Trial Outcomes & Findings for Breeze3:Study of Gabapentin Extended Release in the Treatment of Vasomotor Symptoms(Hot Flashes)in Postmenopausal Women (NCT NCT01080300)
NCT ID: NCT01080300
Last Updated: 2020-05-01
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
600 participants
Primary outcome timeframe
Baseline, Week 4, and Week 12
Results posted on
2020-05-01
Participant Flow
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.
Participant milestones
| Measure |
G-ER 1800 mg
Gabapentin extended-release (G-ER) 1800 mg
|
Sugar Pill
Placebo 1800 mg
|
|---|---|---|
|
Overall Study
STARTED
|
300
|
295
|
|
Overall Study
COMPLETED
|
206
|
191
|
|
Overall Study
NOT COMPLETED
|
94
|
104
|
Reasons for withdrawal
| Measure |
G-ER 1800 mg
Gabapentin extended-release (G-ER) 1800 mg
|
Sugar Pill
Placebo 1800 mg
|
|---|---|---|
|
Overall Study
Adverse Event
|
49
|
35
|
|
Overall Study
Lack of Efficacy
|
12
|
15
|
|
Overall Study
Protocol Violation
|
7
|
13
|
|
Overall Study
Lost to Follow-up
|
10
|
6
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
12
|
28
|
|
Overall Study
Reasons not specified
|
4
|
6
|
Baseline Characteristics
Breeze3:Study of Gabapentin Extended Release in the Treatment of Vasomotor Symptoms(Hot Flashes)in Postmenopausal Women
Baseline characteristics by cohort
| Measure |
G-ER 1800 mg
n=299 Participants
Gabapentin extended-release (G-ER) 1800 mg
|
Sugar Pill
n=294 Participants
Placebo 1800 mg
|
Total
n=593 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.0 years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
54.0 years
STANDARD_DEVIATION 6.0 • n=7 Participants
|
54.0 years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
|
Age, Customized
< 65 years
|
280 participants
n=5 Participants
|
282 participants
n=7 Participants
|
562 participants
n=5 Participants
|
|
Age, Customized
>=65 years
|
19 participants
n=5 Participants
|
12 participants
n=7 Participants
|
31 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
299 Participants
n=5 Participants
|
294 Participants
n=7 Participants
|
593 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
215 participants
n=5 Participants
|
197 participants
n=7 Participants
|
412 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
74 participants
n=5 Participants
|
82 participants
n=7 Participants
|
156 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 participants
n=5 Participants
|
4 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Frequency of hot flashes
Mild
|
1.5 hot flashes
STANDARD_DEVIATION 2.8 • n=5 Participants
|
1.5 hot flashes
STANDARD_DEVIATION 3.3 • n=7 Participants
|
1.5 hot flashes
STANDARD_DEVIATION 3.1 • n=5 Participants
|
|
Frequency of hot flashes
Moderate
|
6.4 hot flashes
STANDARD_DEVIATION 5.3 • n=5 Participants
|
6.1 hot flashes
STANDARD_DEVIATION 4.9 • n=7 Participants
|
6.3 hot flashes
STANDARD_DEVIATION 5.1 • n=5 Participants
|
|
Frequency of hot flashes
Severe
|
7.1 hot flashes
STANDARD_DEVIATION 10.6 • n=5 Participants
|
6.5 hot flashes
STANDARD_DEVIATION 5.4 • n=7 Participants
|
6.8 hot flashes
STANDARD_DEVIATION 8.4 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 4, and Week 12Population: Intent-to-treat (ITT) Population
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.
Outcome measures
| Measure |
G-ER 1800 mg
n=299 Participants
Gabapentin extended-release (G-ER) 1800 mg
|
Sugar Pill
n=294 Participants
Placebo 1800 mg
|
|---|---|---|
|
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.
Baseline LOCF Average Daily Frequency at Week 4
|
-6.72 hot flashes
Interval -7.24 to -6.19
|
-5.01 hot flashes
Interval -5.54 to -4.49
|
|
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.
Baseline LOCF Average Daily Frequency at Week 12
|
-7.64 hot flashes
Interval -8.21 to -7.07
|
-6.50 hot flashes
Interval -7.07 to -5.94
|
PRIMARY outcome
Timeframe: Baseline, Week 4, and Week 12Population: Intent-to-treat (ITT) Population
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.
Outcome measures
| Measure |
G-ER 1800 mg
n=299 Participants
Gabapentin extended-release (G-ER) 1800 mg
|
Sugar Pill
n=294 Participants
Placebo 1800 mg
|
|---|---|---|
|
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.
Baseline LOCF Average Daily Severity at Week 4
|
-0.42 scores on a scale
Interval -0.51 to -0.33
|
-0.22 scores on a scale
Interval -0.31 to -0.13
|
|
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.
Baseline LOCF Average Daily Severity at Week 12
|
-0.65 scores on a scale
Interval -0.77 to -0.52
|
-0.46 scores on a scale
Interval -0.58 to -0.34
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Completer Population
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.
Outcome measures
| Measure |
G-ER 1800 mg
n=185 Participants
Gabapentin extended-release (G-ER) 1800 mg
|
Sugar Pill
n=177 Participants
Placebo 1800 mg
|
|---|---|---|
|
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.
|
-8.99 hot flashes
Interval -9.71 to -8.27
|
-7.91 hot flashes
Interval -8.62 to -7.19
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Completer Population
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.
Outcome measures
| Measure |
G-ER 1800 mg
n=185 Participants
Gabapentin extended-release (G-ER) 1800 mg
|
Sugar Pill
n=177 Participants
Placebo 1800 mg
|
|---|---|---|
|
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.
|
-0.86 scores on a scale
Interval -1.03 to -0.69
|
-0.64 scores on a scale
Interval -0.81 to -0.47
|
SECONDARY outcome
Timeframe: Week 12 and Week 24Population: Intent-to-treat (ITT) Population
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".
Outcome measures
| Measure |
G-ER 1800 mg
n=299 Participants
Gabapentin extended-release (G-ER) 1800 mg
|
Sugar Pill
n=294 Participants
Placebo 1800 mg
|
|---|---|---|
|
Patient Global Impression of Change (PGIC) Scales at Weeks 12 and 24 of the Efficacy Treatment Period.
Baseline LOCF Proportion at Week 12
|
173 Participants
|
130 Participants
|
|
Patient Global Impression of Change (PGIC) Scales at Weeks 12 and 24 of the Efficacy Treatment Period.
Baseline LOCF Proportion at Week 24
|
156 Participants
|
114 Participants
|
SECONDARY outcome
Timeframe: Week 12 and Week 24Population: Intent-to-treat (ITT) Population
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".
Outcome measures
| Measure |
G-ER 1800 mg
n=299 Participants
Gabapentin extended-release (G-ER) 1800 mg
|
Sugar Pill
n=294 Participants
Placebo 1800 mg
|
|---|---|---|
|
Clinical Global Impression of Change (CGIC) Scales at Weeks 12 and 24 of the Efficacy Treatment Period.
Baseline LOCF Proportion at Week 12
|
173 Participants
|
122 Participants
|
|
Clinical Global Impression of Change (CGIC) Scales at Weeks 12 and 24 of the Efficacy Treatment Period.
Baseline LOCF Proportion at Week 24
|
159 Participants
|
124 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12, and Week 24Population: Intent-to-treat (ITT) Population
Outcome measures
| Measure |
G-ER 1800 mg
n=299 Participants
Gabapentin extended-release (G-ER) 1800 mg
|
Sugar Pill
n=294 Participants
Placebo 1800 mg
|
|---|---|---|
|
Percent of Patients With 75% or Greater Reduction in Average Daily Frequency of Moderate to Severe Hot Flashes
Baseline LOCF Proportion at Week 12
|
125 Participants
|
101 Participants
|
|
Percent of Patients With 75% or Greater Reduction in Average Daily Frequency of Moderate to Severe Hot Flashes
Baseline LOCF Proportion at Week 24
|
146 Participants
|
122 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12, and Week 24Population: Intent-to-treat (ITT) Population
Outcome measures
| Measure |
G-ER 1800 mg
n=299 Participants
Gabapentin extended-release (G-ER) 1800 mg
|
Sugar Pill
n=294 Participants
Placebo 1800 mg
|
|---|---|---|
|
Percent of Patients With 75% or Greater Reduction in Average Daily Severity Score of Moderate to Severe Hot Flashes
Baseline LOCF Average Daily Score at Week 12
|
48 Participants
|
36 Participants
|
|
Percent of Patients With 75% or Greater Reduction in Average Daily Severity Score of Moderate to Severe Hot Flashes
Baseline LOCF Average Daily Score at Week 24
|
62 Participants
|
48 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 12, and Week 24Population: Intent-to-treat (ITT) Population
Sleep Interference Score Range: Minimum value = 0, maximum value = 10 Lower scores indicate better outcome (ie, less interference)
Outcome measures
| Measure |
G-ER 1800 mg
n=299 Participants
Gabapentin extended-release (G-ER) 1800 mg
|
Sugar Pill
n=294 Participants
Placebo 1800 mg
|
|---|---|---|
|
Change From Baseline to Weeks 4, Week 12, and Week 24 in Average Daily Sleep Interference Score.
Change from Baseline to Week 4: LOCF daily rating
|
-2.67 units on a scale
Interval -3.0 to -2.33
|
-1.31 units on a scale
Interval -1.64 to -0.97
|
|
Change From Baseline to Weeks 4, Week 12, and Week 24 in Average Daily Sleep Interference Score.
Change from Baseline to Week 12: LOCF daily rating
|
-3.09 units on a scale
Interval -3.47 to -2.71
|
-2.17 units on a scale
Interval -2.56 to -1.79
|
|
Change From Baseline to Weeks 4, Week 12, and Week 24 in Average Daily Sleep Interference Score.
Change from Baseline to Week 24: LOCF daily rating
|
-3.15 units on a scale
Interval -3.56 to -2.75
|
-2.20 units on a scale
Interval -2.6 to -1.8
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 12, and Week 24Population: Intent-to-treat (ITT) Population
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)).
Outcome measures
| Measure |
G-ER 1800 mg
n=299 Participants
Gabapentin extended-release (G-ER) 1800 mg
|
Sugar Pill
n=294 Participants
Placebo 1800 mg
|
|---|---|---|
|
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.
Change from Baseline to Week 4: LOCF ISI rating
|
-6.47 scores on a scale
Interval -7.67 to -5.82
|
-4.13 scores on a scale
Interval -5.04 to -3.21
|
|
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.
Change from Baseline to Week 12: LOCF ISI rating
|
-7.02 scores on a scale
Interval -7.96 to -6.09
|
-5.17 scores on a scale
Interval -6.1 to -4.25
|
|
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.
Change from Baseline to Week 24: LOCF ISI rating
|
-6.71 scores on a scale
Interval -7.65 to -5.77
|
-4.95 scores on a scale
Interval -5.88 to -4.01
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 12, and Week 24Population: Intent-to-treat (ITT) Population
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)
Outcome measures
| Measure |
G-ER 1800 mg
n=299 Participants
Gabapentin extended-release (G-ER) 1800 mg
|
Sugar Pill
n=294 Participants
Placebo 1800 mg
|
|---|---|---|
|
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.
Baseline LOCF MENQOL score at Week 4
|
-0.91 scores on a scale
Interval -1.06 to -0.77
|
-0.71 scores on a scale
Interval -0.85 to -0.57
|
|
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.
Baseline LOCF MENQOL score at Week 12
|
-1.01 scores on a scale
Interval -1.16 to -0.87
|
-0.87 scores on a scale
Interval -1.01 to -0.72
|
|
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.
Baseline LOCF MENQOL score at Week 24
|
-1.01 scores on a scale
Interval -1.17 to -0.86
|
-0.96 scores on a scale
Interval -1.11 to -0.81
|
SECONDARY outcome
Timeframe: Week 4, Week 12, Week 24/Early Termination, Week 28Population: Safety Population
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.
Outcome measures
| Measure |
G-ER 1800 mg
n=300 Participants
Gabapentin extended-release (G-ER) 1800 mg
|
Sugar Pill
n=295 Participants
Placebo 1800 mg
|
|---|---|---|
|
Safety of G-ER Measuring Columbia-Suicide Severity Rating Scale (C-SSRS).
Patients Taking C-SSRS at Week 4 · With Suicidal Ideation
|
0 Participants
|
0 Participants
|
|
Safety of G-ER Measuring Columbia-Suicide Severity Rating Scale (C-SSRS).
Patients Taking C-SSRS at Week 4 · Without Suicidal Ideation
|
260 Participants
|
257 Participants
|
|
Safety of G-ER Measuring Columbia-Suicide Severity Rating Scale (C-SSRS).
Patients Taking C-SSRS at Week 12 · With Suicidal Ideation
|
1 Participants
|
0 Participants
|
|
Safety of G-ER Measuring Columbia-Suicide Severity Rating Scale (C-SSRS).
Patients Taking C-SSRS at Week 12 · Without Suicidal Ideation
|
224 Participants
|
215 Participants
|
|
Safety of G-ER Measuring Columbia-Suicide Severity Rating Scale (C-SSRS).
Patients Taking C-SSRS at Week 24/EarlyTermination · With Suicidal Ideation
|
0 Participants
|
1 Participants
|
|
Safety of G-ER Measuring Columbia-Suicide Severity Rating Scale (C-SSRS).
Patients Taking C-SSRS at Week 24/EarlyTermination · Without Suicidal Ideation
|
271 Participants
|
266 Participants
|
|
Safety of G-ER Measuring Columbia-Suicide Severity Rating Scale (C-SSRS).
Patients Taking C-SSRS at Week 28 · With Suicidal Ideation
|
1 Participants
|
0 Participants
|
|
Safety of G-ER Measuring Columbia-Suicide Severity Rating Scale (C-SSRS).
Patients Taking C-SSRS at Week 28 · Without Suicidal Ideation
|
256 Participants
|
243 Participants
|
Adverse Events
G-ER 1800 mg
Serious events: 4 serious events
Other events: 102 other events
Deaths: 0 deaths
Sugar Pill
Serious events: 7 serious events
Other events: 53 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
G-ER 1800 mg
n=300 participants at risk
Gabapentin extended-release (G-ER) 1800 mg
|
Sugar Pill
n=295 participants at risk
Placebo 1800 mg
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.33%
1/300 • Number of events 1 • 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.
|
0.00%
0/295 • 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.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/300 • 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.
|
0.34%
1/295 • Number of events 1 • 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.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/300 • 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.
|
0.34%
1/295 • Number of events 1 • 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.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/300 • 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.
|
0.34%
1/295 • Number of events 1 • 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.
|
|
Infections and infestations
Arthritis infective
|
0.33%
1/300 • Number of events 1 • 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.
|
0.00%
0/295 • 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.
|
|
Infections and infestations
Bronchitis acute
|
0.00%
0/300 • 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.
|
0.34%
1/295 • Number of events 1 • 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.
|
|
Infections and infestations
Periorbital cellulitis
|
0.33%
1/300 • Number of events 1 • 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.
|
0.00%
0/295 • 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.
|
|
Infections and infestations
Pneumonia primary atypical
|
0.00%
0/300 • 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.
|
0.34%
1/295 • Number of events 1 • 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.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/300 • 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.
|
0.34%
1/295 • Number of events 1 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.33%
1/300 • Number of events 1 • 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.
|
0.00%
0/295 • 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.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/300 • 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.
|
0.34%
1/295 • Number of events 1 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/300 • 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.
|
0.34%
1/295 • Number of events 1 • 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.
|
|
Vascular disorders
Hypertension
|
0.00%
0/300 • 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.
|
0.34%
1/295 • Number of events 1 • 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.
|
Other adverse events
| Measure |
G-ER 1800 mg
n=300 participants at risk
Gabapentin extended-release (G-ER) 1800 mg
|
Sugar Pill
n=295 participants at risk
Placebo 1800 mg
|
|---|---|---|
|
Nervous system disorders
Dizziness
|
12.7%
38/300 • Number of events 44 • 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.
|
3.4%
10/295 • Number of events 10 • 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.
|
|
Nervous system disorders
Headache
|
9.3%
28/300 • Number of events 28 • 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.
|
8.1%
24/295 • Number of events 25 • 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.
|
|
Nervous system disorders
Somnolence
|
6.0%
18/300 • Number of events 18 • 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.
|
2.7%
8/295 • Number of events 8 • 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.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.0%
18/300 • Number of events 18 • 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.
|
3.7%
11/295 • Number of events 14 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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".
- Publication restrictions are in place
Restriction type: OTHER