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The purpose of this study is to assess the safety and efficacy of the long-term use of pregabalin at doses up to 600 mg/day in patients with painful diabetic peripheral neuropathy who have completed 13 weeks of dosing in Study A0081163
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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 participants with all causality adverse events, serious adverse events, severe adverse events, adverse events resulted in discontinuation, dose reduced or temporary discontinuation. Participants are counted only once per treatment in each row. | 53 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Short-Form McGill Pain Questionnaire: Sensory Scores | The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Sensory score ranges from 0-33. Higher scores indicate more severe pain. | From baseline to 52 weeks or study discontinuation (Study 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 | Nagoya | Aichi-ken | Japan | |||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24843530 | Derived | Satoh J, Yagihashi S, Baba M, Suzuki M, Arakawa A, Yoshiyama T. Efficacy and safety evaluation of pregabalin treatment over 52 weeks in patients with diabetic neuropathic pain extended after a double-blind placebo-controlled trial. J Diabetes Investig. 2011 Nov 30;2(6):457-63. doi: 10.1111/j.2040-1124.2011.00122.x. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Patients with pain associated with diabetic peripheral neuropathy who had completed the 13-week treatment phase in the preceding study (Study A0081163: NCT00553475), without any treatment-related serious adverse events or any compliance problems were eligible for the study.
Thirty-six (36) centers in Japan
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| ID | Title | Description |
|---|---|---|
| FG000 | Pregabalin | Participants initiated to take the study drug at a dose of 75 mg in the evening of Day 1, and then 150 mg/day (75 mg BID) for 1 week from Day 2. Thereafter, participants continued the treatment with pregabalin for 52 weeks, with the maximum doses of 300 mg/day (150 mg BID) for participants with low CLcr (30 < CLcr ≤ 60 mL/min) and 600 mg/day (300 mg BID) for participants with normal CLcr (CLcr > 60 mL/min). In consideration of safety and the effect on pain, the doses were adjusted by one step (150 mg/day) at each visit. Participants treated with pregabalin at the doses of 300 mg/day or higher ended the treatment after a 1-week dose reduction period. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Change From Baseline in Short-Form McGill Pain Questionnaire: Affective Scores |
The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Affective score ranges from 0-12. Higher scores indicate more severe pain. |
| From baseline to 52 weeks or study discontinuation (Study Endpoint) |
| Change From Baseline in Short-Form McGill Pain Questionnaire: Total Scores | The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Total score ranges from 0-45. Higher scores indicate more severe pain. | From baseline to 52 weeks or study discontinuation (Study Endpoint) |
| Change From Baseline in Short-Form McGill Pain Questionnaire: Visual Analogue Scale Scores | The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Visual Analogue Scale Score ranges from 0-100 mm. Higher scores indicate more severe pain. | From baseline to 52 weeks or study discontinuation (Study Endpoint) |
| Change From Baseline in Short-Form McGill Pain Questionnaire: Present Pain Intensity Scores | The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Present pain intensity score ranges from 0-5. Higher scores indicate more severe pain. | From baseline to 52 weeks or study discontinuation (Study Endpoint) |
| Date-shi |
| Fukushima |
| Japan |
| Pfizer Investigational Site | Nihommatsu | Fukushima | Japan |
| Pfizer Investigational Site | Shirakawa-shi | Fukushima | Japan |
| Pfizer Investigational Site | Sukagawa | Fukushima | Japan |
| Pfizer Investigational Site | Kamakura | Kanagawa | Japan |
| Pfizer Investigational Site | Yokohama | Kanagawa | Japan |
| Pfizer Investigational Site | Sendai | Miyagi | Japan |
| Pfizer Investigational Site | Matsumoto | Nagano | Japan |
| Pfizer Investigational Site | Ueda | Nagano | Japan |
| Pfizer Investigational Site | Beppu | Oita Prefecture | Japan |
| Pfizer Investigational Site | Yamada | Okayama-ken | Japan |
| Pfizer Investigational Site | Naha | Okinawa | Japan |
| Pfizer Investigational Site | Tomishiro | Okinawa | Japan |
| Pfizer Investigational Site | Urazoe | Okinawa | Japan |
| Pfizer Investigational Site | Hirano-ku | Osaka | Japan |
| Pfizer Investigational Site | Suminoe-ku | Osaka | Japan |
| Pfizer Investigational Site | Sunto-gun | Shizuoka | Japan |
| Pfizer Investigational Site | Oyama-shi | Tochigi | Japan |
| Pfizer Investigational Site | Arakawa City | Tokyo | Japan |
| Pfizer Investigational Site | Bunkyo-ku | Tokyo | Japan |
| Pfizer Investigational Site | Chiyoda-ku | Tokyo | Japan |
| Pfizer Investigational Site | Ohta-ku | Tokyo | Japan |
| Pfizer Investigational Site | Shibuya-ku | Tokyo | Japan |
| Pfizer Investigational Site | Fukuoka | Japan |
| Pfizer Investigational Site | Ōita | Japan |
| Pfizer Investigational Site | Tokushima | Japan |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pregabalin | Participants initiated to take the study drug at a dose of 75 mg in the evening of Day 1, and then 150 mg/day (75 mg BID) for 1 week from Day 2. Thereafter, participants continued the treatment with pregabalin for 52 weeks, with the maximum doses of 300 mg/day (150 mg BID) for participants with low CLcr (30 < CLcr ≤ 60 mL/min) and 600 mg/day (300 mg BID) for participants with normal CLcr (CLcr > 60 mL/min). In consideration of safety and the effect on pain, the doses were adjusted by one step (150 mg/day) at each visit. Participants treated with pregabalin at the doses of 300 mg/day or higher ended the treatment after a 1-week dose reduction period. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
| ||||||||||||||||||||||||||
| Age, Customized | 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 | Summary of Adverse Events | Number of participants with all causality adverse events, serious adverse events, severe adverse events, adverse events resulted in discontinuation, dose reduced or temporary discontinuation. Participants are counted only once per treatment in each row. | Safety analysis set: all participants who had received at least one dose of the study drug. | Posted | Number | participants | 53 weeks |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Short-Form McGill Pain Questionnaire: Sensory Scores | The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Sensory score ranges from 0-33. Higher scores indicate more severe pain. | Full analysis set. No imputations for missing data. | Posted | Mean | Standard Deviation | score on scale | From baseline to 52 weeks or study discontinuation (Study Endpoint) |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Short-Form McGill Pain Questionnaire: Affective Scores | The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Affective score ranges from 0-12. Higher scores indicate more severe pain. | Full analysis set. No imputations for missing data. | Posted | Mean | Standard Deviation | score on scale | From baseline to 52 weeks or study discontinuation (Study Endpoint) |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Short-Form McGill Pain Questionnaire: Total Scores | The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Total score ranges from 0-45. Higher scores indicate more severe pain. | Full analysis set. No imputations for missing data. | Posted | Mean | Standard Deviation | score on scale | From baseline to 52 weeks or study discontinuation (Study Endpoint) |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Short-Form McGill Pain Questionnaire: Visual Analogue Scale Scores | The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Visual Analogue Scale Score ranges from 0-100 mm. Higher scores indicate more severe pain. | Full analysis set. No imputations for missing data. | Posted | Mean | Standard Deviation | mm | From baseline to 52 weeks or study discontinuation (Study Endpoint) |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Short-Form McGill Pain Questionnaire: Present Pain Intensity Scores | The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Present pain intensity score ranges from 0-5. Higher scores indicate more severe pain. | Full analysis set. No imputations for missing data. | Posted | Mean | Standard Deviation | score on scale | From baseline to 52 weeks or study discontinuation (Study Endpoint) |
|
|
53 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 participant and as nonserious in another participant, or one participant 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 | Participants initiated to take the study drug at a dose of 75 mg in the evening of Day 1, and then 150 mg/day (75 mg BID) for 1 week from Day 2. Thereafter, participants continued the treatment with pregabalin for 52 weeks, with the maximum doses of 300 mg/day (150 mg BID) for participants with low CLcr (30 < CLcr ≤ 60 mL/min) and 600 mg/day (300 mg BID) for participants with normal CLcr (CLcr > 60 mL/min). In consideration of safety and the effect on pain, the doses were adjusted by one step (150 mg/day) at each visit. Participants treated with pregabalin at the doses of 300 mg/day or higher ended the treatment after a 1-week dose reduction period. | 21 | 123 | 101 | 123 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrioventricular block complete | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Meniere's disease | Ear and labyrinth disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Diabetic gangrene | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
| |
| Blood glucose abnormal | Investigations | MedDRA 12.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diabetic retinopathy | Eye disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Visual acuity reduced | Eye disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Face oedema | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Contusion | 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 |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D003929 | Diabetic Neuropathies |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine 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 |
|---|---|
|
| >= 65 years |
|
| Title | Measurements |
|---|---|
|
| Participants discontinued due to adverse events |
|
| Dose reduced or temporary discontinuation |
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