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To evaluate the safety and efficacy of pregabalin in reducing neuropathic pain associated with HIV neuropathy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pregabalin | Drug | 75mg BID, titrated up to 300mg according to individual response and tolerability |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Visual Analogue Scale (VAS) Pain Scores | Pain scores were assessed on a 100 mm Visual Analogue Scale (VAS); scores range from 0= no pain to 100= worse pain. Subjects assessed their pain during the last week. Endpoint = last non-missing observation carried forward after Baseline visit. | Baseline, Week 4, Week 8, Week 12, and Endpoint |
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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 | Phoenix | Arizona | 85023 | United States | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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With completion of A0081066 (NCT00232141), subjects had option of initiating treatment with pregabalin under open-label conditions for 3 months in A0081095, an open-label extension trial. Treatment in A0081095 was initiated on the evening of the subjects' Visit 7/Termination Visit in A0081066. A0081095 was conducted in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pregabalin | Subjects who met all eligibility criteria initiated open-label treatment at 150 mg/day (75 mg BID). Further adjustments of total daily dose within the dose range 150 to 600 mg/day (BID) were permitted throughout the study to optimize pain control and minimize adverse events (AEs). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Little Rock |
| Arkansas |
| 72207 |
| United States |
| Pfizer Investigational Site | Los Angeles | California | 90025 | United States |
| Pfizer Investigational Site | Los Angeles | California | 90028 | United States |
| Pfizer Investigational Site | Sacramento | California | 95817-1460 | United States |
| Pfizer Investigational Site | San Diego | California | 92103 | United States |
| Pfizer Investigational Site | San Francisco | California | 94117 | United States |
| Pfizer Investigational Site | Stanford | California | 94305-5235 | United States |
| Pfizer Investigational Site | West Hollywood | California | 90069 | United States |
| Pfizer Investigational Site | Denver | Colorado | 80262 | United States |
| Pfizer Investigational Site | Miami | Florida | 33133 | United States |
| Pfizer Investigational Site | Pensacola | Florida | 32504-5719 | United States |
| Pfizer Investigational Site | Safety Harbor | Florida | 34695 | United States |
| Pfizer Investigational Site | Vero Beach | Florida | 32960 | United States |
| Pfizer Investigational Site | West Palm Beach | Florida | 33407 | United States |
| Pfizer Investigational Site | Atlanta | Georgia | 30309 | United States |
| Pfizer Investigational Site | Chicago | Illinois | 60611 | United States |
| Pfizer Investigational Site | Chicago | Illinois | 60612 | United States |
| Pfizer Investigational Site | Baltimore | Maryland | 21287-7609 | United States |
| Pfizer Investigational Site | Boston | Massachusetts | 02215-3318 | United States |
| Pfizer Investigational Site | Springfield | Massachusetts | 01107 | United States |
| Pfizer Investigational Site | St Louis | Missouri | 63110-1010 | United States |
| Pfizer Investigational Site | St Louis | Missouri | 63110 | United States |
| Pfizer Investigational Site | New York | New York | 10018 | United States |
| Pfizer Investigational Site | New York | New York | 10021 | United States |
| Pfizer Investigational Site | New York | New York | 10029 | United States |
| Pfizer Investigational Site | Rochester | New York | 14642 | United States |
| Pfizer Investigational Site | Philadelphia | Pennsylvania | 19104 | United States |
| Pfizer Investigational Site | Austin | Texas | 78705 | United States |
| Pfizer Investigational Site | Dallas | Texas | 75204 | United States |
| Pfizer Investigational Site | Dallas | Texas | 75208-4234 | United States |
| Pfizer Investigational Site | Dallas | Texas | 75390-9036 | United States |
| Pfizer Investigational Site | San Antonio | Texas | 78229 | United States |
| Pfizer Investigational Site | Seattle | Washington | 98104 | United States |
| Pfizer Investigational Site | Ponce | 00716 | Puerto Rico |
| Pfizer Investigational Site | San Juan | 00909-1711 | Puerto Rico |
| Pfizer Investigational Site | San Juan | 00936 | Puerto Rico |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pregabalin | Subjects who met all eligibility criteria initiated open-label treatment at 150 mg/day (75 mg BID). Further adjustments of total daily dose within the dose range 150 to 600 mg/day (BID) were permitted throughout the study to optimize pain control and minimize adverse events (AEs). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | 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 | Mean Visual Analogue Scale (VAS) Pain Scores | Pain scores were assessed on a 100 mm Visual Analogue Scale (VAS); scores range from 0= no pain to 100= worse pain. Subjects assessed their pain during the last week. Endpoint = last non-missing observation carried forward after Baseline visit. | The full analysis set was defined as all subjects who met all eligibility criteria and took at least one dose of study medication. | Posted | Mean | Standard Deviation | score on scale | Baseline, Week 4, Week 8, Week 12, and Endpoint |
|
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pregabalin | Subjects who met all eligibility criteria initiated open-label treatment at 150 mg/day (75 mg BID). Further adjustments of total daily dose within the dose range 150 to 600 mg/day (BID) were permitted throughout the study to optimize pain control and minimize adverse events (AEs). | 10 | 82 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis | Infections and infestations | MedDRA v11.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v11.0 | Systematic Assessment |
| |
| Alcohol poisoning | Injury, poisoning and procedural complications | MedDRA v11.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA v11.0 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA v11.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA v11.0 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v11.0 | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA v11.0 | Systematic Assessment |
| |
| Streptococcal infection | Infections and infestations | MedDRA v11.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA v11.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA v11.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | MedDRA v11.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA v11.0 | Systematic Assessment |
| |
| Peripheral edema | General disorders | MedDRA v11.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA v11.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v11.0 | Systematic Assessment |
| |
| Euphoric mood | Psychiatric disorders | MedDRA v11.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v11.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v11.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA v11.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v11.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v11.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v11.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v11.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v11.0 | Systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v11.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v11.0 | 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 mo from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info 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 |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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| 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 |
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| Title | Measurements |
|---|---|
|
| Week 12 (n=207) |
|
| Endpoint (n=217) |
|