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Conventional pain efficacy measures such as Visual Analogue Scores (VAS) are often unable to detect treatment efficacy in small-scale clinical trials. Combining conventional pain efficacy measures with quantitative sensory testing (QST) may provide more sensitive and informative outcome measures in clinical trials.
Methodology to assess reproducibility and sensitivity of quantitative sensory testing
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active drug | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregabalin | Drug | Dose titration according to following regimen: 75mg BID for 3 days; 150mg for 4 days; 225mg BID for 4 days; 300mg BID for 17 days. Dose reduced for renally impaired patients |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Dynamic Allodynia Intensity at Visits 3 and 6 and Visits 4 and 7 | Five strokes applied with a standardized brush (somedic) across the painful site, 6cm long and at a control site to allow the participants to appreciate any difference. A painful and clearly dysaesthetic (unpleasant) sensation was considered as representing brush allodynia (whereas a "strange" or "tickly" sensation provoked by the brush was not). After each brush stimuli participants were asked to give a pain rating using 11-point numerical rating scale (NRS) where 0=no pain and 10=worst pain imaginable. The average of 5 brush strokes was calculated to obtain the mean score. | Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period |
| Mean Change From Baseline in Dynamic Allodynia Area at Visits 3 and 6 and Visits 4 and 7 | Dynamic area brush in cm^2: calculated from 8 measured distances by calculating the area of an octagon. The angle between each pair of lines was 45 degrees at point c. The area of the octagon was found by totaling the areas of the 8 triangles. Octagon with 8 radial lengths from center to the outside. Area = Σ ( ½ length * perpendicular height); Σ ( ½ ri * sin(45) r(i+1) ) = Σ ( (ri * r(i+1) )/2√2)). (where ri, i=1 to 8, were the eight radial lengths) | Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period |
| Mean Change From Baseline in Mechanical Pain Sensitivity (Von Frey) at Visits 3 and 6 and Visits 4 and 7 | Sensitivity to mechanical pain stimuli was tested using calibrated Von Frey monofilaments. To obtain a stimulus-response-function, seven different Von Frey monofilaments (size 8 to 512 mN, force increased by a factor of two from filament to filament) applied three times each; each stimulus was participant-rated using 11-point NRS where 0=no pain and 10=worst pain imaginable. If a score of 8 or more was reported for a given intensity no stronger stimuli was applied. Von Frey stimulus was applied to the skin for 1 to 2 seconds. The average of 3 ratings was calculated for the mean score. | Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Weekly Pain Score From the Daily Diary at Visits 3 and 6 and Visits 4 and 7 | Daily pain diary: participant-rated pain during the past 24 hours rated on an 11 point NRS scale where 0=no pain and 10=worst possible pain. For a given week, the pain response was the average of the 7 daily entries for that week, or average of the available data for that week if fewer than 7 entries were recorded (>=1 daily pain score for any given week required). The endpoint for each week consisted of the change from baseline in average pain score (follow-up value minus baseline). |
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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 | Vienna | A-1090 | Austria | |||
| Pfizer Investigational Site |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Not provided
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| ID | Title | Description |
|---|---|---|
| FG000 | Pregabalin Then Placebo | During the 4-week pregabalin treatment period, participants were titrated up to 300 mg twice daily (BID) for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later. Then after a 2-week washout period, participants took placebo to match the pregabalin doses BID during a 4-week treatment period. |
| FG001 | Placebo Then Pregabalin | Participants took placebo to match the pregabalin doses BID during the first 4- week treatment period. Then after a 2-week washout period, participants were titrated up to 300 mg pregabalin BID for the first 2 weeks and then remained at 300 mg BID for the duration of the second 4-week treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
|
| ||||||||||||||||||||||||
| Washout Period |
| |||||||||||||||||||||||||
| Second Intervention |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Includes all participants randomized to receive pregabalin first and placebo first. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Mean Change From Baseline in Dynamic Allodynia Intensity at Visits 3 and 6 and Visits 4 and 7 | Five strokes applied with a standardized brush (somedic) across the painful site, 6cm long and at a control site to allow the participants to appreciate any difference. A painful and clearly dysaesthetic (unpleasant) sensation was considered as representing brush allodynia (whereas a "strange" or "tickly" sensation provoked by the brush was not). After each brush stimuli participants were asked to give a pain rating using 11-point numerical rating scale (NRS) where 0=no pain and 10=worst pain imaginable. The average of 5 brush strokes was calculated to obtain the mean score. | Full analysis set (FAS)=participants with present pain intensity score >=4 out of 10 for brush evoked allodynia at screening and randomization, >=4 out of 7 non missing values in week prior to randomization, >4 for weekly average daily pain score, and who did not withdraw/discontinue. n=number of participants contributing to the mean. | Posted | Mean | Standard Deviation | scores on a scale | Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period |
|
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The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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 | During the 4-week pregabalin treatment period, participants were titrated up to 300 mg BID for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Menopause and related conditions | Reproductive system and breast disorders | MedDRA 12.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Not provided
| ID | Term |
|---|---|
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
Not provided
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Not provided
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| Placebo | Drug | BID dosing for 28 days |
|
| Mean Change From Baseline in Punctate Allodynia Area (Von Frey) at Visits 3 and 6 and Visits 4 and 7 |
Punctate allodynia area in cm^2: calculated from 8 measured distances by calculating the area of an octagon. The angle between each pair of lines was 45 degrees at point c. The area of the octagon was found by totaling the areas of the 8 triangles. Octagon with 8 radial lengths from center to the outside. Area = Σ ( ½ length * perpendicular height); Σ ( ½ ri * sin(45) r(i+1) ) = Σ ( (ri * r(i+1) )/2√2)). (where ri, i=1 to 8, were the eight radial lengths) |
| Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period |
| Mean Change From Baseline in Cold Pain Sensitivity at Visits 3 and 6 and Visits 4 and 7 | Duration of thermal stimuli was 2 seconds and an intensity that is increased in steps of 5 degrees celsius for cold stimuli (between 5 and 20 degrees celsius). Thermal pain sensitivity was participant-rated using 11-point NRS where 0=no pain and 10=worst pain imaginable. The average of 2 ratings was calculated to get the mean score. | Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period |
| Mean Change From Baseline in Heat Pain Sensitivity at Visits 3 and 6 and Visits 4 and 7 | Duration of thermal stimuli was 2 seconds and an intensity that is increased in steps of 4 degrees celsius for heat stimuli (between 40 and 50 degrees celsius). Thermal pain sensitivity was participant-rated using 11-point NRS where 0=no pain and 10=worst pain imaginable. The average of 2 ratings was calculated to get the mean score. | Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period |
| Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period |
| Mean Change From Baseline in Patient's Global Impression of Change (PGIC) at Visits 3 and 6 and Visits 4 and 7 | PGIC: participant-rated assessment measuring change in participant's overall status on a 7-point scale from 1=very much improved to 7=very much worse. | Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period |
| Mean Change From Baseline in Test-Day Global Pain Intensity at Visits 3 and 6 and Visits 4 and 7 | Global pain: participant-rated pain using the test-day global pain scale, consisting of an 11-point NRS where 0 = no pain and 10 = worst possible pain. Participants described intensity of pain in response to "How intense is your pain today?" | Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period |
| Mean Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Total Score at Visits 4 and 7 | NPSI: 10-item self-administered questionnaire assessing 5 dimensions of pain (burning superficial spontaneous pain, pressing deep spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dysesthesia). Each item consists of a question about the specific qualities of pain and an 11-point numerical scale range: 0 (absence of pain) to 10 (maximum intensity imaginable), and 2 temporal items related to spontaneous and paroxysmal pain. Maximum total score possible = 100. | Week 4 (Visits 4 and 7) of each period |
| Brussels |
| 1070 |
| Belgium |
| Pfizer Investigational Site | Boulogne-Billancourt | 92100 | France |
| Pfizer Investigational Site | Liverpool | L9 7AL | United Kingdom |
| Pfizer Investigational Site | London | SW10 9NH | United Kingdom |
| NOT COMPLETED |
|
|
| NOT COMPLETED |
|
|
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Description |
|---|
| OG000 | Pregabalin | During the 4-week pregabalin treatment period, participants were titrated up to 300 mg BID for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later. |
| OG001 | Placebo | Participants took placebo to match the pregabalin doses BID. |
|
|
|
| Primary | Mean Change From Baseline in Dynamic Allodynia Area at Visits 3 and 6 and Visits 4 and 7 | Dynamic area brush in cm^2: calculated from 8 measured distances by calculating the area of an octagon. The angle between each pair of lines was 45 degrees at point c. The area of the octagon was found by totaling the areas of the 8 triangles. Octagon with 8 radial lengths from center to the outside. Area = Σ ( ½ length * perpendicular height); Σ ( ½ ri * sin(45) r(i+1) ) = Σ ( (ri * r(i+1) )/2√2)). (where ri, i=1 to 8, were the eight radial lengths) | FAS. n=number of participants contributing to the mean. | Posted | Mean | Standard Deviation | cm2 | Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period |
|
|
|
|
| Primary | Mean Change From Baseline in Mechanical Pain Sensitivity (Von Frey) at Visits 3 and 6 and Visits 4 and 7 | Sensitivity to mechanical pain stimuli was tested using calibrated Von Frey monofilaments. To obtain a stimulus-response-function, seven different Von Frey monofilaments (size 8 to 512 mN, force increased by a factor of two from filament to filament) applied three times each; each stimulus was participant-rated using 11-point NRS where 0=no pain and 10=worst pain imaginable. If a score of 8 or more was reported for a given intensity no stronger stimuli was applied. Von Frey stimulus was applied to the skin for 1 to 2 seconds. The average of 3 ratings was calculated for the mean score. | FAS. n=number of participants contributing to the mean. Missing values were imputed using a single imputation regression method. | Posted | Mean | Standard Deviation | scores on a scale | Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period |
|
|
|
|
| Primary | Mean Change From Baseline in Punctate Allodynia Area (Von Frey) at Visits 3 and 6 and Visits 4 and 7 | Punctate allodynia area in cm^2: calculated from 8 measured distances by calculating the area of an octagon. The angle between each pair of lines was 45 degrees at point c. The area of the octagon was found by totaling the areas of the 8 triangles. Octagon with 8 radial lengths from center to the outside. Area = Σ ( ½ length * perpendicular height); Σ ( ½ ri * sin(45) r(i+1) ) = Σ ( (ri * r(i+1) )/2√2)). (where ri, i=1 to 8, were the eight radial lengths) | FAS. n=number of participants contributing to the mean. | Posted | Mean | Standard Deviation | cm2 | Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period |
|
|
|
|
| Primary | Mean Change From Baseline in Cold Pain Sensitivity at Visits 3 and 6 and Visits 4 and 7 | Duration of thermal stimuli was 2 seconds and an intensity that is increased in steps of 5 degrees celsius for cold stimuli (between 5 and 20 degrees celsius). Thermal pain sensitivity was participant-rated using 11-point NRS where 0=no pain and 10=worst pain imaginable. The average of 2 ratings was calculated to get the mean score. | FAS. n=number of participants contributing to the mean. Missing values were imputed using a single imputation regression method. | Posted | Mean | Standard Deviation | scores on a scale | Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period |
|
|
|
|
| Primary | Mean Change From Baseline in Heat Pain Sensitivity at Visits 3 and 6 and Visits 4 and 7 | Duration of thermal stimuli was 2 seconds and an intensity that is increased in steps of 4 degrees celsius for heat stimuli (between 40 and 50 degrees celsius). Thermal pain sensitivity was participant-rated using 11-point NRS where 0=no pain and 10=worst pain imaginable. The average of 2 ratings was calculated to get the mean score. | FAS. n=number of participants contributing to the mean. Missing values were imputed using a single imputation regression method. | Posted | Mean | Standard Deviation | scores on a scale | Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period |
|
|
|
|
| Secondary | Mean Change From Baseline in Weekly Pain Score From the Daily Diary at Visits 3 and 6 and Visits 4 and 7 | Daily pain diary: participant-rated pain during the past 24 hours rated on an 11 point NRS scale where 0=no pain and 10=worst possible pain. For a given week, the pain response was the average of the 7 daily entries for that week, or average of the available data for that week if fewer than 7 entries were recorded (>=1 daily pain score for any given week required). The endpoint for each week consisted of the change from baseline in average pain score (follow-up value minus baseline). | FAS. n=number of participants contributing to the mean. Missing weeks within a period were imputed using last observation carried forward (LOCF). | Posted | Mean | Standard Deviation | scores on a scale | Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period |
|
|
|
|
| Secondary | Mean Change From Baseline in Patient's Global Impression of Change (PGIC) at Visits 3 and 6 and Visits 4 and 7 | PGIC: participant-rated assessment measuring change in participant's overall status on a 7-point scale from 1=very much improved to 7=very much worse. | FAS. n=number of participants contributing to the mean. | Posted | Mean | Standard Deviation | scores on a scale | Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period |
|
|
|
|
| Secondary | Mean Change From Baseline in Test-Day Global Pain Intensity at Visits 3 and 6 and Visits 4 and 7 | Global pain: participant-rated pain using the test-day global pain scale, consisting of an 11-point NRS where 0 = no pain and 10 = worst possible pain. Participants described intensity of pain in response to "How intense is your pain today?" | FAS. n=number of participants contributing to the mean. | Posted | Mean | Standard Deviation | scores on a scale | Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period |
|
|
|
|
| Secondary | Mean Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Total Score at Visits 4 and 7 | NPSI: 10-item self-administered questionnaire assessing 5 dimensions of pain (burning superficial spontaneous pain, pressing deep spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dysesthesia). Each item consists of a question about the specific qualities of pain and an 11-point numerical scale range: 0 (absence of pain) to 10 (maximum intensity imaginable), and 2 temporal items related to spontaneous and paroxysmal pain. Maximum total score possible = 100. | FAS. n=18, 18; number of participants contributing to the mean. | Posted | Mean | Standard Deviation | scores on a scale | Week 4 (Visits 4 and 7) of each period |
|
|
|
|
| 1 |
| 28 |
| 20 |
| 28 |
| EG001 | Placebo | Participants took placebo to match the pregabalin doses BID. | 1 | 30 | 15 | 30 |
| Postmenopausal haemorrhage | Reproductive system and breast disorders | MedDRA 12.1 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 12.1 | Systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA 12.1 | Systematic Assessment |
|
| Diplopia | Eye disorders | MedDRA 12.1 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 12.1 | Systematic Assessment |
|
| Change of bowel habit | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Tongue coated | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Eye infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Tooth infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| Increased appetite | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Disturbance in attention | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Psychomotor hyperactivity | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Ataxia | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Poor quality sleep | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
|
| Bradyphrenia | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
|
| Euphoric mood | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
|
| Withdrawal syndrome | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hypnagogic hallucination | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
|
| Initial insomnia | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 12.1 | Systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA 12.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hypoaesthesia facial | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA 12.1 | 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.
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| ANCOVA |
| 0.3678 |
| Mean Difference (Net) |
| -23.91 |
| Standard Error of the Mean |
| 25.807 |
| 2-Sided |
| 95 |
| -78.54 |
| 30.72 |
| Superiority or Other |
| Week 3 (Visits 3 and 6) (Size 32, n=15,16) |
|
| Week 3 (Visits 3 and 6) (Size 64, n=15,16) |
|
| Week 3 (Visits 3 and 6) (Size 128, n=15,16) |
|
| Week 3 (Visits 3 and 6) (Size 256, n=15,16) |
|
| Week 3 (Visits 3 and 6) (Size 512, n=15,16) |
|
| Week 4 (Visits 4 and 7) (Size 8, n=18,21) |
|
| Week 4 (Visits 4 and 7) (Size 16, n=18,21) |
|
| Week 4 (Visits 4 and 7) (Size 32, n=18,21) |
|
| Week 4 (Visits 4 and 7) (Size 64, n=18,21) |
|
| Week 4 (Visits 4 and 7) (Size 128, n=18,21) |
|
| Week 4 (Visits 4 and 7) (Size 256, n=18,21) |
|
| Week 4 (Visits 4 and 7) (Size 512, n=18,21) |
|
Week 4 (Visits 4 and 7) |
| ANCOVA |
Statistical analysis was based on the average pain score across all levels of stimuli. |
| 0.1294 |
| Mean Difference (Net) |
| -0.59 |
| Standard Error of the Mean |
| 0.370 |
| 2-Sided |
| 95 |
| -1.36 |
| 0.19 |
| Superiority or Other |
| ANCOVA |
| 0.0844 |
| Mean Difference (Net) |
| -49.06 |
| Standard Error of the Mean |
| 26.501 |
| 2-Sided |
| 95 |
| -105.67 |
| 7.55 |
| Superiority or Other |
| Week 3 (Visits 3 and 6) (15 degrees, n=15,16) |
|
| Week 3 (Visits 3 and 6) (20 degrees, n=15,16) |
|
| Week 4 (Visits 4 and 7) (5 degrees, n=18,21) |
|
| Week 4 (Visits 4 and 7) (10 degrees, n=18,21) |
|
| Week 4 (Visits 4 and 7) (15 degrees, n=18,21) |
|
| Week 4 (Visits 4 and 7) (20 degrees, n=18,21) |
|
Week 4 (Visits 4 and 7) |
| ANCOVA |
Statistical analysis was based on the average pain score across all levels of stimuli. |
| 0.9673 |
| Mean Difference (Net) |
| 0.01 |
| Standard Error of the Mean |
| 0.299 |
| 2-Sided |
| 95 |
| -0.61 |
| 0.64 |
| Superiority or Other |
| Week 3 (Visits 3 and 6) (47 degrees, n=15,16) |
|
| Week 3 (Visits 3 and 6) (50 degrees, n=15,16) |
|
| Week 4 (Visits 4 and 7) (40 degrees, n=18,21) |
|
| Week 4 (Visits 4 and 7) (44 degrees, n=18,21) |
|
| Week 4 (Visits 4 and 7) (47 degrees, n=18,21) |
|
| Week 4 (Visits 4 and 7) (50 degrees, n=18,21) |
|
Week 4 (Visits 4 and 7) |
| ANCOVA |
Statistical analysis was based on the average pain score across all levels of stimuli. |
| 0.8536 |
| Mean Difference (Net) |
| -0.09 |
| Standard Error of the Mean |
| 0.500 |
| 2-Sided |
| 95 |
| -1.15 |
| 0.96 |
| Superiority or Other |
Week 4 (Visits 4 and 7) |
| ANCOVA |
| 0.0403 |
| Mean Difference (Net) |
| -1.00 |
| Standard Error of the Mean |
| 0.467 |
| 2-Sided |
| 95 |
| -1.95 |
| -0.05 |
In statistical analyses, scores were further grouped to 1-3 'improved', 4 'no change' and 5-7 'worsened'. |
| Superiority or Other |
| ANCOVA |
| 0.0022 |
| Mean Difference (Net) |
| -1.54 |
| Standard Error of the Mean |
| 0.465 |
| 2-Sided |
| 95 |
| -2.48 |
| -0.59 |
| Superiority or Other |
| ANCOVA |
| 0.0198 |
| Mean Difference (Net) |
| -1.51 |
| Standard Error of the Mean |
| 0.588 |
| 2-Sided |
| 95 |
| -2.75 |
| -0.27 |
| Superiority or Other |