Trial Outcomes & Findings for Xyrem(Sodium Oxybate) and Ambien(Zolpidem Tartrate) in the Treatment of Chronic Insomnia. (NCT NCT00383643)
NCT ID: NCT00383643
Last Updated: 2017-06-01
Results Overview
Clinician assessment of Clinical Global Impression-Change score at week 12 of treatment intervention. The Clinical Global Impression - Change scale is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the current time point. It is rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. One one clinician provided the ratings in this trial.
COMPLETED
PHASE2
48 participants
Baseline to week 12
2017-06-01
Participant Flow
Subjects were recruited through local newspaper ads and from the Stanford Sleep Disorders Clinic. A general description of the study was provided. Preliminary screening was conducted by telephone. Interested and qualified persons were scheduled for an in-person screening visit.
Participant milestones
| Measure |
Zolpidem Tartrate
Eligible subjects randomized to this arm received zolpidem as a gelatin capsule and a placebo liquid capsule to fully maintain the blind.
|
Placebo
Eligible subjects randomized to this arm received placebo (also known as a sugar pill) as gelatin capsule and a liquid capsule to fully maintain the blind.
|
Sodium Oxybate
Eligible subjects randomized to this arm received placebo as a gelatin capsule and a sodium oxybate capsule to fully maintain the blind.
|
|---|---|---|---|
|
Overall Study
STARTED
|
18
|
16
|
14
|
|
Overall Study
COMPLETED
|
17
|
15
|
13
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Xyrem(Sodium Oxybate) and Ambien(Zolpidem Tartrate) in the Treatment of Chronic Insomnia.
Baseline characteristics by cohort
| Measure |
Zolpidem Tartrate
n=18 Participants
Eligible subjects randomized to this arm received zolpidem as a gelatin capsule and a placebo liquid capsule to fully maintain the blind.
|
Placebo
n=16 Participants
Eligible subjects randomized to this arm received placebo (also known as a sugar pill) as gelatin capsule and a liquid capsule to fully maintain the blind.
|
Sodium Oxybate
n=14 Participants
Eligible subjects randomized to this arm received placebo as a gelatin capsule and a sodium oxybate capsule to fully maintain the blind.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
52.3 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
56.4 years
STANDARD_DEVIATION 10.4 • n=7 Participants
|
49.6 years
STANDARD_DEVIATION 16.3 • n=5 Participants
|
53.2 years
STANDARD_DEVIATION 12.3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Ethnic Minorities
|
3 participants
n=5 Participants
|
5 participants
n=7 Participants
|
3 participants
n=5 Participants
|
11 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
16 participants
n=7 Participants
|
14 participants
n=5 Participants
|
48 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to week 12Population: All analysis are intent to treat. In the case of missing data, an average value of the available data points (weeks 4 \& 8) were used to replace the missing value.
Clinician assessment of Clinical Global Impression-Change score at week 12 of treatment intervention. The Clinical Global Impression - Change scale is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the current time point. It is rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. One one clinician provided the ratings in this trial.
Outcome measures
| Measure |
Zolpidem Tartrate
n=18 Participants
Eligible subjects randomized to this arm received zolpidem as a gelatin capsule and a placebo liquid capsule to fully maintain the blind.
|
Placebo
n=16 Participants
Eligible subjects randomized to this arm received placebo (also known as a sugar pill) as gelatin capsule and a liquid capsule to fully maintain the blind.
|
Sodium Oxybate
n=14 Participants
Eligible subjects randomized to this arm received placebo as a gelatin capsule and a sodium oxybate capsule to fully maintain the blind.
|
|---|---|---|---|
|
Assessment of Clinical Global Impression-change.
|
3.0 units on a scale
Standard Deviation 1.2
|
4.2 units on a scale
Standard Deviation 1.4
|
2.7 units on a scale
Standard Deviation 0.6
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: All analysis are intent to treat. In the case of missing data, an average value of the available data points (weeks 4 \& 8) were used to replace the missing value.
Current self-report on Insomnia Severity Index at week 12 of treatment intervention. This is a seven-item questionnaire where the sum of the answers indicate the severity of insomnia. Total score categories: 0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe)
Outcome measures
| Measure |
Zolpidem Tartrate
n=18 Participants
Eligible subjects randomized to this arm received zolpidem as a gelatin capsule and a placebo liquid capsule to fully maintain the blind.
|
Placebo
n=16 Participants
Eligible subjects randomized to this arm received placebo (also known as a sugar pill) as gelatin capsule and a liquid capsule to fully maintain the blind.
|
Sodium Oxybate
n=14 Participants
Eligible subjects randomized to this arm received placebo as a gelatin capsule and a sodium oxybate capsule to fully maintain the blind.
|
|---|---|---|---|
|
Assessment of Insomnia Severity Index
|
10.5 units on a scale
Standard Deviation 3.9
|
10.8 units on a scale
Standard Deviation 6.5
|
8.4 units on a scale
Standard Deviation 4.3
|
PRIMARY outcome
Timeframe: One monthPopulation: All analysis are intent to treat. In the case of missing data, an average value of the available data points (weeks 4 \& 8) were used to replace the missing value.
Current self-report on Pittsburgh Sleep Quality Index (PSQI) at week 12 of intervention. Consisting of 19 items, the PSQI measures several different aspects of sleep which can be combined into one global score. Each item measure is scored on a scale of 0 to 3 where 3 is the extreme negative. The composite PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality. Based on this questionnaire, a composite score of 5 or greater is indicative of poor sleep quality.
Outcome measures
| Measure |
Zolpidem Tartrate
n=18 Participants
Eligible subjects randomized to this arm received zolpidem as a gelatin capsule and a placebo liquid capsule to fully maintain the blind.
|
Placebo
n=16 Participants
Eligible subjects randomized to this arm received placebo (also known as a sugar pill) as gelatin capsule and a liquid capsule to fully maintain the blind.
|
Sodium Oxybate
n=14 Participants
Eligible subjects randomized to this arm received placebo as a gelatin capsule and a sodium oxybate capsule to fully maintain the blind.
|
|---|---|---|---|
|
Assessment of Pittsburgh Sleep Quality Index (PSQI)
|
8.3 units on a scale
Standard Deviation 2.6
|
10.2 units on a scale
Standard Deviation 3.5
|
7.9 units on a scale
Standard Deviation 2.9
|
PRIMARY outcome
Timeframe: One monthPopulation: All analysis are intent to treat. In the case of missing data, an average value of the available data points (weeks 4 \& 8) were used to replace the missing value.
Current self-report on Profile of Mood State -- Fatigue (POMS-F) at week 12 of intervention. This subscale of the POMS consists of 7 items each scored on a scale of 0 (not at all) to 4 (extremely) which are summed to provide a composite score of fatigue. The range is 0 to 28 for this subscale. Higher scores indicate more fatigue.
Outcome measures
| Measure |
Zolpidem Tartrate
n=18 Participants
Eligible subjects randomized to this arm received zolpidem as a gelatin capsule and a placebo liquid capsule to fully maintain the blind.
|
Placebo
n=16 Participants
Eligible subjects randomized to this arm received placebo (also known as a sugar pill) as gelatin capsule and a liquid capsule to fully maintain the blind.
|
Sodium Oxybate
n=14 Participants
Eligible subjects randomized to this arm received placebo as a gelatin capsule and a sodium oxybate capsule to fully maintain the blind.
|
|---|---|---|---|
|
Assessment of Fatigue
|
9.7 units on a scale
Standard Deviation 5.4
|
8.0 units on a scale
Standard Deviation 7.1
|
5.1 units on a scale
Standard Deviation 4.4
|
PRIMARY outcome
Timeframe: One monthPopulation: All analysis are intent to treat. In the case of missing data, an average value of the available data points (weeks 4 \& 8) were used to replace the missing value.
Current self-report on Epworth Sleepiness Scale (ESS) at week 12 of intervention. This measure consists of 8 scenarios in which the participant is asked to assess how likely s/he is to fall asleep. Scale: 0 = would never doze; 1 = slight chance of dozing; 2 = moderate chance of dozing; 3 = high chance of dozing. Responses are summed for a total score ranging from 0 to 24. The higher the score, the greater the self-reported sleepiness. Scores of 9 and below are considered in the normal range.
Outcome measures
| Measure |
Zolpidem Tartrate
n=18 Participants
Eligible subjects randomized to this arm received zolpidem as a gelatin capsule and a placebo liquid capsule to fully maintain the blind.
|
Placebo
n=16 Participants
Eligible subjects randomized to this arm received placebo (also known as a sugar pill) as gelatin capsule and a liquid capsule to fully maintain the blind.
|
Sodium Oxybate
n=14 Participants
Eligible subjects randomized to this arm received placebo as a gelatin capsule and a sodium oxybate capsule to fully maintain the blind.
|
|---|---|---|---|
|
Assessment of Sleepiness
|
5.7 units on a scale
Standard Deviation 3.7
|
2.9 units on a scale
Standard Deviation 2.7
|
4.4 units on a scale
Standard Deviation 3.6
|
Adverse Events
Zolpidem Tartrate
Placebo
Sodium Oxybate
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Zolpidem Tartrate
n=18 participants at risk
Eligible subjects randomized to this arm received zolpidem as a gelatin capsule and a placebo liquid capsule to fully maintain the blind.
|
Placebo
n=16 participants at risk
Eligible subjects randomized to this arm received placebo (also known as a sugar pill) as gelatin capsule and a liquid capsule to fully maintain the blind.
|
Sodium Oxybate
n=15 participants at risk
Eligible subjects randomized to this arm received placebo as a gelatin capsule and a sodium oxybate capsule to fully maintain the blind.
|
|---|---|---|---|
|
General disorders
seasonal allergy
|
0.00%
0/18
|
6.2%
1/16 • Number of events 1
|
0.00%
0/15
|
|
General disorders
Chills
|
0.00%
0/18
|
0.00%
0/16
|
6.7%
1/15 • Number of events 1
|
|
General disorders
Toothache
|
0.00%
0/18
|
6.2%
1/16 • Number of events 1
|
0.00%
0/15
|
|
General disorders
Dehydration
|
5.6%
1/18 • Number of events 1
|
0.00%
0/16
|
0.00%
0/15
|
|
General disorders
Dry Mouth
|
0.00%
0/18
|
12.5%
2/16 • Number of events 2
|
0.00%
0/15
|
|
General disorders
Dry eyes
|
5.6%
1/18 • Number of events 1
|
0.00%
0/16
|
0.00%
0/15
|
|
General disorders
Thirst
|
0.00%
0/18
|
0.00%
0/16
|
6.7%
1/15 • Number of events 1
|
|
Cardiac disorders
Hypertension
|
11.1%
2/18 • Number of events 2
|
0.00%
0/16
|
0.00%
0/15
|
|
Nervous system disorders
Memory
|
11.1%
2/18 • Number of events 2
|
0.00%
0/16
|
6.7%
1/15 • Number of events 1
|
|
Nervous system disorders
Pressured speech
|
5.6%
1/18 • Number of events 1
|
0.00%
0/16
|
0.00%
0/15
|
|
Nervous system disorders
Slow/disorganized speech
|
0.00%
0/18
|
0.00%
0/16
|
6.7%
1/15 • Number of events 1
|
|
Nervous system disorders
Racing thoughts
|
0.00%
0/18
|
6.2%
1/16 • Number of events 1
|
0.00%
0/15
|
|
Nervous system disorders
Difficulty with spelling
|
5.6%
1/18 • Number of events 1
|
0.00%
0/16
|
0.00%
0/15
|
|
Nervous system disorders
Coordination/balance
|
22.2%
4/18 • Number of events 4
|
0.00%
0/16
|
13.3%
2/15 • Number of events 2
|
|
Nervous system disorders
Disorientation/confusion upon waking
|
5.6%
1/18 • Number of events 1
|
0.00%
0/16
|
0.00%
0/15
|
|
Nervous system disorders
Dizziness
|
5.6%
1/18 • Number of events 1
|
18.8%
3/16 • Number of events 3
|
66.7%
10/15 • Number of events 10
|
|
Nervous system disorders
Lightheadedness
|
0.00%
0/18
|
0.00%
0/16
|
13.3%
2/15 • Number of events 2
|
|
Nervous system disorders
Drugged/intoxication feeling
|
11.1%
2/18 • Number of events 2
|
0.00%
0/16
|
26.7%
4/15 • Number of events 4
|
|
Nervous system disorders
Groggy/hangover
|
16.7%
3/18 • Number of events 3
|
0.00%
0/16
|
6.7%
1/15 • Number of events 1
|
|
Nervous system disorders
Residual/daytime drowsiness
|
50.0%
9/18 • Number of events 9
|
12.5%
2/16 • Number of events 2
|
6.7%
1/15 • Number of events 1
|
|
Nervous system disorders
Headache
|
38.9%
7/18 • Number of events 7
|
12.5%
2/16 • Number of events 2
|
26.7%
4/15 • Number of events 4
|
|
Nervous system disorders
Neuralgia
|
5.6%
1/18 • Number of events 1
|
0.00%
0/16
|
0.00%
0/15
|
|
Nervous system disorders
Tinglingness
|
0.00%
0/18
|
6.2%
1/16 • Number of events 1
|
0.00%
0/15
|
|
Nervous system disorders
Tremor
|
0.00%
0/18
|
0.00%
0/16
|
6.7%
1/15 • Number of events 1
|
|
Gastrointestinal disorders
Cramp
|
0.00%
0/18
|
0.00%
0/16
|
13.3%
2/15 • Number of events 2
|
|
Gastrointestinal disorders
Pain
|
5.6%
1/18 • Number of events 1
|
12.5%
2/16 • Number of events 2
|
0.00%
0/15
|
|
Gastrointestinal disorders
Constipation
|
11.1%
2/18 • Number of events 2
|
0.00%
0/16
|
0.00%
0/15
|
|
Gastrointestinal disorders
Diarrhea
|
11.1%
2/18 • Number of events 2
|
0.00%
0/16
|
6.7%
1/15 • Number of events 1
|
|
Gastrointestinal disorders
Loose stools
|
0.00%
0/18
|
12.5%
2/16 • Number of events 2
|
0.00%
0/15
|
|
Gastrointestinal disorders
Gagging
|
5.6%
1/18 • Number of events 1
|
0.00%
0/16
|
0.00%
0/15
|
|
Gastrointestinal disorders
Nausea
|
11.1%
2/18 • Number of events 2
|
12.5%
2/16 • Number of events 2
|
60.0%
9/15 • Number of events 9
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
2/18 • Number of events 2
|
0.00%
0/16
|
26.7%
4/15 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Aches & pains
|
33.3%
6/18 • Number of events 6
|
6.2%
1/16 • Number of events 1
|
6.7%
1/15 • Number of events 1
|
|
Renal and urinary disorders
Nocturnia
|
0.00%
0/18
|
0.00%
0/16
|
20.0%
3/15 • Number of events 3
|
|
Infections and infestations
Cold
|
22.2%
4/18 • Number of events 4
|
25.0%
4/16 • Number of events 4
|
6.7%
1/15 • Number of events 1
|
|
Infections and infestations
Influenza-like symptom
|
11.1%
2/18 • Number of events 2
|
12.5%
2/16 • Number of events 2
|
0.00%
0/15
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/18
|
18.8%
3/16 • Number of events 3
|
0.00%
0/15
|
|
Infections and infestations
Urinary Tract Infection
|
5.6%
1/18 • Number of events 1
|
0.00%
0/16
|
0.00%
0/15
|
|
Infections and infestations
Laryngitis
|
5.6%
1/18 • Number of events 1
|
0.00%
0/16
|
0.00%
0/15
|
|
Infections and infestations
Gum inflammation
|
0.00%
0/18
|
0.00%
0/16
|
6.7%
1/15 • Number of events 1
|
|
Metabolism and nutrition disorders
Appetite loss
|
0.00%
0/18
|
6.2%
1/16 • Number of events 1
|
13.3%
2/15 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Cramps
|
0.00%
0/18
|
0.00%
0/16
|
13.3%
2/15 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Twitch
|
5.6%
1/18 • Number of events 1
|
0.00%
0/16
|
0.00%
0/15
|
|
Musculoskeletal and connective tissue disorders
Stiffness
|
0.00%
0/18
|
6.2%
1/16 • Number of events 1
|
6.7%
1/15 • Number of events 1
|
|
Nervous system disorders
Peripheral neuropathy
|
5.6%
1/18 • Number of events 1
|
6.2%
1/16 • Number of events 1
|
0.00%
0/15
|
|
Psychiatric disorders
Anxiety
|
5.6%
1/18 • Number of events 1
|
0.00%
0/16
|
6.7%
1/15 • Number of events 1
|
|
Psychiatric disorders
Depressed mood
|
5.6%
1/18 • Number of events 1
|
0.00%
0/16
|
6.7%
1/15 • Number of events 1
|
|
Psychiatric disorders
Irritability
|
5.6%
1/18 • Number of events 1
|
0.00%
0/16
|
0.00%
0/15
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.6%
1/18 • Number of events 1
|
0.00%
0/16
|
0.00%
0/15
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.6%
1/18 • Number of events 1
|
0.00%
0/16
|
0.00%
0/15
|
|
General disorders
Sleep apnea
|
0.00%
0/18
|
0.00%
0/16
|
6.7%
1/15 • Number of events 1
|
|
General disorders
Nightmares
|
5.6%
1/18 • Number of events 1
|
0.00%
0/16
|
6.7%
1/15 • Number of events 1
|
|
General disorders
Periodic limb movements
|
5.6%
1/18 • Number of events 1
|
0.00%
0/16
|
0.00%
0/15
|
|
General disorders
Insomnia
|
0.00%
0/18
|
0.00%
0/16
|
6.7%
1/15 • Number of events 1
|
|
General disorders
Sleep paralysis
|
0.00%
0/18
|
0.00%
0/16
|
6.7%
1/15 • Number of events 1
|
|
General disorders
Confusional arousal
|
0.00%
0/18
|
0.00%
0/16
|
6.7%
1/15 • Number of events 1
|
|
General disorders
Snoring
|
0.00%
0/18
|
0.00%
0/16
|
13.3%
2/15 • Number of events 2
|
|
General disorders
Eating during sleep
|
0.00%
0/18
|
0.00%
0/16
|
6.7%
1/15 • Number of events 1
|
|
General disorders
Enuresis
|
0.00%
0/18
|
0.00%
0/16
|
6.7%
1/15 • Number of events 1
|
|
Renal and urinary disorders
Kidney stone
|
0.00%
0/18
|
6.2%
1/16 • Number of events 1
|
0.00%
0/15
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/18
|
6.2%
1/16 • Number of events 1
|
0.00%
0/15
|
|
Reproductive system and breast disorders
Hot flashes
|
5.6%
1/18 • Number of events 1
|
0.00%
0/16
|
0.00%
0/15
|
|
General disorders
Bitter aftertaste
|
0.00%
0/18
|
6.2%
1/16 • Number of events 1
|
0.00%
0/15
|
|
Injury, poisoning and procedural complications
Sprained ankle
|
0.00%
0/18
|
0.00%
0/16
|
6.7%
1/15 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/18
|
6.2%
1/16 • Number of events 1
|
0.00%
0/15
|
Additional Information
Dr. Jed Black
Stanford University School of Medicine, Dept of Psychiatry
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place