Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to assess whether a cross-over type study design in post-traumatic neuropathic patients can be used to assess the activity of potential analgesic agents
Methodology study to evaluate a cross-over study design in post-traumatic neuropathic pain patients.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator |
| |
| B | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregabalin (Lyrica) | Drug | Oral, 75mg or 150mg capsules, BID |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Treatment Week 2 in Daily Pain Rating Scale | Daily Pain Rating Scale by treatment and sequence using an 11-point Likert scale: range 0 (no pain) to 10 (worst possible pain) over the past 24 hours. Self-assessment was performed daily on rising from bed (for the final time in the case of interrupted sleep). Average daily pain score: mean of the previous 7 days daily pain scores. Baseline was defined as the mean of the last 7 pre-treatment pain scores for each period. End of treatment was defined as the mean of the last 7 on treatment pain scores for each period. | Week 0 to Week 2, Week 4 to Week 6 (Baseline to Week 2 [End of Treatment] for each treatment period) |
| Measure | Description | Time Frame |
|---|---|---|
| Neuropathic Pain Symptom Inventory (NPSI) | NPSI at end of treatment: 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Calgary | Alberta | T2N 4N1 | Canada | ||
| Pfizer Investigational Site |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Subjects meeting entry criteria entered into a 1-week screening period to monitor daily pain scores and activity levels. If pain severity met inclusion criteria subjects could enter the double-blind part of the study and were randomized to 1 of 2 treatment sequence crossovers (pregabalin/placebo or placebo/pregabalin).
Subjects participated in the study between 05 May 2008 and 10 February 2009.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Pregabalin First Then Placebo | Pregabalin: Day 1: 75 mg in the evening, Days 2 & 3: 150 mg/day, Day 4: 225 mg/day, Days 5 to 14: 300 mg/day, Day 15: 150 mg in the morning. Twice daily (BID) dosing on Days 2-14. Placebo: Day 1 in the evening, Days 2-14 BID, Day 15 in the morning. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Oral, matched capsules, BID |
|
| Week 0 to Week 2, Week 4 to Week 6 (Baseline to End of Treatment in Treatment Periods 1 and 2) |
| Subject Activity as Captured by the Actiwatch Score Device: Total Activity Score at End of Treatment | Total activity score: Day (8 am to 8 pm) at end of treatment. Accelerometer measured physical activity by monitoring degree and intensity of body motion. Data is reported as activity counts. Subject activity was collected hourly for the variables: peak, average, and total activity. Higher score indicates greater activity (no activity = 0; total possible score was not defined). | Week 0 to Week 2, Week 4 to Week 6 (Baseline to End of Treatment in Treatment Periods 1 and 2) |
| Hamilton |
| Ontario |
| L8N 3Z5 |
| Canada |
| Pfizer Investigational Site | Sarnia | Ontario | N7T 4X3 | Canada |
| Pfizer Investigational Site | Jönköping | 551 85 | Sweden |
| Pfizer Investigational Site | Linköping | 581 85 | Sweden |
| Placebo First Then Pregabalin |
Placebo: Day 1 in the evening, Days 2-14 BID, Day 15 in the morning. Pregabalin: Day 1: 75 mg in the evening, Days 2 & 3: 150 mg/day, Day 4: 225 mg/day, Days 5 to 14: 300 mg/day, Day 15: 150 mg in the morning. Twice daily (BID) dosing on Days 2-14. |
| Received Study Treatment |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Washout Period of 2 Weeks |
|
| Period 2 |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pregabalin Then Placebo | Pregabalin: Day 1: 75 mg in the evening, Days 2 & 3: 150 mg/day, Day 4: 225 mg/day, Days 5 to 14: 300 mg/day, Day 15: 150 mg in the morning. BID dosing Days 2-14. Placebo: Day 1 in the evening, Days 2 to 14 BID, Day 15 in the morning. |
| BG001 | Placebo Then Pregabalin | Placebo: Day 1 in the evening, Days 2 to 14 BID, Day 15 in the morning. Pregabalin: Day 1: 75 mg in the evening, Days 2 & 3: 150 mg/day, Day 4: 225 mg/day, Days 5 to 14: 300 mg/day, Day 15: 150 mg in the morning. BID dosing Days 2-14. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | years |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | Change From Baseline to Treatment Week 2 in Daily Pain Rating Scale | Daily Pain Rating Scale by treatment and sequence using an 11-point Likert scale: range 0 (no pain) to 10 (worst possible pain) over the past 24 hours. Self-assessment was performed daily on rising from bed (for the final time in the case of interrupted sleep). Average daily pain score: mean of the previous 7 days daily pain scores. Baseline was defined as the mean of the last 7 pre-treatment pain scores for each period. End of treatment was defined as the mean of the last 7 on treatment pain scores for each period. | Full Analysis Set: (FAS): all subjects randomized who received at least one dose of study drug, regardless of whether they had efficacy data. Baseline is Week 0 and Week 4 for Periods 1 and 2, respectively. Treatment Week 2 is End of Treatment (Week 2 and Week 6) for Periods 1 and 2, respectively. | Posted | Mean | Standard Deviation | scores on scale | Week 0 to Week 2, Week 4 to Week 6 (Baseline to Week 2 [End of Treatment] for each treatment period) |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Neuropathic Pain Symptom Inventory (NPSI) | NPSI at end of treatment: 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. Weeks 0 and 4 are baseline for Periods 1 and 2, respectively. Weeks 2 and 6 are End of Treatment for Periods 1 and 2, respectively. | Posted | Mean | Standard Deviation | scores on scale | Week 0 to Week 2, Week 4 to Week 6 (Baseline to End of Treatment in Treatment Periods 1 and 2) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Subject Activity as Captured by the Actiwatch Score Device: Total Activity Score at End of Treatment | Total activity score: Day (8 am to 8 pm) at end of treatment. Accelerometer measured physical activity by monitoring degree and intensity of body motion. Data is reported as activity counts. Subject activity was collected hourly for the variables: peak, average, and total activity. Higher score indicates greater activity (no activity = 0; total possible score was not defined). | FAS; End of Treatment is treatment week 2 (Week 2 and Week 6) for Periods 1 and 2. | Posted | Least Squares Mean | Standard Error | scores on scale | Week 0 to Week 2, Week 4 to Week 6 (Baseline to End of Treatment in Treatment Periods 1 and 2) |
|
|
Not provided
Safety analysis set: all randomized subjects who received study medication. Twenty-four (24) subjects received both pregabalin and placebo and were evaluated for adverse events; this includes 12 subjects who started on pregabalin and crossed over to placebo, and 12 subjects who started on placebo and crossed over to pregabalin.
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 | Day 1: 75 mg in the evening, Days 2 & 3: 150 mg/day, Day 4: 225 mg/day, Days 5 to 14: 300 mg/day, Day 15: 150 mg in the morning. BID dosing Days 2-14. | 0 | 24 | 11 | 24 | ||
| EG001 | Placebo | Day 1 in the evening, Days 2 to 14 BID, Day 15 in the morning. | 0 | 24 | 10 | 24 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Eye disorder | Eye disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Therapeutic response unexpected | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Increased appetite | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Disturbance in attention | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Thinking abnormal | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Diaphragmalgia | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.govCallCenter@pfizer.com |
| ID | Term |
|---|---|
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| 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 |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
|
| >=65 years |
|
| Male |
|
| Treatment Week 2 |
|
| Change from Baseline |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|