Trial Outcomes & Findings for Safety and Tolerability Study Comparing Sodium Oxybate Given as an Oral Solution to a Single-blinded Combination of Oral Tablets Plus Oral Solution in Subjects With Fibromyalgia (NCT NCT00803023)
NCT ID: NCT00803023
Last Updated: 2011-08-19
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
129 participants
Primary outcome timeframe
4 weeks
Results posted on
2011-08-19
Participant Flow
Participant milestones
| Measure |
4.5g SXB
Sodium Oxybate Oral Solution (4.5 grams/night)
|
4.5g SXB + 6 Tablets
Sodium Oxybate Oral Solution (4.5 grams/night)and 6 Placebo Tablets per night
|
6g SXB
Sodium Oxybate Oral Solution (6 grams/night)
|
6g SXB + 8 Tablets
Sodium Oxybate Oral Solution (6 grams/night) and 8 Placebo Tablets per night
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
32
|
33
|
31
|
33
|
|
Overall Study
COMPLETED
|
27
|
25
|
20
|
25
|
|
Overall Study
NOT COMPLETED
|
5
|
8
|
11
|
8
|
Reasons for withdrawal
| Measure |
4.5g SXB
Sodium Oxybate Oral Solution (4.5 grams/night)
|
4.5g SXB + 6 Tablets
Sodium Oxybate Oral Solution (4.5 grams/night)and 6 Placebo Tablets per night
|
6g SXB
Sodium Oxybate Oral Solution (6 grams/night)
|
6g SXB + 8 Tablets
Sodium Oxybate Oral Solution (6 grams/night) and 8 Placebo Tablets per night
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
5
|
4
|
8
|
6
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
2
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
1
|
1
|
Baseline Characteristics
Safety and Tolerability Study Comparing Sodium Oxybate Given as an Oral Solution to a Single-blinded Combination of Oral Tablets Plus Oral Solution in Subjects With Fibromyalgia
Baseline characteristics by cohort
| Measure |
4.5g SXB
n=32 Participants
Sodium Oxybate Oral Solution (4.5 grams/night)
|
4.5g SXB + 6 Tablets
n=33 Participants
Sodium Oxybate Oral Solution (4.5 grams/night)and 6 Placebo Tablets per night
|
6g SXB
n=31 Participants
Sodium Oxybate Oral Solution (6 grams/night)
|
6g SXB + 8 Tablets
n=33 Participants
Sodium Oxybate Oral Solution (6 grams/night) and 8 Placebo Tablets per night
|
Total
n=129 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Continuous
|
48.3 years
STANDARD_DEVIATION 12.31 • n=5 Participants
|
49.6 years
STANDARD_DEVIATION 11.69 • n=7 Participants
|
49.3 years
STANDARD_DEVIATION 12.76 • n=5 Participants
|
50.7 years
STANDARD_DEVIATION 12.24 • n=4 Participants
|
49.5 years
STANDARD_DEVIATION 12.13 • n=21 Participants
|
|
Age, Customized
18 - 39
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
|
Age, Customized
40 - 49
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
|
Age, Customized
50 - 64
|
15 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
62 Participants
n=21 Participants
|
|
Age, Customized
>=65
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
119 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
109 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
118 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=5 Participants
|
33 participants
n=7 Participants
|
31 participants
n=5 Participants
|
33 participants
n=4 Participants
|
129 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 4 weeksOutcome measures
| Measure |
4.5g SXB
n=32 Participants
Sodium Oxybate Oral Solution (4.5 grams/night)
|
4.5g SXB + 6 Tablets
n=33 Participants
Sodium Oxybate Oral Solution (4.5 grams/night)and 6 Placebo Tablets per night
|
6g SXB
n=31 Participants
Sodium Oxybate Oral Solution (6 grams/night)
|
6g SXB + 8 Tablets
n=33 Participants
Sodium Oxybate Oral Solution (6 grams/night) and 8 Placebo Tablets per night
|
|---|---|---|---|---|
|
Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects
Any Adverse Event
|
20 participants
|
21 participants
|
21 participants
|
23 participants
|
|
Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects
Gastrointestinal Disorders
|
7 participants
|
6 participants
|
5 participants
|
11 participants
|
|
Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects
Diarrhea
|
0 participants
|
0 participants
|
1 participants
|
2 participants
|
|
Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects
Nausea
|
4 participants
|
3 participants
|
2 participants
|
7 participants
|
|
Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects
Vomiting
|
0 participants
|
1 participants
|
1 participants
|
2 participants
|
|
Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects
General Disorders & Administration Site Conditions
|
2 participants
|
4 participants
|
5 participants
|
6 participants
|
|
Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects
Fatigue
|
1 participants
|
0 participants
|
0 participants
|
3 participants
|
|
Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects
Edema Peripheral
|
1 participants
|
2 participants
|
1 participants
|
1 participants
|
|
Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects
Infections & Infestation
|
3 participants
|
5 participants
|
2 participants
|
3 participants
|
|
Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects
Sinusitis
|
0 participants
|
1 participants
|
1 participants
|
2 participants
|
|
Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects
Urinary Tract Infection
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
|
Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects
Injury, Posioning, & Procedural Complications
|
4 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects
Investigations
|
0 participants
|
3 participants
|
3 participants
|
1 participants
|
|
Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects
Metabolism & Nutrition Disorders
|
0 participants
|
0 participants
|
3 participants
|
1 participants
|
|
Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects
Musculoskeletal & Connective tissue Disorders
|
2 participants
|
3 participants
|
3 participants
|
3 participants
|
|
Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects
Back Pain
|
1 participants
|
0 participants
|
2 participants
|
2 participants
|
|
Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects
Nervous System Disorders
|
8 participants
|
5 participants
|
9 participants
|
10 participants
|
|
Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects
Dizziness
|
3 participants
|
1 participants
|
4 participants
|
2 participants
|
|
Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects
Headache
|
2 participants
|
3 participants
|
2 participants
|
3 participants
|
|
Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects
Somnolence
|
0 participants
|
0 participants
|
1 participants
|
2 participants
|
|
Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects
Tremor
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
|
Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects
Psychiatric Disorders
|
4 participants
|
5 participants
|
5 participants
|
11 participants
|
|
Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects
Anxiety
|
1 participants
|
1 participants
|
0 participants
|
2 participants
|
|
Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects
Insomnia
|
2 participants
|
3 participants
|
0 participants
|
3 participants
|
|
Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects
Major Depression
|
1 participants
|
0 participants
|
2 participants
|
0 participants
|
|
Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects
Renal & Urinary Disorders
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
|
Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects
Respiratory, Thoracic, & Mediastinal Disorders
|
2 participants
|
2 participants
|
2 participants
|
5 participants
|
|
Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects
Pharyngolaryngeal Pain
|
0 participants
|
1 participants
|
0 participants
|
2 participants
|
|
Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects
Sinus Congestion
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
|
Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects
Skin & Subcutaneous Tissue Disorders
|
1 participants
|
1 participants
|
3 participants
|
3 participants
|
SECONDARY outcome
Timeframe: 4 weeksOutcome measures
Outcome data not reported
Adverse Events
4.5g SXB
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
4.5g SXB + 6 Tablets
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
6g SXB
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
6g SXB + 8 Tablets
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
4.5g SXB
n=32 participants at risk
Sodium Oxybate Oral Solution (4.5 grams/night)
|
4.5g SXB + 6 Tablets
n=33 participants at risk
Sodium Oxybate Oral Solution (4.5 grams/night)and 6 Placebo Tablets per night
|
6g SXB
n=31 participants at risk
Sodium Oxybate Oral Solution (6 grams/night)
|
6g SXB + 8 Tablets
n=33 participants at risk
Sodium Oxybate Oral Solution (6 grams/night) and 8 Placebo Tablets per night
|
|---|---|---|---|---|
|
Infections and infestations
Diverticulitis
|
3.1%
1/32 • Number of events 1
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/33
|
|
Psychiatric disorders
Suicidal Behavior
|
0.00%
0/32
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/33
|
|
Psychiatric disorders
Major Depression
|
0.00%
0/32
|
0.00%
0/33
|
3.2%
1/31 • Number of events 1
|
0.00%
0/33
|
Other adverse events
| Measure |
4.5g SXB
n=32 participants at risk
Sodium Oxybate Oral Solution (4.5 grams/night)
|
4.5g SXB + 6 Tablets
n=33 participants at risk
Sodium Oxybate Oral Solution (4.5 grams/night)and 6 Placebo Tablets per night
|
6g SXB
n=31 participants at risk
Sodium Oxybate Oral Solution (6 grams/night)
|
6g SXB + 8 Tablets
n=33 participants at risk
Sodium Oxybate Oral Solution (6 grams/night) and 8 Placebo Tablets per night
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/32
|
0.00%
0/33
|
3.2%
1/31
|
6.1%
2/33
|
|
Gastrointestinal disorders
Nausea
|
12.5%
4/32
|
9.1%
3/33
|
6.5%
2/31
|
21.2%
7/33
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/32
|
3.0%
1/33
|
3.2%
1/31
|
6.1%
2/33
|
|
General disorders
Fatigue
|
3.1%
1/32
|
0.00%
0/33
|
0.00%
0/31
|
9.1%
3/33
|
|
General disorders
Edema Peripheral
|
3.1%
1/32
|
6.1%
2/33
|
3.2%
1/31
|
3.0%
1/33
|
|
Infections and infestations
Sinusitus
|
0.00%
0/32
|
3.0%
1/33
|
3.2%
1/31
|
6.1%
2/33
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/32
|
6.1%
2/33
|
0.00%
0/31
|
0.00%
0/33
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
3.1%
1/32
|
0.00%
0/33
|
6.5%
2/31
|
6.1%
2/33
|
|
Nervous system disorders
Dizziness
|
9.4%
3/32
|
3.0%
1/33
|
12.9%
4/31
|
6.1%
2/33
|
|
Nervous system disorders
Headache
|
6.2%
2/32
|
9.1%
3/33
|
6.5%
2/31
|
9.1%
3/33
|
|
Nervous system disorders
Somnolence
|
0.00%
0/32
|
0.00%
0/33
|
3.2%
1/31
|
6.1%
2/33
|
|
Nervous system disorders
Tremor
|
0.00%
0/32
|
0.00%
0/33
|
0.00%
0/31
|
6.1%
2/33
|
|
Psychiatric disorders
Anxiety
|
3.1%
1/32
|
3.0%
1/33
|
0.00%
0/31
|
6.1%
2/33
|
|
Psychiatric disorders
Insomnia
|
6.2%
2/32
|
9.1%
3/33
|
0.00%
0/31
|
9.1%
3/33
|
|
Psychiatric disorders
Major Depression
|
3.1%
1/32
|
0.00%
0/33
|
6.5%
2/31
|
0.00%
0/33
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
0.00%
0/32
|
3.0%
1/33
|
0.00%
0/31
|
6.1%
2/33
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
0.00%
0/32
|
0.00%
0/33
|
0.00%
0/31
|
6.1%
2/33
|
Additional Information
Director of Clinical Development
Jazz Pharmaceuticals
Phone: 650-496-3777
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place