Trial Outcomes & Findings for Study of Gabapentin Extended Release (G-ER)in the Treatment of Vasomotor (Hot Flashes/Hot Flushes) Symptoms in Postmenopausal Women. (NCT NCT00777023)
NCT ID: NCT00777023
Last Updated: 2012-02-22
Results Overview
Mean change from baseline in average daily number of moderate or severe hot flashes at stable dose week (SDW) 4 of treatment relative to placebo; last observation carried forward (LOCF) analysis
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
565 participants
Primary outcome timeframe
At baseline and 4 weeks of treatment
Results posted on
2012-02-22
Participant Flow
A total of 565 patients were randomly assigned to treatment: 190 in G-ER 1800 mg group, 192 in G-ER 1200 mg group, and 183 in placebo group. Of these 565 patients, 559 patients (190 in G-ER 1800 mg group, 186 in 1200 mg group, and 183 in placebo group) received study treatment and were included in intent to treat (ITT) and safety populations.
Participant milestones
| Measure |
G-ER 1200 mg
Gabapentin extended-release (G-ER) 1200 mg
|
G-ER 1800 mg
Gabapentin extended-release (G-ER) 1800 mg
|
Sugar Pill
Placebo 1200 mg or 1800 mg
|
|---|---|---|---|
|
Overall Study
STARTED
|
186
|
190
|
183
|
|
Overall Study
COMPLETED
|
151
|
149
|
146
|
|
Overall Study
NOT COMPLETED
|
35
|
41
|
37
|
Reasons for withdrawal
| Measure |
G-ER 1200 mg
Gabapentin extended-release (G-ER) 1200 mg
|
G-ER 1800 mg
Gabapentin extended-release (G-ER) 1800 mg
|
Sugar Pill
Placebo 1200 mg or 1800 mg
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
15
|
21
|
8
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
14
|
|
Overall Study
Protocol Violation
|
2
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
3
|
|
Overall Study
Death
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
7
|
7
|
8
|
|
Overall Study
Missing data
|
1
|
1
|
0
|
|
Overall Study
Reasons not specified
|
4
|
4
|
2
|
|
Overall Study
Last dose date unknown
|
3
|
3
|
1
|
Baseline Characteristics
Study of Gabapentin Extended Release (G-ER)in the Treatment of Vasomotor (Hot Flashes/Hot Flushes) Symptoms in Postmenopausal Women.
Baseline characteristics by cohort
| Measure |
G-ER 1200 mg
n=186 Participants
Gabapentin extended-release (G-ER) 1200 mg
|
G-ER 1800 mg
n=190 Participants
Gabapentin extended-release (G-ER) 1800 mg
|
Sugar Pill
n=183 Participants
Placebo 1200 mg or 1800 mg
|
Total
n=559 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
53.1 years
STANDARD_DEVIATION 7.0 • n=5 Participants
|
53.6 years
STANDARD_DEVIATION 6.1 • n=7 Participants
|
52.9 years
STANDARD_DEVIATION 6.0 • n=5 Participants
|
53.2 years
STANDARD_DEVIATION 6.4 • n=4 Participants
|
|
Age, Customized
<65 years
|
175 participants
n=5 Participants
|
181 participants
n=7 Participants
|
177 participants
n=5 Participants
|
533 participants
n=4 Participants
|
|
Age, Customized
>=65 years
|
11 participants
n=5 Participants
|
9 participants
n=7 Participants
|
6 participants
n=5 Participants
|
26 participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
186 Participants
n=5 Participants
|
190 Participants
n=7 Participants
|
183 Participants
n=5 Participants
|
559 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Frequency of hot flashes
Mild
|
1.1 Hot flashes
STANDARD_DEVIATION 2.0 • n=5 Participants
|
1.0 Hot flashes
STANDARD_DEVIATION 2.0 • n=7 Participants
|
1.7 Hot flashes
STANDARD_DEVIATION 2.9 • n=5 Participants
|
1.2 Hot flashes
STANDARD_DEVIATION 2.3 • n=4 Participants
|
|
Frequency of hot flashes
Moderate
|
6.1 Hot flashes
STANDARD_DEVIATION 5.8 • n=5 Participants
|
5.4 Hot flashes
STANDARD_DEVIATION 4.0 • n=7 Participants
|
6.2 Hot flashes
STANDARD_DEVIATION 5.1 • n=5 Participants
|
5.9 Hot flashes
STANDARD_DEVIATION 5.0 • n=4 Participants
|
|
Frequency of hot flashes
Severe
|
6.7 Hot flashes
STANDARD_DEVIATION 5.1 • n=5 Participants
|
6.9 Hot flashes
STANDARD_DEVIATION 5.5 • n=7 Participants
|
6.6 Hot flashes
STANDARD_DEVIATION 4.9 • n=5 Participants
|
6.8 Hot flashes
STANDARD_DEVIATION 5.2 • n=4 Participants
|
PRIMARY outcome
Timeframe: At baseline and 4 weeks of treatmentPopulation: Intention to treat population
Mean change from baseline in average daily number of moderate or severe hot flashes at stable dose week (SDW) 4 of treatment relative to placebo; last observation carried forward (LOCF) analysis
Outcome measures
| Measure |
G-ER 1200 mg
n=186 Participants
Gabapentin extended-release (G-ER) 1200 mg
|
G-ER 1800 mg
n=190 Participants
Gabapentin extended-release (G-ER) 1800 mg
|
Sugar Pill
n=183 Participants
Placebo 1200 mg or 1800 mg
|
|---|---|---|---|
|
Change From Baseline in Average Daily Frequency of Moderate or Severe Hot Flashes After 4 Weeks of Treatment
|
-7.0 Hot flashes
Interval -7.77 to -6.19
|
-6.9 Hot flashes
Interval -7.68 to -6.08
|
-5.4 Hot flashes
Interval -6.18 to -4.46
|
PRIMARY outcome
Timeframe: At baseline and 12 weeks of treatmentPopulation: Intent to treat population
Mean change from baseline in average daily number of moderate or severe hot flashes at stable dose week (SDW) 12 of treatment relative to placebo; last observation carried forward (LOCF) analysis
Outcome measures
| Measure |
G-ER 1200 mg
n=186 Participants
Gabapentin extended-release (G-ER) 1200 mg
|
G-ER 1800 mg
n=190 Participants
Gabapentin extended-release (G-ER) 1800 mg
|
Sugar Pill
n=183 Participants
Placebo 1200 mg or 1800 mg
|
|---|---|---|---|
|
Change From Baseline in Average Daily Frequency of Moderate or Severe Hot Flashes After 12 Weeks of Treatment
|
-7.7 Hot flashes
Interval -8.5 to -6.97
|
-7.3 Hot flashes
Interval -8.06 to -6.52
|
-6.2 Hot flashes
Interval -6.96 to -5.38
|
PRIMARY outcome
Timeframe: At baseline and 4 weeks of treatmentPopulation: Intent to treat population
Mean change from baseline in average daily severity score of moderate or severe hot flashes at stable dose week (SDW) 4 of treatment relative to placebo; last observation carried forward (LOCF) analysis. Severity of hot flashes is scored on a scale of 1 to 3 where 1=mild, 2=moderate, 3=severe.
Outcome measures
| Measure |
G-ER 1200 mg
n=186 Participants
Gabapentin extended-release (G-ER) 1200 mg
|
G-ER 1800 mg
n=190 Participants
Gabapentin extended-release (G-ER) 1800 mg
|
Sugar Pill
n=183 Participants
Placebo 1200 mg or 1800 mg
|
|---|---|---|---|
|
Change From Baseline in Average Daily Severity Score of Moderate or Severe Hot Flashes After 4 Weeks of Treatment
|
-0.5 Units on a scale
Interval -0.63 to -0.4
|
-0.6 Units on a scale
Interval -0.76 to -0.53
|
-0.4 Units on a scale
Interval -0.49 to -0.25
|
PRIMARY outcome
Timeframe: At baseline and 12 weeks of treatmentPopulation: Intent to treat population
Mean change from baseline in average daily severity score of moderate or severe hot flashes at stable dose week (SDW) 12 of treatment relative to placebo; last observation carried forward (LOCF) analysis. Severity of hot flashes is scored on a scale of 1 to 3 where 1=mild, 2=moderate, 3=severe.
Outcome measures
| Measure |
G-ER 1200 mg
n=186 Participants
Gabapentin extended-release (G-ER) 1200 mg
|
G-ER 1800 mg
n=190 Participants
Gabapentin extended-release (G-ER) 1800 mg
|
Sugar Pill
n=183 Participants
Placebo 1200 mg or 1800 mg
|
|---|---|---|---|
|
Change From Baseline in Average Daily Severity Score of Moderate or Severe Hot Flashes After 12 Weeks of Treatment
|
-0.8 Units on a scale
Interval -0.9 to -0.61
|
-0.8 Units on a scale
Interval -0.97 to -0.68
|
-0.5 Units on a scale
Interval -0.69 to -0.39
|
Adverse Events
G-ER 1200 mg
Serious events: 2 serious events
Other events: 70 other events
Deaths: 0 deaths
G-ER 1800 mg
Serious events: 2 serious events
Other events: 83 other events
Deaths: 0 deaths
Sugar Pill
Serious events: 2 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
G-ER 1200 mg
n=186 participants at risk
Gabapentin extended-release (G-ER) 1200 mg
|
G-ER 1800 mg
n=190 participants at risk
Gabapentin extended-release (G-ER) 1800 mg
|
Sugar Pill
n=183 participants at risk
Placebo 1200 mg or 1800 mg
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.54%
1/186 • Number of events 1 • Adverse events collected for total of 13 weeks: from baseline to end of stable dosing week (SDW) 12 (treatment Week 13; end-of-treatment period).
Adverse event collection began at baseline and continued through Week 14 follow-up phone call; serious adverse events followed for 30 days after study completion.
|
0.00%
0/190 • Adverse events collected for total of 13 weeks: from baseline to end of stable dosing week (SDW) 12 (treatment Week 13; end-of-treatment period).
Adverse event collection began at baseline and continued through Week 14 follow-up phone call; serious adverse events followed for 30 days after study completion.
|
0.00%
0/183 • Adverse events collected for total of 13 weeks: from baseline to end of stable dosing week (SDW) 12 (treatment Week 13; end-of-treatment period).
Adverse event collection began at baseline and continued through Week 14 follow-up phone call; serious adverse events followed for 30 days after study completion.
|
|
Injury, poisoning and procedural complications
Overdose; attempted suicide
|
0.54%
1/186 • Number of events 1 • Adverse events collected for total of 13 weeks: from baseline to end of stable dosing week (SDW) 12 (treatment Week 13; end-of-treatment period).
Adverse event collection began at baseline and continued through Week 14 follow-up phone call; serious adverse events followed for 30 days after study completion.
|
0.00%
0/190 • Adverse events collected for total of 13 weeks: from baseline to end of stable dosing week (SDW) 12 (treatment Week 13; end-of-treatment period).
Adverse event collection began at baseline and continued through Week 14 follow-up phone call; serious adverse events followed for 30 days after study completion.
|
0.00%
0/183 • Adverse events collected for total of 13 weeks: from baseline to end of stable dosing week (SDW) 12 (treatment Week 13; end-of-treatment period).
Adverse event collection began at baseline and continued through Week 14 follow-up phone call; serious adverse events followed for 30 days after study completion.
|
|
General disorders
Chest pain
|
0.00%
0/186 • Adverse events collected for total of 13 weeks: from baseline to end of stable dosing week (SDW) 12 (treatment Week 13; end-of-treatment period).
Adverse event collection began at baseline and continued through Week 14 follow-up phone call; serious adverse events followed for 30 days after study completion.
|
0.53%
1/190 • Number of events 1 • Adverse events collected for total of 13 weeks: from baseline to end of stable dosing week (SDW) 12 (treatment Week 13; end-of-treatment period).
Adverse event collection began at baseline and continued through Week 14 follow-up phone call; serious adverse events followed for 30 days after study completion.
|
0.00%
0/183 • Adverse events collected for total of 13 weeks: from baseline to end of stable dosing week (SDW) 12 (treatment Week 13; end-of-treatment period).
Adverse event collection began at baseline and continued through Week 14 follow-up phone call; serious adverse events followed for 30 days after study completion.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/186 • Adverse events collected for total of 13 weeks: from baseline to end of stable dosing week (SDW) 12 (treatment Week 13; end-of-treatment period).
Adverse event collection began at baseline and continued through Week 14 follow-up phone call; serious adverse events followed for 30 days after study completion.
|
0.53%
1/190 • Number of events 1 • Adverse events collected for total of 13 weeks: from baseline to end of stable dosing week (SDW) 12 (treatment Week 13; end-of-treatment period).
Adverse event collection began at baseline and continued through Week 14 follow-up phone call; serious adverse events followed for 30 days after study completion.
|
0.00%
0/183 • Adverse events collected for total of 13 weeks: from baseline to end of stable dosing week (SDW) 12 (treatment Week 13; end-of-treatment period).
Adverse event collection began at baseline and continued through Week 14 follow-up phone call; serious adverse events followed for 30 days after study completion.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/186 • Adverse events collected for total of 13 weeks: from baseline to end of stable dosing week (SDW) 12 (treatment Week 13; end-of-treatment period).
Adverse event collection began at baseline and continued through Week 14 follow-up phone call; serious adverse events followed for 30 days after study completion.
|
0.00%
0/190 • Adverse events collected for total of 13 weeks: from baseline to end of stable dosing week (SDW) 12 (treatment Week 13; end-of-treatment period).
Adverse event collection began at baseline and continued through Week 14 follow-up phone call; serious adverse events followed for 30 days after study completion.
|
0.55%
1/183 • Number of events 1 • Adverse events collected for total of 13 weeks: from baseline to end of stable dosing week (SDW) 12 (treatment Week 13; end-of-treatment period).
Adverse event collection began at baseline and continued through Week 14 follow-up phone call; serious adverse events followed for 30 days after study completion.
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.00%
0/186 • Adverse events collected for total of 13 weeks: from baseline to end of stable dosing week (SDW) 12 (treatment Week 13; end-of-treatment period).
Adverse event collection began at baseline and continued through Week 14 follow-up phone call; serious adverse events followed for 30 days after study completion.
|
0.00%
0/190 • Adverse events collected for total of 13 weeks: from baseline to end of stable dosing week (SDW) 12 (treatment Week 13; end-of-treatment period).
Adverse event collection began at baseline and continued through Week 14 follow-up phone call; serious adverse events followed for 30 days after study completion.
|
0.55%
1/183 • Number of events 1 • Adverse events collected for total of 13 weeks: from baseline to end of stable dosing week (SDW) 12 (treatment Week 13; end-of-treatment period).
Adverse event collection began at baseline and continued through Week 14 follow-up phone call; serious adverse events followed for 30 days after study completion.
|
Other adverse events
| Measure |
G-ER 1200 mg
n=186 participants at risk
Gabapentin extended-release (G-ER) 1200 mg
|
G-ER 1800 mg
n=190 participants at risk
Gabapentin extended-release (G-ER) 1800 mg
|
Sugar Pill
n=183 participants at risk
Placebo 1200 mg or 1800 mg
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
3.2%
6/186 • Number of events 6 • Adverse events collected for total of 13 weeks: from baseline to end of stable dosing week (SDW) 12 (treatment Week 13; end-of-treatment period).
Adverse event collection began at baseline and continued through Week 14 follow-up phone call; serious adverse events followed for 30 days after study completion.
|
7.4%
14/190 • Number of events 14 • Adverse events collected for total of 13 weeks: from baseline to end of stable dosing week (SDW) 12 (treatment Week 13; end-of-treatment period).
Adverse event collection began at baseline and continued through Week 14 follow-up phone call; serious adverse events followed for 30 days after study completion.
|
1.6%
3/183 • Number of events 3 • Adverse events collected for total of 13 weeks: from baseline to end of stable dosing week (SDW) 12 (treatment Week 13; end-of-treatment period).
Adverse event collection began at baseline and continued through Week 14 follow-up phone call; serious adverse events followed for 30 days after study completion.
|
|
Nervous system disorders
Dizziness
|
17.2%
32/186 • Number of events 32 • Adverse events collected for total of 13 weeks: from baseline to end of stable dosing week (SDW) 12 (treatment Week 13; end-of-treatment period).
Adverse event collection began at baseline and continued through Week 14 follow-up phone call; serious adverse events followed for 30 days after study completion.
|
18.9%
36/190 • Number of events 36 • Adverse events collected for total of 13 weeks: from baseline to end of stable dosing week (SDW) 12 (treatment Week 13; end-of-treatment period).
Adverse event collection began at baseline and continued through Week 14 follow-up phone call; serious adverse events followed for 30 days after study completion.
|
2.7%
5/183 • Number of events 5 • Adverse events collected for total of 13 weeks: from baseline to end of stable dosing week (SDW) 12 (treatment Week 13; end-of-treatment period).
Adverse event collection began at baseline and continued through Week 14 follow-up phone call; serious adverse events followed for 30 days after study completion.
|
|
Nervous system disorders
Headache
|
4.8%
9/186 • Number of events 9 • Adverse events collected for total of 13 weeks: from baseline to end of stable dosing week (SDW) 12 (treatment Week 13; end-of-treatment period).
Adverse event collection began at baseline and continued through Week 14 follow-up phone call; serious adverse events followed for 30 days after study completion.
|
7.4%
14/190 • Number of events 14 • Adverse events collected for total of 13 weeks: from baseline to end of stable dosing week (SDW) 12 (treatment Week 13; end-of-treatment period).
Adverse event collection began at baseline and continued through Week 14 follow-up phone call; serious adverse events followed for 30 days after study completion.
|
7.7%
14/183 • Number of events 14 • Adverse events collected for total of 13 weeks: from baseline to end of stable dosing week (SDW) 12 (treatment Week 13; end-of-treatment period).
Adverse event collection began at baseline and continued through Week 14 follow-up phone call; serious adverse events followed for 30 days after study completion.
|
|
Nervous system disorders
Somnolence
|
7.0%
13/186 • Number of events 13 • Adverse events collected for total of 13 weeks: from baseline to end of stable dosing week (SDW) 12 (treatment Week 13; end-of-treatment period).
Adverse event collection began at baseline and continued through Week 14 follow-up phone call; serious adverse events followed for 30 days after study completion.
|
8.4%
16/190 • Number of events 16 • Adverse events collected for total of 13 weeks: from baseline to end of stable dosing week (SDW) 12 (treatment Week 13; end-of-treatment period).
Adverse event collection began at baseline and continued through Week 14 follow-up phone call; serious adverse events followed for 30 days after study completion.
|
3.3%
6/183 • Number of events 6 • Adverse events collected for total of 13 weeks: from baseline to end of stable dosing week (SDW) 12 (treatment Week 13; end-of-treatment period).
Adverse event collection began at baseline and continued through Week 14 follow-up phone call; serious adverse events followed for 30 days after study completion.
|
|
Nervous system disorders
Sedation
|
5.4%
10/186 • Number of events 10 • Adverse events collected for total of 13 weeks: from baseline to end of stable dosing week (SDW) 12 (treatment Week 13; end-of-treatment period).
Adverse event collection began at baseline and continued through Week 14 follow-up phone call; serious adverse events followed for 30 days after study completion.
|
1.6%
3/190 • Number of events 3 • Adverse events collected for total of 13 weeks: from baseline to end of stable dosing week (SDW) 12 (treatment Week 13; end-of-treatment period).
Adverse event collection began at baseline and continued through Week 14 follow-up phone call; serious adverse events followed for 30 days after study completion.
|
0.55%
1/183 • Number of events 1 • Adverse events collected for total of 13 weeks: from baseline to end of stable dosing week (SDW) 12 (treatment Week 13; end-of-treatment period).
Adverse event collection began at baseline and continued through Week 14 follow-up phone call; 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 the sponsor shall have the right to the first publication of the results of the study which is intended to be a joint, multi-center publication. Following the first publication, the PI may publish data or results from the study, provide however PI submits the proposed publication to sponsor for review at least 60 days prior to the date of the proposed publication. Sponsor may remove any information that is considered confidential and/or proprietary other than study data.
- Publication restrictions are in place
Restriction type: OTHER