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 NCT00755417)

Last Updated: 2012-03-07

Results Overview

Change from baseline in average daily frequency of moderate to severe hot flashes after 4 weeks of treatment with stable daily doses of G-ER 1200 mg or G-ER 1800 mg compared with placebo, using last observation carried forward (LOCF) method of imputation for missing data in intent-to-treat (ITT) population.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

541 participants

Primary outcome timeframe

From baseline to 4 weeks

Results posted on

2012-03-07

Participant Flow

541 participants were randomized (enrolled), but only 532 participants received treatment and are included as STARTED.

Participant milestones

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	174	181	177
Overall Study COMPLETED	112	126	135
Overall Study NOT COMPLETED	62	55	42

Reasons for withdrawal

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	28	20	7
Overall Study Lack of Efficacy	8	4	9
Overall Study Protocol Violation	2	1	1
Overall Study Lost to Follow-up	3	0	1
Overall Study Withdrawal by Subject	12	12	12
Overall Study Not specified or missing data	9	18	12

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

Baseline characteristics by cohort
Measure	G-ER 1200 mg n=174 Participants Gabapentin extended-release (G-ER) 1200 mg	G-ER 1800 mg n=181 Participants Gabapentin extended-release (G-ER) 1800 mg	Sugar Pill n=177 Participants Placebo 1200 mg or 1800 mg	Total n=532 Participants Total of all reporting groups
Age Continuous	52.9 Years STANDARD_DEVIATION 5.3 • n=5 Participants	52.9 Years STANDARD_DEVIATION 6.5 • n=7 Participants	53.0 Years STANDARD_DEVIATION 6.6 • n=5 Participants	52.9 Years STANDARD_DEVIATION 6.2 • n=4 Participants
Age, Customized <65 years	170 Participants n=5 Participants	176 Participants n=7 Participants	170 Participants n=5 Participants	516 Participants n=4 Participants
Age, Customized >=65 years	4 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants	16 Participants n=4 Participants
Sex: Female, Male Female	174 Participants n=5 Participants	181 Participants n=7 Participants	177 Participants n=5 Participants	532 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
Race/Ethnicity, Customized White	121 Participants n=5 Participants	125 Participants n=7 Participants	111 Participants n=5 Participants	357 Participants n=4 Participants
Race/Ethnicity, Customized Black	39 Participants n=5 Participants	37 Participants n=7 Participants	50 Participants n=5 Participants	126 Participants n=4 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Race/Ethnicity, Customized Hispanic	12 Participants n=5 Participants	13 Participants n=7 Participants	12 Participants n=5 Participants	37 Participants n=4 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	9 Participants n=4 Participants
Number of hot flashes in 24-hour period Moderate hot flashes	6.1 Hot flashes STANDARD_DEVIATION 4.5 • n=5 Participants	6.2 Hot flashes STANDARD_DEVIATION 5.7 • n=7 Participants	6.3 Hot flashes STANDARD_DEVIATION 5.6 • n=5 Participants	6.2 Hot flashes STANDARD_DEVIATION 5.3 • n=4 Participants
Number of hot flashes in 24-hour period Severe hot flashes	6.4 Hot flashes STANDARD_DEVIATION 4.6 • n=5 Participants	7.4 Hot flashes STANDARD_DEVIATION 5.8 • n=7 Participants	7.1 Hot flashes STANDARD_DEVIATION 5.9 • n=5 Participants	7.0 Hot flashes STANDARD_DEVIATION 5.5 • n=4 Participants

PRIMARY outcome

Timeframe: From baseline to 4 weeks

Outcome measures

Outcome measures
Measure	G-ER 1200 mg n=174 Participants Gabapentin extended-release (G-ER) 1200 mg	G-ER 1800 mg n=181 Participants Gabapentin extended-release (G-ER) 1800 mg	Sugar Pill n=177 Participants Placebo 1200 mg or 1800 mg
Change From Baseline in Average Daily Frequency of Hot Flashes After 4 Weeks of Treatment With Daily Doses of G-ER 1200 mg or G-ER 1800 mg Compared to Placebo	-6.8 Moderate or severe hot flashes Interval -7.37 to -6.13	-7.3 Moderate or severe hot flashes Interval -7.89 to -6.71	-5.8 Moderate or severe hot flashes Interval -6.41 to -5.18

PRIMARY outcome

Timeframe: Form baseline to 12 weeks

Change from baseline in average daily frequency of moderate to severe hot flashes after 12 weeks of treatment with stable daily doses of G-ER 1200 mg or G-ER 1800 mg compared with placebo, using last observation carried forward (LOCF) method of imputation for missing data in intent-to-treat (ITT) population.

Outcome measures

Outcome measures
Measure	G-ER 1200 mg n=174 Participants Gabapentin extended-release (G-ER) 1200 mg	G-ER 1800 mg n=181 Participants Gabapentin extended-release (G-ER) 1800 mg	Sugar Pill n=177 Participants Placebo 1200 mg or 1800 mg
Change From Baseline in Average Daily Frequency of Hot Flashes After 12 Weeks of Treatment With Daily Doses of G-ER 1200 mg or G-ER 1800 mg Compared to Placebo	-7.4 Moderate or severe hot flashes Interval -8.1 to -6.73	-7.4 Moderate or severe hot flashes Interval -8.04 to -6.74	-6.9 Moderate or severe hot flashes Interval -7.53 to -6.18

PRIMARY outcome

Timeframe: From baseline to 4 weeks

Change from baseline in average daily severity score of moderate to severe hot flashes after 4 weeks of treatment with stable daily doses of G-ER 1200 mg or G-ER 1800 mg compared with placebo, using last observation carried forward (LOCF) method of imputation for missing data in intent-to-treat (ITT) population. Severity score is on a 3-point scale where 1=Mild, 2=Moderate, and 3=Severe.

Outcome measures

Outcome measures
Measure	G-ER 1200 mg n=174 Participants Gabapentin extended-release (G-ER) 1200 mg	G-ER 1800 mg n=181 Participants Gabapentin extended-release (G-ER) 1800 mg	Sugar Pill n=177 Participants Placebo 1200 mg or 1800 mg
Change From Baseline in Average Daily Severity Score of Hot Flashes After 4 Weeks of Treatment With Daily Doses of G-ER 1200 mg or G-ER 1800 mg Compared to Placebo	-0.5 Score on a numerical scale Interval -0.68 to -0.41	-0.6 Score on a numerical scale Interval -0.74 to -0.48	-0.3 Score on a numerical scale Interval -0.42 to -0.15

PRIMARY outcome

Timeframe: From baseline to 12 weeks

Change from baseline in average daily severity score of moderate to severe hot flashes after 12 weeks of treatment with stable daily doses of G-ER 1200 mg or G-ER 1800 mg compared with placebo, using last observation carried forward (LOCF) method of imputation for missing data in intent-to-treat (ITT) population. Severity score is on a 3-point scale were 1=Mild, 2=Moderate, and 3=Severe.

Outcome measures

Outcome measures
Measure	G-ER 1200 mg n=174 Participants Gabapentin extended-release (G-ER) 1200 mg	G-ER 1800 mg n=181 Participants Gabapentin extended-release (G-ER) 1800 mg	Sugar Pill n=177 Participants Placebo 1200 mg or 1800 mg
Change From Baseline in Average Daily Severity Score of Hot Flashes After 12 Weeks of Treatment With Daily Doses of G-ER 1200 mg or G-ER 1800 mg Compared to Placebo	-0.7 Score on a numerical scale Interval -0.91 to -0.58	-0.7 Score on a numerical scale Interval -0.9 to -0.59	-0.5 Score on a numerical scale Interval -0.71 to -0.38

Adverse Events

G-ER 1200 mg

Serious events: 2 serious events

Other events: 148 other events

Deaths: 0 deaths

G-ER 1800 mg

Serious events: 6 serious events

Other events: 167 other events

Deaths: 0 deaths

Sugar Pill

Serious events: 4 serious events

Other events: 65 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	G-ER 1200 mg n=174 participants at risk Gabapentin extended-release (G-ER) 1200 mg	G-ER 1800 mg n=181 participants at risk Gabapentin extended-release (G-ER) 1800 mg	Sugar Pill n=177 participants at risk Placebo 1200 mg or 1800 mg
Gastrointestinal disorders Abdominal hernia	0.00% 0/174 • Total of 26 weeks: from randomization through 1 week after study completion (week 25). Adverse events that occurred when patient signed informed consent form through completion of 1-week follow-up telephone contact after end-of-treatment visit at week 25 (stable dosing week 24).	0.00% 0/181 • Total of 26 weeks: from randomization through 1 week after study completion (week 25). Adverse events that occurred when patient signed informed consent form through completion of 1-week follow-up telephone contact after end-of-treatment visit at week 25 (stable dosing week 24).	0.56% 1/177 • Number of events 1 • Total of 26 weeks: from randomization through 1 week after study completion (week 25). Adverse events that occurred when patient signed informed consent form through completion of 1-week follow-up telephone contact after end-of-treatment visit at week 25 (stable dosing week 24).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.57% 1/174 • Number of events 1 • Total of 26 weeks: from randomization through 1 week after study completion (week 25). Adverse events that occurred when patient signed informed consent form through completion of 1-week follow-up telephone contact after end-of-treatment visit at week 25 (stable dosing week 24).	0.55% 1/181 • Number of events 1 • Total of 26 weeks: from randomization through 1 week after study completion (week 25). Adverse events that occurred when patient signed informed consent form through completion of 1-week follow-up telephone contact after end-of-treatment visit at week 25 (stable dosing week 24).	0.00% 0/177 • Total of 26 weeks: from randomization through 1 week after study completion (week 25). Adverse events that occurred when patient signed informed consent form through completion of 1-week follow-up telephone contact after end-of-treatment visit at week 25 (stable dosing week 24).
Nervous system disorders Cerebrovascular disorder	0.00% 0/174 • Total of 26 weeks: from randomization through 1 week after study completion (week 25). Adverse events that occurred when patient signed informed consent form through completion of 1-week follow-up telephone contact after end-of-treatment visit at week 25 (stable dosing week 24).	0.00% 0/181 • Total of 26 weeks: from randomization through 1 week after study completion (week 25). Adverse events that occurred when patient signed informed consent form through completion of 1-week follow-up telephone contact after end-of-treatment visit at week 25 (stable dosing week 24).	0.56% 1/177 • Number of events 1 • Total of 26 weeks: from randomization through 1 week after study completion (week 25). Adverse events that occurred when patient signed informed consent form through completion of 1-week follow-up telephone contact after end-of-treatment visit at week 25 (stable dosing week 24).
General disorders Chest pain	0.00% 0/174 • Total of 26 weeks: from randomization through 1 week after study completion (week 25). Adverse events that occurred when patient signed informed consent form through completion of 1-week follow-up telephone contact after end-of-treatment visit at week 25 (stable dosing week 24).	0.00% 0/181 • Total of 26 weeks: from randomization through 1 week after study completion (week 25). Adverse events that occurred when patient signed informed consent form through completion of 1-week follow-up telephone contact after end-of-treatment visit at week 25 (stable dosing week 24).	0.56% 1/177 • Number of events 1 • Total of 26 weeks: from randomization through 1 week after study completion (week 25). Adverse events that occurred when patient signed informed consent form through completion of 1-week follow-up telephone contact after end-of-treatment visit at week 25 (stable dosing week 24).
Cardiac disorders Coronary artery disease	0.00% 0/174 • Total of 26 weeks: from randomization through 1 week after study completion (week 25). Adverse events that occurred when patient signed informed consent form through completion of 1-week follow-up telephone contact after end-of-treatment visit at week 25 (stable dosing week 24).	0.00% 0/181 • Total of 26 weeks: from randomization through 1 week after study completion (week 25). Adverse events that occurred when patient signed informed consent form through completion of 1-week follow-up telephone contact after end-of-treatment visit at week 25 (stable dosing week 24).	0.56% 1/177 • Number of events 1 • Total of 26 weeks: from randomization through 1 week after study completion (week 25). Adverse events that occurred when patient signed informed consent form through completion of 1-week follow-up telephone contact after end-of-treatment visit at week 25 (stable dosing week 24).
Gastrointestinal disorders Gastroesophageal reflux disease exacerbation	0.57% 1/174 • Number of events 1 • Total of 26 weeks: from randomization through 1 week after study completion (week 25). Adverse events that occurred when patient signed informed consent form through completion of 1-week follow-up telephone contact after end-of-treatment visit at week 25 (stable dosing week 24).	0.00% 0/181 • Total of 26 weeks: from randomization through 1 week after study completion (week 25). Adverse events that occurred when patient signed informed consent form through completion of 1-week follow-up telephone contact after end-of-treatment visit at week 25 (stable dosing week 24).	0.00% 0/177 • Total of 26 weeks: from randomization through 1 week after study completion (week 25). Adverse events that occurred when patient signed informed consent form through completion of 1-week follow-up telephone contact after end-of-treatment visit at week 25 (stable dosing week 24).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant lung neoplasm	0.00% 0/174 • Total of 26 weeks: from randomization through 1 week after study completion (week 25). Adverse events that occurred when patient signed informed consent form through completion of 1-week follow-up telephone contact after end-of-treatment visit at week 25 (stable dosing week 24).	0.55% 1/181 • Number of events 1 • Total of 26 weeks: from randomization through 1 week after study completion (week 25). Adverse events that occurred when patient signed informed consent form through completion of 1-week follow-up telephone contact after end-of-treatment visit at week 25 (stable dosing week 24).	0.00% 0/177 • Total of 26 weeks: from randomization through 1 week after study completion (week 25). Adverse events that occurred when patient signed informed consent form through completion of 1-week follow-up telephone contact after end-of-treatment visit at week 25 (stable dosing week 24).
Nervous system disorders Nerve compression	0.00% 0/174 • Total of 26 weeks: from randomization through 1 week after study completion (week 25). Adverse events that occurred when patient signed informed consent form through completion of 1-week follow-up telephone contact after end-of-treatment visit at week 25 (stable dosing week 24).	0.55% 1/181 • Number of events 1 • Total of 26 weeks: from randomization through 1 week after study completion (week 25). Adverse events that occurred when patient signed informed consent form through completion of 1-week follow-up telephone contact after end-of-treatment visit at week 25 (stable dosing week 24).	0.00% 0/177 • Total of 26 weeks: from randomization through 1 week after study completion (week 25). Adverse events that occurred when patient signed informed consent form through completion of 1-week follow-up telephone contact after end-of-treatment visit at week 25 (stable dosing week 24).
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/174 • Total of 26 weeks: from randomization through 1 week after study completion (week 25). Adverse events that occurred when patient signed informed consent form through completion of 1-week follow-up telephone contact after end-of-treatment visit at week 25 (stable dosing week 24).	0.55% 1/181 • Number of events 1 • Total of 26 weeks: from randomization through 1 week after study completion (week 25). Adverse events that occurred when patient signed informed consent form through completion of 1-week follow-up telephone contact after end-of-treatment visit at week 25 (stable dosing week 24).	0.00% 0/177 • Total of 26 weeks: from randomization through 1 week after study completion (week 25). Adverse events that occurred when patient signed informed consent form through completion of 1-week follow-up telephone contact after end-of-treatment visit at week 25 (stable dosing week 24).
Injury, poisoning and procedural complications Rib fracture	0.00% 0/174 • Total of 26 weeks: from randomization through 1 week after study completion (week 25). Adverse events that occurred when patient signed informed consent form through completion of 1-week follow-up telephone contact after end-of-treatment visit at week 25 (stable dosing week 24).	0.55% 1/181 • Number of events 1 • Total of 26 weeks: from randomization through 1 week after study completion (week 25). Adverse events that occurred when patient signed informed consent form through completion of 1-week follow-up telephone contact after end-of-treatment visit at week 25 (stable dosing week 24).	0.00% 0/177 • Total of 26 weeks: from randomization through 1 week after study completion (week 25). Adverse events that occurred when patient signed informed consent form through completion of 1-week follow-up telephone contact after end-of-treatment visit at week 25 (stable dosing week 24).
Infections and infestations Urinary tract infection	0.00% 0/174 • Total of 26 weeks: from randomization through 1 week after study completion (week 25). Adverse events that occurred when patient signed informed consent form through completion of 1-week follow-up telephone contact after end-of-treatment visit at week 25 (stable dosing week 24).	0.55% 1/181 • Number of events 1 • Total of 26 weeks: from randomization through 1 week after study completion (week 25). Adverse events that occurred when patient signed informed consent form through completion of 1-week follow-up telephone contact after end-of-treatment visit at week 25 (stable dosing week 24).	0.00% 0/177 • Total of 26 weeks: from randomization through 1 week after study completion (week 25). Adverse events that occurred when patient signed informed consent form through completion of 1-week follow-up telephone contact after end-of-treatment visit at week 25 (stable dosing week 24).

Other adverse events

Other adverse events
Measure	G-ER 1200 mg n=174 participants at risk Gabapentin extended-release (G-ER) 1200 mg	G-ER 1800 mg n=181 participants at risk Gabapentin extended-release (G-ER) 1800 mg	Sugar Pill n=177 participants at risk Placebo 1200 mg or 1800 mg
Musculoskeletal and connective tissue disorders Back pain	2.3% 4/174 • Number of events 4 • Total of 26 weeks: from randomization through 1 week after study completion (week 25). Adverse events that occurred when patient signed informed consent form through completion of 1-week follow-up telephone contact after end-of-treatment visit at week 25 (stable dosing week 24).	2.8% 5/181 • Number of events 5 • Total of 26 weeks: from randomization through 1 week after study completion (week 25). Adverse events that occurred when patient signed informed consent form through completion of 1-week follow-up telephone contact after end-of-treatment visit at week 25 (stable dosing week 24).	5.1% 9/177 • Number of events 9 • Total of 26 weeks: from randomization through 1 week after study completion (week 25). Adverse events that occurred when patient signed informed consent form through completion of 1-week follow-up telephone contact after end-of-treatment visit at week 25 (stable dosing week 24).
Nervous system disorders Dizziness	23.6% 41/174 • Number of events 41 • Total of 26 weeks: from randomization through 1 week after study completion (week 25). Adverse events that occurred when patient signed informed consent form through completion of 1-week follow-up telephone contact after end-of-treatment visit at week 25 (stable dosing week 24).	19.3% 35/181 • Number of events 35 • Total of 26 weeks: from randomization through 1 week after study completion (week 25). Adverse events that occurred when patient signed informed consent form through completion of 1-week follow-up telephone contact after end-of-treatment visit at week 25 (stable dosing week 24).	2.8% 5/177 • Number of events 5 • Total of 26 weeks: from randomization through 1 week after study completion (week 25). Adverse events that occurred when patient signed informed consent form through completion of 1-week follow-up telephone contact after end-of-treatment visit at week 25 (stable dosing week 24).
General disorders Fatigue	5.2% 9/174 • Number of events 9 • Total of 26 weeks: from randomization through 1 week after study completion (week 25). Adverse events that occurred when patient signed informed consent form through completion of 1-week follow-up telephone contact after end-of-treatment visit at week 25 (stable dosing week 24).	5.0% 9/181 • Number of events 9 • Total of 26 weeks: from randomization through 1 week after study completion (week 25). Adverse events that occurred when patient signed informed consent form through completion of 1-week follow-up telephone contact after end-of-treatment visit at week 25 (stable dosing week 24).	1.7% 3/177 • Number of events 3 • Total of 26 weeks: from randomization through 1 week after study completion (week 25). Adverse events that occurred when patient signed informed consent form through completion of 1-week follow-up telephone contact after end-of-treatment visit at week 25 (stable dosing week 24).
Gastrointestinal disorders Flatulence	6.3% 11/174 • Number of events 11 • Total of 26 weeks: from randomization through 1 week after study completion (week 25). Adverse events that occurred when patient signed informed consent form through completion of 1-week follow-up telephone contact after end-of-treatment visit at week 25 (stable dosing week 24).	3.9% 7/181 • Number of events 7 • Total of 26 weeks: from randomization through 1 week after study completion (week 25). Adverse events that occurred when patient signed informed consent form through completion of 1-week follow-up telephone contact after end-of-treatment visit at week 25 (stable dosing week 24).	1.1% 2/177 • Number of events 2 • Total of 26 weeks: from randomization through 1 week after study completion (week 25). Adverse events that occurred when patient signed informed consent form through completion of 1-week follow-up telephone contact after end-of-treatment visit at week 25 (stable dosing week 24).
Nervous system disorders Headache	8.6% 15/174 • Number of events 15 • Total of 26 weeks: from randomization through 1 week after study completion (week 25). Adverse events that occurred when patient signed informed consent form through completion of 1-week follow-up telephone contact after end-of-treatment visit at week 25 (stable dosing week 24).	9.4% 17/181 • Number of events 17 • Total of 26 weeks: from randomization through 1 week after study completion (week 25). Adverse events that occurred when patient signed informed consent form through completion of 1-week follow-up telephone contact after end-of-treatment visit at week 25 (stable dosing week 24).	5.6% 10/177 • Number of events 10 • Total of 26 weeks: from randomization through 1 week after study completion (week 25). Adverse events that occurred when patient signed informed consent form through completion of 1-week follow-up telephone contact after end-of-treatment visit at week 25 (stable dosing week 24).
Infections and infestations Nasopharyngitis	8.0% 14/174 • Number of events 14 • Total of 26 weeks: from randomization through 1 week after study completion (week 25). Adverse events that occurred when patient signed informed consent form through completion of 1-week follow-up telephone contact after end-of-treatment visit at week 25 (stable dosing week 24).	6.1% 11/181 • Number of events 11 • Total of 26 weeks: from randomization through 1 week after study completion (week 25). Adverse events that occurred when patient signed informed consent form through completion of 1-week follow-up telephone contact after end-of-treatment visit at week 25 (stable dosing week 24).	4.0% 7/177 • Number of events 7 • Total of 26 weeks: from randomization through 1 week after study completion (week 25). Adverse events that occurred when patient signed informed consent form through completion of 1-week follow-up telephone contact after end-of-treatment visit at week 25 (stable dosing week 24).
Gastrointestinal disorders Nausea	6.9% 12/174 • Number of events 12 • Total of 26 weeks: from randomization through 1 week after study completion (week 25). Adverse events that occurred when patient signed informed consent form through completion of 1-week follow-up telephone contact after end-of-treatment visit at week 25 (stable dosing week 24).	8.8% 16/181 • Number of events 16 • Total of 26 weeks: from randomization through 1 week after study completion (week 25). Adverse events that occurred when patient signed informed consent form through completion of 1-week follow-up telephone contact after end-of-treatment visit at week 25 (stable dosing week 24).	4.0% 7/177 • Number of events 7 • Total of 26 weeks: from randomization through 1 week after study completion (week 25). Adverse events that occurred when patient signed informed consent form through completion of 1-week follow-up telephone contact after end-of-treatment visit at week 25 (stable dosing week 24).
Nervous system disorders Somnolence	13.2% 23/174 • Number of events 23 • Total of 26 weeks: from randomization through 1 week after study completion (week 25). Adverse events that occurred when patient signed informed consent form through completion of 1-week follow-up telephone contact after end-of-treatment visit at week 25 (stable dosing week 24).	19.3% 35/181 • Number of events 35 • Total of 26 weeks: from randomization through 1 week after study completion (week 25). Adverse events that occurred when patient signed informed consent form through completion of 1-week follow-up telephone contact after end-of-treatment visit at week 25 (stable dosing week 24).	2.3% 4/177 • Number of events 4 • Total of 26 weeks: from randomization through 1 week after study completion (week 25). Adverse events that occurred when patient signed informed consent form through completion of 1-week follow-up telephone contact after end-of-treatment visit at week 25 (stable dosing week 24).
Infections and infestations Upper respiratory tract infection	6.3% 11/174 • Number of events 11 • Total of 26 weeks: from randomization through 1 week after study completion (week 25). Adverse events that occurred when patient signed informed consent form through completion of 1-week follow-up telephone contact after end-of-treatment visit at week 25 (stable dosing week 24).	5.5% 10/181 • Number of events 10 • Total of 26 weeks: from randomization through 1 week after study completion (week 25). Adverse events that occurred when patient signed informed consent form through completion of 1-week follow-up telephone contact after end-of-treatment visit at week 25 (stable dosing week 24).	5.6% 10/177 • Number of events 10 • Total of 26 weeks: from randomization through 1 week after study completion (week 25). Adverse events that occurred when patient signed informed consent form through completion of 1-week follow-up telephone contact after end-of-treatment visit at week 25 (stable dosing week 24).
Gastrointestinal disorders Vomiting	1.7% 3/174 • Number of events 3 • Total of 26 weeks: from randomization through 1 week after study completion (week 25). Adverse events that occurred when patient signed informed consent form through completion of 1-week follow-up telephone contact after end-of-treatment visit at week 25 (stable dosing week 24).	7.2% 13/181 • Number of events 13 • Total of 26 weeks: from randomization through 1 week after study completion (week 25). Adverse events that occurred when patient signed informed consent form through completion of 1-week follow-up telephone contact after end-of-treatment visit at week 25 (stable dosing week 24).	2.3% 4/177 • Number of events 4 • Total of 26 weeks: from randomization through 1 week after study completion (week 25). Adverse events that occurred when patient signed informed consent form through completion of 1-week follow-up telephone contact after end-of-treatment visit at week 25 (stable dosing week 24).
Investigations Weight increased	2.9% 5/174 • Number of events 5 • Total of 26 weeks: from randomization through 1 week after study completion (week 25). Adverse events that occurred when patient signed informed consent form through completion of 1-week follow-up telephone contact after end-of-treatment visit at week 25 (stable dosing week 24).	5.0% 9/181 • Number of events 9 • Total of 26 weeks: from randomization through 1 week after study completion (week 25). Adverse events that occurred when patient signed informed consent form through completion of 1-week follow-up telephone contact after end-of-treatment visit at week 25 (stable dosing week 24).	2.3% 4/177 • Number of events 4 • Total of 26 weeks: from randomization through 1 week after study completion (week 25). Adverse events that occurred when patient signed informed consent form through completion of 1-week follow-up telephone contact after end-of-treatment visit at week 25 (stable dosing week 24).

Additional Information

Head of Research & Development

Depomed

Phone: 650-462-5900

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The PI agree that the sponsor shall have the right to the first publication of the results of the study which is intended to be joint, multi-center publication. Following the first publication, the PI may publish data or results from the study, provided however PI submits the proposed publication to sponsor for review at least 60 days prior to the data 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