Fibromyalgia
Conditions
Brief summary
To compare the safety and tolerability of sodium oxybate given as a combination of an oral solution and oral tablets for 4 weeks in subjects with fibromyalgia (FM).
Interventions
DRUGSodium Oxybate Oral Solution (6 grams)
6 grams per night taken in two equally divided doses
DRUGSodium Oxybate
4.5 grams per night taken in two equally divided doses
DRUGSodium Oxybate & 6 Tablets
4.5 grams taken as a combination of liquid and 6 Placebo tablets in two equally divided doses per night
DRUGSodium Oxybate & 8 Tablets
6 grams taken as a combination of liquid and 8 Placebo tablets in two equally divided doses per night
Sponsors
Jazz Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is able to understand the written informed consent * Subject is 18 years of age or older. * Subject meets the ACR criteria for fibromyalgia * Subject is willing to discontinue prohibited by the protocol * Subject agrees to use only non-sedating over-the-counter (OTC)medication * Subject is willing to abstain from the ingestion of alcohol for the duration of the trial.
Exclusion criteria
* Subject has protocol prohibited medical & psychiatric conditions that would exclude subject * Subject has a current or past history of a substance use disorder including alcohol abuse * Subject has a clinically significant history of seizure disorder either past or present * Female subject who is pregnant, nursing or lactating. * Subject is diagnosed with sleep apnea * Subject is unable to discontinue protocol prohibited medications * Subject is experiencing fatigue and/or drowsiness/sedation in association with intake of allowed medications. * Subject has taken any investigational drug within 5 half-lives of the investigational drug prior to signing the informed consent form. * Subject has an allergic reaction to GHB or sodium oxybate or any of its constituents (e.g. malic acid). * Subject is on a sodium-restricted diet. * Subject has abnormal liver function test or other abnormal lab values * Subject has an occupation that requires variable shift work or routine night shifts or cannot routinely spend at least 6 hours per night in bed. * Subject has any other problems that, in the investigator's opinion, would preclude the subject's participation and completion of this trial or compromise reliable representation of subjective symptoms. * Subject has been randomized into a previous Xyrem (sodium oxybate) clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Tolerability Assessed by Adverse Events | 4 weeks |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 4.5g SXB Sodium Oxybate Oral Solution (4.5 grams/night) | 32 |
| 4.5g SXB + 6 Tablets Sodium Oxybate Oral Solution (4.5 grams/night)and 6 Placebo Tablets per night | 33 |
| 6g SXB Sodium Oxybate Oral Solution (6 grams/night) | 31 |
| 6g SXB + 8 Tablets Sodium Oxybate Oral Solution (6 grams/night) and 8 Placebo Tablets per night | 33 |
| Total | 129 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 5 | 4 | 8 | 6 |
| Overall Study | Lack of Efficacy | 0 | 1 | 1 | 1 |
| Overall Study | Lost to Follow-up | 0 | 1 | 2 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 2 | 0 | 0 |
Baseline characteristics
| Characteristic | 4.5g SXB + 6 Tablets | 6g SXB | 4.5g SXB | 6g SXB + 8 Tablets | Total |
|---|---|---|---|---|---|
| Age Continuous | 49.6 years STANDARD_DEVIATION 11.69 | 49.3 years STANDARD_DEVIATION 12.76 | 48.3 years STANDARD_DEVIATION 12.31 | 50.7 years STANDARD_DEVIATION 12.24 | 49.5 years STANDARD_DEVIATION 12.13 |
| Age, Customized 18 - 39 | 7 Participants | 7 Participants | 9 Participants | 5 Participants | 28 Participants |
| Age, Customized 40 - 49 | 6 Participants | 8 Participants | 6 Participants | 8 Participants | 28 Participants |
| Age, Customized 50 - 64 | 18 Participants | 12 Participants | 15 Participants | 17 Participants | 62 Participants |
| Age, Customized >=65 | 2 Participants | 4 Participants | 2 Participants | 3 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 3 Participants | 5 Participants | 7 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 28 Participants | 28 Participants | 27 Participants | 26 Participants | 109 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 1 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 31 Participants | 28 Participants | 29 Participants | 30 Participants | 118 Participants |
| Region of Enrollment United States | 33 participants | 31 participants | 32 participants | 33 participants | 129 participants |
| Sex: Female, Male Female | 29 Participants | 27 Participants | 31 Participants | 32 Participants | 119 Participants |
| Sex: Female, Male Male | 4 Participants | 4 Participants | 1 Participants | 1 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 12 / 32 | 13 / 33 | 11 / 31 | 17 / 33 |
| serious Total, serious adverse events | 1 / 32 | 0 / 33 | 1 / 31 | 0 / 33 |
Outcome results
Primary
Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects
Time frame: 4 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 4.5g SXB | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Anxiety | 1 participants |
| 4.5g SXB | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Back Pain | 1 participants |
| 4.5g SXB | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Nervous System Disorders | 8 participants |
| 4.5g SXB | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Vomiting | 0 participants |
| 4.5g SXB | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Psychiatric Disorders | 4 participants |
| 4.5g SXB | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Dizziness | 3 participants |
| 4.5g SXB | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Headache | 2 participants |
| 4.5g SXB | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Sinus Congestion | 0 participants |
| 4.5g SXB | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Tremor | 0 participants |
| 4.5g SXB | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Somnolence | 0 participants |
| 4.5g SXB | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Gastrointestinal Disorders | 7 participants |
| 4.5g SXB | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Pharyngolaryngeal Pain | 0 participants |
| 4.5g SXB | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | General Disorders & Administration Site Conditions | 2 participants |
| 4.5g SXB | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Fatigue | 1 participants |
| 4.5g SXB | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Respiratory, Thoracic, & Mediastinal Disorders | 2 participants |
| 4.5g SXB | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Edema Peripheral | 1 participants |
| 4.5g SXB | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Skin & Subcutaneous Tissue Disorders | 1 participants |
| 4.5g SXB | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Infections & Infestation | 3 participants |
| 4.5g SXB | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Diarrhea | 0 participants |
| 4.5g SXB | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Renal & Urinary Disorders | 0 participants |
| 4.5g SXB | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Sinusitis | 0 participants |
| 4.5g SXB | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Urinary Tract Infection | 0 participants |
| 4.5g SXB | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Any Adverse Event | 20 participants |
| 4.5g SXB | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Major Depression | 1 participants |
| 4.5g SXB | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Injury, Posioning, & Procedural Complications | 4 participants |
| 4.5g SXB | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Investigations | 0 participants |
| 4.5g SXB | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Nausea | 4 participants |
| 4.5g SXB | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Insomnia | 2 participants |
| 4.5g SXB | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Metabolism & Nutrition Disorders | 0 participants |
| 4.5g SXB | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Musculoskeletal & Connective tissue Disorders | 2 participants |
| 4.5g SXB + 6 Tablets | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Edema Peripheral | 2 participants |
| 4.5g SXB + 6 Tablets | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Injury, Posioning, & Procedural Complications | 0 participants |
| 4.5g SXB + 6 Tablets | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Back Pain | 0 participants |
| 4.5g SXB + 6 Tablets | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Pharyngolaryngeal Pain | 1 participants |
| 4.5g SXB + 6 Tablets | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Psychiatric Disorders | 5 participants |
| 4.5g SXB + 6 Tablets | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Renal & Urinary Disorders | 2 participants |
| 4.5g SXB + 6 Tablets | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Nervous System Disorders | 5 participants |
| 4.5g SXB + 6 Tablets | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Sinus Congestion | 0 participants |
| 4.5g SXB + 6 Tablets | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Infections & Infestation | 5 participants |
| 4.5g SXB + 6 Tablets | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Insomnia | 3 participants |
| 4.5g SXB + 6 Tablets | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Dizziness | 1 participants |
| 4.5g SXB + 6 Tablets | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Vomiting | 1 participants |
| 4.5g SXB + 6 Tablets | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Tremor | 0 participants |
| 4.5g SXB + 6 Tablets | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Nausea | 3 participants |
| 4.5g SXB + 6 Tablets | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Headache | 3 participants |
| 4.5g SXB + 6 Tablets | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Investigations | 3 participants |
| 4.5g SXB + 6 Tablets | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Sinusitis | 1 participants |
| 4.5g SXB + 6 Tablets | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Diarrhea | 0 participants |
| 4.5g SXB + 6 Tablets | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Somnolence | 0 participants |
| 4.5g SXB + 6 Tablets | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Major Depression | 0 participants |
| 4.5g SXB + 6 Tablets | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Anxiety | 1 participants |
| 4.5g SXB + 6 Tablets | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Urinary Tract Infection | 2 participants |
| 4.5g SXB + 6 Tablets | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | General Disorders & Administration Site Conditions | 4 participants |
| 4.5g SXB + 6 Tablets | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Gastrointestinal Disorders | 6 participants |
| 4.5g SXB + 6 Tablets | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Respiratory, Thoracic, & Mediastinal Disorders | 2 participants |
| 4.5g SXB + 6 Tablets | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Skin & Subcutaneous Tissue Disorders | 1 participants |
| 4.5g SXB + 6 Tablets | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Fatigue | 0 participants |
| 4.5g SXB + 6 Tablets | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Any Adverse Event | 21 participants |
| 4.5g SXB + 6 Tablets | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Musculoskeletal & Connective tissue Disorders | 3 participants |
| 4.5g SXB + 6 Tablets | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Metabolism & Nutrition Disorders | 0 participants |
| 6g SXB | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Headache | 2 participants |
| 6g SXB | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Any Adverse Event | 21 participants |
| 6g SXB | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Gastrointestinal Disorders | 5 participants |
| 6g SXB | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Diarrhea | 1 participants |
| 6g SXB | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Nausea | 2 participants |
| 6g SXB | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Vomiting | 1 participants |
| 6g SXB | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | General Disorders & Administration Site Conditions | 5 participants |
| 6g SXB | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Fatigue | 0 participants |
| 6g SXB | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Edema Peripheral | 1 participants |
| 6g SXB | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Infections & Infestation | 2 participants |
| 6g SXB | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Sinusitis | 1 participants |
| 6g SXB | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Urinary Tract Infection | 0 participants |
| 6g SXB | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Injury, Posioning, & Procedural Complications | 0 participants |
| 6g SXB | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Investigations | 3 participants |
| 6g SXB | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Metabolism & Nutrition Disorders | 3 participants |
| 6g SXB | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Musculoskeletal & Connective tissue Disorders | 3 participants |
| 6g SXB | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Back Pain | 2 participants |
| 6g SXB | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Nervous System Disorders | 9 participants |
| 6g SXB | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Dizziness | 4 participants |
| 6g SXB | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Somnolence | 1 participants |
| 6g SXB | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Tremor | 0 participants |
| 6g SXB | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Psychiatric Disorders | 5 participants |
| 6g SXB | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Anxiety | 0 participants |
| 6g SXB | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Insomnia | 0 participants |
| 6g SXB | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Major Depression | 2 participants |
| 6g SXB | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Renal & Urinary Disorders | 0 participants |
| 6g SXB | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Respiratory, Thoracic, & Mediastinal Disorders | 2 participants |
| 6g SXB | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Pharyngolaryngeal Pain | 0 participants |
| 6g SXB | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Sinus Congestion | 0 participants |
| 6g SXB | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Skin & Subcutaneous Tissue Disorders | 3 participants |
| 6g SXB + 8 Tablets | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Metabolism & Nutrition Disorders | 1 participants |
| 6g SXB + 8 Tablets | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Pharyngolaryngeal Pain | 2 participants |
| 6g SXB + 8 Tablets | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Anxiety | 2 participants |
| 6g SXB + 8 Tablets | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Investigations | 1 participants |
| 6g SXB + 8 Tablets | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Injury, Posioning, & Procedural Complications | 0 participants |
| 6g SXB + 8 Tablets | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Diarrhea | 2 participants |
| 6g SXB + 8 Tablets | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Insomnia | 3 participants |
| 6g SXB + 8 Tablets | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Urinary Tract Infection | 0 participants |
| 6g SXB + 8 Tablets | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Sinusitis | 2 participants |
| 6g SXB + 8 Tablets | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Skin & Subcutaneous Tissue Disorders | 3 participants |
| 6g SXB + 8 Tablets | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Major Depression | 0 participants |
| 6g SXB + 8 Tablets | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Infections & Infestation | 3 participants |
| 6g SXB + 8 Tablets | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Edema Peripheral | 1 participants |
| 6g SXB + 8 Tablets | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Sinus Congestion | 2 participants |
| 6g SXB + 8 Tablets | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Renal & Urinary Disorders | 0 participants |
| 6g SXB + 8 Tablets | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Fatigue | 3 participants |
| 6g SXB + 8 Tablets | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | General Disorders & Administration Site Conditions | 6 participants |
| 6g SXB + 8 Tablets | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Gastrointestinal Disorders | 11 participants |
| 6g SXB + 8 Tablets | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Respiratory, Thoracic, & Mediastinal Disorders | 5 participants |
| 6g SXB + 8 Tablets | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Vomiting | 2 participants |
| 6g SXB + 8 Tablets | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Somnolence | 2 participants |
| 6g SXB + 8 Tablets | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Headache | 3 participants |
| 6g SXB + 8 Tablets | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Dizziness | 2 participants |
| 6g SXB + 8 Tablets | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Nausea | 7 participants |
| 6g SXB + 8 Tablets | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Tremor | 2 participants |
| 6g SXB + 8 Tablets | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Nervous System Disorders | 10 participants |
| 6g SXB + 8 Tablets | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Back Pain | 2 participants |
| 6g SXB + 8 Tablets | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Any Adverse Event | 23 participants |
| 6g SXB + 8 Tablets | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Psychiatric Disorders | 11 participants |
| 6g SXB + 8 Tablets | Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects | Musculoskeletal & Connective tissue Disorders | 3 participants |
Secondary
Tolerability Assessed by Adverse Events
Time frame: 4 weeks