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| ID | Type | Description | Link |
|---|---|---|---|
| 2007_650 |
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The purpose of this study is to determine the best way to conduct clinical trials in patients with neuropathic pain (nerve pain). This study will see if generic pregabalin has any effect on neuropathic pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | Patients in Group A will remain on pregabalin (up to 600 mg/day po) treatment for the entire double-blind period. |
|
| B | Placebo Comparator | Patients in Group B will be treated with placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparator: pregabalin | Drug | pregabalin (up to 600 mg/day by mouth (po)). Duration of Treatment: 6 Weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Daily Evening Patient Reported Pain Intensity Scores | Change from mean of last 3 days of maintenance period to last 3 days of double-blind period; Pain Intensity was rated on a 0-10 numeric rating scale (NRS: 0=no pain, 10=worst pain you can imagine) | Baseline and 6 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 'Time to Efficacy Failure' During the Randomized Withdrawal Portion of the Study | Time to treatment failure (3 day mean of average 24 hour pain intensity ≥ 4 with at least a 30% increase relative to the last 3 days prior to randomization) | 6 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21185118 | Result | Hewitt DJ, Ho TW, Galer B, Backonja M, Markovitz P, Gammaitoni A, Michelson D, Bolognese J, Alon A, Rosenberg E, Herman G, Wang H. Impact of responder definition on the enriched enrollment randomized withdrawal trial design for establishing proof of concept in neuropathic pain. Pain. 2011 Mar;152(3):514-521. doi: 10.1016/j.pain.2010.10.050. Epub 2010 Dec 23. |
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All patients were titrated up to the maximum tolerated dose of active treatment (pregabalin) over approximately 12 days. Patient were treated at the maximum tolerated dose until randomization at which time patient were either continued on active treatment or withdrawn from active treatment (i.e. placebo) in a double-blind fashion.
Last Patient Entered: 06-Dec-07
Last Patient Last Visit: 11-Sep-08
# Sites: 20 sites randomized at least 1 patient.
21 sites screened at least 1 patient
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| ID | Title | Description |
|---|---|---|
| FG000 | Pregabalin | Patients were treated with pregabalin (up to 600 mg/day by mouth (po)) for the entire double-blind period. |
| FG001 | Placebo | Patients were treated with placebo starting at randomization. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pregabalin | Patients who were randomized to pregabalin and were categorized in the primary responder population. Primary responders were defined as having ≥30% decrease in mean of average daily pain intensity during the last 3 days of the pre-randomization maintenance phase relative to baseline. |
| BG001 |
| 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 | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Daily Evening Patient Reported Pain Intensity Scores | Change from mean of last 3 days of maintenance period to last 3 days of double-blind period; Pain Intensity was rated on a 0-10 numeric rating scale (NRS: 0=no pain, 10=worst pain you can imagine) | Patients who had a ≥30% decrease in mean of average daily pain intensity during the last 3 days of the maintenance phase relative to baseline. | Posted | Least Squares Mean | Full Range | Units on a Scale | Baseline and 6 Weeks |
|
The reported AEs were collected after patients were randomized to the double-blind withdrawal period of the study. AEs that were collected prior to randomization are not reported in this document.
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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 | Patients were treated with pregabalin (up to 600 mg/day by mouth (po)) for the entire double-blind period. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia | Cardiac disorders | MedDRA 12.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D051474 | Neuralgia, Postherpetic |
| D003929 | Diabetic Neuropathies |
| ID | Term |
|---|---|
| D009437 | Neuralgia |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| Comparator: Placebo (unspecified) | Drug | pregabalin Pbo (up to 600 mg/day by mouth (po)). Duration of Treatment: 6 Weeks |
|
| Placebo |
Patients who were randomized to placebo and were categorized in the primary responder population. Primary responders were defined as having ≥30% decrease in mean of average daily pain intensity during the last 3 days of the pre-randomization maintenance phase relative to baseline. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Body Mass Index | Mean | Full Range | kilograms/meter^2 |
|
| Placebo |
Patients who were randomized to placebo and were categorized in the primary responder population. Primary responders were defined as having ≥30% decrease in mean of average daily pain intensity during the last 3 days of the pre-randomization maintenance phase relative to baseline. |
|
|
|
| Secondary | 'Time to Efficacy Failure' During the Randomized Withdrawal Portion of the Study | Time to treatment failure (3 day mean of average 24 hour pain intensity ≥ 4 with at least a 30% increase relative to the last 3 days prior to randomization) | Primary Responders: ≥30% decrease in mean of average daily pain intensity during the last 3 days of the maintenance phase relative to baseline. | Posted | Least Squares Mean | Full Range | Days | 6 Weeks |
|
|
|
|
| 0 |
| 51 |
| 37 |
| 51 |
| EG001 | Placebo | Patients were treated with placebo starting at randomization. | 1 | 53 | 36 | 53 |
| Blindness | Eye disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Diplopia | Eye disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Eye Irritation | Eye disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Eye Pain | Eye disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Vision Blurred | Eye disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Visual Acuity Reduced | Eye disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Dry Mouth | Gastrointestinal disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Energy Increased | General disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Gait Disturbance | General disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Oedema Peripheral | General disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Pain | General disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
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| Cystitis | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
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| Gastric Infection | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
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| Localised Infection | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
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| Respiratory Tract Infection | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
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| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
|
| Accidental Overdose | Injury, poisoning and procedural complications | MedDRA 12.1 | Non-systematic Assessment |
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| Excoriation | Injury, poisoning and procedural complications | MedDRA 12.1 | Non-systematic Assessment |
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| Joint Sprain | Injury, poisoning and procedural complications | MedDRA 12.1 | Non-systematic Assessment |
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| Muscle Strain | Injury, poisoning and procedural complications | MedDRA 12.1 | Non-systematic Assessment |
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| Skin Laceration | Injury, poisoning and procedural complications | MedDRA 12.1 | Non-systematic Assessment |
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| Blood Glucose Decreased | Investigations | MedDRA 12.1 | Non-systematic Assessment |
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| Blood Glucose Increased | Investigations | MedDRA 12.1 | Non-systematic Assessment |
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| Weight Increased | Investigations | MedDRA 12.1 | Non-systematic Assessment |
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| Fluid Retention | Metabolism and nutrition disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Increased Appetite | Metabolism and nutrition disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Limb Discomfort | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Ataxia | Nervous system disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Balance Disorder | Nervous system disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Cluster Headache | Nervous system disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Cognitive Disorder | Nervous system disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Disturbance In Attention | Nervous system disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Drooling | Nervous system disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Hypersomnia | Nervous system disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Hypokinesia | Nervous system disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Lethargy | Nervous system disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Memory Impairment | Nervous system disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Neuralgia | Nervous system disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Peroneal Nerve Palsy | Nervous system disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Poor Quality Sleep | Nervous system disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Restless Legs Syndrome | Nervous system disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Sedation | Nervous system disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Sinus Headache | Nervous system disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Abnormal Dreams | Psychiatric disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Agitation | Psychiatric disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Bradyphrenia | Psychiatric disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Confusional State | Psychiatric disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Euphoric Mood | Psychiatric disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Hallucination | Psychiatric disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Initial Insomnia | Psychiatric disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Libido Decreased | Psychiatric disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Polyuria | Renal and urinary disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Urinary Hesitation | Renal and urinary disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Non-systematic Assessment |
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| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Photodermatosis | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Peripheral Coldness | Vascular disorders | MedDRA 12.1 | Non-systematic Assessment |
|
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |