 |
|
|
|
| Secondary | 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). | FAS included all the participants who were enrolled in the study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | Least Squares Mean | Standard Error | units on a scale | Day 8, 22, 36 |
|
|
|
| Secondary | 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. | Data for this outcome measure was plotted against treatment for each participant as per planned analysis but not statistically summarized for analysis. | Posted | Day -35 |
|
|
| 0 |
| 17 |
| 14 |
| 17 |
| EG001 | Tramadol | Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in either of the intervention periods. | 0 | 17 | 14 | 17 |
| EG002 | Placebo | Matching placebo capsule orally for 7 days in either of the intervention periods. | 0 | 18 | 11 | 18 |
| Vision blurred | Eye disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Tooth loss | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Adverse drug reaction | General disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Feeling hot | General disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Feeling of body temperature change | General disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Thirst | General disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Increased appetite | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Mobility decreased | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Balance disorder | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Clumsiness | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Disturbance in attention | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Dysarthria | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Libido decreased | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Loss of libido | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Mood swings | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Nasal polyps | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Tooth extraction | Surgical and medical procedures | MedDRA 13.1 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
|
| AIC_R |
|
| MIC_L |
|
| MIC_R |
|
| PIC_L |
|
| PIC_R |
|
| Amyg_L |
|
| Amyg_R |
|
| S1 |
|
| S2 |
|
| SensTHAL |
|
| MRF |
|
| NucCun |
|
| PAG |
|
|
| AIC_R |
|
| MIC_L |
|
| MIC_R |
|
| PIC_L |
|
| PIC_R |
|
| Amyg_L |
|
| Amyg_R |
|
| S1 |
|
| S2 |
|
| SensTHAL |
|
| MRF |
|
| NucCun |
|
| PAG |
|
|
| AIC_R |
|
| MIC_L |
|
| MIC_R |
|
| PIC_L |
|
| PIC_R |
|
| Amyg_L |
|
| Amyg_R |
|
| S1 |
|
| S2 |
|
| SensTHAL |
|
| MRF |
|
| NucCun |
|
| PAG |
|
|