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To evaluate the safety of the long-term use of pregabalin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pregabalin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pregabalin | Drug | Dosage: 150-600 mg/day (75-300 mg bid), oral administration, Treatment duration: 52 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Summary of Adverse Events | Number of subjects with all causality adverse events, serious adverse events, severe adverse events, adverse events resulted in discontinuation, dose reduced or temporary discontinuation. Subjects are counted only once per treatment in each row. | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Short-Form McGill Pain Questionnaire the Efficacy of Change: Sensory Score | Score ranges: 0-33. Higher scores indicate more severe pain. Baseline: The last evaluation on or before Day 1 of double-blind for subjects that took pregabalin in double-blind and last visit <= Day 1 of open-label for subjects that took placebo in double-blind. Endpoint: The last evaluation during dose adjustment/maintenance step of open-label. |
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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 |
|---|---|---|---|---|---|---|
| National Hospital Organization Nagoya Medical Center | Nagoya | Aichi-ken | 460-0001 | Japan | ||
| Kobayashi Clinic |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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A total of 126 subjects who completed the 13-week treatment regimen in the preceding double-blind Study A0081120 and had no serious adverse events or issues with compliance were enrolled to this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pregabalin | Subjects initiated study drug at 75 mg in the evening of Day 1, and then 75 mg BID (150 mg/day) for 1 week from Day 2. Subsequent dose modifications were based on subjects' safety and efficacy response and the maximum doses were 150 mg BID (300 mg/day) for subjects with low creatinine clearance (CLcr) (30 < CLcr ≤ 60 mL/min) and 300 mg BID (600 mg/day) for subjects with normal CLcr (CLcr > 60 mL/min). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 52 weeks |
| Short-Form McGill Pain Questionnaire the Efficacy of Change: Affective Score | Score ranges: 0-12. Higher scores indicate more severe pain. Baseline: The last evaluation on or before Day 1 of double-blind for subjects that took pregabalin in double-blind and last visit <= Day 1 of open-label for subjects that took placebo in double-blind. Endpoint: The last evaluation during dose adjustment/maintenance step of open-label. | 52 weeks |
| Short-Form McGill Pain Questionnaire the Efficacy of Change: Total Score | Score ranges: 0-45. Higher scores indicate more severe pain. Baseline: The last evaluation on or before Day 1 of double-blind for subjects that took pregabalin in double-blind and last visit <= Day 1 of open-label for subjects that took placebo in double-blind. Endpoint: The last evaluation during dose adjustment/maintenance step of open-label. | 52 weeks |
| Short-Form McGill Pain Questionnaire the Efficacy of Change: Present Pain Intensity | Score ranges: 0-5. Higher scores indicate more severe pain. Baseline: The last evaluation on or before Day 1 of double-blind for subjects that took pregabalin in double-blind and last visit <= Day 1 of open-label for subjects that took placebo in double-blind. Endpoint: The last evaluation during dose adjustment/maintenance step of open-label. | 52 weeks |
| Short-Form McGill Pain Questionnaire the Efficacy of Change: Visual Analog Scale | Ranges: 0-100 mm. Larger scale indicate more severe pain. Baseline: The last evaluation on or before Day 1 of double-blind for subjects that took pregabalin in double-blind and last visit <= Day 1 of open-label for subjects that took placebo in double-blind. Endpoint: The last evaluation during dose adjustment/maintenance step of open-label. | 52 weeks |
| Urayasu |
| Chiba |
| 279-0012 |
| Japan |
| Okabe Hospital | Kasuya-gun | Fukuoka | 811-2122 | Japan |
| Gunma Pain Clinic Hospital | Maebashi | Gunma | 379-2147 | Japan |
| Takasaki Pain Clinic | Takasaki | Gunma | 370-0035 | Japan |
| Asahikawa Pain Clinic Hospital | Asahikawa | Hokkaido | 070-0034 | Japan |
| Kamui Pain Clinic | Asahikawa | Hokkaido | 070-8013 | Japan |
| Sapporo Asabu Clinic | Sapporo | Hokkaido | 001-0045 | Japan |
| Higashi Sapporo Hospital | Sapporo | Hokkaido | 003-8585 | Japan |
| Seimei Clinic | Akashi | Hyōgo | 673-0016 | Japan |
| Uchida Pain Relief Clinic | Amagasaki | Hyōgo | 661-0012 | Japan |
| National Hospital Organization Himeji Medical Center | Himeji | Hyōgo | 670-8520 | Japan |
| National Hospital Organization Kobe Medical Center | Kobe | Hyōgo | 654-0155 | Japan |
| Nakamura Clinic | Kobe | Hyōgo | 655-0854 | Japan |
| National Hospital Organization Sagamihara National Hospital | Sagamihara | Kanagawa | 228-8522 | Japan |
| Suzuki Pain Clinic | Yokohama | Kanagawa | 227-0043 | Japan |
| Hajiri Pain Clinic | Yokohama | Kanagawa | 236-0037 | Japan |
| National Hospital Organization Yokohama Medical Center | Yokohama | Kanagawa | 245-8575 | Japan |
| Sendai Pain Clinic | Sendai | Miyagi | 983-0036 | Japan |
| Nakamura Hospital | Beppu | Ohita | 874-0937 | Japan |
| Kawaguchi Kogyo General Hospital | Kawaguchi | Saitama | 332-0031 | Japan |
| Kinoshita Clinic | Tokorozawa | Saitama | 359-0038 | Japan |
| Tokyo Women's Medical University Center East | Arakawa-ku | Tokyo | 116-8567 | Japan |
| Juntendo University Hospital | Bunkyo-ku | Tokyo | 113-8431 | Japan |
| Mitaka Pain Clinic | Mitaka | Tokyo | 181-0013 | Japan |
| Toriumi Pain Clinic | Nakano-ku | Tokyo | 165-0027 | Japan |
| Kanto Medical NTT East Corporation | Shinagawa-ku | Tokyo | 141-0022 | Japan |
| Naganuma Pain Clinic | Shinagawa-ku | Tokyo | 141-0022 | Japan |
| Tokyo Women's Medical University Hospital | Shinjuku-ku | Tokyo | 162-8666 | Japan |
| Mukai Clinic | Fukuoka | 812-0011 | Japan |
| KM Pain Clinic | Fukuoka | 814-0001 | Japan |
| Otsuki Sleep Clinic | Fukushima | 960-8044 | Japan |
| Hasumi Pain Clinic | Saitama | 330-0805 | Japan |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pregabalin | Subjects initiated study drug at 75 mg in the evening of Day 1, and then 75 mg BID (150 mg/day) for 1 week from Day 2. Subsequent dose modifications were based on subjects' safety and efficacy response and the maximum doses were 150 mg BID (300 mg/day) for subjects with low creatinine clearance (CLcr) (30 < CLcr ≤ 60 mL/min) and 300 mg BID (600 mg/day) for subjects with normal CLcr (CLcr > 60 mL/min). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | Subjects |
| ||||||||||||||||||||||||||
| 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 | Summary of Adverse Events | Number of subjects with all causality adverse events, serious adverse events, severe adverse events, adverse events resulted in discontinuation, dose reduced or temporary discontinuation. Subjects are counted only once per treatment in each row. | Safety population: all subjects who took at least 1 dose of study medication. | Posted | Number | subjects | 52 weeks |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Short-Form McGill Pain Questionnaire the Efficacy of Change: Sensory Score | Score ranges: 0-33. Higher scores indicate more severe pain. Baseline: The last evaluation on or before Day 1 of double-blind for subjects that took pregabalin in double-blind and last visit <= Day 1 of open-label for subjects that took placebo in double-blind. Endpoint: The last evaluation during dose adjustment/maintenance step of open-label. | Full Analysis Set, N = Number of subjects assessed | Posted | Mean | Standard Deviation | score on scale | 52 weeks |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Short-Form McGill Pain Questionnaire the Efficacy of Change: Affective Score | Score ranges: 0-12. Higher scores indicate more severe pain. Baseline: The last evaluation on or before Day 1 of double-blind for subjects that took pregabalin in double-blind and last visit <= Day 1 of open-label for subjects that took placebo in double-blind. Endpoint: The last evaluation during dose adjustment/maintenance step of open-label. | Full Analysis Set, N = Number of subjects assessed | Posted | Mean | Standard Deviation | score on scale | 52 weeks |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Short-Form McGill Pain Questionnaire the Efficacy of Change: Total Score | Score ranges: 0-45. Higher scores indicate more severe pain. Baseline: The last evaluation on or before Day 1 of double-blind for subjects that took pregabalin in double-blind and last visit <= Day 1 of open-label for subjects that took placebo in double-blind. Endpoint: The last evaluation during dose adjustment/maintenance step of open-label. | Full Analysis Set, N = Number of subjects assessed | Posted | Mean | Standard Deviation | score on scale | 52 weeks |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Short-Form McGill Pain Questionnaire the Efficacy of Change: Present Pain Intensity | Score ranges: 0-5. Higher scores indicate more severe pain. Baseline: The last evaluation on or before Day 1 of double-blind for subjects that took pregabalin in double-blind and last visit <= Day 1 of open-label for subjects that took placebo in double-blind. Endpoint: The last evaluation during dose adjustment/maintenance step of open-label. | Full Analysis Set, N = Number of subjects assessed | Posted | Mean | Standard Deviation | score on scale | 52 weeks |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Short-Form McGill Pain Questionnaire the Efficacy of Change: Visual Analog Scale | Ranges: 0-100 mm. Larger scale indicate more severe pain. Baseline: The last evaluation on or before Day 1 of double-blind for subjects that took pregabalin in double-blind and last visit <= Day 1 of open-label for subjects that took placebo in double-blind. Endpoint: The last evaluation during dose adjustment/maintenance step of open-label. | Full Analysis Set, N = Number of subjects assessed | Posted | Mean | Standard Deviation | mm | 52 weeks |
|
|
52 weeks
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.
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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 initiated study drug at 75 mg in the evening of Day 1, and then 75 mg BID (150 mg/day) for 1 week from Day 2. Subsequent dose modifications were based on subjects' safety and efficacy response and the maximum doses were 150 mg BID (300 mg/day) for subjects with low creatinine clearance (CLcr) (30 < CLcr ≤ 60 mL/min) and 300 mg BID (600 mg/day) for subjects with normal CLcr (CLcr > 60 mL/min). | 15 | 126 | 98 | 126 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA (v11.0) | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Gastroduodenal ulcer | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Heat stroke | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
| |
| Open fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
| |
| Occult blood | Investigations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Completed suicide | Psychiatric disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Malignant palate neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Retinal haemorrhage | Eye disorders | MedDRA (v11.0) | Non-systematic Assessment |
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| Visual acuity reduced | Eye disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
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| Weight increased | Investigations | MedDRA 11.0 | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 11.0 | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D051474 | Neuralgia, Postherpetic |
| ID | Term |
|---|---|
| D009437 | Neuralgia |
| 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 |
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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 |
|---|---|
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| Title | Measurements |
|---|---|
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| Subjects discontinued due to adverse events |
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| Dose reduced or temporary discontinuation |
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