Trial Outcomes & Findings for Trial Comparing the Effects of Xyrem (Sodium Oxybate) With Placebo for the Treatment of Fibromyalgia (NCT NCT00087555)
NCT ID: NCT00087555
Last Updated: 2012-01-24
Results Overview
The percentage of participants who met all 3 of the following criteria: Reduction of \>=20% from baseline to week 8 in both PVAS \& FIQ total score and PGI-C response of "very much better" or "much better". Analysis was based on LOCF (Last Observation Carried Forward) data. The PVAS ranges from 0 (no pain) to 100 (worst imaginable pain). The FIQ ranges from 0 (best function) to 100 (worst function). PGI-C is a 7 point likert scale measuring change in the participant's fibromyalgia symptoms that ranges from "very much worse" to "very much better"
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
195 participants
Primary outcome timeframe
Baseline to week 8
Results posted on
2012-01-24
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo taken as two equally divided nightly doses
|
Xyrem (Sodium Oxybate) 4.5g
Xyrem 4.5g taken as two equally divided nightly doses
|
Xyrem (Sodium Oxybate) 6.0g
Xyrem 6.0g taken as two equally divided nightly doses
|
|---|---|---|---|
|
Overall Study
STARTED
|
66
|
62
|
67
|
|
Overall Study
Treated
|
65
|
60
|
67
|
|
Overall Study
COMPLETED
|
54
|
51
|
46
|
|
Overall Study
NOT COMPLETED
|
12
|
11
|
21
|
Reasons for withdrawal
| Measure |
Placebo
Placebo taken as two equally divided nightly doses
|
Xyrem (Sodium Oxybate) 4.5g
Xyrem 4.5g taken as two equally divided nightly doses
|
Xyrem (Sodium Oxybate) 6.0g
Xyrem 6.0g taken as two equally divided nightly doses
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
6
|
14
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
1
|
|
Overall Study
Non - Compliance
|
1
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
2
|
|
Overall Study
Screen Failure
|
1
|
1
|
0
|
|
Overall Study
Pregnancy
|
0
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
1
|
|
Overall Study
Lack of Efficacy
|
2
|
0
|
1
|
|
Overall Study
Non Compliance
|
0
|
0
|
1
|
|
Overall Study
Chronic Migraine Headaches (Med History)
|
1
|
0
|
0
|
|
Overall Study
Patient wanted to go back on Med
|
1
|
0
|
0
|
Baseline Characteristics
Trial Comparing the Effects of Xyrem (Sodium Oxybate) With Placebo for the Treatment of Fibromyalgia
Baseline characteristics by cohort
| Measure |
Placebo
n=66 Participants
Placebo taken as two equally divided nightly doses
|
Xyrem (Sodium Oxybate) 4.5g
n=62 Participants
Xyrem 4.5g taken as two equally divided nightly doses
|
Xyrem (Sodium Oxybate) 6.0g
n=67 Participants
Xyrem 6.0g taken as two equally divided nightly doses
|
Total
n=195 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
47.2 years
STANDARD_DEVIATION 10.69 • n=5 Participants
|
47.2 years
STANDARD_DEVIATION 11.89 • n=7 Participants
|
45.1 years
STANDARD_DEVIATION 11.51 • n=5 Participants
|
46.5 years
STANDARD_DEVIATION 11.35 • n=4 Participants
|
|
Age, Customized
18 - 39 Years
|
16 participants
n=5 Participants
|
14 participants
n=7 Participants
|
23 participants
n=5 Participants
|
53 participants
n=4 Participants
|
|
Age, Customized
40 - 49 Years
|
24 participants
n=5 Participants
|
19 participants
n=7 Participants
|
17 participants
n=5 Participants
|
60 participants
n=4 Participants
|
|
Age, Customized
50 - 64 Years
|
22 participants
n=5 Participants
|
26 participants
n=7 Participants
|
25 participants
n=5 Participants
|
73 participants
n=4 Participants
|
|
Age, Customized
>=65 years
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
2 participants
n=5 Participants
|
9 participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
184 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
59 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
180 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
African American
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
66 participants
n=5 Participants
|
62 participants
n=7 Participants
|
67 participants
n=5 Participants
|
195 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to week 8The percentage of participants who met all 3 of the following criteria: Reduction of \>=20% from baseline to week 8 in both PVAS \& FIQ total score and PGI-C response of "very much better" or "much better". Analysis was based on LOCF (Last Observation Carried Forward) data. The PVAS ranges from 0 (no pain) to 100 (worst imaginable pain). The FIQ ranges from 0 (best function) to 100 (worst function). PGI-C is a 7 point likert scale measuring change in the participant's fibromyalgia symptoms that ranges from "very much worse" to "very much better"
Outcome measures
| Measure |
Placebo
n=66 Participants
Placebo taken as two equally divided nightly doses
|
Xyrem (Sodium Oxybate) 4.5g
n=62 Participants
Xyrem 4.5g taken as two equally divided nightly doses
|
Xyrem (Sodium Oxybate) 6.0g
n=67 Participants
Xyrem 6.0g taken as two equally divided nightly doses
|
|---|---|---|---|
|
The Primary Outcome Measure Was a Composite of Changes From Baseline in Three Co-primary Self Report Measures: Pain Visual Analog Scale (PVAS, Electronic Diaries), Fibromyalgia Impact Questionnaire (FIQ), and Patient Global Impression of Change (PGI-C).
Responders
|
12.9 Percentage of Participants
|
29.8 Percentage of Participants
|
28.1 Percentage of Participants
|
|
The Primary Outcome Measure Was a Composite of Changes From Baseline in Three Co-primary Self Report Measures: Pain Visual Analog Scale (PVAS, Electronic Diaries), Fibromyalgia Impact Questionnaire (FIQ), and Patient Global Impression of Change (PGI-C).
Non - Responders
|
87.1 Percentage of Participants
|
70.2 Percentage of Participants
|
71.9 Percentage of Participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 39 other events
Deaths: 0 deaths
Xyrem (Sodium Oxybate) 4.5g
Serious events: 1 serious events
Other events: 41 other events
Deaths: 0 deaths
Xyrem (Sodium Oxybate) 6.0g
Serious events: 1 serious events
Other events: 52 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=65 participants at risk
Placebo taken as two equally divided nightly doses
|
Xyrem (Sodium Oxybate) 4.5g
n=60 participants at risk
Xyrem 4.5g taken as two equally divided nightly doses
|
Xyrem (Sodium Oxybate) 6.0g
n=67 participants at risk
Xyrem 6.0g taken as two equally divided nightly doses
|
|---|---|---|---|
|
Infections and infestations
Respiratory Tract Infection
|
0.00%
0/65
|
1.7%
1/60 • Number of events 1
|
0.00%
0/67
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/65
|
1.7%
1/60 • Number of events 1
|
0.00%
0/67
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/65
|
0.00%
0/60
|
1.5%
1/67 • Number of events 1
|
|
Vascular disorders
Hypertension
|
0.00%
0/65
|
0.00%
0/60
|
1.5%
1/67 • Number of events 1
|
|
Psychiatric disorders
Bipolar Disorder
|
0.00%
0/65
|
0.00%
0/60
|
1.5%
1/67 • Number of events 1
|
Other adverse events
| Measure |
Placebo
n=65 participants at risk
Placebo taken as two equally divided nightly doses
|
Xyrem (Sodium Oxybate) 4.5g
n=60 participants at risk
Xyrem 4.5g taken as two equally divided nightly doses
|
Xyrem (Sodium Oxybate) 6.0g
n=67 participants at risk
Xyrem 6.0g taken as two equally divided nightly doses
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Joint Injury
|
0.00%
0/65
|
0.00%
0/60
|
1.5%
1/67
|
|
Gastrointestinal disorders
Nausea
|
9.2%
6/65
|
16.7%
10/60
|
28.4%
19/67
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/65
|
8.3%
5/60
|
6.0%
4/67
|
|
Gastrointestinal disorders
Diarrhoea
|
6.2%
4/65
|
6.7%
4/60
|
0.00%
0/67
|
|
Infections and infestations
Nasopharyngitis
|
4.6%
3/65
|
3.3%
2/60
|
13.4%
9/67
|
|
Infections and infestations
Sinusitis
|
3.1%
2/65
|
5.0%
3/60
|
9.0%
6/67
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
1.5%
1/65
|
8.3%
5/60
|
1.5%
1/67
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/65
|
6.7%
4/60
|
0.00%
0/67
|
|
Nervous system disorders
Headache
|
6.2%
4/65
|
13.3%
8/60
|
16.4%
11/67
|
|
Nervous system disorders
Dizziness
|
3.1%
2/65
|
8.3%
5/60
|
17.9%
12/67
|
|
Nervous system disorders
Paraesthesia
|
1.5%
1/65
|
6.7%
4/60
|
1.5%
1/67
|
|
Psychiatric disorders
Insomnia
|
1.5%
1/65
|
6.7%
4/60
|
3.0%
2/67
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/65
|
5.0%
3/60
|
1.5%
1/67
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/65
|
5.0%
3/60
|
0.00%
0/67
|
|
Renal and urinary disorders
Urinary Incontinence
|
0.00%
0/65
|
0.00%
0/60
|
6.0%
4/67
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
0.00%
0/65
|
5.0%
3/60
|
1.5%
1/67
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/65
|
1.7%
1/60
|
0.00%
0/67
|
|
Cardiac disorders
Palpitations
|
0.00%
0/65
|
1.7%
1/60
|
1.5%
1/67
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/65
|
0.00%
0/60
|
1.5%
1/67
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/65
|
1.7%
1/60
|
1.5%
1/67
|
|
Eye disorders
Eye Irritation
|
1.5%
1/65
|
1.7%
1/60
|
0.00%
0/67
|
|
Eye disorders
Mydriasis
|
0.00%
0/65
|
0.00%
0/60
|
1.5%
1/67
|
|
Eye disorders
Photophobia
|
1.5%
1/65
|
0.00%
0/60
|
0.00%
0/67
|
|
Gastrointestinal disorders
Abdominal Pain upper
|
1.5%
1/65
|
1.7%
1/60
|
0.00%
0/67
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/65
|
1.7%
1/60
|
1.5%
1/67
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/65
|
1.7%
1/60
|
1.5%
1/67
|
|
Gastrointestinal disorders
Hypoaesthesia Oral
|
0.00%
0/65
|
0.00%
0/60
|
3.0%
2/67
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
1.5%
1/65
|
0.00%
0/60
|
0.00%
0/67
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/65
|
0.00%
0/60
|
1.5%
1/67
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
1.5%
1/65
|
0.00%
0/60
|
0.00%
0/67
|
|
General disorders
Chest Pain
|
1.5%
1/65
|
1.7%
1/60
|
3.0%
2/67
|
|
General disorders
Oedema Peripheral
|
1.5%
1/65
|
1.7%
1/60
|
3.0%
2/67
|
|
General disorders
Irritability
|
0.00%
0/65
|
1.7%
1/60
|
3.0%
2/67
|
|
General disorders
Fatigue
|
1.5%
1/65
|
0.00%
0/60
|
1.5%
1/67
|
|
General disorders
Feeling Hot
|
0.00%
0/65
|
0.00%
0/60
|
3.0%
2/67
|
|
General disorders
Hangover
|
0.00%
0/65
|
0.00%
0/60
|
3.0%
2/67
|
|
General disorders
Influenza Like Illness
|
1.5%
1/65
|
0.00%
0/60
|
1.5%
1/67
|
|
General disorders
Thirst Decreased
|
0.00%
0/65
|
1.7%
1/60
|
1.5%
1/67
|
|
General disorders
Asthenia
|
0.00%
0/65
|
0.00%
0/60
|
1.5%
1/67
|
|
General disorders
Feeling Drunk
|
0.00%
0/65
|
0.00%
0/60
|
1.5%
1/67
|
|
General disorders
Feeling Jittery
|
0.00%
0/65
|
0.00%
0/60
|
1.5%
1/67
|
|
General disorders
Oedema
|
0.00%
0/65
|
1.7%
1/60
|
0.00%
0/67
|
|
General disorders
Pain
|
1.5%
1/65
|
0.00%
0/60
|
0.00%
0/67
|
|
General disorders
Swelling
|
1.5%
1/65
|
0.00%
0/60
|
0.00%
0/67
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/65
|
0.00%
0/60
|
1.5%
1/67
|
|
Infections and infestations
Influenza
|
3.1%
2/65
|
3.3%
2/60
|
3.0%
2/67
|
|
Infections and infestations
Viral Infection
|
1.5%
1/65
|
1.7%
1/60
|
3.0%
2/67
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/65
|
1.7%
1/60
|
3.0%
2/67
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
0.00%
0/65
|
1.7%
1/60
|
3.0%
2/67
|
|
Infections and infestations
Cystitis
|
1.5%
1/65
|
0.00%
0/60
|
1.5%
1/67
|
|
Infections and infestations
Gastroenteritis Viral
|
3.1%
2/65
|
0.00%
0/60
|
0.00%
0/67
|
|
Infections and infestations
Acute Sinusitis
|
1.5%
1/65
|
0.00%
0/60
|
0.00%
0/67
|
|
Infections and infestations
Bronchitis
|
0.00%
0/65
|
1.7%
1/60
|
0.00%
0/67
|
|
Infections and infestations
Ear Infection
|
0.00%
0/65
|
0.00%
0/60
|
1.5%
1/67
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/65
|
1.7%
1/60
|
0.00%
0/67
|
|
Infections and infestations
Herpes Zoster
|
0.00%
0/65
|
1.7%
1/60
|
0.00%
0/67
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
1.5%
1/65
|
0.00%
0/60
|
0.00%
0/67
|
|
Infections and infestations
Otitis Media
|
0.00%
0/65
|
0.00%
0/60
|
1.5%
1/67
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/65
|
1.7%
1/60
|
0.00%
0/67
|
|
Infections and infestations
Pharyngitis Streptococcal
|
1.5%
1/65
|
0.00%
0/60
|
0.00%
0/67
|
|
Infections and infestations
Pyelonephritis
|
1.5%
1/65
|
0.00%
0/60
|
0.00%
0/67
|
|
Infections and infestations
Respiratory Tract Infection
|
0.00%
0/65
|
1.7%
1/60
|
0.00%
0/67
|
|
Infections and infestations
Vaginal Infection
|
0.00%
0/65
|
0.00%
0/60
|
1.5%
1/67
|
|
Infections and infestations
Vulvovaginal Mycotic Infection
|
1.5%
1/65
|
0.00%
0/60
|
0.00%
0/67
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.00%
0/65
|
0.00%
0/60
|
1.5%
1/67
|
|
Investigations
Blood Calcium Increased
|
1.5%
1/65
|
0.00%
0/60
|
0.00%
0/67
|
|
Investigations
Heart Rate Increased
|
1.5%
1/65
|
0.00%
0/60
|
0.00%
0/67
|
|
Investigations
Heart Rate Irregular
|
0.00%
0/65
|
0.00%
0/60
|
1.5%
1/67
|
|
Investigations
Weight Decreased
|
0.00%
0/65
|
1.7%
1/60
|
0.00%
0/67
|
|
Investigations
Weight Increased
|
1.5%
1/65
|
0.00%
0/60
|
0.00%
0/67
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/65
|
0.00%
0/60
|
3.0%
2/67
|
|
Metabolism and nutrition disorders
Increased Appetite
|
1.5%
1/65
|
0.00%
0/60
|
1.5%
1/67
|
|
Metabolism and nutrition disorders
Diabetes Mellitus Insulin-Dependent
|
1.5%
1/65
|
0.00%
0/60
|
0.00%
0/67
|
|
Metabolism and nutrition disorders
Fluid Retention
|
0.00%
0/65
|
0.00%
0/60
|
1.5%
1/67
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/65
|
0.00%
0/60
|
1.5%
1/67
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/65
|
1.7%
1/60
|
0.00%
0/67
|
|
Metabolism and nutrition disorders
Iron Deficiency
|
0.00%
0/65
|
1.7%
1/60
|
0.00%
0/67
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.5%
1/65
|
0.00%
0/60
|
0.00%
0/67
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
1.5%
1/65
|
0.00%
0/60
|
0.00%
0/67
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.00%
0/65
|
0.00%
0/60
|
1.5%
1/67
|
|
Musculoskeletal and connective tissue disorders
Muscle Disorder
|
0.00%
0/65
|
0.00%
0/60
|
1.5%
1/67
|
|
Musculoskeletal and connective tissue disorders
Muscle Twitching
|
0.00%
0/65
|
1.7%
1/60
|
0.00%
0/67
|
|
Nervous system disorders
Somnolence
|
0.00%
0/65
|
3.3%
2/60
|
4.5%
3/67
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/65
|
0.00%
0/60
|
4.5%
3/67
|
|
Nervous system disorders
Migraine
|
0.00%
0/65
|
1.7%
1/60
|
1.5%
1/67
|
|
Nervous system disorders
Myoclonus
|
0.00%
0/65
|
0.00%
0/60
|
3.0%
2/67
|
|
Nervous system disorders
Syncope
|
1.5%
1/65
|
0.00%
0/60
|
1.5%
1/67
|
|
Nervous system disorders
Tremor
|
0.00%
0/65
|
0.00%
0/60
|
3.0%
2/67
|
|
Nervous system disorders
Akathisia
|
0.00%
0/65
|
1.7%
1/60
|
0.00%
0/67
|
|
Nervous system disorders
Balance Disorder
|
0.00%
0/65
|
0.00%
0/60
|
1.5%
1/67
|
|
Nervous system disorders
Cognitive Disorder
|
0.00%
0/65
|
0.00%
0/60
|
1.5%
1/67
|
|
Nervous system disorders
Paralysis
|
0.00%
0/65
|
0.00%
0/60
|
1.5%
1/67
|
|
Nervous system disorders
Sedation
|
1.5%
1/65
|
0.00%
0/60
|
0.00%
0/67
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/65
|
0.00%
0/60
|
1.5%
1/67
|
|
Psychiatric disorders
Depression
|
1.5%
1/65
|
3.3%
2/60
|
3.0%
2/67
|
|
Psychiatric disorders
Abnormal Dreams
|
3.1%
2/65
|
3.3%
2/60
|
0.00%
0/67
|
|
Psychiatric disorders
Agitation
|
1.5%
1/65
|
3.3%
2/60
|
0.00%
0/67
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/65
|
0.00%
0/60
|
3.0%
2/67
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/65
|
0.00%
0/60
|
3.0%
2/67
|
|
Psychiatric disorders
Affect Lability
|
1.5%
1/65
|
0.00%
0/60
|
0.00%
0/67
|
|
Psychiatric disorders
Anger
|
1.5%
1/65
|
0.00%
0/60
|
0.00%
0/67
|
|
Psychiatric disorders
Apathy
|
0.00%
0/65
|
0.00%
0/60
|
1.5%
1/67
|
|
Psychiatric disorders
Bipolar Disorder
|
0.00%
0/65
|
0.00%
0/60
|
1.5%
1/67
|
|
Psychiatric disorders
Confusional State
|
0.00%
0/65
|
1.7%
1/60
|
0.00%
0/67
|
|
Psychiatric disorders
Depressed Mood
|
0.00%
0/65
|
1.7%
1/60
|
0.00%
0/67
|
|
Psychiatric disorders
Depression Suicidal
|
0.00%
0/65
|
0.00%
0/60
|
1.5%
1/67
|
|
Psychiatric disorders
Emotional Disorder
|
0.00%
0/65
|
0.00%
0/60
|
1.5%
1/67
|
|
Psychiatric disorders
Frustration
|
0.00%
0/65
|
0.00%
0/60
|
1.5%
1/67
|
|
Psychiatric disorders
Initial Insomnia
|
0.00%
0/65
|
1.7%
1/60
|
0.00%
0/67
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/65
|
0.00%
0/60
|
1.5%
1/67
|
|
Psychiatric disorders
Panic Attack
|
0.00%
0/65
|
1.7%
1/60
|
0.00%
0/67
|
|
Psychiatric disorders
Paranoia
|
0.00%
0/65
|
1.7%
1/60
|
0.00%
0/67
|
|
Psychiatric disorders
Sleep Walking
|
0.00%
0/65
|
0.00%
0/60
|
1.5%
1/67
|
|
Psychiatric disorders
Thinking Abnormal
|
1.5%
1/65
|
0.00%
0/60
|
0.00%
0/67
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/65
|
1.7%
1/60
|
1.5%
1/67
|
|
Renal and urinary disorders
Urine Odour Abnormal
|
0.00%
0/65
|
0.00%
0/60
|
1.5%
1/67
|
|
Reproductive system and breast disorders
Erectile Dysfunction
|
0.00%
0/65
|
0.00%
0/60
|
1.5%
1/67
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/65
|
1.7%
1/60
|
0.00%
0/67
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/65
|
3.3%
2/60
|
0.00%
0/67
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.5%
1/65
|
1.7%
1/60
|
0.00%
0/67
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
3.1%
2/65
|
0.00%
0/60
|
0.00%
0/67
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/65
|
1.7%
1/60
|
0.00%
0/67
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/65
|
1.7%
1/60
|
0.00%
0/67
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Dryness
|
1.5%
1/65
|
0.00%
0/60
|
0.00%
0/67
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Congestion
|
0.00%
0/65
|
0.00%
0/60
|
1.5%
1/67
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
1.5%
1/65
|
0.00%
0/60
|
0.00%
0/67
|
|
Respiratory, thoracic and mediastinal disorders
Sleep Apnoea Syndrome
|
1.5%
1/65
|
0.00%
0/60
|
0.00%
0/67
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Congestion
|
0.00%
0/65
|
1.7%
1/60
|
0.00%
0/67
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/65
|
3.3%
2/60
|
3.0%
2/67
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.5%
1/65
|
1.7%
1/60
|
0.00%
0/67
|
|
Skin and subcutaneous tissue disorders
Pruritus Generalised
|
0.00%
0/65
|
1.7%
1/60
|
0.00%
0/67
|
|
Skin and subcutaneous tissue disorders
Skin Disorder
|
1.5%
1/65
|
0.00%
0/60
|
0.00%
0/67
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/65
|
1.7%
1/60
|
0.00%
0/67
|
|
Vascular disorders
Hypertension
|
1.5%
1/65
|
0.00%
0/60
|
3.0%
2/67
|
|
Vascular disorders
Hot Flush
|
0.00%
0/65
|
3.3%
2/60
|
0.00%
0/67
|
|
Vascular disorders
Poor Peripheral Circulation
|
1.5%
1/65
|
0.00%
0/60
|
0.00%
0/67
|
|
Vascular disorders
Raynaud's Phenomenon
|
1.5%
1/65
|
0.00%
0/60
|
0.00%
0/67
|
Additional Information
Grace Wang, MD Director of Clinical Development & Medical Monitor
Jazz Pharmaceuticals, Inc.
Phone: 650-496-3777
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER