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Depomed's Gabapentin Extended Release is an investigational, extended release formulation of Gabapentin that is being studied for the treatment of Hot Flashes/Hot Flushes in postmenopausal women
The primary study objective is to assess the efficacy of G-ER dosed at 1800mg daily (600mg AM, 1200mg PM), compared to placebo in reducing the average daily frequency and severity score of moderate to severe hot flashes in postmenopausal women at weeks 4 & 12 of the efficacy treatment period, compared with baseline.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gabapentin Extended Release | Experimental | Active treatment |
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| Placebo | Other | Placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gabapentin Extended Release | Drug | Gabapentin ER 1800mg daily |
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| Measure | Description | Time Frame |
|---|---|---|
| G-ER at 1800mg Daily Compared With Placebo in Reducing the Average Daily Frequency of Moderate to Severe Hot Flashes at Weeks 4 & 12 of the Efficacy Treatment Period, Compared With Baseline. | G-ER dosed at 1800mg daily(600mg AM, 1200mg PM), compared with placebo in reducing the average daily frequency of moderate to severe hot flashes in post menopausal women at Week 4 of the efficacy treatment period compared with Baseline and at Week 12 of the efficacy treatment period compared with Baseline. | Baseline, Week 4, and Week 12 |
| G-ER at 1800mg Daily Compared With Placebo in Reducing the Average Daily Severity Score of Moderate to Severe Hot Flashes at Weeks 4 & 12 of the Efficacy Treatment Period, Compared With Baseline. | G-ER dosed at 1800mg daily(600mg AM, 1200mg PM), compared with placebo in reducing the average daily severity score of moderate to severe hot flashes in post menopausal women (score defined as "Mild" (1), "Moderate" (2), and "Severe" (3)) at Week 4 of the efficacy treatment period compared with Baseline and at Week 12 of the efficacy treatment period compared with Baseline. | Baseline, Week 4, and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| G-ER at 1800mg Daily Compared With Placebo in Reducing the Average Daily Frequency of Moderate to Severe Hot Flashes at Week 24 of the Efficacy Treatment Period, Compared With Baseline. | G-ER dosed at 1800mg daily(600mg AM, 1200mg PM), compared with placebo in reducing the average daily frequency of moderate to severe hot flashes in post menopausal women at Week 24 of the efficacy treatment period compared with Baseline. |
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Inclusion Criteria:
Other inclusions apply.
Exclusion Criteria:
Other exclusions apply.
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| Name | Affiliation | Role |
|---|---|---|
| Rekha Sathyanarayana | Depomed | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24149930 | Derived | Pinkerton JV, Kagan R, Portman D, Sathyanarayana R, Sweeney M; Breeze 3 Investigators. Phase 3 randomized controlled study of gastroretentive gabapentin for the treatment of moderate-to-severe hot flashes in menopause. Menopause. 2014 Jun;21(6):567-73. doi: 10.1097/GME.0b013e3182a7c073. |
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A total of 600 subjects were randomly assigned to treatment: 302 in G-ER 1800 mg group and 298 in placebo group. Of these 600 subjects, 595 subjects (300 in G-ER 1800 mg group and 295 in placebo group) received study treatment and were included in the safety population, and 593 subjects were included in the intent-to-treat (ITT) population.
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| ID | Title | Description |
|---|---|---|
| FG000 | G-ER 1800 mg | Gabapentin extended-release (G-ER) 1800 mg |
| FG001 | Sugar Pill | Placebo 1800 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo |
| Drug |
Sugar pill |
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| Baseline, Week 24 |
| G-ER at 1800mg Daily Compared With Placebo in Reducing the Average Daily Severity Score of Moderate to Severe Hot Flashes at Week 24 of the Efficacy Treatment Period, Compared With Baseline. | G-ER dosed at 1800mg daily(600mg AM, 1200mg PM), compared with placebo in reducing the average daily severity score of moderate to severe hot flashes in post menopausal women (score defined as "Mild" (1), "Moderate" (2), and "Severe" (3)) at Week 24 of the efficacy treatment period compared with Baseline. | Baseline, Week 24 |
| Patient Global Impression of Change (PGIC) Scales at Weeks 12 and 24 of the Efficacy Treatment Period. | Proportion of patients who were categorized as "very much" or "much improved" for PGIC at Week 12 and Week 24. Scale range is 6 categories: "minimum value = very much worse" to "maximum value = very much improved". | Week 12 and Week 24 |
| Clinical Global Impression of Change (CGIC) Scales at Weeks 12 and 24 of the Efficacy Treatment Period. | Proportion of patients who were categorized as "very much" or "much improved" in CGIC at Week 12 and Week 24. Scale range is 6 categories: "minimum value = very much worse" to "maximum value = very much improved". | Week 12 and Week 24 |
| Percent of Patients With 75% or Greater Reduction in Average Daily Frequency of Moderate to Severe Hot Flashes | Baseline, Week 12, and Week 24 |
| Percent of Patients With 75% or Greater Reduction in Average Daily Severity Score of Moderate to Severe Hot Flashes | Baseline, Week 12, and Week 24 |
| Change From Baseline to Weeks 4, Week 12, and Week 24 in Average Daily Sleep Interference Score. | Sleep Interference Score Range: Minimum value = 0, maximum value = 10 Lower scores indicate better outcome (ie, less interference) | Baseline, Week 4, Week 12, and Week 24 |
| Changes From Baseline in Sleep Quality Scores, Measured by the Insomnia Severity Index (ISI) to Week 4, Week 12, and Week 24 of the Efficacy Treatment Period. | Insomnia Severity Index (ISI) scored on 4-point Likert-scales ('0' not at all - '4' extremely) for 7 sub-categories. Final score is sum of each sub-category generating a total sleep quality score (0-28). Minimum value = 0, maximum value = 28 (Lower scores indicate better outcome (ie, less severity)). | Baseline, Week 4, Week 12, and Week 24 |
| Changes From Baseline in Quality of Life Scores, Measured by the Menopause-Specific Quality of Life Questionnaire (MENQOL) to Weeks, 4, 12, 24 of the Efficacy Treatment Period. | 4 sub-categories each scored individually: Minimum value = 1, maximum value = 8. Overall summary score was mean of the 4 sub-category scores (minimum = 1 and maximum = 8). Lower scores indicate better outcome (ie, less severity) | Baseline, Week 4, Week 12, and Week 24 |
| Safety of G-ER Measuring Columbia-Suicide Severity Rating Scale (C-SSRS). | Columbia-Suicide Severity Rating Scale (C-SSRS). Subjects were classified as 0=no suicidal ideation or 1=suicidal ideation. Outcome Measure is number of participants with or without suicidal ideation. Higher counts without suicidal ideation = better outcome. | Week 4, Week 12, Week 24/Early Termination, Week 28 |
| Mobile |
| Alabama |
| United States |
| Phoenix | Arizona | United States |
| Scottsdale | Arizona | United States |
| Tucson | Arizona | United States |
| Little Rock | Arkansas | United States |
| Berkeley | California | United States |
| Roseville | California | United States |
| San Diego | California | United States |
| Denver | Colorado | United States |
| Danbury | Connecticut | United States |
| Milford | Connecticut | United States |
| Brooksville | Florida | United States |
| Clearwater | Florida | United States |
| DeLand | Florida | United States |
| Gainesville | Florida | United States |
| Naples | Florida | United States |
| New Port Richey | Florida | United States |
| North Miami | Florida | United States |
| Orlando | Florida | United States |
| Decatur | Georgia | United States |
| Idaho Falls | Idaho | United States |
| Indianapolis | Indiana | United States |
| South Bend | Indiana | United States |
| Overland Park | Kansas | United States |
| Louisville | Kentucky | United States |
| New Orleans | Louisiana | United States |
| Paw Paw | Michigan | United States |
| Brooklyn Center | Minnesota | United States |
| Las Vegas | Nevada | United States |
| Reno | Nevada | United States |
| Moorestown | New Jersey | United States |
| Plainsboro | New Jersey | United States |
| Albuquerque | New Mexico | United States |
| Charlotte | North Carolina | United States |
| New Bern | North Carolina | United States |
| Raleigh | North Carolina | United States |
| Winston-Salem | North Carolina | United States |
| Bismarck | North Dakota | United States |
| Fargo | North Dakota | United States |
| Akron | Ohio | United States |
| Cincinnati | Ohio | United States |
| Cleveland | Ohio | United States |
| Columbus | Ohio | United States |
| Kettering | Ohio | United States |
| Oklahoma City | Oklahoma | United States |
| Eugene | Oregon | United States |
| Philadelphia | Pennsylvania | United States |
| Pittsburgh | Pennsylvania | United States |
| West Reading | Pennsylvania | United States |
| Wexford | Pennsylvania | United States |
| Warwick | Rhode Island | United States |
| Anderson | South Carolina | United States |
| Columbia | South Carolina | United States |
| Goose Creek | South Carolina | United States |
| Greer | South Carolina | United States |
| Rapid City | South Dakota | United States |
| Chattanooga | Tennessee | United States |
| Nashville | Tennessee | United States |
| Dallas | Texas | United States |
| Lake Jackson | Texas | United States |
| San Antonio | Texas | United States |
| Salt Lake City | Utah | United States |
| Charlottesville | Virginia | United States |
| Richmond | Virginia | United States |
| Seattle | Washington | United States |
| COMPLETED |
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| NOT COMPLETED |
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Intent-to-treat (ITT) Population
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| ID | Title | Description |
|---|---|---|
| BG000 | G-ER 1800 mg | Gabapentin extended-release (G-ER) 1800 mg |
| BG001 | Sugar Pill | Placebo 1800 mg |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Frequency of hot flashes | Number of hot flashes in a 24-hour period. | Mean | Standard Deviation | hot flashes |
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| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | G-ER at 1800mg Daily Compared With Placebo in Reducing the Average Daily Frequency of Moderate to Severe Hot Flashes at Weeks 4 & 12 of the Efficacy Treatment Period, Compared With Baseline. | G-ER dosed at 1800mg daily(600mg AM, 1200mg PM), compared with placebo in reducing the average daily frequency of moderate to severe hot flashes in post menopausal women at Week 4 of the efficacy treatment period compared with Baseline and at Week 12 of the efficacy treatment period compared with Baseline. | Intent-to-treat (ITT) Population | Posted | Least Squares Mean | 95% Confidence Interval | hot flashes | Baseline, Week 4, and Week 12 |
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| Primary | G-ER at 1800mg Daily Compared With Placebo in Reducing the Average Daily Severity Score of Moderate to Severe Hot Flashes at Weeks 4 & 12 of the Efficacy Treatment Period, Compared With Baseline. | G-ER dosed at 1800mg daily(600mg AM, 1200mg PM), compared with placebo in reducing the average daily severity score of moderate to severe hot flashes in post menopausal women (score defined as "Mild" (1), "Moderate" (2), and "Severe" (3)) at Week 4 of the efficacy treatment period compared with Baseline and at Week 12 of the efficacy treatment period compared with Baseline. | Intent-to-treat (ITT) Population | Posted | Least Squares Mean | 95% Confidence Interval | scores on a scale | Baseline, Week 4, and Week 12 |
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| Secondary | G-ER at 1800mg Daily Compared With Placebo in Reducing the Average Daily Frequency of Moderate to Severe Hot Flashes at Week 24 of the Efficacy Treatment Period, Compared With Baseline. | G-ER dosed at 1800mg daily(600mg AM, 1200mg PM), compared with placebo in reducing the average daily frequency of moderate to severe hot flashes in post menopausal women at Week 24 of the efficacy treatment period compared with Baseline. | Completer Population | Posted | Least Squares Mean | 95% Confidence Interval | hot flashes | Baseline, Week 24 |
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| Secondary | G-ER at 1800mg Daily Compared With Placebo in Reducing the Average Daily Severity Score of Moderate to Severe Hot Flashes at Week 24 of the Efficacy Treatment Period, Compared With Baseline. | G-ER dosed at 1800mg daily(600mg AM, 1200mg PM), compared with placebo in reducing the average daily severity score of moderate to severe hot flashes in post menopausal women (score defined as "Mild" (1), "Moderate" (2), and "Severe" (3)) at Week 24 of the efficacy treatment period compared with Baseline. | Completer Population | Posted | Least Squares Mean | 95% Confidence Interval | scores on a scale | Baseline, Week 24 |
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| Secondary | Patient Global Impression of Change (PGIC) Scales at Weeks 12 and 24 of the Efficacy Treatment Period. | Proportion of patients who were categorized as "very much" or "much improved" for PGIC at Week 12 and Week 24. Scale range is 6 categories: "minimum value = very much worse" to "maximum value = very much improved". | Intent-to-treat (ITT) Population | Posted | Count of Participants | Participants | Week 12 and Week 24 |
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| Secondary | Clinical Global Impression of Change (CGIC) Scales at Weeks 12 and 24 of the Efficacy Treatment Period. | Proportion of patients who were categorized as "very much" or "much improved" in CGIC at Week 12 and Week 24. Scale range is 6 categories: "minimum value = very much worse" to "maximum value = very much improved". | Intent-to-treat (ITT) Population | Posted | Count of Participants | Participants | Week 12 and Week 24 |
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| Secondary | Percent of Patients With 75% or Greater Reduction in Average Daily Frequency of Moderate to Severe Hot Flashes | Intent-to-treat (ITT) Population | Posted | Count of Participants | Participants | Baseline, Week 12, and Week 24 |
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| Secondary | Percent of Patients With 75% or Greater Reduction in Average Daily Severity Score of Moderate to Severe Hot Flashes | Intent-to-treat (ITT) Population | Posted | Count of Participants | Participants | Baseline, Week 12, and Week 24 |
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| Secondary | Change From Baseline to Weeks 4, Week 12, and Week 24 in Average Daily Sleep Interference Score. | Sleep Interference Score Range: Minimum value = 0, maximum value = 10 Lower scores indicate better outcome (ie, less interference) | Intent-to-treat (ITT) Population | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, Week 4, Week 12, and Week 24 |
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| Secondary | Changes From Baseline in Sleep Quality Scores, Measured by the Insomnia Severity Index (ISI) to Week 4, Week 12, and Week 24 of the Efficacy Treatment Period. | Insomnia Severity Index (ISI) scored on 4-point Likert-scales ('0' not at all - '4' extremely) for 7 sub-categories. Final score is sum of each sub-category generating a total sleep quality score (0-28). Minimum value = 0, maximum value = 28 (Lower scores indicate better outcome (ie, less severity)). | Intent-to-treat (ITT) Population | Posted | Least Squares Mean | 95% Confidence Interval | scores on a scale | Baseline, Week 4, Week 12, and Week 24 |
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| Secondary | Changes From Baseline in Quality of Life Scores, Measured by the Menopause-Specific Quality of Life Questionnaire (MENQOL) to Weeks, 4, 12, 24 of the Efficacy Treatment Period. | 4 sub-categories each scored individually: Minimum value = 1, maximum value = 8. Overall summary score was mean of the 4 sub-category scores (minimum = 1 and maximum = 8). Lower scores indicate better outcome (ie, less severity) | Intent-to-treat (ITT) Population | Posted | Least Squares Mean | 95% Confidence Interval | scores on a scale | Baseline, Week 4, Week 12, and Week 24 |
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| Secondary | Safety of G-ER Measuring Columbia-Suicide Severity Rating Scale (C-SSRS). | Columbia-Suicide Severity Rating Scale (C-SSRS). Subjects were classified as 0=no suicidal ideation or 1=suicidal ideation. Outcome Measure is number of participants with or without suicidal ideation. Higher counts without suicidal ideation = better outcome. | Safety Population | Posted | Count of Participants | Participants | Week 4, Week 12, Week 24/Early Termination, Week 28 |
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Adverse events collected for a total of 28-42 weeks: from after signing the informed consent to the end of the study (Week 28).
Adverse event collection began after signing the informed consent and continued through Week 28 visit; serious adverse events followed for 30 days after study completion.
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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 | G-ER 1800 mg | Gabapentin extended-release (G-ER) 1800 mg | 4 | 300 | 102 | 300 | ||
| EG001 | Sugar Pill | Placebo 1800 mg | 7 | 295 | 53 | 295 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders |
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| Acute myocardial infarction | Cardiac disorders |
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| Palpitations | Cardiac disorders |
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| Acute sinusitis | Infections and infestations |
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| Arthritis infective | Infections and infestations |
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| Bronchitis acute | Infections and infestations |
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| Periorbital cellulitis | Infections and infestations |
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| Pneumonia primary atypical | Infections and infestations |
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| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders |
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| Chronic lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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| Haemorrhagic stroke | Nervous system disorders |
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| Asthma | Respiratory, thoracic and mediastinal disorders |
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| Hypertension | Vascular disorders |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| Dizziness | Nervous system disorders |
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| Headache | Nervous system disorders |
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| Somnolence | Nervous system disorders |
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| Upper respiratory tract infection | Infections and infestations |
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The PI agrees that sponsor shall have the right to first publication of study results which is intended to be a joint, multi-center publication. Following first publication, the PI may publish study data or results, provided however PI submits proposed publication to sponsor for review at least 60 days prior to the date of proposed publication. Sponsor may remove any information that is considered confidential and/or proprietary other than study data.
ACCEPTED FOR PUBLICATION IN "MENOPAUSE".
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of R&D | Depomed | 510-744-8000 | msweeney@depomed.com |
| ID | Term |
|---|---|
| D019584 | Hot Flashes |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| >=65 years |
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| Male |
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| Black |
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| Asian |
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| Hispanic |
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| Other |
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| Moderate |
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| Severe |
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| Superiority or Other (legacy) |
| Baseline LOCF Average Daily Frequency at Week 12: Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily number of moderate to severe hot flashes at Week 12. | Based on Van Elteren | Multiplicity addressed by requiring significance for all primary endpoints. | 0.1000 | P-value for the test of difference of the least square mean change from baseline between Gabapentin ER 1800 mg and placebo group is based on the F-test of Type III analysis. | Mean Difference (Net) | -1.14 | Standard Error of the Mean | 0.335 | 2-Sided | 95 | -1.80 | -0.48 | Based on ANCOVA | Superiority or Other (legacy) |
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| Without Suicidal Ideation |
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| Without Suicidal Ideation |
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| Without Suicidal Ideation |
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