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| ID | Type | Description | Link |
|---|---|---|---|
| ATLAS |
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A Non-Interventional, Post-Marketing Surveillance (NI-PMS) study whose objectives were to assess the impact of pregabalin on subjects' pain, quality of sleep, and their general wellbeing, as well as the tolerance and safety of pregabalin in subjects with neuropathic pain.
A non-interventional study of patients diagnosed with neuropathic pain administered pregabalin and followed up for 8 weeks
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with neuropathic pain |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregabalin | Drug | Capsules, 150 - 600 mg/day, 2-3 times/day, 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Daily Average Pain Scores | Change is observed value at final visit (Week 8 or discontinuation) minus baseline value. Daily average pain score is measured using a 10-point Likert scale where 0 = no pain to 10 = pain as bad as you can imagine. | Baseline, Final Visit (Week 8 or discontinuation) |
| Pain Related Sleep Interference | Change is observed value at final visit (Week 8 or discontinuation) minus baseline value. Pain related sleep interference is measured by a 10-point Likert scale where 0 = does not interfere with sleep, and 10 = completely interferes with sleep | Baseline, Final Visit (Week 8 or discontinuation) |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety and Depression Symptoms | The presence of anxiety and depression symptoms were measured, based on how often the subject felt a certain emotion over the past week. Q1:Have you felt calm and relaxed? Q2: Have you felt full of energy? Q3: Have you felt discouraged and sad? Final Visit = Week 8 or time of discontinuation. | Baseline, Final Visit (Week 8 or discontinuation) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with neuropathic pain
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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This study enrolled subjects with a confirmed diagnosis of neuropathic pain, according to the neuropathic pain diagnostic (DN4) Questionnaire, completed by the investigator at baseline
The study was conducted at 23 sites in Greece by investigators contracted by and under the direction of the sponsor. This study was performed by office-based physicians and in hospitals.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | 275 subjects received pregabalin alone while 416 subjects received pregabalin in combination with another neuropathic pain medication. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | 275 subjects received pregabalin alone while 416 subjects received pregabalin in combination with another neuropathic pain medication. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Anxiety and Depression Symptoms | The presence of anxiety and depression symptoms were measured, based on how often the subject felt a certain emotion over the past week. Q1:Have you felt calm and relaxed? Q2: Have you felt full of energy? Q3: Have you felt discouraged and sad? Final Visit = Week 8 or time of discontinuation. | Full analysis set (FAS). Full analysis set was derived from the set of all enrolled subjects who were administered the study medication and had post baseline documentation of efficacy. Last observation carried forward method (LOCF) was used. | Posted | Number | participants | Baseline, Final Visit (Week 8 or discontinuation) |
|
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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 (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | 275 subjects received pregabalin alone while 416 subjects received pregabalin in combination with another neuropathic pain medication. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiopulmonary failure | Cardiac disorders | MedDRA v11.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | MedDRA v 11.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc | 1-800-718-1021 | ClinicalTrials.govCallCenter@pfizer.com |
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| ID | Term |
|---|---|
| D009437 | Neuralgia |
| D010146 | Pain |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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| Clinician Global Improvement of Change (CGIC) at Final Visit (Week 8 or Discontinuation) | Clinician Global Improvement of Change (CGIC) indicates the change of the severity of the condition from baseline, graded from "very much improved" to "very much worse". | Final Visit (Week 8 or discontinuation) |
| Patient Global Improvement of Change (PGIC) at Final Visit (Week 8 or Discontinuation) | Patient Global Improvement of Change (PGIC) indicates the change of severity of conditions from baseline, graded from "very much improved" to "very much worse". | Final Visit (Week 8 or discontinuation) |
| Other |
|
| Withdrawal by Subject |
|
| Death |
|
| years |
|
| Sex/Gender, Customized | Number | participants |
|
|
|
| Primary | Daily Average Pain Scores | Change is observed value at final visit (Week 8 or discontinuation) minus baseline value. Daily average pain score is measured using a 10-point Likert scale where 0 = no pain to 10 = pain as bad as you can imagine. | Full analysis set (FAS). Full analysis set was derived from the set of all enrolled subjects who were administered the study medication and had post baseline documentation of efficacy. Last observation carried forward (LOCF) method was used. | Posted | Mean | Standard Deviation | scores on scale | Baseline, Final Visit (Week 8 or discontinuation) |
|
|
|
|
| Primary | Pain Related Sleep Interference | Change is observed value at final visit (Week 8 or discontinuation) minus baseline value. Pain related sleep interference is measured by a 10-point Likert scale where 0 = does not interfere with sleep, and 10 = completely interferes with sleep | Full analysis set (FAS) was derived from the set of all enrolled subjects who were administered the study medication and had post baseline documentation of efficacy. Last observation carried forward (LOCF) method was used. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, Final Visit (Week 8 or discontinuation) |
|
|
|
|
| Secondary | Clinician Global Improvement of Change (CGIC) at Final Visit (Week 8 or Discontinuation) | Clinician Global Improvement of Change (CGIC) indicates the change of the severity of the condition from baseline, graded from "very much improved" to "very much worse". | Full analysis set (FAS). Full analysis set was derived from the set of all enrolled subjects who were administered the study medication and had post baseline documentation of efficacy. Last observation carried forward (LOCF) method was used. Three subjects were not included in the analysis due to incomplete case report forms. | Posted | Number | participants | Final Visit (Week 8 or discontinuation) |
|
|
|
| Secondary | Patient Global Improvement of Change (PGIC) at Final Visit (Week 8 or Discontinuation) | Patient Global Improvement of Change (PGIC) indicates the change of severity of conditions from baseline, graded from "very much improved" to "very much worse". | Full analysis set (FAS). Full analysis set was derived from the set of all enrolled subjects who were administered the study medication and had post baseline documentation of efficacy. Last observation carried forward (LOCF) method was used. | Posted | Number | participants | Final Visit (Week 8 or discontinuation) |
|
|
|
| 7 |
| 151 |
| Abdominal pain | Gastrointestinal disorders | MedDRA v 11.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA v 11.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA v11.1 | Systematic Assessment |
|
| Death | General disorders | MedDRA v 11.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA v11.1 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA v 11.1 | Systematic Assessment |
|
| Dysphoria | Psychiatric disorders | MedDRA v11.1 | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA v11.1 | Systematic Assessment |
|
| Walking disability | Social circumstances | MedDRA v11.1 | Systematic Assessment |
|
| Somnolence | Surgical and medical procedures | MedDRA v 11.1 | 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 info other than study results.
| 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 |
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Minimally improved |
|
| No change |
|
| Minimally worse |
|
| Much worse |
|
| Very much worse |
|
| Not done |
|
| Title | Measurements |
|---|---|
|
| Minimally improved |
|
| No change |
|
| Minimally worse |
|
| Much worse |
|
| Very much worse |
|
| Not done |
|